Hot on the heels of CUTISS’ $60M Series C round, we catch up once more with CEO and co-founder Daniela Marino.
We chat about the company’s mission to develop an engineered tissue therapy to reduce the need for skin grafts in patients with severe burns. She also explains the decentralization of tissue manufacturing with automation and the need for perseverance as a founder and CEO.
This episode is sponsored by CUTISS, the only TechBio company in the advanced clinical stage of developing skin tissue therapies. Learn how you can support CUTISS on its path to Series C success: https://bit.ly/flotbio-cutiss
⭐️ ABOUT THE SPEAKER
In 2023, Daniela Marino was named as one of the 30 Rising Leaders in the healthcare industry, thanks to the impact of CUTISS, the company she co-founded as a spin-off from the University of Zurich. Here, she and her team have made waves for people suffering from severe skin injuries and defects through regenerative medicine, tissue engineering, and skin pigmentation.
🔗 LINKS MENTIONED
- CUTISS’ website – https://cutiss.swiss/
- CUTISS’ Series C round – https://cutiss.swiss/cutiss-closes-chf-56m-series-c-round-and-signs-agreement-with-leading-european-burn-center/
- CUTISS’ Phase II trial data – https://cutiss.swiss/phase-2-clinical-trials-update-from-cutiss/
- Daniela Marino, CUTISS 🇨🇭 | Skin Tissue Therapeutics, TechBio | E33 – https://flot.bio/episode/daniela-marino-cutiss-skin-tissue-therapeutics/
Transcript
[00:00:00] Intro
Philip Hemme: You close the series C, exactly what you were aiming for. So $60 million in
Daniela Marino: this environment, it’s pretty remarkable. But it really is a testimony to the fact that when there is a good product with a good science and a clear arm need, it is possible to find the right investors. Our model is not to have everything produced in one place and having gigantic logistics to manage, but rather taking our machines into a decentralized manufacturing model where you can be as close as you can to the largest hospitals and try to serve the patients in a quicker and cheaper way.
I will never forget one of my investors, say seven years ago, I am not gonna look at your financial projections because we all know that you have no clue what the financial projections in five years and you know, I found that refreshing. Like let’s just build the story
Philip Hemme: we have new to a new episode. I’m your host, Philip, and on this show I’m entering the best Europeans in biotech to help to grow a new avenue for advanced therapies is tissue therapeutics. One of the best companies in Europe and even globally is CUTISS, which has just closed a $60 million series C and is recruiting for its phase three.
So I caught up with his founder, Daniella, while I was in Zurich. We actually had recorded a previous episode online back in April. But recording offline is just so much better. We talked about the challenges of developing a new category of therapeutics from clinical trials to partner interests to reimbursement.
We also talked about the intersection of tech hardware and biotech, AK Tech bio and why perseverance is key in life. For transparency, this episode has been sponsored by CUTISS. So here’s my conversation with Daniella and please hit the like or follow button if you’re enjoying it.
Alright. Welcome to the show, Daniela.
Daniela Marino: Thank you for having me again. Yeah, pleasure to be here. Welcome back.
Philip Hemme: So much better in person.
Daniela Marino: Yes.
Philip Hemme: Yeah, absolutely. And I like your office like it’s good. I like the CUTISS house. Es house. Yeah.
Daniela Marino: Yes.
Philip Hemme: I like the vibe.
Daniela Marino: Now we think big. Yeah, it’s good. It’s good.
Philip Hemme: I will show some, some footage from the lab as well, and so have it in the episode.
[00:02:31] Investors in CUTISS’ Series C round
Philip Hemme: So really great news. I mean, you closed the series C exactly what you were aiming for, so $60 million. Yes. And you closed it this month there, just how do you feel about it?
Daniela Marino: Yeah, look, I feel good because I think we have some angels in, in, in Nevin you know, closing. Now you mentioned dollars, but if you say Swiss Francs is 56 million Swiss francs in this environment.
Yes. It’s, it’s pretty remarkable. I mean, it was a lot of work, so it’s not something, you know, that just happened for. For the fun of it. But this is really a story of resilience and commitment over few, few months. Yeah. A few years almost. But it really is a testimony, you know, testimony to the fact that when there is a good product with a good science and, and a clear urban need, nobody can deny anymore.
Yeah. It, it’s, is possible to, to find the, the, the right investors.
Philip Hemme: Yeah. And I saw that on the investor note. So the family office of Giuliani family office mm-hmm. They co led the round. Mm-hmm. And then there’s another family office coming in
Daniela Marino: from the us
Philip Hemme: from the us which I think was important for you as well.
Yes. How like. Yeah. Can you tell a bit more on the, on the investor profile, on like, how it came about?
Daniela Marino: Absolutely. So in the history of CUTISS, we have had you know, fundraising activities mostly with family offices and private individuals and, and foundations. So this time, this co-lead position was very important for me because it shows that an existing investor is still trusting the technology many years after his first chip in, when did I first investor?
2017. Happy. Wow. Yeah. So and that a new brand new family from the us actually comes into the story and agrees to Coli. So I think it’s, it’s, it’s an interesting interesting move and this, I mean, the first closing happened last year that everybody knows. And under the same terms, you know, we manage now to, to reach the, the final goal of 56 and additional hos, additional investors came in.
Again, family offices and, and private individuals, but also you know, a strategic one, which is you know, the, the Red Cross Hospital in Beba, Vik in the Netherlands, which is again, I think an incredible stamp you know, to have as a validation because this is a very large, you know, renowned burn unit in Europe which basically decided to, to get as close as they could get to K is at this point in time of development.
So it’s it’s really you know. Testimony that you know, clients, if you wanna call them that way, surgeons and patients and, and hospitals really wanna have access to technology as soon as possible. So altogether, the classical, let’s say family office, private, individual, story of ties, but this time we have a very nice cherry in the cake, which is strategics.
And and I think that’s I feel extremely proud and the entire team is very proud of what we did. Yeah,
Philip Hemme: that’s amazing. We’ll talk about the, the Netherlands a bit more, but I found it quite amazing that the existing investor, even eight years long later, co-led around again, I mean. Yeah, it’s pretty, I haven’t seen that that often lately.
Daniela Marino: He pretty much likes us a lot. Yes, he likes us a lot.
Philip Hemme: Yes. Deep pocket.
Daniela Marino: Well, I mean you know I dunno, dunno, dunno how you define deep pockets, but yes, I mean, it’s, it’s, I think it’s important to show legacy and to show loyalty to, to programs like those because it really takes long to go to the finish line.
And and if you’re an investor which wants to invest and, and, and exit very fast, then you rather don’t invest in Kuti. Right. So I think I’m extremely lucky with my cap table. I mean, these are all people that really care and they really wanna help us get to the finish line. And they all knew. I think that this would take a little, so, yeah.
Good. Fair
Philip Hemme: enough. That’s good. That’s good.
[00:06:45] Expanding a hospital collaboration
Philip Hemme: And in the, in the Netherlands, so yeah, they also, it’s kind of, it’s expansion, but they also invested a bit. Is that
Daniela Marino: correct? They invested, yes. I mean the, the hospital holding invested in the equity.
Philip Hemme: Common. Like, which is not common. Yeah. But
Daniela Marino: I mean, as I said, you know, things happen and yeah.
