0:00

Today I'm speaking

0:00

with Luca Benatti, CEO of

0:03

EryDel, headquartered in Bresso,

0:03

Italy. Welcome to BioBoss, Luca.

0:08

Nice to meet you,

0:08

John. My pleasure to be here and

0:11

have the chance to speak to you.

0:13

Luca, what led you

0:13

to your role as CEO at EryDel?

0:16

I was already a

0:16

CEO of another company that,

0:20

actually, I founded. I started

0:20

early on with my entrepreneurial

0:25

spirit to move from my first

0:25

experience as a researcher first

0:33

and then into the pharma

0:33

industry. Then I wanted to

0:36

become an entrepreneur. So I

0:36

founded my first company and I

0:41

developed the company up to

0:41

becoming a public company in

0:48

Switzerland. We developed assets

0:48

and a product that became now a

0:53

marketed product for Parkinsons.

0:53

At a certain point in time, in

0:58

that experience, I always have

0:58

my entrepreurial spirit that

1:04

kicks in at some point in time.

1:04

I wanted to, since that was a

1:09

company already developed at a

1:09

certain stage, I thought it was

1:14

time for me to do something

1:14

else. So I remained somewhat

1:18

connected with the former

1:18

company, I'm still on the board

1:22

of that company. And I had my

1:22

chief financial officer take

1:27

over the role of CEO. And then I

1:27

was just looking around and

1:34

occasionally, really by chance,

1:34

I came across this fascinating

1:42

story from a spinoff from a an

1:42

Italian university in a small

1:49

city called Urbino, where the

1:49

famous painter Raphael was born.

1:54

And there is a lot of nice

1:54

painting of Raphael there. But

2:00

there is also good science. So

2:00

Professor Magnani was the

2:04

inventor of this technology, a

2:04

spin out in a small, really very

2:09

tiny, small startup. When I came

2:09

across it I was fascinated by

2:14

the technology. And I said,

2:14

that's what I want to do. And

2:19

that's the start.

2:21

When you fastened

2:21

onto that and realized this

2:24

really held your interest, did

2:24

you go through a period anything

2:28

like, well, maybe I'll find the

2:28

CEO to run this, and I'll be on

2:33

the board, or I will direct it

2:33

in some way. But how did you

2:35

make that decision to say, I'll

2:35

be the CEO of this?

2:39

It's a good

2:39

question, because I started as a

2:42

board member of that company. So

2:42

they invited me to join and

2:48

provide my strategic thought.

2:48

And that helped me in balancing,

2:56

a bit, the idea that I had just

2:56

to relax a bit for a year or so

3:02

because as you know, the life of

3:02

the CEO is quite hectic, and

3:06

particularly running biotech

3:06

companies. And I wanted to slow

3:11

down a bit. So being a board

3:11

member, although that was q

3:14

fairly active activity, it was

3:14

not like being a CEO. And, and

3:20

helped me learn a bit more about

3:20

the company, get in touch with

3:24

the people and get more attached

3:24

to the idea. And when I realized

3:30

that my thoughts on where the

3:30

company should be going were

3:35

getting a lot of attention and

3:35

traction with the board, then it

3:41

was becoming a bit of a natural

3:41

decision for me to say then,

3:47

yeah, I'm here, I have the

3:47

expertise with the elements and

3:52

I will start becoming the CEO of

3:52

the company.

3:56

Was there something about your early experiences and being raised in

3:58

the way that you were that made

4:01

you open to this, this kind of

4:01

work that you set out to do?

4:05

The field my

4:05

father was working in was a

4:08

completely different field. And

4:08

I had really zero interest to

4:15

continue what he was doing, I

4:15

was fascinated by other stuff.

