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Topical Ocular Biologics with Claris Bio's Clarke Atwell

Topical Ocular Biologics with Claris Bio's Clarke Atwell

Released Monday, 1st July 2024
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Topical Ocular Biologics with Claris Bio's Clarke Atwell

Topical Ocular Biologics with Claris Bio's Clarke Atwell

Topical Ocular Biologics with Claris Bio's Clarke Atwell

Topical Ocular Biologics with Claris Bio's Clarke Atwell

Monday, 1st July 2024
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0:00

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0:59

. Cross

1:03

my heart , hope to die , stick

1:06

a needle in my eye . I'm

1:08

quite certain that schoolyard phrase which suggests

1:11

the acceptance of torturous pain

1:13

and even death before a vow be

1:15

broken , was not derived

1:18

from some kid's experience with the perinatal

1:20

delivery of a drug to the back of the eyeball

1:22

. But I'm also quite certain

1:25

that it does fairly capture

1:27

the prevailing sentiment about needles

1:30

and their contact with eyeballs . And

1:32

I'm certain that , while biopharma has developed

1:34

some amazing large molecule therapeutics

1:37

for multiple diseases of the eye , the

1:39

patient experience and thus

1:41

adherence would be orders of

1:43

magnitude better if their administration

1:46

did not involve long needles

1:48

plunged deep into eye sockets

1:50

. I'm Matt Pillar , and my guest

1:52

on today's episode of the Business of

1:54

Biotech agrees . His name is Clarke

1:56

Atwell and he's a biopharma

1:58

veteran who's spent the last 20

2:01

some years founding and leading

2:03

companies focused largely

2:05

on ophthalmology . He's

2:08

currently leading ClarisBio as

2:10

founding CEO , a company

2:12

that's in a phase 1-2 trial

2:14

of its lead candidate , a hepatocyte

2:17

growth factor called CSB001

2:20

in patients with neurotrophic

2:22

keratitis . In patients with neurotrophic

2:24

keratitis and you guessed it , the candidate is currently

2:27

and hopefully will remain topically

2:29

administered . Cross

2:32

my heart , hope that I stick a needle in my eye

2:34

. I

2:39

interviewed Clark for Bioprocess Online a few months back and I enjoyed our visit so

2:41

much that I just had to have him on the podcast to share his story . Clark

2:44

, it is great to see you and welcome to

2:46

the business of biotech . Thank

2:48

you very much . It's a pleasure

2:50

to have you , and I want to start

2:52

out by getting to know you a little bit

2:55

and what inspired you to

2:57

become an entrepreneur and

2:59

founder in biotech

3:02

. Given that you started your career

3:04

with some heavyweights Merck

3:07

and Roche and

3:09

directorial positions there before

3:11

you jumped into your first startup . I think your

3:14

first startup was Lux Biosciences

3:16

. You can correct me if I'm wrong here , but generally

3:19

, what inspired this pivot

3:21

that you made away from big

3:23

bio and into the murky

3:26

depths of biotech ? Well

3:31

, it actually wasn't a pivot . So my father

3:33

is a serial entrepreneur , my

3:35

grandfather was a serial entrepreneur and

3:38

I always wanted to be in

3:40

a biotech a smaller company

3:42

I applied to

3:45

coming out of college . After my master's

3:47

I applied to Amgen

3:50

and Genentech and at the time

3:52

this is how old I am at the time they were

3:54

small companies and

3:56

when I called them at

3:59

Amgen specifically , the head of HR

4:01

said that they were hiring

4:03

over 200 people and they were

4:05

not over 200 people and they were not hiring people

4:07

who didn't have any experience . So she

4:10

very wisely said that I should go learn my

4:12

craft at a large pharma and

4:15

I was very fortunate that Merck

4:17

at the time hired a lot of people

4:19

out of my master's program about eight people

4:21

a year and

4:27

so I joined Merck and the pivot there was that I had

4:29

to actually reconsider whether I wanted to be an entrepreneur

4:32

because Merck was such a great company . When

4:34

I was there , I was still under Dr Vagelos and

4:37

it was just an amazing

4:39

company . I did not go to an Ivy

4:41

League school , but I imagine that the

4:44

same level

4:46

of intelligence and thoughtfulness

4:48

and process would be at Harvard

4:50

or MIT or something like that . So

4:54

I always walked into the room and felt I was

4:56

the dumbest person in the room and

4:58

I just continually learned every day

5:01

when I was at Merck and it was just a pleasure

5:03

to be there . So the real pivot was leaving

5:05

. That was the harder thing to

5:07

leave . Yeah

5:10

, you said , your dad and your grandfather were

5:12

entrepreneurs . Were they in life sciences as well

5:14

?