And then we have a, in the collaboration agreement, which sets the stage to expand into Netherlands as soon as the product will be approved.
Philip Hemme: Okay, that’s good. So it’s, it’s kind of, I guess you’re already running the clinical trial there, the
Daniela Marino: phase three? Yes. We already ran the phase two there, so phase two and now phase three as well.
So, so
Philip Hemme: that’s kind of a pre-commercial agreement. It’s
Daniela Marino: some sort of, you know, commitment to, to make sure that they will have access to the technology as soon as as possible. So it really pays the ground for us to one day eventually install a facility in the Netherlands which is totally aligned with what we always said.
I mean, our model is not to have everything produced in one place and having gigantic logistics to manage, but rather taking our machines into a decentralized manufacturing model where you can be as close as you can to the largest hospitals and try to serve the patients in a quicker and cheaper way.
And again, I mean, their hospi, their, their unit is one of the most renowned and, and biggest in Europe. So it, it makes perfectly sense and it’s perfectly in line what we also always wanted to do, so
Philip Hemme: I guess you know them for. I mean, we have
Daniela Marino: been treating a lot of patients in that hospital, as I said, since the beginning of phase two.
So we started with them with phase two in 2018. So it’s quite Okay. That’s good. Yeah.
Philip Hemme: That’s I was young back then. Fresh.
Daniela Marino: I was younger.
Philip Hemme: You’re still young. You still
Daniela Marino: come.
[00:08:34] Decentralized manufacturing drive
Philip Hemme: That’s, I’m wondering on the, on the decentralized, because I mean, when I think about, let’s say even in cell therapy, usually you go more by, by continent. If I like, if I don’t think about more other cell therapy, some of them even, I’m thinking at autos, I think I saw recently that day. Mm-hmm. Yeah, they were managing actually everything from London area.
Mm-hmm. And then with East World, they could go like very rapidly. Yeah. US, Asia, and they would not even have a regional census. Yeah. But I think most of the others have more like a regional per region like Europe, us Yeah. Asia. So how much in, in your case. How much do you actually save? I mean, Netherland, Switzerland is not that far away either, so I mean, it is, but it’s, it’s not that far.
So how, how, how important is it to be like more decentralized than local? Yeah. Versus per region.
Daniela Marino: I mean, we, let’s not forget that we are not doing cell therapy. Yeah. As per strict definition, we have cells in our product, but we do tissue therapy, which means we don’t have a cold chain. We can’t freeze and ship.
So for cell therapy where you have a vial of cells in a frozen stage, it’s easier, in a way, it’s still tough, the logistic, but you have small volumes and you have, you know, cold chain that’s liquid with literally liquid nitrogen. And it, it’s some way, some way easier. So in our case, everything is leaving.
We can’t freeze. So there is a certain component of risk that shipping from Switzerland to let’s say Finland or Ireland or Iceland would be critical. So we always thought that if we, you know, want to expand in Europe, it would be, it would make sense to go a bit north of Switzerland. Okay. So I mean, again, it was a combination of events.
We didn’t necessarily target Amsterdam or Netherlands per se, but altogether it makes a lot of sense to be a bit more north than Switzerland. Yeah. Okay. And to answer your question, I mean, we intend to have a few more. I mean, we are, we are gonna be having for sure something on, in, in the American continent.
Yeah. Something in the Middle East, something in Asia. I mean, we will not have a hundred hubs, but we definitely need to be strategically in some areas where, again, airports will be close by, ports will be close by and vicinity to the largest units. Because let’s not forget burn patients are centralized.
I mean, they’re treated in, in certain spatial hospitals which have the burn units. So if you can stay as close as possible to the largest units where you have a lot of patients coming in from different regions, then that’s the best call you can do. So it’s not as straightforward as for cell therapy, maybe it’s just a little different.
And nobody’s really doing that quite yet. I mean, nobody has a decentralized model for tissue therapy production. So we are kind of. The first ones and we’ll see how it goes. I mean, we will make it work.
Philip Hemme: And I guess in the Netherlands, as you said, it’s the biggest center. So I guess a lot of network,
Daniela Marino: there is a lot of confidence also from maybe Denmark and Germany.
You have Belgians. I mean, but it’s, again, it’s an interesting place to be because also the historical knowledge they have in, in, in burn treatment. So yeah, I think it’s, it’s really the best call we could have done for that. Yeah.
[00:11:50] Tissue therapeutics vs skin grafts
Philip Hemme: And how, how is it how is other tissue therapies doing? Because you said you, you are kind of the first one on the more decentralized model, so how is the other one.
Managing.
Daniela Marino: So at the moment, there’s not that many issues being sold. You see
Philip Hemme: there’s a few now on the market and which is, there is corn, which is
Daniela Marino: now on a mono centric production manual production. So again, this decentralized story only works if you’ve got machines because then it’s easy, easier to decentralize.
Yeah. So companies which are still producing manually, like the cornea, like the blood vessels, and, and now there is a few other tissues coming up. They are still in one production site. So, and how do they
Philip Hemme: ship them? Like
Daniela Marino: they, they have the same thing. They’re shipping, they’re shipping warm chain as well.
So to the best of my knowledge, but I mean, I don’t know the details of all of these. So it’s, I think at this point in time, we really are the first one, which are trying to do a decentralized model with the machines. So they, you know, and we are also moving away from. Cold chain to room, temperature chain.
So these guys may also change and improve their logistics. It’s not just a matter of what it looks like. It’s a matter of what, where you wanna go. And if you wanna have a product, which is really getting a global outreach, you can’t project everything in one mono centric production. I mean
Philip Hemme: and I guess, I guess what you say also from a living tissue just makes me think it’s, is it like more compared to organ transplant and, but organs are also like shipped
Daniela Marino: organs I think are shipped in culture like four degrees.
Yeah. I’m I’m not so sure whether this is also depending on which organ. So, because you cannot freeze it. Yeah. Again, we cannot freeze it as well. But
Philip Hemme: you can still ship it like across the country. You
Daniela Marino: can still ship. Yeah. But honestly, today with technology we have, we can ship pretty much at every temperature.
It is not, it’s, it’s really a question of of a strategy and de-risking
The logistics
Philip Hemme: looking for the optimal.
Daniela Marino: Yes, we are somewhere in between. We are not. And we are not Oregon. We are a tissue, which is you know, a gray zone.
Philip Hemme: And maybe before jumping to automation into the phase three, maybe if you could just.
Give a bit of a top, top level of how it works. Mm-hmm. Just how the technology works for the audience, so forth. Not catch the, the first episode, the first one.
Daniela Marino: Guys, go watch it first. The first.
Philip Hemme: Maybe just a one minute, like high level. Mm-hmm. Yeah.
Daniela Marino: Yeah. So, when people today need to undergo a skin surgery because of a burn, a cancer, a trauma, a plus a surgery, a reconstructive surgery the technology used or the method used to, to do the surgery is auto grafting.
Meaning that you have to have a piece of skin, healthy skin taken from somewhere on the patient’s body. And this graft is grafted on the wound area. You have two major issues, donor size, shortage. In large area, in large wounds and scarring because this autograph is unfortunately developing into scars.