4:22

But in terms of approach, there

4:22

are a lot of commonalities. So

4:28

what I found very interesting,

4:28

although you're not interested

4:37

in what your family's doing, or

4:37

your father is doing, you always

4:42

get something running by your

4:42

side, and you get a lot from

4:51

that. And there was a common

4:51

sense, which is common with my

4:58

father, we like to be driving

4:58

something. And that is what

5:08

really made me also in the first

5:08

place, change from being a

5:14

manager in a pharma company,

5:14

where I have to admit that I

5:18

learned a great deal of stuff,

5:18

from my experience at university

5:24

I didn't even hear about it. But

5:24

at some point in time, I ran

5:30

kind of dry, as we say. I

5:30

learned and now, the only thing

5:37

I have in front of me is to

5:37

become a higher manager and have

5:40

a better salary, but that was

5:40

not of any interest to me. So I

5:45

prefered to just to say, thank

5:45

you. And I wanted really to move

5:50

in that direction. But

5:50

interesting enough, I didn't

5:54

realize until I reflected in

5:54

some previous interview or some

6:01

other discussions I had, that

6:01

what I did was exactly mirroring

6:06

what my father did in a

6:06

completely different field. It

6:09

was kind of something that I had

6:09

inside that I needed, but I was

6:16

not really reflecting on that

6:16

commonality.

6:19

Was it a

6:19

realization that leading was

6:23

very important? Or was it more a

6:23

realization that creating was

6:27

very important?

6:29

Leading in a sense

6:29

of having the opportunity to be

6:34

effective, much more than what

6:34

you can do in a much larger

6:39

organization that I have

6:39

experienced for more than a

6:43

decade of my business

6:43

experience. And when you really

6:50

understand where you want to go,

6:50

you have to create a team. And

6:55

you have to care not of the

6:55

infrastructure, while in some

7:04

organizations it's more spending

7:04

most of your time taking care of

7:07

the infrastructure that the

7:07

actual projects. And that is

7:11

where creativity can be more

7:11

free to play. And ultimately,

7:18

you much more fun in what you're

7:18

doing, I believe, at least from

7:24

my perspective,

7:25

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

7:27

another company?

7:30

You can do many

7:30

multiple things in college and

7:33

biotech. What I found myself

7:33

more and more engaged with is

7:39

really geting into something

7:39

real. And something real for me

7:44

is not building a company and

7:44

making money. But it's getting

7:50

new therapies. And I did with my

7:50

first company; we have the novel

7:54

treatment for Parkinson's

7:54

disease. It's now available

7:57

worldwide. So there are patients

7:57

that benefit from the work that

8:03

my team and I did in the

8:03

previous company. With EryDel,

8:07

though, what we are aiming at

8:07

is, as you know, we are focused

8:13

on rare disease conditions. And

8:13

I have to say this has been

8:20

really something new as a field

8:20

for my previous experience. So I

8:25

had the opportunity and it was a

8:25

great experience for me to get

8:32

in more direct contact with the

8:32

patients and the families. And I

8:38

realized more directly, because

8:38

it's one thing to read in a

8:41

paper or in a publications, but

8:41

to get really face to face with

8:45

the people and understand their

8:45

problem, the issues with the

8:50

disease, how difficult could be

8:50

their life and not only for the

8:55

patient, but for the caregivers.

8:55

It's making the work you're

9:00

doing even more important. It's

9:00

not that other diseases that are

9:08

out there are less important

9:08

because they are simply

9:12

affecting a large number of

9:12

people. But I don't think that

9:16

you have working outside the

9:16

rare disease, this opportunity

9:21

to really be so close to the

9:21

patients and that has been an

9:25

important element and component

9:25

of the experience and the growth

9:31

I had through EryDel. And what

9:31

we are trying to achieve here is

9:38

to really use this technology

9:38

that we believe has many other

9:44

opportunities to really develop

9:44

and get access for the patients

9:51

to a novel treatment for this

9:51

devastating disease. And this is

9:56

really what is the driver for me

9:56

is the driver for all the team

10:00

and the people at EryDel.

10:02

When you're speaking with someone who is intelligent, thoughtful, doesn't

10:04

work in biopharma and biotech

10:08

and says,Luca, what do you do

10:08

for a living? What's your answer

10:12

for that?

10:13

I work in a

10:13

biotech company and we develop

10:19

therapeutics for rare disease

10:19

conditions. Now from that

10:24

statement, you can get any kind

10:24

of questions. You can approach

10:29

someone that is saying, Oh, you

10:29

are a bad guy working in the

10:33

pharma industry, and you're

10:33

going to charge us with a high

10:36

price. And that's what you want

10:36

to do in life, you make money.