5:15

No , my grandfather was in

5:17

electronics mostly and

5:20

my father went from . There

5:24

was no common theme . He would start

5:26

. He was a stockbroker . He

5:29

had a shipping company . We

5:31

had a farm in Africa . We

5:34

went all over the place .

5:36

Yeah , Well , I can see where those seeds were

5:38

definitely planted there right . If your dad

5:40

was a risk taker who was willing

5:42

to plunge himself , you know , make

5:44

such , you know lateral moves

5:47

. It was kind of written on the wall

5:49

for you , wasn't it ? Yeah , so

5:51

it was . Since

5:56

you left Merck , what was , I

5:58

guess , the inspiration for the

6:00

attention that you've been focusing on

6:03

ophthalmic diseases since

6:06

you kind of charted this

6:08

entrepreneurial path , I

6:10

think ?

6:11

two things . I think the path there was immunology

6:13

. When I was at Roche

6:16

I was lucky enough to be on the

6:18

team to launch CellCept in

6:20

solid organ transplantation and I just I

6:22

loved immunology . It was one of

6:24

those areas that's still being discovered

6:26

and there's lots of new . Everything

6:29

changes . You know , if you have Janeway's book of immunology

6:31

you can pretty much throw it out and start again because

6:34

they update it regularly and it

6:36

was . It's a field that that

6:38

changes dramatically and they're

6:40

just learning so much about it and it touches

6:43

so many aspects of or so many diseases

6:45

or conditions in the body . So

6:48

I really enjoyed that and

6:51

that was how , at Lux Biosciences

6:54

, our first disease

6:56

in the eye was uveitis , which is an autoimmune

6:58

disease of the eye . But

7:00

my introduction to ophthalmology

7:02

came through a brief stint

7:05

at iTech , which was

7:07

David Geyer's company and

7:09

it was his first company and

7:13

it was eye-opening excuse

7:16

the pun , but I enjoyed

7:18

it very , very much . And

7:21

I came to the company through Merck

7:23

alumni that brought me in and

7:25

so I consulted there for about nine

7:28

months and I really enjoyed it .

7:30

Yeah , Was it sort of a conscious

7:32

? You know ? I mean , I spend a lot of time talking

7:34

with biotech leaders who

7:36

don't necessarily marry

7:38

themselves to a specific organ

7:41

or a specific indication even

7:43

, and then some who do you

7:45

know , they decide that that's where they want to play

7:48

and that's where they want to build their career , and it's a conscious

7:50

decision . Where do you kind

7:52

of fall on that ? Do you feel like it was a conscious

7:54

decision to go there and stay

7:56

there ?

7:58

No , I don't think it's a conscious decision

8:01

. I think there are a couple of things

8:03

about ophthalmology that I like a lot . One

8:05

is there are very few organs in the body that

8:07

you can actually observe and you can actually

8:09

see what you're doing and having an effect . So

8:11

that is definitely a benefit

8:14

. The other benefit of ophthalmology

8:16

is , as long as you're doing things that are

8:18

just exclusive to the eye in

8:20

the sense of delivery of drugs , you don't

8:22

have to worry about first pass effect and all

8:25

the other things that you do with a systemic drug

8:27

, so your timelines are a little shorter in the

8:29

eye . And then the other thing I think that

8:31

keeps you in a therapeutic area is

8:33

you develop a network of

8:36

colleagues , friends , people

8:38

you trust and people who your

8:41

team basically . And I think you see that

8:43

in a lot of companies where you

8:45

you work with the same people

8:47

over and over again because you trust each other , you

8:49

finish , you finish each other sentences and

8:52

I think that network kind of creates

8:54

a gravity that keeps you in a therapeutic

8:56

area . But yeah

8:59

, I've worked in infectious disease , uh

9:01

, solid organ transplant , cardiovascular

9:03

HIV , and

9:06

I've enjoyed them all , because

9:08

I enjoy the learning process

9:10

and you learn so

9:12

much when you're deep into

9:14

an indication .