So what we try to do with Qta is trying to hit those two problems with two solutions. Unifying that into the no skin. The no skin is a bio-engineered personalized human skin graft made on demand. So there is no rejection issue. Every patient gets his own piece of skin. We take a tiny piece of skin from the patient, very small, and we can make large quantities of skin.
So no issue with donor size shortage anymore, and because of the way we, it’s like a
Philip Hemme: hundred,
Daniela Marino: at least 103 weeks. Yes, we can of course do much more with, with more time. And and then. Because of the way we have developed the product our phase two data and our phase one data show a huge promise to actually drastically reduce the scarring which means improved quality of life, reduce costs, higher mobility growth in children, I mean, a gigantic benefit altogether for the patients.
Philip Hemme: That’s amazing. Yeah. I remember from our conversation also like what, what I, what I didn’t, or what I realized is like for small burns, basically, I guess autographing kind of works course, but once it’s like, I guess double digits of the body, it’s 20%
Daniela Marino: of your body surface. You, you start having exactly troubles.
Philip Hemme: Yeah. And then you really need something. Yeah. Better. Yeah. And actually, but what you said is also. We are counting in, I don’t know the, the prevalence, but was, I think globally is like in the millions of patients who have or something. Yes. I mean, we did
Daniela Marino: our own search between Europe and US because there is no real report on skin surgery in general.
You have a lot of reports on aesthetics. Yeah. And some reports. Reports on burns, but we actually doing much more than burns and, and, and much more than aesthetic. So if you consider purely the burns and the medical reconstruction, think about cancer trauma tumors can, I mean, or, or, or scars or giant ni it’s about a million people per year between Europe.
Yes. That undergoes the skin surgery. If you add the aesthetics to that, I don’t know what the number goes to.
Philip Hemme: That’s a lot. I mean, it’s a very high. Unmet medical need and the big market as a company as well,
Daniela Marino: and totally underserved because there is not really much you can buy, especially in the reconstructions in burns.
You’ve got a few products which were developed from the nineties on, especially given the military interest for treatment of burns. But for reconstructions that is basically not, not really much. So we will be really, you know, filling up a gigantic hole in the system.
Philip Hemme: Yeah, absolutely. And actually talking about the, the clinical data as well, like, I mean, you had, you, you went through the phase one, phase two and now you’re running your phase three.
Just amazing.
Daniela Marino: It’s a challenge. It’s challenge
Philip Hemme: and we talked a bit about it, but I’m curious just how, how things are going. Yeah, sure. Any update? No, absolutely.
Daniela Marino: I mean, actually we were trying to get some statistics out and we failed even using AI because it’s apparently extremely rare to have a, a small company out of academia taking a product of this complexity all the way through phase three.
So I think that we found like four companies in the world with that. So, you know, we feel pretty special. Okay. This means that other you
Philip Hemme: even four or like it tissue therapies or also cell therapies. Cell
Daniela Marino: therapy in general at very complex, at TAP orphan product, out of university, out of academia, all the way alone without partners, without an m and a, without an IPO, without major collaborators, without pharma backing.
Pretty much less than five in the world, so, so we do feel very special. What? That’s a lot of criteria. It’s a lot of criteria, of course, but it is the reality of many
Philip Hemme: academics. I think auto, which I think came out of academia, I think the commercial, but. They did an IPO.
Daniela Marino: Yeah, exactly. And they
Philip Hemme: had, yeah, I think they commercialized themself, but yeah, but not
Daniela Marino: so, so now, yeah, without, let’s say with the, you know, with the fundraising and remaining private, without raising you know, we, we, as of today raised 125 million Swiss francs, which is also not a billion, right?
So we did our best. And now that’s the biggest challenge. I mean, phase three started. We are recruiting in 20 centers in eight countries. We are growing the team to make sure that we can keep capacity and you know, more patients, more stories, more events to manage, more PIs, surgeons to, you know, to instruct and train and, and keep on track.
So everything is just big. So the complexity is there by definition. But I mean, we started and we will get done. So we are up to the challenge, but it’s it’s it’s something which we have to do and we’ll do
Philip Hemme: so, yeah. Yeah. Can you just on how many patients you are recruiting for the trial? Yeah.
And what’s the expected timelines? Mm-hmm.
Daniela Marino: So we have to recruit 70 patients altogether, and we expect the first data set by the end of next year because there is of course, follow up and, and more to come over time. But we should be able to have a good grasp on, on the situation by the end of next year.
Philip Hemme: Okay. So you’ve, what’s the plan for the full enrollment, like
Daniela Marino: in the next months
Philip Hemme: by year? By the end of the year, and then I
Daniela Marino: can, I don’t give you the, the exact timeline, but you know, we should be able to have a good grasp by the end of next year. So give us a year and a bit to, to do
Philip Hemme: the work. Okay. And then you, you.
I’m just curious also on the endpoints, because you mm-hmm. Is it like primary endpoint, second endpoint or is Oh, there’s plenty of endpoint. Yes. Yeah. But once you’re pioneering with your field, like how do you, like what has the endpoints Yeah. What has the bio market, whatever, I mean,
Daniela Marino: that, that, that’s interesting.
So this has been a discussion from day zero, so already decided the endpoint of phase two was a big challenge and we had to, the only way to make sure that the endpoint we chose was correct in terms of compliance or clinical relevance or what, what have you. We immediately discussed that with the EMA and the Swiss medics.
So we never decided to run things without having. A meeting with them to, to align on certain things. So what we did in phase two was to basically check our capacity of sparing cyte. So the Premarin point really focused on how much skin can we produce versus the biopsy compared to the standard of care.
And the standard of care has been an intrapatient control. So every patient received a no skin and the autographt. Okay? So we can check this dataset on data point on each and every single patient. Okay. We pro proved that, I mean, with high statistical significance. So clearly we can’t spare cyte. Yeah.
And now in phase three, we went again to the regulatory to say, okay, what shall we do for phase three? What’s, what’s your take on the comp, on the, on the endpoint of phase three? And the discussion took some time. I mean, it was not straightforward because as you say nobody really, we cannot follow the steps of, of many others.
So and now we basically agreed to have a, a primary endpoint which will focus on the closure of the wounds, which is a primary point. I mean, you have to close the wounds at the same, the same way as the control. So it’s a non-inferiority endpoint. But in composition with the scar quality, because now that’s the next thing that we wanna show right after cyte, what matters is the scar quality.
So we will we will have, we will focus on this now for the, for the phase three.
Philip Hemme: But you will, you will still do the autograph and absolutely same setting on the same patients setting. Okay.
Daniela Marino: Same setting, intra patient randomized control.
Philip Hemme: Okay. Well. Yeah. And I remember, and I will show some, some footage of like, I remember, I think it’s on the arm, you have some pictures where you can see the differences, where you’re
Daniela Marino: naked eyes.
Yeah, it’s crazy. You need low PhD nor MD to actually understand the difference. And that is actually one of the big advantages. We, we can see very fast if it’s on the right track or not. And, and you can see that visually there is no big assay or big testing that you need to run compared to what, for example, pharma people have to do.
You know, and, and this is, that’s why it’s an open label study. There is no way to blind it. It’s absolutely impossible to blind. So, yeah.