10:43

Some other maybe, and this is

10:43

fortunately, some cases that I

10:49

will not disregard, but they are

10:49

happening. But most of the

10:53

people start getting interested

10:53

in how you do that. Because

10:59

people don't know what is behind

10:59

the pill that they are taking

11:06

when they go to the pharmacy.

11:06

And I realized that there is a

11:11

tremendous gap in knowledge.

11:11

Even if you're dealing with

11:17

educated people, they don't

11:17

understand the complexity of

11:22

that process, the time that is

11:22

required to get there, and how

11:29

many attempts simply fail

11:29

regardless of whether you have

11:35

good science behind, or not.

11:35

Most of the cases, they have

11:40

very good science behind them.

11:40

But it's so complex and so

11:44

difficult to develop drugs. And

11:44

I realized that this is really a

11:51

significant gap out there, and

11:51

people don't get it.

11:55

When people get

11:55

curious about that, if they do

11:58

listen to what you were just

11:58

saying to me. if they go down

12:02

the route of picturing what

12:02

you're doing during the day,

12:05

like I imagine a certain number

12:05

of people picture you in a lab

12:09

smock making scientific

12:09

decisions. How do you explain

12:14

what you do all day as a CEO?

12:14

What does a biopharma biotech

12:18

CEO do?

12:19

I explain that

12:19

first of all, there is one

12:24

context that they need to

12:24

understand that is, you are not

12:30

Pfizer or Biogen of the kind. So

12:30

you don't have basically a

12:38

running business, you have a

12:38

running fundraising business. So

12:46

most of your time is, how do I

12:46

convince people, that are smart

12:52

people, because they are very

12:52

educated and experienced

12:55

investors to support what you're

12:55

doing. And until you have raised

13:03

some money to do it, then you

13:03

have to start thinking to raise

13:06

the next level of money. And you

13:06

need to demonstrate that. So

13:11

that is something that I explain

13:11

to the people, that is another

13:16

piece that is not understood,

13:16

because it looks like you got

13:21

the money, you do it and you

13:21

make business. That's it, and

13:24

it's not the case. Then the

13:24

other things I am doing, and I

13:31

explain, is in this small

13:31

organization, you need really to

13:40

make sure that you have very

13:40

straightforward connections with

13:48

everyone. And that goes from the

13:48

board, to your shareholders, to

13:56

all your collaborators. And

13:56

because it's so important that

14:03

you are part of all the issues,

14:03

and I'm telling you there is an

14:07

issue, not every day—every

14:07

morning and every afternoon. And

14:15

if you really want to work it

14:15

out, you need to have straight

14:21

communications with everyone.

14:21

And it's not an organization of

14:25

200 people, you can do it, but

14:25

you need to establish the right

14:30

environment so that people are

14:30

free to talk to you. They are

14:35

not afraid. And there is a

14:35

ground where you can work

14:41

together and try to move tjomgs

14:41

forward. And that applies,

14:46

again, to the higher level which

14:46

is the board or the

14:49

shareholders, the one that

14:49

provides the money with your

14:53

collaborator. And that's my

14:53

work.

14:57

How would you describe your management approach?

15:00

First of all,

15:00

listen. Although sometimes you

15:04

may be under stress, and you

15:04

want to get to the point, you

15:09

need always, with any of your

15:09

collaborators, to find the right

15:14

time to listen. Because it's a

15:14

very easy approach just to meet

15:22

an order; you do it, give me the

15:22

results. But in my experience,

15:28

the outcome is not the one you

15:28

want. So you need to understand,

15:34

you need to look at the

15:34

different characteristics of

15:38

your collaborator and try to use

15:38

their capacity because everyone

15:44

has pros and cons, including

15:44

myself. And you need to create

15:48

an environment where the process

15:48

counts. And I'm trying to

15:57

explain, in all my conversations

15:57

with the team, that they should

16:02

be applying the same with their

16:02

collaborators, because that's

16:06

the way you can really extract

16:06

the best from from the team and

16:11

the people.