9:16

Yeah , have you found that

9:18

there's any transfer , common

9:24

threads from those other indications that you've worked in to ophthalmology or , I guess , learnings

9:27

that you've taken away from some of those other experiences

9:29

with you know , organ transplant

9:32

and other indications

9:34

that transfer well to the work that you do

9:36

now ?

9:40

I think the thread of immunology is

9:43

very , very helpful and

9:46

a lot of the diseases we'll look at

9:48

with HGF there is an immunological

9:50

component . I think that

9:53

the

9:56

other elements I think are more

9:58

from the patient side . When

10:00

I was fortunate enough to work on Crixivan

10:03

at Merck , it was the early

10:05

days of HIV and Merck

10:07

, when they launched Crixivan , never really saw it

10:09

as a product in the sense of it

10:12

was going to drive revenue or profitability

10:14

. They kind of looked at it as more

10:16

of a service and

10:18

it was something that they had a capability

10:20

in for the protease inhibitors and

10:23

they worked to bring

10:25

that forward . And so the way they

10:27

they worked with the community and their

10:30

relationship with the community taught

10:32

me a lot about how to how to work with

10:34

patients and how to be thoughtful

10:37

not you're not just making a drug , but you're also

10:39

helping a patient population

10:41

and how to look at it you

10:44

, uh , you mentioned , you mentioned teams

10:47

and sort of building momentum and having some gravity

10:49

around people in a

10:51

space .

10:53

And when I think about the Claris bio origin

10:55

story , I want to get

10:57

that from you because I think about the

11:00

doctors . I believe there were

11:02

two Harvard researchers and I'll probably

11:04

mispronounce their names , so correct me if I get these wrong

11:06

, but Drs Reza , dana and

11:08

Sunil . Chauhan Chauhan yes , yeah

11:14

, chauhan . Okay , so they

11:16

were the hepatocyte

11:19

growth factor researchers . That sort

11:21

of became the nucleus

11:24

of the molecule , I

11:26

guess , for lack of a better way of putting

11:28

it , tell me a little bit about

11:30

their work and how

11:32

it sort of well

11:35

, tell me about their work and then we'll kind

11:37

of talk about how that evolved

11:39

into the buildup of

11:41

a company of clarice bio yeah

11:44

.

11:44

So I had met , uh , I had met dr

11:46

reza dana at when I was at lux

11:48

. He was a consultant to us and as

11:50

uh , as we were developing our

11:52

drug there and um , so

11:55

I , I I got a call from him

11:57

and he said would you , would you be interested in starting

11:59

a company ? So I went to meet them

12:01

and they had um . So Reza

12:04

Dan is a cornea specialist everything I'm talking about

12:06

is in the cornea but

12:10

he and Dr Sunil Chauhan

12:12

were working with mesenchymal

12:14

stem cells and

12:17

they were seeing this very positive effect

12:19

in the sense of prevention of

12:21

fibrosis and acceleration of healing in

12:24

several animal models that they were working on

12:26

. But they also realized that with

12:29

applying cells to

12:31

the surface of the eye was going to be tricky

12:33

in the sense of what's your

12:35

dose , how do you make

12:37

them ? And then consistently make the same cells

12:40

and then apply them to the eye . They

12:42

saw it was a regulatory minefield

12:45

, which I think it would have been , but

12:47

cleverly they looked at the secretome

12:50

of the mesenchymal stem cells and

12:52

said these are the top five or six

12:54

proteins that are being produced and

12:56

they went in and silenced them one by one

12:58

. And it's when they silenced HGF

13:01

that the effect of the cells basically went away

13:03

. And that was their

13:05

aha moment , and that was when they

13:07

discovered that it was HGF that was driving

13:09

the salubrious effects of the cells . And

13:12

so from there they

13:14

methodically went through

13:16

several animal models of

13:18

injury and healing . But

13:21

they also . What I thought was very

13:23

satisfying when I met them is they'd spent

13:25

a lot of time working on the mechanism of action

13:27

. And I think in

13:29

the drug world at least my experience is

13:31

in the package insert you always have the mechanism

13:34

of action and there's a lot of hand

13:36

waving there . And I would

13:38

do at Merck , even at Merck , when we would

13:40

put in the mechanism of action , it would

13:42

, years later we'd learn more

13:44

and more and more about what the real mechanism was

13:47

. But with , with , with , with

13:49

raisins you know what they had done is

13:51

because they are very , very curious people

13:54

. They had gone through and systematically

13:56

looked at the mechanism of

13:58

action .