Philip Hemme: Actually what you mentioned was a farmer, which is pretty amazing when you. Always think about controlling placebo, but you can, yeah. Until the
Daniela Marino: end, you have no clue.
Right. You can
Philip Hemme: never do it in the same patient versus you guys can do it basically the same patient. So you know, if it’s exactly the same cells, the same immune reaction, everything. Everything. And you can really compare exactly.
Daniela Marino: Every patient has its own little story. And if the patient has a, an issue with wound healing you would, you, you will see it on both areas, right?
While in a classical blinded study, you never know exactly if any of the patient specific feedback, you know the situation has any influence. So in our case, yeah, we can really tell 70 different stories, which is interesting. That’s good.
Philip Hemme: And so I guess also that’s why. You will see the, the results of the clinical trial pretty rapidly, I guess.
Yes. That’s why. Within whatever,
Daniela Marino: yeah, because I mean, as I said, of 18 months, it’s you know, the, the, the, it’s, it’s an open label and we will be able to, to very quickly say after recruitment if it’s on a good track or not. Okay.
[00:24:35] Reimbursement and health economics
Philip Hemme: And then, but then I guess from the, because I mean the next challenge will be, I guess commercial and Yeah.
And reimbursement. And there, I guess you want to have more like.
Daniela Marino: Long term.
Philip Hemme: Yeah, long term and I guess stats as well.
Daniela Marino: Yeah.
Philip Hemme: Not just like visual, but like stats of like, okay, we are helping by X percent, but then also like we are lower complications by whatever X percent. Yeah. And I guess that’s where you need to statist like a more, something we’ll
Daniela Marino: need to build an health economics model, an impact budget model.
And we are already working on that now that we close around and we know that we can move ahead because we, we are not just relying on phase three for that. I mean, we have done a phase one with five years follow up on these patients. We have done a phase two with three years follow up on these patients.
And now the phase three will have two years follow up on top of that. And we have compassionate patients, which we treated also many, many years ago that we, that we can, that we can add to the package. So our health economics will have to be based on this. But let’s not forget that we have an interpatient control.
So we have a limit, intrinsic limit in our study, which is, for example, quality of life. How are you gonna. You know, es estimate the quality of life if a patient has half the novel skin and half autographs. So the amount of work we have to do, it’s also based on the, the current costs and the retrospective work done on repositories, for example, so that we build a story of what today is the burden and how we could extrapolate based on our data, a successful cost effectiveness study.
So it’s much more complex than. Just collecting health economics data on a protocol. So wish me good luck, but we’ll get there.
Philip Hemme: And, and also what I mean, what you mentioned in the, like in the top level is that the autographing, one of the complicated is the scars and the scars management afterwards. Yes.
Daniela Marino: Lifelong. Lifelong, lifelong. So can you build the health economics on a lifelong data set? Ooh, that. Good luck with that. So, you know, we used to build, build the model which
Philip Hemme: runs, I guess you have kind of annual costs.
Yes. You have some percentage of patient, kind of some averages. I guess you can compare.
Daniela Marino: Yeah, of course. That’s what I’m saying. We can go back to even respectively, to those, those data sets, you know, that the hospital have, you know, about reentering the hospital reconstructions, rehabilitation, physiotherapy.
But there is also an entire world of micro costs that the patient has to go through with gowning, lotions, creams, lasers pressure garments you know, different kind of therapies that they do basically at their costs very often to try and keep up with, you know, with a good quality scar and. This entire world has to be considered.
You cannot just say, okay, the patient underwent two reconstruction. So that’s the, the total cost of the patient spend. It is not true. And more and more, you know, especially in tissues and cell therapy, this micro world has to be considered. And for us is a gigantic amount because it’s not just having, like in oncology, you know, a follow up of survival over five years.
I mean, if somebody gets burned at the age of three and lives 98 years old, you have 95 years of micro costs, right? So it is something which is extremely challenging. So we are gonna need to have a very creative way to, to build this model. But again, I mean it just the beginning, I think many other tissue companies and organ transplantations and cell therapy companies going beyond oncology will have to do.
So let’s just start. We’ll get somewhere
Philip Hemme: and, yeah. Yeah. And what’s the, what’s your expectation instead of like, pricing, reimbursement? Yeah, like, let’s say. Or total addressable markets.
Daniela Marino: I mean, we have done analysis without, without, but like, yeah, we have done an analysis in the Europe and us considering, you know, the big five plus additional countries like Switzerland and, and Netherlands, for example, already back then and the us of course what we did is good for now, but we need to now you know, move on also because things are different changing, especially in the us you know?
We have to follow the situation. So I don’t have a clear answer as of today. Nation, I mean, in Europe we need to go nation by nation. There is no centralized reimbursement or pricing situation. So we will need to just go really country by country and, and, and set the price, and negotiate the price with the h HTAs.
And again, I mean, to do that we wanted to go with a dossier, which is solid. And that’s why we we, we have been waiting to have the phase two completed with a three year long follow up. And that’s happening right now. So the last visit of phase three, oh, sorry, of phase two was just couple of weeks ago.
So definitely let me build a dossier. Let me give, build let me build, you know evidence of what the product can do. And now we are ready to start this kind of conversation. But to your point, I mean, we already have an idea of the price and the reimbursement options we have at our plate, but again, there is more to build.
What’s the,
Philip Hemme: what’s, what is it like, I mean, I’m just have an idea as well. Is it, are we talking whatever. Like the price of maps, like whatever, 50 K we’re working with self. Happy half a million. I
Daniela Marino: mean, the thing is that we, we are selling skin on demand, so, and skin is big and every patient will have a different request.
So one patient could buy two skin units and another patient coming the day after may want 50 units. So we are not gonna have a price per therapy, we’re gonna have a price per skin unit sold. And that’s again, different from all CAR T or cell therapy round. Again, it’s a very specific model for tissues and very specific model for skin.
Because if you sell cornea, it is one or two per patient. Yeah. Okay. If you sell a blood vessel, it is one per patient. Yeah. If you sell a heart, it is one heart per patient skin. Again, we need to be extremely elegant in our model and extremely extremely pragmatic, you know, and again, nobody has done it in the past.
So there is some companies in the US which sell carat high sheets and they, they price it per square centimeter. Yeah. And, and we are now pricing it per unit in our model. But is that gonna be the real one? Are there, you know, is the HDA gonna negotiate something else? We’ll see, but it’s it, it’s challenging because of the, the physical characteristics of of, of skin.
Yeah. Okay. Which is, you know, every patient has a different size. Yeah. Oh, I had, every patient has a different request, so. Yeah.
Philip Hemme: And I guess for you also from a, from a process, I guess doing, you have a minimal. Cost of handle to do one unit is not the same as doing three units.
Daniela Marino: Exactly. So we will need to have some sort of economy or scale because if I do one unit or a hundred, it’s not simply one multiplied by a hundred, you know?
Yeah, exactly. So that’s all work in progress. And I mean, I have to say we have some assumptions. We, you know, we build a model, but we are also really, really much better now than three years ago in our production costs and everything, and efficiency. So. You know, I think now is the right time to start building something which could be ready for a discussion with the authorities.
