Luca Benatti: CEO of EryDel

Luca Benatti,  CEO of EryDel, shares his thoughts with BioBoss host John Simboli about leadership in biopharma and how EryDel is working to develop specialized therapies for the treatment of rare diseases by using the patient’s own blood.

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John Simboli: 0:00

Today I'm speaking with Luca Benatti, CEO of EryDel, headquartered in Bresso, Italy. Welcome to BioBoss, Luca.

Luca Benatti: 0:08

Nice to meet you, John. My pleasure to be here and have the chance to speak to you.

John Simboli: 0:13

Luca, what led you to your role as CEO at EryDel?

Luca Benatti: 0:16

I was already a CEO of another company that, actually, I founded. I started early on with my entrepreneurial spirit to move from my first experience as a researcher first and then into the pharma industry. Then I wanted to become an entrepreneur. So I founded my first company and I developed the company up to becoming a public company in Switzerland. We developed assets and a product that became now a marketed product for Parkinsons. At a certain point in time, in that experience, I always have my entrepreurial spirit that kicks in at some point in time. I wanted to, since that was a company already developed at a certain stage, I thought it was time for me to do something else. So I remained somewhat connected with the former company, I'm still on the board of that company. And I had my chief financial officer take over the role of CEO. And then I was just looking around and occasionally, really by chance, I came across this fascinating story from a spinoff from a an Italian university in a small city called Urbino, where the famous painter Raphael was born. And there is a lot of nice painting of Raphael there. But there is also good science. So Professor Magnani was the inventor of this technology, a spin out in a small, really very tiny, small startup. When I came across it I was fascinated by the technology. And I said, that's what I want to do. And that's the start.

John Simboli: 2:21

When you fastened onto that and realized this really held your interest, did you go through a period anything like, well, maybe I'll find the CEO to run this, and I'll be on the board, or I will direct it in some way. But how did you make that decision to say, I'll be the CEO of this?

Luca Benatti: 2:39

It's a good question, because I started as a board member of that company. So they invited me to join and provide my strategic thought. And that helped me in balancing, a bit, the idea that I had just to relax a bit for a year or so because as you know, the life of the CEO is quite hectic, and particularly running biotech companies. And I wanted to slow down a bit. So being a board member, although that was q fairly active activity, it was not like being a CEO. And, and helped me learn a bit more about the company, get in touch with the people and get more attached to the idea. And when I realized that my thoughts on where the company should be going were getting a lot of attention and traction with the board, then it was becoming a bit of a natural decision for me to say then, yeah, I'm here, I have the expertise with the elements and I will start becoming the CEO of the company.

John Simboli: 3:56

Was there something about your early experiences and being raised in the way that you were that made you open to this, this kind of work that you set out to do?

Luca Benatti: 4:05

The field my father was working in was a completely different field. And I had really zero interest to continue what he was doing, I was fascinated by other stuff. But in terms of approach, there are a lot of commonalities. So what I found very interesting, although you're not interested in what your family's doing, or your father is doing, you always get something running by your side, and you get a lot from that. And there was a common sense, which is common with my father, we like to be driving something. And that is what really made me also in the first place, change from being a manager in a pharma company, where I have to admit that I learned a great deal of stuff, from my experience at university I didn't even hear about it. But at some point in time, I ran kind of dry, as we say. I learned and now, the only thing I have in front of me is to become a higher manager and have a better salary, but that was not of any interest to me. So I prefered to just to say, thank you. And I wanted really to move in that direction. But interesting enough, I didn't realize until I reflected in some previous interview or some other discussions I had, that what I did was exactly mirroring what my father did in a completely different field. It was kind of something that I had inside that I needed, but I was not really reflecting on that commonality.

John Simboli: 6:19

Was it a realization that leading was very important? Or was it more a realization that creating was very important?