13:58

So we have the three publications

14:00

already published and there's a fourth coming out on

14:03

the mechanism of action , and

14:14

I think when you can marry the mechanism of action

14:16

with the activity , it gives you a lot of confidence that the drug is going

14:18

to be effective . Yeah

14:25

, so how does that confidence equate to something valuable and tangible as a business , given that you know

14:27

to the point that you just made and I can I can certainly validate that based on conversations that

14:29

I've had with hundreds of of biotech

14:31

founders given that mechanism

14:34

of action hasn't historically

14:36

been like a super

14:38

important thing

14:41

to understand , you know , as

14:43

long as there are safety and efficacy , right

14:45

, like it's sort of been tertiary to

14:47

the equation , right . So , given

14:49

that historic , I guess , record

14:52

, open

14:54

that up for us a little bit , why is it advantageous

14:57

to pursue that curiosity

15:00

and fully understand the MOA ?

15:03

I think so . If you're

15:05

in a biotech , you usually

15:07

get one shot on goal , maybe two , and

15:10

so you have to be very

15:13

we're about failing , and failing quickly

15:15

. That's our job , right , but

15:17

you want to give yourself the best chance of success

15:20

. If you understand your MOA , it

15:22

allows you to marry your mechanism

15:24

of action to your

15:26

disease that you're going to treat and

15:29

you try to pair those up as much as possible

15:31

. So whatever activity the drug has

15:33

and you look at the disease and you look at what's

15:35

causing that disease or how to

15:38

ameliorate the effect of that disease

15:40

, then if you can marry those

15:42

two , I think it's very helpful . I think

15:44

from the founding of a

15:46

company building the team around a molecule

15:49

where you understand the mechanism

15:51

of action , it gives you a certain level

15:53

of confidence . And then I think the third

15:55

thing , and probably equally

15:57

important , is that when you're raising

15:59

money , having that , if

16:01

you don't have any human data or you're just

16:03

starting out pre-ind , having

16:06

that mechanism of action and

16:08

the animal models , it builds confidence

16:10

with potential investors as well that you are

16:12

, that you will succeed or potentially

16:14

could succeed .

16:15

It's not guaranteed sure

16:18

, yeah , yeah , no guarantees . What

16:20

? Um , when , when dr dana

16:22

first reached out to you and said , hey , would you

16:24

be interested in in putting a company

16:26

together around this ? And you obviously did

16:29

your due diligence and looked at the , that

16:31

MOA and the and the molecule itself

16:33

, what was what

16:36

was sort of step one on on

16:38

Clark Atwell's mind in terms

16:40

of , okay , if we're going to put

16:42

a business together around this , this is

16:44

what we need to do imminently .

16:49

I think , a couple of things . The first one was

16:51

trying to figure out what disease we wanted to go

16:53

after and thinking the potential

16:55

applications . That was

16:57

one . The second one was we were pre-IND , so

17:01

the HGF

17:03

itself at the time was

17:06

we were using research-grade HGF

17:08

from research suppliers

17:11

that had HGF , and

17:14

in order to move

17:16

as quickly as possible into the clinic , we

17:18

needed a source , and so we

17:20

found a partner in Japan called

17:23

Kringle Pharma , and they had

17:25

been developing HGF in several

17:27

systemic indications and so they

17:29

had GMP drug and they also

17:31

had a package

17:36

of data that was both clinical

17:38

and preclinical . So that allowed

17:40

us to leapfrog . So that

17:42

, combined with some

17:45

idea of where we wanted to go with the molecule

17:47

, we could

17:49

build a business plan around that , where we weren't

17:51

funding a company where we're going to have to go out

17:53

and manufacture the drug and we

17:55

were starting from

18:03

the beginning line . We already had some momentum

18:05

behind us with all of those things . So

18:07

that allowed us to go

18:10

to several VCs

18:12

and say , look , you know , we can be in the clinic

18:14

in less than a year , and

18:17

that was something that I think was attractive

18:19

to the team but was also attractive to

18:21

the VCs the

18:26

team but was also attractive to the VCs and it allowed you to get a different kind