In the past, everything was still so low volume. You know, we did one patient every bit and small quantities, and so now it’s all, I think it’s just the right time to start, but we are not there yet. Yeah,
Philip Hemme: that’s okay. Yes. I still, you still didn’t tell me a ballpark.
Daniela Marino: A ballpark. I mean, look, we have to consider we need to go with assumptions.
So let’s say a patient burned 50%. Yeah. Today, forget about the no skin. Getting all the treatments, getting all the, all the, the transplantations over five years will cost the system about 2 million. Euros. So over five years, if you use the novel skin, partially not even to cover the full 50%, our estimates are that by the end of the fifth year post grafting, we could spare at least 30% of the total cost.
So. If you can spare money, then the, you know, the price is, it will be acceptable. So we have to play with, with this idea of you know, reduction of total costs and maybe five years is too farfetched. We will need to consider 18 months or 24 months, you know to, to, to show that we are already positive much earlier than the five years.
But again it’s, it’s a consideration that needs to, that needs to be based on current, the current situation because yeah.
Philip Hemme: And now I understand also your point is the micro cost, because I guess you guys are more expensive upfront,
Daniela Marino: but then,
Philip Hemme: but over five years is a reduction.
Daniela Marino: Exactly. And the number I mentioned to you, the 30% that we, we kind of calculated in our preliminary analysis is not considering the micro costs.
Okay. So that’s why, I mean, it’s very hard for me to give you a ballpark because there’s a lot of work to do to, to price it correctly. Yeah.
Philip Hemme: But I guess it’s also. A similar challenge to some of the, let’s say, seller other at t products, Excel G therapy was the upfront cost is, is huge. Yeah. But actually what you saved down the road is quite a lot.
Exactly. But demonstrate that from a, like health economics,
Daniela Marino: it’s, it’s a challenge. It’s a challenge, yeah. Yeah. But I mean, we also need to understand that there is a, a shift in the paradigm, right? I mean, selling and pricing and reimbursing tissue or cell therapy 10 years ago was, mm-hmm. Almost like you know, like, oh wow, you know what, how, what do we do?
And now the stakeholders are getting educated and they’re understanding and I think, you know, it’s, it’s a little easier than it used to be 10 years ago. So let’s hope that the, the future trend continues that way. Because if you only consider the time at, at tra treatment, how can, how do you want such an innovative therapy to be cheaper than, yeah.
Than anything standard on care wise. So it has to be, it has to be the model that works for everybody looking at what happens after or nothing will move. We will stay with what we have and never move.
Philip Hemme: Yeah. That’s, that’s good that you have a, in, in the way the, the other ATPs help you.
Daniela Marino: Absolutely.
Philip Hemme: The pricing reimbursement benefits.
Daniela Marino: Yeah, we all trying to actually work together. I mean, we are part of this alliance for regenerative medicine and I was in Rome at the meeting this, this spring. I mean, pretty much everybody has the same kind of strategy going forward. And that’s why I say, I mean at one point this may become routine, you know, that you look into the post grafting post application to, to consider the, the benefit.
Otherwise it’s not gonna fly. Yeah.
Philip Hemme: And from a originative medicine point of view, like I’m curious, how much are you impacted by right now, the just cell gene therapy are quite going down.
Daniela Marino: I think it’s coming up again. There’s been quite some good s in the last few weeks, so I think it’s slowly,
Philip Hemme: slowly, but slowly, slowly.
But but still, I mean just overall, I think overall it’s done in the past. 24 months. It’s quite low. Yeah. How, how does it affect you, say, in the final, in the fundraising? No, it
Daniela Marino: affects me. I’m going straight, I’m going straight to my, to my, my wave of, there’s no wall in front of me at one point. No, I mean, the sentiment is definitely on the negative side.
Yeah. And, and that’s why, I mean, also for us, it didn’t take, you know, this money was raised over a long stretch because the sentiment is, it’s not just about cell therapy, it’s all about, it’s about technology in health. Somehow, altogether. Just had a conversation with the, with the CEO of a MedTech company, not a biotech.
And she says also like, oh, you know, all the investors are like, yeah, but when are you gonna be cash positive? Or when are you gonna do the multiples? It’s like, yeah, but, you know, it’s not so simple. You know, look at what the world looks like and all these, you know, geopolitical distractions are influencing negatively investors.
I mean, we cannot do much about it. I think health is health and we cannot just stop investing in, in technology for health because it’s, it grows to extinction. So it’s just a phase. And maybe there was also a lot of you know, a lot of a, a kind of a small bubble around cell in therapy a few years ago, and there was maybe a bit too much.
And, and now you know, the first reaction is like, oh, then enough, we don’t invest anymore. But I think it’s gonna reopen. I mean, we can’t stop investing in health. There’s no way we can, we can do that.
Philip Hemme: Yeah. I mean, yeah. But I, I think also just from a. Also for the audience a bit like, I think the, the expectations were really high.
Daniela Marino: They’re really high and over promised a little and pressed a bit,
Philip Hemme: but also the, the commercial performance yes, was lower than effect and Car T some of them I think in the billion dollar in the blockbuster range, I think especially the Kite Gilead one. Yeah. But a lot of the other, especially in gene therapy, is like not going that well.
And even some of them I even like, stopped commercializing because of the commercial performance was really low. So it’s But isn’t
Daniela Marino: that mostly oncology?
Philip Hemme: No, no. Especially gene therapy and like in rare disease was just.
Daniela Marino: Not really up to the, because it was just promise
Philip Hemme: too expensive, not reimbursed, too little Patient numbers too complex.
Yeah, even too complex, like and quite some side effects in some cases. Yeah. So it was like just the whole mix,
Daniela Marino: it was not up to the expectations. Yeah. So let’s try to get better. I mean, we got low. Now. We can only go upwards.
[00:38:39] CUTISS’ partnering and exit options
Philip Hemme: That actually brings me also to one thing that, that you, you said like you don’t have a pharma, pharma partner.
I’m curious on how much, like how, how much of pharma par pharma interested in you guys and tissue therapeutic in general? Like, are they just like, okay, let’s wait and see what’s coming out? Or are they like, okay, we believe in the, like we see the potential, but we want to see x, y, z milestone? Mm-hmm. Or like, how, how is the reaction there?
Like.
Daniela Marino: Yeah, I mean, at the moment, I, I, to be honest, I have not started deep conversation with you know, 10 different players. I mean, at the moment, what we all want to do is to try and get through this phase three and say, okay, this is, you know, co development is completed and who, who wants to talk?
You know, that. So we haven’t really pushed quite hard, and I have to say there is some. Rumors that pharma, you know, could open the door to discussion after phase three is kind of going well. So I think we, we kind of understood that and it has been confirmed. But what is interesting here is that we are not necessarily a pharma bite.
I mean, we can be a pharma byte, we can be a med tech byte. Yeah, we can be a deep tech byte. We could be a tech bio byte. So we have to see which player you know, which of the sectors will move more into tissue organ. And probably this would be the first conversations to be started. It’s not necessarily pharma, so, okay.
Yeah,
Philip Hemme: because that’s, that’s actually where I was, or like from your answer where, where I’m a bit going is like, who are your most, most likely partners or exit, like, what’s. Like,
Daniela Marino: I mean, in, in skin surgery there is quite some good med tech players in Europe. Okay. Pretty solid med tech in Europe. So this could be an interesting approach for us because you’re
Philip Hemme: selling products for autographing Yes.