Luca Benatti: 6:29

Leading in a sense of having the opportunity to be effective, much more than what you can do in a much larger organization that I have experienced for more than a decade of my business experience. And when you really understand where you want to go, you have to create a team. And you have to care not of the infrastructure, while in some organizations it's more spending most of your time taking care of the infrastructure that the actual projects. And that is where creativity can be more free to play. And ultimately, you much more fun in what you're doing, I believe, at least from my perspective,

John Simboli: 7:25

What were you hoping to achieve that could be done at EryDel and not at another company?

Luca Benatti: 7:30

You can do many multiple things in college and biotech. What I found myself more and more engaged with is really geting into something real. And something real for me is not building a company and making money. But it's getting new therapies. And I did with my first company; we have the novel treatment for Parkinson's disease. It's now available worldwide. So there are patients that benefit from the work that my team and I did in the previous company. With EryDel, though, what we are aiming at is, as you know, we are focused on rare disease conditions. And I have to say this has been really something new as a field for my previous experience. So I had the opportunity and it was a great experience for me to get in more direct contact with the patients and the families. And I realized more directly, because it's one thing to read in a paper or in a publications, but to get really face to face with the people and understand their problem, the issues with the disease, how difficult could be their life and not only for the patient, but for the caregivers. It's making the work you're doing even more important. It's not that other diseases that are out there are less important because they are simply affecting a large number of people. But I don't think that you have working outside the rare disease, this opportunity to really be so close to the patients and that has been an important element and component of the experience and the growth I had through EryDel. And what we are trying to achieve here is to really use this technology that we believe has many other opportunities to really develop and get access for the patients to a novel treatment for this devastating disease. And this is really what is the driver for me is the driver for all the team and the people at EryDel.

John Simboli: 10:02

When you're speaking with someone who is intelligent, thoughtful, doesn't work in biopharma and biotech and says,Luca, what do you do for a living? What's your answer for that?

Luca Benatti: 10:13

I work in a biotech company and we develop therapeutics for rare disease conditions. Now from that statement, you can get any kind of questions. You can approach someone that is saying, Oh, you are a bad guy working in the pharma industry, and you're going to charge us with a high price. And that's what you want to do in life, you make money. Some other maybe, and this is fortunately, some cases that I will not disregard, but they are happening. But most of the people start getting interested in how you do that. Because people don't know what is behind the pill that they are taking when they go to the pharmacy. And I realized that there is a tremendous gap in knowledge. Even if you're dealing with educated people, they don't understand the complexity of that process, the time that is required to get there, and how many attempts simply fail regardless of whether you have good science behind, or not. Most of the cases, they have very good science behind them. But it's so complex and so difficult to develop drugs. And I realized that this is really a significant gap out there, and people don't get it.

John Simboli: 11:55

When people get curious about that, if they do listen to what you were just saying to me. if they go down the route of picturing what you're doing during the day, like I imagine a certain number of people picture you in a lab smock making scientific decisions. How do you explain what you do all day as a CEO? What does a biopharma biotech CEO do?

Luca Benatti: 12:19

I explain that first of all, there is one context that they need to understand that is, you are not Pfizer or Biogen of the kind. So you don't have basically a running business, you have a running fundraising business. So most of your time is, how do I convince people, that are smart people, because they are very educated and experienced investors to support what you're doing. And until you have raised some money to do it, then you have to start thinking to raise the next level of money. And you need to demonstrate that. So that is something that I explain to the people, that is another piece that is not understood, because it looks like you got the money, you do it and you make business. That's it, and it's not the case. Then the other things I am doing, and I explain, is in this small organization, you need really to make sure that you have very straightforward connections with everyone. And that goes from the board, to your shareholders, to all your collaborators. And because it's so important that you are part of all the issues, and I'm telling you there is an issue, not every day—every morning and every afternoon. And if you really want to work it out, you need to have straight communications with everyone. And it's not an organization of 200 people, you can do it, but you need to establish the right environment so that people are free to talk to you. They are not afraid. And there is a ground where you can work together and try to move tjomgs forward. And that applies, again, to the higher level which is the board or the shareholders, the one that provides the money with your collaborator. And that's my work.