18:28

of venture capital group behind you because they could see that you

18:30

could get into the clinic very quickly . So

18:32

getting the drug , we had to have

18:34

a license with our partners

18:36

in Japan and

18:39

they were fun to work with , because doing

18:42

partnerships in Japan is

18:45

notoriously difficult , but our partners

18:47

are . They're biotech

18:49

so they think like us , so they move very , very

18:52

quickly . And that was nice because we got to

18:54

learn how we would behave as partners

18:56

together and

18:58

we were very happy that they were like-minded

19:00

. And I think the next thing

19:02

was we had to . So

19:05

we reached out to Novo and

19:07

I had a previous relationship

19:09

with Novo through Lux Biosciences

19:12

and Thomas Derberg

19:14

and reached out to him and

19:16

he liked . He liked the

19:18

concept very much , but

19:20

we wanted to see if we could recapitulate

19:23

everything that had been done at Harvard at

19:25

at scale . And

19:27

so Ken Harrison's , our partner

19:29

from Novo , and he had recommended

19:31

or suggested using OxyVator

19:34

NGF as

19:36

a predicate molecule . We had not decided to go

19:38

into NK yet , but we redid

19:41

everything that was done at Harvard . We took

19:43

those models and transferred them

19:45

to a CRO and

19:47

had them redo

19:49

those models at scale . So instead

19:51

of the three animals that they'll use in

19:54

an academic lab , we were using 10 animals

19:56

per group and we looked at different

19:58

concentrations of the drug . We used our GMP

20:01

drug from our partner and

20:03

we looked at comparing it to

20:05

NGF , which is the active ingredient

20:07

in OxyVein's drug . And

20:10

at Harvard , ray

20:12

and Sumil had done various different

20:15

models . They'd done a mechanical injury

20:17

, a bacterial

20:20

or chemical injury model

20:23

and they had looked at prevention

20:25

of scarring , they'd looked at acceleration

20:27

of healing and they'd looked at regressing

20:30

preformed scars . And

20:32

so we did all of that work at

20:35

a CRO

20:37

in North Carolina , howard Research

20:39

, and we had set

20:41

up with Novo preset

20:43

success criteria

20:45

and we exceeded those , and

20:48

so that was when we closed

20:50

our Series A .

20:51

Yeah , If you look

20:53

at the sort of accelerated

20:56

you know early timeline that

20:58

you recognize that you would be

21:00

able to take advantage of , Can you

21:02

even begin to quantify how

21:04

big a head start , in terms of I

21:07

don't know years or even dollars , you

21:09

might have had as you came

21:12

into this engagement ?

21:16

I think the partnership with the

21:18

work that Reza and Sunil

21:20

had done and the partnership with Kringle

21:22

probably cut

21:24

three to four years off of our timeline

21:28

.

21:28

Yeah , it's incredible . Yeah

21:30

, good starting position . Yeah

21:33

, so you mentioned you

21:35

know you had to determine what you were going to put

21:38

a stake in the ground in around your

21:41

lead candidate and

21:43

you've got a molecule that is showing

21:45

a whole lot of positive data

21:47

in any number

21:49

of indications Trauma , you

21:52

know other

21:54

diseases that cause scarring

21:56

, and how

22:00

do you decide it's an advantageous position

22:02

to be in ? Right Boy ? We could probably

22:04

affect quite a few

22:06

conditions with this molecule

22:09

. What goes into that

22:11

decision-making ?

22:12

process

22:16

with the investors

22:18

, a lot of conversations with the

22:22

team , a lot of consultation

22:24

with Reza and Sunil and

22:26

outside key opinion leaders

22:28

, and

22:34

we did have , initially , another indication that we were thinking about . And as we were going through

22:36

it and having these discussions it

22:38

became very apparent from our scientific

22:41

advisory board they're like guys , there's a

22:43

much better disease for this drug and

22:45

that was when neurotrophic keratitis

22:47

sort of came into it . So it marries

22:49

, you have an active wound

22:51

, so we have the ability to accelerate

22:54

wound healing . It

22:56

is a disease where the

22:58

nerves are impacted

23:00

and damaged . We actually regrow nerves . The nerves are impacted and damaged . We

23:03

actually regrow nerves . And then it

23:06

does have a scarring component in that a

23:08

lot of the patients when they develop

23:10

an ulcer , the stroma is impacted

23:13

and

23:17

when you impact the stroma you are going

23:19

to get a scar . So it sort of fit a lot

23:22

of . We sort of think of HGF

23:24

as a Swiss army knife and

23:26

it was using the spoon , the saw , the

23:28

pliers . It used a lot

23:31

of the attributes of the drug

23:33

. So it's something that we thought as

23:35

an initial indication it would be

23:37

a good way to go forward .