Daniela Marino: For skin surgery. Okay. So this could be an very interesting scenario to explore. But there is also companies that produce now machines bioreactors for cell therapy. And are they gonna go into tissues? Would we be an appealing. A package given the fact that we have an at and p in phase three or approved plus the machines, maybe they wanna take the machines angle and then we could be really, really interesting for them because to the best of our knowledge, there is no other company producing machine or developing machines for tissue production on demand.
There is also, I mean, the classical pharma of course interested in the tissue therapeutics right? Kind of thing. The orphan indication, the fact that we are unique and you know, feeling an animal need and then there is this new tech bio story that it’s popping up. And that’s maybe the perfect combination because that tech bio needs to have a biological component, a biotech component, but also very strong machine slash ai slash deep tech component.
And maybe basically that’s gonna be a natural direction for us to go to. But who is the strongest leader in tech Bio? It’s to be seen. So
Philip Hemme: working in progress, mosque, startups, and earlier stage players, like it’s
Daniela Marino: already changing a little. Okay. But I think we have got,
Philip Hemme: I mean, I, I just mean there’s no, like,
Daniela Marino: no big, big player Yeah.
Tech
Philip Hemme: value at the moment, at least. I don’t know.
Daniela Marino: There is somebody who slowly will be calling themselves tech value. You’ll see it’s just a change of name rebranding, a rebranding, a repurposing reping. But I think it’s the right time. I mean, if you, if you can all keep a little bit of, peace of mind and, and wait two years from now, I think things will change, I think will become much more clear for everybody right now.
It’s give, you know, give us some time.
Philip Hemme: That’s good. So far for you guys to have the options, I guess.
Daniela Marino: Yeah, I think it’s an interesting thing. You know, when we started we knew that we are taking a risk, you know, doing clinical trials and machines at the same time. And, but now I think, you know, with all the, you know, the, the, the, the hard work done and the sweat, I think it was the right decision because you see where the world is going.
And today having a full tech, I mean a sort of full, full A TMP in phase three, we doubt any clue how to scale that up would probably be a, a complete no go for, for many of the potential m and a candidates.
Philip Hemme: Mm-hmm. I, I’m curious from if we stay a bit on this, on the, on the, on the challenges attached to that.
I mean, especially from, let’s say raising money. Usually, I mean, investors like to have a, a quite clear pass in terms of like potential exits, especially exit Pass as it’s like a IPO and they go, or like a mm-hmm.
Daniela Marino: An MA or,
Philip Hemme: or more like a exit partnership. Mm-hmm. But in your case, it, it, from what I hear is also was basically not, not that clear, and you could go more at towards conversation, commercialization yourself, but was also like lot of changes.
So how, how was that like?
Daniela Marino: Yeah, I think, I mean, I don’t know. This is my first company and many other people that have done more than one company have, have better overview of that. I, when we started. We knew that we had to go through the clinical development and it will take time. And we knew that we’d rather start working on machines now it’s gonna be too late.
So we just focused on that. Let’s just go to the point, let’s see whether our, our call was correct. Let’s see where the, the entire field is going. And I think right now it is, it was the right choice, but our investors knew that this is so new and it’s so pioneering in a way that having a plan fully fledged fully ready would be probably a stupid idea because I will never forget one of my investors say, I, you know, back then, like seven years ago.
I am not gonna look at your financial projections because we all know that you have no clue what the financial projections in five years and, you know, I found that refreshing. Like, let’s just build the story. Let’s just get the science right, the, the story, right. And when the time will come that we are closer to commercialization, things will be much more clear.
Yeah. And now what’s the plan now? Because now we are there. I mean, we are more than ready to start commercializing ourselves and I’m not afraid at all of going public and doing this, you know bottom up, let’s say. But I’m not gonna just do, take that decision now and close up the possibility of doing an m and a with a company which could open five geographies.
You know, having the full fledged team. So at the moment, again, I mean, let’s just finish what we started and let’s take the, the, the possibilities you know, in front of us and the opportunities and the conversations the best we can. Why? Because all we want. And that will not change, is to get this product out as fast as possible to as many people as possible.
If that will be better done with an IPO. Fair enough. If that will be better, better done with an m and a better If at the end we do a partnership with pharma, we can do it together. Why not? We try to stay focused on our goal and, and yeah. We’ll, we’ll do our best to do the right call. I mean, yeah.
Philip Hemme: And the, the series C, you said you can go com. Is it enough like to start co commercialization? It depends
Daniela Marino: on how fast the approval comes, which again, we don’t have really a lot of, a lot of visibility quite yet. I mean, there is really extremely good options to be fast in certain geographies because of the orphan drug designation and the good quality of data we have generated.
So there is a possibility that the, this fundraise would allow me to. To start commercially. Yeah, of course. With not too many geographies and not too many volume, but much volume. But yeah, but I mean, we don’t have a lot of visibility there, so we are trying our best, but it’s also true that I have now engaged on the cap table with some big investors, which could also support you know, a bridging financing if needed be, or we are applying for different grants.
We are looking at more investment if people are interested now because now that we closed around, the interest popped up back again, you know. So at the moment, I mean, again, we have closed around, we are secured financing. We can go a speed now. There is no more doubt whether the company will be making it or not.
And, and I’m pretty sure we’ll get there with additional investors rather soon. I mean, some conversation has already started. I’m like, I’ve been fundraising for two years. Why are you talking, why? Yeah. But that’s how it’s, it’s fun. Yeah. Yeah. So we take it from there. So, so the call is still open. If somebody wants to, to invest, just reach out to me.
Sure.
Philip Hemme: And I guess also for all our discussion, once you have some commercial data would help with
Daniela Marino: Yeah, absolutely.
Philip Hemme: Interest and I mean,
Daniela Marino: this would be a gigantic proof of concept, you know, that somebody can take an academic product out and go through the, the most expensive clinical development ever producing in-house, building a GMP facility, building the team, and getting commercial.
I mean, this would be the biggest success ever.
Philip Hemme: Yeah. That’s for me and my team. Of course. Yeah. Yeah.
[00:47:54] Automation and artificial intelligence
Philip Hemme: You mentioned automation quite a lot. Yeah. And so. Which I think is one of the thing that is quite amazing with you guys. Like you have actually lot done it. And now I’ve actually developed the machine, which also what I remember is like there was no of just off the shelf existing machine to, to grow the tissue.
So you had to do everything from scratch. From scratch,
Daniela Marino: yeah.
Philip Hemme: And what I’ve seen as well is I’ve now taken a, yeah. More partner, which I think they are really big in, in general in machine automation. Yeah. And they can help you basically. Yeah. Bring your own machine to the next level. Yeah. Can you talk a bit about like, all of that and I, we started, and now
Daniela Marino: clearly there was an evolution there as well.
I mean, when we started, we had great partners for the, for the discovery phase like Ulka and CSEM and Inno Suite helped us a lot. And because we had to literally build it from scratch. So it was a long process and a very, very fun process because literally we were, you know, drawing prototypes on paper and trying to make it work, you know, and that was extremely fun.