John Simboli: 14:57

How would you describe your management approach?

Luca Benatti: 15:00

First of all, listen. Although sometimes you may be under stress, and you want to get to the point, you need always, with any of your collaborators, to find the right time to listen. Because it's a very easy approach just to meet an order; you do it, give me the results. But in my experience, the outcome is not the one you want. So you need to understand, you need to look at the different characteristics of your collaborator and try to use their capacity because everyone has pros and cons, including myself. And you need to create an environment where the process counts. And I'm trying to explain, in all my conversations with the team, that they should be applying the same with their collaborators, because that's the way you can really extract the best from from the team and the people.

John Simboli: 16:13

Do you remember what it was you wanted to do when you were maybe eight or nine or 10? In that period, when we're all probably had an image of what we want to be as a grown up based on what we thought our parents might want us to be? Can you remember that? Does that have anything to do with your professional life now?

Luca Benatti: 16:29

Not at all. I remember that very vividly because I was spending a significant part of my time doing models, building airplanes, and I wanted to become an airplane engineer. I want to build airplanes. Everybody in the family, parents or whatever, oh, so Luca, what are you going to do in life? I will build big airplanes, I want to have that. And then my life is completely different.

John Simboli: 17:12

Was there a moment when that dream became another dream?

Luca Benatti: 17:17

Then I think I had my high school days, when it was just fading away, although I was still a bit attached to that. And then it becomes the period of my life where I was kind of moving one week in one direction the other week in another direction. I finished my school. And I didn't make during the summer, yet, about the decision of where to go for the university. And I just flipped three options. One was still the engineering, another one was physics. And the other one was biology, that I did. And then I decided to go for biology, but just with no real, not really being convinced. And I was about, after the first year, to change because I was completely disappointed by the first year of university. Because it was full of chemistry, mathematics, things that I didn't really enjoy. And I was about to switch into informatics. And I was really preparing the paper for that. Then I said, Okay, let's go for starting this course on genetics. That was the second year of the university. And I listened to the first lesson and I said, Wow, that's what I want to do. And then I became really attracted by all the genetic studies. I did my thesis on genetics for two years in a lab. And that became really what I loved. And I'm still very attracted by all this genetic molecular biology. It was the early days of molecular biology. But that was just by chance. You know, if I had a bit more time, and not willing to get into that course, I would have been maybe in informatics.

John Simboli: 19:17

Can you recall what that realization was that this was for you? What was it about it that drew you?

Luca Benatti: 19:25

One aspect was how the teacher was passionate in talking about his experience, because he was talking about experiments that he was running in the lab. He was very lively; an entertaining lesson. But also I have to tell you, I was fascinated because I hadn't thought until that time in my in my school experience, the guy was making an example, I still remember that example, that I was saying, Wow. That was making the example, and probably it was shocking for some in the room. If your mother has blue eyes, and your father has blue eyes, and you have black eyes, there is something wrong. And then I realized that there is something inside of you that can be so precise in what is happening. And then I started looking inside and the genes and the transmissions, Mandel, and all the story that was completely brand new for me.

John Simboli: 20:53

Luca, what do you say when people ask who is EryDel?

Luca Benatti: 20:57

We are a platform technology company. And we have the only technology worldwide available today that allows a point of care process that takes a small amount of blood from the patient, processes into this small machine, the component of the blood that is called red blood cells, so erythrocytes, in a way that allows us to insert into the erythrocytes a drug, therapeutics. And then those red blood cells are infused back into the patients and distributed in the body. So it's a delivery technology that is utilizing the patient's blood. So it's. if you wish, a kind of personalized medicine that is a point of care technology. So that's the technology itself. We have multiple applications of that technology. The first one, the most advanced, is a treatment for a devastating neurological rare condition called ataxia-telangiectasia.

John Simboli: 22:29

Patients suffering from ataxia, I understand there are many different varieties of the subset that you're working on, what do those patients go through? What current treatments do they have and where do you hope to take that?