23:39

Yeah , yeah , it's a great analogy . I

23:41

love an analogy that really helps a simple-minded

23:43

guy like me visualize what's

23:45

going on ? there . You mentioned just

23:47

a few minutes ago that

23:50

the data

23:53

that had been put together from

23:55

the early days you

23:58

knew would make Claris more

24:00

attractive to . I think the words you used

24:03

were a different kind of VC

24:05

, so I want to understand that a little bit better

24:07

the funding , the funding scene in

24:09

general and your , your strategy around

24:11

funding the company . But what do you mean

24:13

by a different kind or a different

24:15

group of VCs ?

24:19

I think if

24:23

you think of VCs as

24:25

an ecosystem , you

24:27

have the mice and then you have the

24:29

elephants and the

24:32

larger VCs . They move together

24:34

. So

24:38

they're always investing together and the reason for that is they like

24:40

to write big checks or they have to write big checks right , and the

24:43

reason for that is they like to write big checks or they have

24:45

to write big checks , right . So if you have a large fund , you have to , you have to spend

24:47

your time on larger investments

24:49

and then

24:51

you only invest with people who are

24:53

like minded that write those large checks

24:55

. Because you can't have , you

24:58

obviously can't deal with a smaller VC that

25:00

can't write those checks right . Eventually they can't

25:02

write the $20 million , $30

25:04

million checks . So

25:10

I think when you get closer to the clinic , as a function of the amount of money you need to raise

25:13

and what you're going to spend , those VCs will come in . So I think in

25:15

the early days you tend

25:17

to attract smaller VCs . But

25:20

those VCs that are going to help you with an IPO

25:22

or launch a product , or maybe

25:25

eventually you might be sold to a larger

25:27

pharma , but those VCs

25:29

are going to want to

25:31

write the bigger checks . So the closer you're

25:33

to the clinic or in the clinic . That's where

25:35

they tend to invest . Novo

25:38

is a little different . They do seed all

25:40

the way through and they're different in many ways

25:42

, a little different . They do seed all the way through and they're they're different

25:44

in many ways . Um , they're also an evergreen fund , so they don't , um , they don't have limited

25:46

partners , and so they um

25:48

, they're a lot more patient , uh

25:51

, and can be more patient .

25:53

So yeah , um , so tell

25:56

me about that . I guess the those days

25:58

for you , clark , um , I mean

26:00

, you got Novo's , you got , you got Novo

26:02

on board early . Were

26:05

there other fundraising partners

26:08

, players , other efforts on your part

26:10

, or was it sort of like we

26:12

got our big partner ? Let's move forward

26:14

?

26:15

Oh no , no , we talked to a lot of people . You

26:19

talk to a lot of people and I

26:21

think in raising money , the

26:23

first thing is you have to be prepared with your plan and

26:25

ready to go , because if you're out

26:27

there for too long , that becomes

26:29

a reason not to invest , right ? If you've been raising

26:32

money for a year and nobody's moving

26:34

, that becomes that hurts you

26:36

. So I think you have to have everything ready to go . So

26:38

we had our key opinion leaders

26:40

ready to go , our SAB , we

26:43

had our plan , we had our deck together , we'd

26:45

already talked to Kringle , we'd

26:47

spent a lot of time getting everything

26:49

ready and then we went out

26:51

the door . We were fortunate

26:54

that Novo came in early , but

26:56

we had been talking to a lot of other groups

26:59

, such as RA , who also invested in us

27:01

, and we were also fortunate

27:03

because it's a Harvard technology of

27:06

having well

27:09

, at the time they were called were

27:13

they called ? I'm forgetting the name now , but

27:15

they're Mass General . They came in as

27:18

investors as

27:20

well , and so we were very fortunate

27:22

to have them because they obviously

27:24

understood that ecosystem , especially in

27:26

Boston , so they were able to introduce us to a lot

27:28

of investors as well . But no

27:30

, we talked to a lot of people .

27:31

Yeah , yeah , was that like

27:34

90% of your job

27:36

at the time ?

27:38

Yes .

27:39

Raising money .