With the idea that the man, the manual process, which was the one running in phase two, was still not the complete finished one because we are still in phase two, so we are still changing parameters and things, and so can we lock the machine design when the manual process is still work in progress? I mean, it didn’t make sense.
Now that we started phase three and we have a process, which is the pivotal one, which will most likely be the commercial, at least to start, don’t take me wrong, manufacturing process will evolve. I mean, science is. You know, we, we cannot say that’s the process, which will be for the next 20 years, but now we have a process which is in phase three.
So this process now can be translated into the automated one. So we were at the point where the discovery was finished, innovation kind of had ended up to the dead end, meaning we did our patents, we did our testings. Now we need a machine that can actually go industrial. And we needed a partner that could do that stage, having the knowledge of how to industrialize a machine and also manufacturing capacity because I need to one point produce these machines and I cannot do that myself.
So the step forward to Tecan was a, a really interesting one because they have the competency and they really love the project. I mean, I dunno whether you saw the CEO the new CEO and the old CEO have taken quotes in our press release. I mean, they really, really believe that tissue making is gonna be the future.
And now with them, I mean the path is. Is is set. I mean, we will, we will be able to accelerate this now and and really make it a reality. I mean, there will be a machine that will produce skin for human use. Yeah. That’s amazing. But it’s, it’s not like we are late or we could have done it earlier.
No. I mean, this is now the right time. Yes. You know, because our machines need to replicate the manual process. They’re not just reinventing anything, you know? And, and now, now we can push for speed. Yeah.
Philip Hemme: And how, how many machines are we talking about, like from a. Scale. Like,
Daniela Marino: I mean, we are not selling machines, right?
Yeah. So our business model, number one, I i, not excluding business model number two and three going forward but at the moment we, we plan to have the machines in house. So we are still selling skin. You are selling
Philip Hemme: the skin. Skin.
Daniela Marino: We are selling skin, and the machines are in our control. And this means that we will have manufacturing lines and each line will have a certain number, number of machines.
So it’s not gonna be producing thousands of machines because that’s not necessary. So we are talking about hundreds num. I mean, it’s, it’s really a reasonable number. But again, these are very complex machine, so mm-hmm. You, we needed a solid partner that could. Manufacture that complexity. It’s not just a question of volumes.
Philip Hemme: Okay. And I guess it’s also very custom machine,
Daniela Marino: very custom machine software. You know, these all you know, recording and tracking and coding because it’s personalized therapy. You’re not producing a batch over three months and stop and restart. Right? Yeah. So it’s, it, it’s an interesting concept and I think Tecan is really one of the best partner we could have ever engaged with for now.
Philip Hemme: And I guess for Tecan, is, is a way to have a kind of a proof of concept in tissue therapy therapy? Yeah. And then they can expand to this applications?
Daniela Marino: Yeah. I mean, I don’t know what their, their idea is for the future, but they clearly took a, a step to say we wanna be part of this tissue therapy you know game, which is starting and, but, you know, let’s see how it goes. Was they,
Philip Hemme: did they invest also equity or,
Daniela Marino: I mean, I, I cannot disclose this information unfortunately, so you can ask them. But the collaboration has started already this march and and it’s going very well and investing or not, is not honestly, really relevant at this point.
Philip Hemme: Yeah. And you mentioned a bit of software as well?
Daniela Marino: Yeah, for sure
Philip Hemme: is software, which is amazing because there’s, it is the more mechanical, the software, the bio. Mm-hmm. It’s a lot of, it’s easy, it’s very simple. Yes. Curious on the software of like, what are we exactly talking about and how much, let’s say all the ai, how, how much of some of the AI is helping, is helping, now are you using, or whatever, some.
I don’t know which kind of gene ai, some transformers to like do some data sampling, recognition something or is it like, okay,
Daniela Marino: gimme a headache. Yes. Look, step by step, there is a software component which is extremely regulatory. You know, heavy meaning that the software has to be compliant to very strict regulation because again, the software will control the way we, we grow the cells and we do the tissue.
So it has to be A GMP compliant, you know, like
Philip Hemme: a super reliable, super
Daniela Marino: reliable, super robust open. You can go and check every step, you can go and that part is the one which we have to do. Yeah. Of course, again, going to the tech bio story, which it’s gonna kick in every batch we do is different and every batch we do is personalized.
So. Can we build a system where at every batch we learn something, the software will learn how to get the next one more predictable and maybe avoid that and that step, which caused a two, two days delay on the process. So it’s a component of machine learning, which is probably gonna hit very fast because if we wanna produce at scale, you know, there must be some, some, some.
AI support in trying to optimize the culture and reduce the volumes or minimize waste or minimize time or predict potential contamination issues based on, there is a world of things to explore and we always had the idea of doing this, so one, one point, but you see now there is no way back. I don’t think there is a way to say now we are never gonna do machine learning.
I mean, it’s impossible right now. It’s just a question of time. So, I mean, I’m actually gonna hire soon a transformation officer, so we are gonna kick in with AI very soon. Good.
Philip Hemme: And I guess the whole machine learning is also much easier today than three to five years ago.
Daniela Marino: Today’s, as I said, it’s basically a must.
It’s just a question of choosing the right tool, validating the right tool, and, and, and personalized to your needs 10 years ago, I mean, if I would’ve told an investor, I’m gonna do ai, machine learning,
Philip Hemme: machine learning, what is.
Daniela Marino: They will go like, okay, you are crazy indeed. So now the question is when are you starting, starting?
Just a bit crazy,
Philip Hemme: but not too crazy. Yeah, exactly.
Daniela Marino: Yeah, but that, I think that would’ve been the end, the top, but no, I mean that’s, that’s the beauty of it. You know, I think we kind of got on the right wave back then, which is now we are ready to go to that. And without having thought about the machines and the software initially, now we will be like, ai, what?
I mean, you cannot use AI in a manual process. Yeah. So,
Philip Hemme: yeah. And, and you need kind of the whole basis Yeah. And the data and something that works and then you can build on top. Yeah.
Daniela Marino: And you need to know your process very well because you can get data, but then what do you do with it? I mean, if you don’t know how to read the data, make something out of it.
Anybody can collect data, but so it’s, yeah. 10 years ago it would’ve been completely out of scope.
Philip Hemme: Yeah. Yeah.
[00:56:32] Europe can show its strength in biotech
Philip Hemme: One thing on, with switching of the topic, and you, you tell me you wanted to discuss it on the US Europe Yeah. Thing. You mentioned a bit on the US that there’s some complexity, some. Yeah.
Uncertainties. Yeah. But then you tell me also, it’s probably a chance for, for you, for Europe, way for Europe. Yeah. Can you like,
Daniela Marino: yeah. You know, it’s almost like we were, again, I’m a bio technologist. This is my first company. I’ve heard it all right. And one, the first thing was, ah, but you know, why did you so, you know, create the company Switzerland.
You could have, you should have gone straight to the us. This was a mistake. Why did you start a phase three in Europe? You should have gone straight to the us. This is a mistake because I mean, US is the land of opportunities and there is much more money and there is much more possibility of collaboration.
The FDA is much faster and hospitals are faster and you know, PIs are faster in recruiting and everything was faster and bigger and better. Right. And now we see that. Right now, I mean this faster, bigger, and better is. A little bit more dimension because biotech funding has been cut and FDA has been reduced in, in, in people working for that.