Luca Benatti: 22:47

Most of the patients have a severe form of the disease, meaning that in early days in life, call it when they start really walking independently, you start noticing that they have some stability problem, you know, gait walking capabilities become more and more progressing to a point where by the age of, call it the second decade of life, unfortunately, they become wheelchair-bound. And so, they cannot really work anymore. The impairment they have affects also the upper part of the body. And so, they have coordination problems that may affect their day to day life, in capability of dressing, in combing, in eating, in writing, typing. It affects also a bit the speech capabilities. And so, with all that, you may see that progressively the child has impairment in communications, in capability to play with the adults, in going to school and progressively, of course, the amount of time the family has to support the child becomes more and more extensive up to a point where some of the members of the family may quit work and become full-time dedicated to the children. So the main component is neurological. But there are other, unfortunately, other aspects of the disease. For instance, the immune system is also significantly impaired in this child And because of that, they have very recurrent numbers of infections. And in most cases are severe infections, they get very frequent pulmonary infections. And therefore they're very fragile themselves. But the real, because you can be treated for infection, so the real unmet need is the neurological impairment of the child and currently there is no treatment. And what they can do is a bit of physical therapy that may facilitate, a bit, their coordination, but nothing is really available, so far, for this case,

John Simboli: 25:49

If EryDel succeeds, as you hope it will, and there is a treatment that you can get approved and the doctors can prescribe, what can you picture that treatment doing for those patients? How would it change their lives?

Luca Benatti: 26:03

If we look at the results that we have obtained so far, there is one analysis that has been recently completed from the phase three trial that we have conducted and is basically an analysis that looks at the patients that have been enrolled in the trial. And just to explain the word patients, in the trial is randomized into three groups: patients that have been treated with placebo, patients that have been treated with low dose and a high dose. And we followed those patients over time to look at when they became non-autonomous, in their walking capabilities. Being this is a very hard and direct endpoint to really measure something that is affecting, immediately, their their quality of life, right? You need a trolley; your life is completely affected. So we measured that, and that analysis showed that there is a dramatic delay in becoming non-autonomous, in your walking, that is dramatically positive for the high-dose group it is also very importantly by the low-dose group. And unfortunately, if you were in the placebo, that effect is very, very negative. So just to give you some number, 50% of the patients in placebo became non-autonomous in their walking in nine months, low-dose group in 20 months, high dose group didn't even reach the 50%. So the number of patients that were protected from becoming non-autonomous, it's much, much higher number. So that is a very clear demonstration, that by taking this treatment, unfortunately, you're not going to cure the disease, we are far from there. But you have a dramatic delay in the occurrence of the effect that will impair dramatically the quality of your life. So the sooner you're going to get the treatment and access to the treatment, the better is going to be your outcome. Because you're going to delay the point in time you're going to get in the wheelchair. You can maintain your autonomous life without being completely dependent on a caregiver. There are elements that may also cause you depression symptoms, psychologically. If you are leaving the car that brings you to the school and you can get out from the car and go inside your classroom without any help. You can imagine how you will be seen by the other kids. If you have to come with a trolley or if you go to a restaurant with your family and you cannot feed yourself autonomously, I believe that a good number of these kids, if that is what is happening to them, they don't even want to go to a restaurant anymore. So that is the kind of thing that one has to translate in day to day activities. And think how much this is going to affect, not only from a functional point of view, your day to day, but also psychologically, your life.

John Simboli: 30:30

How would you describe the mechanism of action for what EryDel does?