16:13

Do you remember

16:13

what it was you wanted to do

16:15

when you were maybe eight or

16:15

nine or 10? In that period, when

16:18

we're all probably had an image

16:18

of what we want to be as a grown

16:22

up based on what we thought our

16:22

parents might want us to be? Can

16:25

you remember that? Does that

16:25

have anything to do with your

16:28

professional life now?

16:29

Not at all. I

16:29

remember that very vividly

16:36

because I was spending a

16:36

significant part of my time

16:43

doing models, building

16:43

airplanes, and I wanted to

16:52

become an airplane engineer. I

16:52

want to build airplanes.

17:00

Everybody in the family, parents

17:00

or whatever, oh, so Luca, what

17:04

are you going to do in life? I

17:04

will build big airplanes, I want

17:07

to have that. And then my life

17:07

is completely different.

17:12

Was there a moment

17:12

when that dream became another

17:16

dream?

17:17

Then I think I had

17:17

my high school days, when it was

17:21

just fading away, although I was

17:21

still a bit attached to that.

17:27

And then it becomes the period

17:27

of my life where I was kind of

17:31

moving one week in one direction

17:31

the other week in another

17:35

direction. I finished my school.

17:35

And I didn't make during the

17:41

summer, yet, about the decision

17:41

of where to go for the

17:43

university. And I just flipped

17:43

three options. One was still the

17:51

engineering, another one was

17:51

physics. And the other one was

17:55

biology, that I did. And then I

17:55

decided to go for biology, but

18:00

just with no real, not really

18:00

being convinced. And I was

18:04

about, after the first year, to

18:04

change because I was completely

18:08

disappointed by the first year

18:08

of university. Because it was

18:14

full of chemistry, mathematics,

18:14

things that I didn't really

18:19

enjoy. And I was about to switch

18:19

into informatics. And I was

18:27

really preparing the paper for

18:27

that. Then I said, Okay, let's

18:32

go for starting this course on

18:32

genetics. That was the second

18:38

year of the university. And I

18:38

listened to the first lesson and

18:43

I said, Wow, that's what I want

18:43

to do. And then I became really

18:50

attracted by all the genetic

18:50

studies. I did my thesis on

18:55

genetics for two years in a lab.

18:55

And that became really what I

19:00

loved. And I'm still very

19:00

attracted by all this genetic

19:04

molecular biology. It was the

19:04

early days of molecular biology.

19:08

But that was just by chance. You

19:08

know, if I had a bit more time,

19:12

and not willing to get into that

19:12

course, I would have been maybe

19:16

in informatics.

19:17

Can you recall

19:17

what that realization was that

19:20

this was for you? What was it

19:20

about it that drew you?

19:25

One aspect was how

19:25

the teacher was passionate in

19:32

talking about his experience,

19:32

because he was talking about

19:39

experiments that he was running

19:39

in the lab. He was very lively;

19:44

an entertaining lesson. But also

19:44

I have to tell you, I was

19:50

fascinated because I hadn't

19:50

thought until that time in my in

19:55

my school experience, the guy

19:55

was making an example, I still

20:01

remember that example, that I

20:01

was saying, Wow. That was making

20:06

the example, and probably it was

20:06

shocking for some in the room.

20:16

If your mother has blue eyes,

20:16

and your father has blue eyes,

20:24

and you have black eyes, there

20:24

is something wrong. And then I

20:33

realized that there is something

20:33

inside of you that can be so

20:40

precise in what is happening.

20:40

And then I started looking

20:45

inside and the genes and the

20:45

transmissions, Mandel, and all

20:50

the story that was completely

20:50

brand new for me.

20:53

Luca, what do you

20:53

say when people ask who is

20:56

EryDel?

20:57

We are a platform

20:57

technology company. And we have

21:04

the only technology worldwide

21:04

available today that allows a

21:11

point of care process that takes

21:11

a small amount of blood from the

21:19

patient, processes into this

21:19

small machine, the component of

21:27

the blood that is called red

21:27

blood cells, so erythrocytes, in

21:33

a way that allows us to insert

21:33

into the erythrocytes a drug,

21:40

therapeutics. And then those red

21:40

blood cells are infused back

21:46

into the patients and

21:46

distributed in the body. So it's

21:52

a delivery technology that is

21:52

utilizing the patient's blood.