A lot of startups are struggling to, you know, to even engage in m and a conversations. Everybody’s kind of cautious and, and, and Europe has been always like that. Very conservative, very cautious little capital, little everything. So now if the bar on the other side lowers a little and we have been low, you know, it would be easier to compensate right now with much less effort than it used to be in the past.
So it’s a window of opportunity, I think for the, for European to step up and to, to show that there is actually funds here as well. There is good science here as well, and the clinical trials can be run here as well, and that m and a can be done here as well. And that actually, you know, we shouldn’t make it a question of geographies, but the best technologies all over the world should be having the chance to, to get approved and, and to, to move forward.
So I don’t think it’s the, you know, like, oh, now you know, the geopolitical situation is the only chance, but I think if you look at it holistically, Europe could, could have a chance this time, this time to, to show its strengths and we’ll see.
[00:58:52] Daniela Marino answers quick-fire questions
Philip Hemme: Yeah, I like that. I wanna finish with a bit of a quick fire, quick questions.
Okay, I’m ready. Ready Now? One one a bit personal question, but I think, and I remember, and I can still feel it, you’re, I think you’re quite intense and working hard. Yeah. Like why why is it so important to work hard and to be the like, or where is this intensity machine, machine working hard coming from?
Daniela Marino: Yeah. I mean, I don’t know. It’s a combination of things. I really, really believe in what we are doing. Yeah. So it’s almost a personal cause now, you know, you know that I have to get this done. I really think that when you decide to do something, you gotta do it the best you can and the fastest you can because time is money and because doing it not at the best means.
That actually you could have done more. You didn’t, I mean, this is like a horrible thing for me. Like if I could have done more, I should have done more. Right. And I really think everything is going very fast in, in the tech bio and the biotech and everything, so you can’t afford to be behind of even a week on what’s going on.
So it’s an attitude of mine by definition, like to be fast and very competitive. But I think in the sector we are honestly, without this competitiveness and this speed you will not succeed because there will be somebody else doing it. And, and so it has to be like that. And actually even more, I’m actually even too slow these days.
Too slow. I’m getting too old. I need to, I need to find some solutions.
Philip Hemme: What were some of your lessons on perseverance?
Daniela Marino: I mean, that’s what I’m trying to teach my kids. You know, if you really want something there is limits to what one can do and can do or shall not do, but you just have to, to get it done.
You just have to find a way and life will throw anything at you, and you will probably change your path a hundred times, but just don’t drop what you start, you know, because dropping, it’s, it’s, it’s a failure in a way. And things, I mean, you know, it’s like energy. Energy cannot be created and cannot be dis destroy, dis what you say, disrupted or destroyed.
Destroyed, yeah. It’s like that. I mean, if you wanna do something, just get it done one way or another, and eventually what you wanted will also be reshaped. Eventually, you’re not gonna get exactly what you started, you thought you would want. But perseverance is everything. I mean, resilience, you know, just try to get it done one way or another.
That’s what I’m trying to teach my kids because now they’re like, you know, having the first big exam and stuff. Like, what if I don’t pass? If you don’t pass, what do you wanna do? Then we try to find another way, but what do you want? And this is a thing. The, yeah, the never give up kind of attitude. Yeah.
Good.
Philip Hemme: What were some of your challenges on, on work life balance
Daniela Marino: really, don’t you have another question? Okay. I don’t manage to lose weight. I don’t manage to go to sports. I don’t manage to spend some quality time with my husband. So when in a restaurant very often, and I wish I could spend.
More time talking to myself which is not on the trend because I think people still soon think that I’m crazy because I, you know, I’m on the trend like, okay, so what am I doing again? So yeah. It’s tough. Yeah, it’s tough. It’s also special time in my life. I mean, my, you know, with the children it would be easier once they’re bigger.
So now it’s, they need a lot of attention and, and, it’s tough to find time for myself, but I’m good with cutting all possible minutes outta my day to still do what I like. So I have a lot of pleasure in singing and look, you know, stand up comedy and, and other silly things I do to relax. So no big real plan on any sort of meditation or god knows what I’ll, I’ll try to do some sports.
But yeah, it’s tough to balance, but so far so good.
Philip Hemme: Yeah. What do people get wrong about the tissue therapies?
Daniela Marino: What do people
Philip Hemme: get wrong? Yeah.
Daniela Marino: Yeah, if, I dunno, I think they still don’t understand that this is a living thing and they still mix it with MedTech a lot, so they still think that there is no difference between a collagen sponge and the no skin.
Yeah. It’s like, but isn’t that like a. Like something you can just, you know, sell in a box and and like no, this is a tissue, it’s a living tissue. It’s closer to cell therapy than way, you know, than to any med tech thing. And people start, you know, there, it’s been a big mis, especially in my field, skin substitutes.
They have been called skin substitutes, artificial skin for centuries. And this was all collagen sponges and smart dressings. And now I come with a skin substitute myself and and yeah, real actual skin substitute. Yeah, they kind of confuse it a little bit, but it’s changing. I mean, I think it’s becoming much more clear now than it used to be a few years ago.
Philip Hemme: Yeah. One, one, just one advice you would give except we, we mentioned a bit on, on resilience and, but one other advice you would. Give yourself yourself when you were starting the company, like
Daniela Marino: mean apart from losing weight before turning 40. Which would probably be because now it’s impossible. No.
Apart from that I. I mean, honestly speaking the, what really I struggled with at the beginning was trying to filter all the inputs and suggestions and recommendations I got from all the experts around me trying to always remind me that I have the one that doesn’t know. Right? And I think one of the, one of, of my recommendation, if you start now something is that really build your shoulders.
I mean, you will be told that you don’t know that somebody else will do it better, that somebody else can do it better, and that you should just do what they say and whoever this day is right. And I think the best advice I can give is like, listen to everybody and get all the things in, in front of you and build your she comms kind of map and try to build your story out of all of that, because eventually all of them are right and all of them are wrong, but they don’t know.
You don’t know either, right? So just try to be extremely creative. And absorb all possible inputs as as you can, but then you have to build your own story. And I think story building is tough. It’s extremely tough. So dedicate time to build your own story rather than getting distracted and changing your idea because somebody told you, or you heard or build a story and whatever you hear, just put it back on the map, you know?
And maybe the story will change over time, but it’s your story. Yeah. And especially in, in biotech or pioneering fields like ours, I mean, who knows what’s right and what’s wrong. So there is some fundamentals, but. At the end of the days you have to just have to make it work one way or another. So just build your shoulders in a way that you can, you know, head on weight without losing instability.
That’s otherwise you go nuts. I mean, because everybody will always tell you they know better than you.
Philip Hemme: Yeah. Great. And you did it well, so you good.
Thanks Daniel. Great, great second conversation. Yes, thanks a lot. Good luck with everything.
Daniela Marino: Thank you. Fingers crossed.
Philip Hemme: I’m impressed by how Daniella managed to take Q test from a id, academic ID to what it is now today. I’m also impressed by her intensity and perseverance while keeping really good vibes. If you’ve also enjoyed this episode, please hit the like, follow, or review button. Any of these action will help many more people discover the podcast.
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