Luca Benatti: 30:34

We have basically three areas where we are applying our technology. The first is for solving the unmet medical need in ataxia-telangiectasia. I will call it AT because it's easier to say and understand. And basically, what our technology is able to do is to create sustained release formulations of known therapeutics that otherwise cannot be used in oral delivery, like a normal pill, because it's causing, in these patients, an enormous number of side effects that limits the use. The second group of applications of our technology is for solving the issues that is in a good chunk of other rare disease conditions, where there is a difference, from AT, an existing therapeutics. But those therapeutics have dramatic limitations, because they cause anaphylactic shock risk. They have a blackbox warning, because these are recombinant proteins. So with the delivery into the red blood cells, in this case it's not a sustained release formulation, but we keep the enzyme into the red blood cells. In this way, we protect the enzyme from the immune response of the of the organism. And therefore we have a better and safer way to administer known therapeutics and as a better next generation of therapeutics for responding to the unmet medical need in these diseases. The third area where we are applying our technology is that in the gene therapy space, we have developed a procedure where we generate from red blood cells as more or less the cellular vesicles that are a natural component of the red blood cells, and can be used for delivery of RNA and other genetic materials into the organism. And this is, call it at the infancy of that technology. But this could be the next generation of products that through our technology, we hope to develop in the near future.

John Simboli: 33:11

When you present those three related ideas, and perhaps to a potential investor, and that person may misunderstand what it is that your company is about, what categories do you sometimes find yourself being put into that you have to backtrack and say no, it's actually not that? I can imagine for instance, oh, your device company.

Luca Benatti: 33:33

You know, at the beginning, I have to say we have been quite often classified as a device company. But then once you enter, and you get more clarity on what we are doing, we are definitely in the space of therapeutics. So we are not a device. And sometimes people also understand the biology linked to the erythrocytes and they kind of think of a cell therapy kind of approach. So I'm glad you raised the point because ultimately the way we should be identified, and this is actually the the way that the FDA has considered us., we're dealing with a combination product here. And that's actually the regulatory pathway by the FDA. Because ultimately, this technology requires a drug that could be a small molecule or DNA or RNA or could be a protein, requires cells which are specific cells of our organism which are the erythrocytes, or red blood cells, and requires a device. And the combination of these three components makes our technology, our product or the characteristic of what we're doing. A combination product kind of things.

John Simboli: 35:08

Does that differentiate the company? Are there others working in that same combination?

Luca Benatti: 35:13

I will say that the main distinctions with our technologies that, as I said at the beginning, we are the only one that are able to perform this technology at the point of care with the device. While other companies that are using the red blood cells, they are using the cell factory approach. So they don't have a dedicated device technology linked to that. So I have to say that in terms of combination product of this kind, we are kind of unique.

John Simboli: 35:48

And to follow up on that, the patient is in a hospital and receives the treatment?

Luca Benatti: 35:53

You don't need to hospitaliz the patients. What we're thinking also in a more commercial setting. For instance, if you take an ataxia patient, as I told you ataxia patients are immunocompromised, they go to infusion centers for receiving immunoglobulin infusions on a monthly basis, our treatment is also monthly. So we think that what is How does the EryDel pipeline express your vision for the happening, the patient goes to the infusion center, takes the immunoglobulin infusions, takes our treatment and then goes home. One important feature of our technology is that the patient doesn't need to stay attached to the device. It's only required for five minutes blood withdrawal as a normal blood exam, and then for 15 minutes infusions, but during the procedure while the machine is working, the patients can go have breakfast or play or whatever, there are no real time consuming issues for the patients. Apart from the time is required for blood withdrawal and blood infusions. company? We focus our technology on rare diseases, and this is the field we are covering. The next plan we have moving forward on top of the ataxia-telangiectasia program, we are thinking to explore the potential of this product for other forms of ataxia because there are similarities and commonality between the different forms of ataxia. And this has also been extremely suggested and supported by the key opinion leader in the field. We have now other programs moving forward for other diseases like Phenylketonuria or refractory gout, which are coming along and we hope to have success with our first product, get these medications to the patients and have the resources to develop the rest of the pipeline and solve some of the unmet medical needs for these devastating diseases.

John Simboli: 38:16

Thanks for speaking with me today, Luca.

Luca Benatti: 38:19

Thank you, John. It was very nice, having the opportunity to talk to you. Very interesting questions. I think I enjoy my time.