21:59

So it's. if you wish, a kind of

21:59

personalized medicine that is a

22:08

point of care technology. So

22:08

that's the technology itself. We

22:13

have multiple applications of

22:13

that technology. The first one,

22:18

the most advanced, is a

22:18

treatment for a devastating

22:24

neurological rare condition

22:24

called ataxia-telangiectasia.

22:29

Patients suffering

22:29

from ataxia, I understand there

22:33

are many different varieties of

22:33

the subset that you're working

22:38

on, what do those patients go

22:38

through? What current treatments

22:44

do they have and where do you

22:44

hope to take that?

22:47

Most of the

22:47

patients have a severe form of

22:50

the disease, meaning that in

22:50

early days in life, call it when

22:57

they start really walking

22:57

independently, you start

23:01

noticing that they have some

23:01

stability problem, you know,

23:09

gait walking capabilities become

23:09

more and more progressing to a

23:17

point where by the age of, call

23:17

it the second decade of life,

23:22

unfortunately, they become

23:22

wheelchair-bound. And so, they

23:27

cannot really work anymore. The

23:27

impairment they have affects

23:33

also the upper part of the body.

23:33

And so, they have coordination

23:39

problems that may affect their

23:39

day to day life, in capability

23:46

of dressing, in combing, in

23:46

eating, in writing, typing. It

23:56

affects also a bit the speech

23:56

capabilities. And so, with all

24:03

that, you may see that

24:03

progressively the child has

24:09

impairment in communications, in

24:09

capability to play with the

24:14

adults, in going to school and

24:14

progressively, of course, the

24:20

amount of time the family has to

24:20

support the child becomes more

24:28

and more extensive up to a point

24:28

where some of the members of the

24:34

family may quit work and become

24:34

full-time dedicated to the

24:40

children. So the main component

24:40

is neurological. But there are

24:49

other, unfortunately, other

24:49

aspects of the disease. For

24:54

instance, the immune system is

24:54

also significantly impaired in

24:58

this child And because of that,

24:58

they have very recurrent numbers

25:05

of infections. And in most cases

25:05

are severe infections, they get

25:12

very frequent pulmonary

25:12

infections. And therefore

25:17

they're very fragile themselves.

25:17

But the real, because you can be

25:24

treated for infection, so the

25:24

real unmet need is the

25:28

neurological impairment of the

25:28

child and currently there is no

25:33

treatment. And what they can do

25:33

is a bit of physical therapy

25:41

that may facilitate, a bit,

25:41

their coordination, but nothing

25:45

is really available, so far, for

25:45

this case,

25:49

If EryDel

25:49

succeeds, as you hope it will,

25:51

and there is a treatment that

25:51

you can get approved and the

25:55

doctors can prescribe, what can

25:55

you picture that treatment doing

26:00

for those patients? How would it

26:00

change their lives?

26:03

If we look at the

26:03

results that we have obtained so

26:06

far, there is one analysis that

26:06

has been recently completed from

26:16

the phase three trial that we

26:16

have conducted and is basically

26:21

an analysis that looks at the

26:21

patients that have been enrolled

26:25

in the trial. And just to

26:25

explain the word patients, in

26:30

the trial is randomized into

26:30

three groups: patients that have

26:36

been treated with placebo,

26:36

patients that have been treated

26:41

with low dose and a high dose.

26:41

And we followed those patients

26:47

over time to look at when they

26:47

became non-autonomous, in their

26:57

walking capabilities. Being this

26:57

is a very hard and direct

27:04

endpoint to really measure

27:04

something that is affecting,

27:08

immediately, their their quality

27:08

of life, right? You need a

27:14

trolley; your life is completely

27:14

affected. So we measured that,

27:21

and that analysis showed that

27:21

there is a dramatic delay in

27:29

becoming non-autonomous, in your

27:29

walking, that is dramatically

27:36

positive for the high-dose group

27:36

it is also very importantly by

27:42

the low-dose group. And

27:42

unfortunately, if you were in

27:44

the placebo, that effect is

27:44

very, very negative. So just to

27:50

give you some number, 50% of the

27:50

patients in placebo became

27:55

non-autonomous in their walking

27:55

in nine months, low-dose group

27:59

in 20 months, high dose group

27:59

didn't even reach the 50%. So

28:08

the number of patients that were

28:08

protected from becoming

28:12

non-autonomous, it's much, much

28:12

higher number. So that is a very

28:18

clear demonstration, that by

28:18

taking this treatment,

28:24

unfortunately, you're not going

28:24

to cure the disease, we are far

28:27

from there. But you have a

28:27

dramatic delay in the occurrence

28:33

of the effect that will impair

28:33

dramatically the quality of your

28:40

life. So the sooner you're going

28:40

to get the treatment and access

28:49

to the treatment, the better is

28:49

going to be your outcome.

28:54

Because you're going to delay

28:54

the point in time you're going

28:58

to get in the wheelchair. You

28:58

can maintain your autonomous

29:05

life without being completely

29:05

dependent on a caregiver. There

29:11

are elements that may also cause

29:11

you depression symptoms,

29:22

psychologically. If you are

29:22

leaving the car that brings you

29:30

to the school and you can get

29:30

out from the car and go inside

29:36

your classroom without any help.

29:36

You can imagine how you will be

29:42

seen by the other kids. If you

29:42

have to come with a trolley or

29:48

if you go to a restaurant with

29:48

your family and you cannot feed

29:52

yourself autonomously, I believe

29:52

that a good number of these

30:00

kids, if that is what is

30:00

happening to them, they don't

30:03

even want to go to a restaurant

30:03

anymore. So that is the kind of

30:09

thing that one has to translate

30:09

in day to day activities. And

30:16

think how much this is going to

30:16

affect, not only from a

30:21

functional point of view, your

30:21

day to day, but also

30:25

psychologically, your life.

30:30

How would you

30:30

describe the mechanism of action

30:32

for what EryDel does?

30:34

We have basically

30:34

three areas where we are

30:38

applying our technology. The

30:38

first is for solving the unmet

30:46

medical need in

30:46

ataxia-telangiectasia. I will

30:50

call it AT because it's easier

30:50

to say and understand. And

30:56

basically, what our technology

30:56

is able to do is to create

31:02

sustained release formulations

31:02

of known therapeutics that

31:07

otherwise cannot be used in oral

31:07

delivery, like a normal pill,

31:13

because it's causing, in these

31:13

patients, an enormous number of

31:17

side effects that limits the

31:17

use. The second group of

31:25

applications of our technology

31:25

is for solving the issues that

31:31

is in a good chunk of other rare

31:31

disease conditions, where there

31:37

is a difference, from AT, an

31:37

existing therapeutics. But those

31:43

therapeutics have dramatic

31:43

limitations, because they cause

31:49

anaphylactic shock risk. They

31:49

have a blackbox warning, because

31:53

these are recombinant proteins.

31:53

So with the delivery into the

31:58

red blood cells, in this case

31:58

it's not a sustained release

32:03

formulation, but we keep the

32:03

enzyme into the red blood cells.

32:07

In this way, we protect the

32:07

enzyme from the immune response

32:11

of the of the organism. And

32:11

therefore we have a better and

32:16

safer way to administer known

32:16

therapeutics and as a better

32:20

next generation of therapeutics

32:20

for responding to the unmet

32:24

medical need in these diseases.

32:24

The third area where we are

32:28

applying our technology is that

32:28

in the gene therapy space, we

32:35

have developed a procedure where

32:35

we generate from red blood cells

32:41

as more or less the cellular

32:41

vesicles that are a natural

32:46

component of the red blood

32:46

cells, and can be used for

32:51

delivery of RNA and other

32:51

genetic materials into the

32:57

organism. And this is, call it

32:57

at the infancy of that

33:01

technology. But this could be

33:01

the next generation of products

33:05

that through our technology, we

33:05

hope to develop in the near

33:09

future.

33:11

When you present

33:11

those three related ideas, and

33:16

perhaps to a potential investor,

33:16

and that person may

33:20

misunderstand what it is that

33:20

your company is about, what

33:24

categories do you sometimes find

33:24

yourself being put into that you

33:27

have to backtrack and say no,

33:27

it's actually not that? I can

33:31

imagine for instance, oh, your

33:31

device company.

33:33

You know, at the

33:33

beginning, I have to say we have

33:35

been quite often classified as a

33:35

device company. But then once

33:45

you enter, and you get more

33:45

clarity on what we are doing, we

33:50

are definitely in the space of

33:50

therapeutics. So we are not a

33:54

device. And sometimes people

33:54

also understand the biology

34:03

linked to the erythrocytes and

34:03

they kind of think of a cell

34:07

therapy kind of approach. So I'm

34:07

glad you raised the point

34:13

because ultimately the way we

34:13

should be identified, and this

34:18

is actually the the way that the

34:18

FDA has considered us., we're

34:24

dealing with a combination

34:24

product here. And that's

34:27

actually the regulatory pathway

34:27

by the FDA. Because ultimately,

34:33

this technology requires a drug

34:33

that could be a small molecule

34:39

or DNA or RNA or could be a

34:39

protein, requires cells which

34:46

are specific cells of our

34:46

organism which are the

34:49

erythrocytes, or red blood

34:49

cells, and requires a device.

34:56

And the combination of these

34:56

three components makes our

35:00

technology, our product or the

35:00

characteristic of what we're

35:04

doing. A combination product

35:04

kind of things.

35:08

Does that

35:08

differentiate the company? Are

35:10

there others working in that

35:10

same combination?

35:13

I will say that

35:13

the main distinctions with our

35:18

technologies that, as I said at

35:18

the beginning, we are the only

35:22

one that are able to perform

35:22

this technology at the point of

35:27

care with the device. While

35:27

other companies that are using

35:32

the red blood cells, they are

35:32

using the cell factory approach.

35:38

So they don't have a dedicated

35:38

device technology linked to

35:42

that. So I have to say that in

35:42

terms of combination product of

35:46

this kind, we are kind of unique.

35:48

And to follow up

35:48

on that, the patient is in a

35:51

hospital and receives the

35:51

treatment?

35:53

You don't need to

35:53

hospitaliz the patients. What

35:57

we're thinking also in a more

35:57

commercial setting. For

36:01

instance, if you take an ataxia

36:01

patient, as I told you ataxia

36:06

patients are immunocompromised,

36:06

they go to infusion centers for

36:11

receiving immunoglobulin

36:11

infusions on a monthly basis,

36:15

our treatment is also monthly.

36:15

So we think that what is

36:17

How does the EryDel pipeline

36:17

express your vision for the

36:20

happening, the patient goes to

36:20

the infusion center, takes the

36:25

immunoglobulin infusions, takes

36:25

our treatment and then goes

36:29

home. One important feature of

36:29

our technology is that the

36:34

patient doesn't need to stay

36:34

attached to the device. It's

36:39

only required for five minutes

36:39

blood withdrawal as a normal

36:43

blood exam, and then for 15

36:43

minutes infusions, but during

36:48

the procedure while the machine

36:48

is working, the patients can go

36:53

have breakfast or play or

36:53

whatever, there are no real time

36:58

consuming issues for the

36:58

patients. Apart from the time is

37:02

required for blood withdrawal

37:02

and blood infusions.

37:09

company? We focus our technology on rare

37:11

diseases, and this is the field

37:16

we are covering. The next plan

37:16

we have moving forward on top of

37:24

the ataxia-telangiectasia

37:24

program, we are thinking to

37:29

explore the potential of this

37:29

product for other forms of

37:34

ataxia because there are

37:34

similarities and commonality

37:37

between the different forms of

37:37

ataxia. And this has also been

37:41

extremely suggested and

37:41

supported by the key opinion

37:46

leader in the field. We have now

37:46

other programs moving forward

37:51

for other diseases like

37:51

Phenylketonuria or refractory

37:55

gout, which are coming along and

37:55

we hope to have success with our

38:02

first product, get these

38:02

medications to the patients and

38:06

have the resources to develop

38:06

the rest of the pipeline and

38:11

solve some of the unmet medical

38:11

needs for these devastating

38:14

diseases.

38:16

Thanks for speaking with me today, Luca.

38:19

Thank you, John.

38:19

It was very nice, having the

38:22

opportunity to talk to you. Very

38:22

interesting questions. I think I

38:25

enjoy my time.