27:39

That was the biggest part of the job . Yes , raising money was that , was that was

27:41

that was the biggest part of the job , and it's it's

27:44

a , it's , it's an , it's

27:46

a necessary evil . I don't enjoy it . It's

27:49

not fun , it is

27:51

. It is , however , really

27:54

, really valuable if , in

27:56

lots of different ways , one is

27:58

you , your , your , your business

28:00

plan is pressure tested and

28:03

it's tested by very smart people . And

28:05

there are people who are wanting to say no

28:07

. Every VC that you talk to , their

28:09

first thought is how do I just get rid of this

28:12

? And if they can't come up with a

28:14

reason , then they start to get interested and they move

28:16

forward . But we

28:18

learned a lot from talking to VCs . They

28:21

pressure tested and fortunately , our plan was pretty good , but

28:24

they did give us ideas . Every meeting we would

28:26

get something new or think of something new

28:28

. There'd be a question . It was like how do we

28:30

answer that ? So that was very , very helpful . I

28:33

think through the process of talking to VCs

28:35

and how they do their diligence , you

28:37

learn a lot , and so all

28:41

of our investors were very

28:43

, very thorough in their diligence and we enjoyed

28:45

the diligence . It was rigorous , but

28:48

you also learned that they're very smart people

28:50

, and they're people who you want on your side more

28:53

than just the money , but you want the thoughtful

28:55

conversations and then the value they added

28:57

during the process . So I think that's

29:00

very , very helpful . And

29:02

then there's some that you , you walk out of the meeting

29:05

room . It's like I really don't want their money . They're

29:08

not nice people and they don't treat each

29:10

other well Like you can watch how they treat their

29:12

partners . It's like this is the people they

29:14

work with . I don't want to work with how

29:16

they treat people . So it's very , it's

29:18

very , it's very it's . It's a necessary

29:21

evil , but it could be very valuable .

29:23

Yeah , you mentioned that

29:25

. You know , you said it's hard work

29:27

and you said you don't enjoy

29:29

it . You know

29:31

which I can totally relate with

29:33

. I'm like the furthest thing from a business development

29:36

person , like sales , not my gig , Um

29:38

. But how do you , how did you

29:41

personally , uh learn

29:43

it and , even more

29:45

importantly , reconcile

29:48

uh with yourself

29:50

, Like that that this is something that you

29:52

need to do and that you're going to go out there and you're going to do it

29:54

right , Like you've got to get comfortable with it , Despite

29:57

your aversions , you , you've got to , you've got

29:59

to embrace it and you've got to go out there , Otherwise you'll drive

30:01

yourself mad , Right ? So

30:04

I guess , personally , what did you do to reconcile it ? And then

30:06

, you know , you said you , you learned with

30:09

every meeting and improved with every meeting

30:11

, but even even in advance of that , going

30:13

into it , like how , how did you learn how to be a fundraiser

30:15

?

30:18

Well , I think I was . So my education

30:20

started at

30:22

at iTech and I . It

30:25

was my first time at a company where I was

30:27

a consultant , but I had a lot of interactions

30:29

with their board and so I

30:31

saw how investors their investors

30:33

ask questions , what they were concerned

30:36

about , what they were interested in . So I think that was

30:38

my first sort of touch , I

30:40

think at Lux . I

30:42

was one of the co-founders of Lux and

30:44

Dr Uli Grau was our CEO

30:47

and I watched as he approached

30:49

the fundraising . So

30:51

I was with him through that process

30:53

, so I was kind of co-pilot , as

30:55

it were , in that process as

30:57

a COO and so

30:59

I followed that COO

31:05

and so I followed that . And then I was very fortunate that at that time I had Thomas Derberg

31:07

was on our board at Lux and

31:10

he very much became a mentor

31:12

to me and I learned a lot from

31:15

his , from conversations

31:17

through him , how an investor thought and

31:19

what was important to them . I

31:21

think the fact that I don't like the process

31:24

it helps you select

31:27

better projects , because

31:29

you're like I'm going to go out and I'm going to have to

31:32

for the want of a better

31:34

word drink from the fire

31:36

hose and I'm not going to

31:38

enjoy it , so it better be worth

31:40

it . At the other side of this , I

31:42

think you pick projects that you

31:44

you think will , uh , really

31:46

work and that you're excited about , and so I think

31:49

that it kind of it's

31:51

a good litmus test for for

31:53

a good project . It's like , oh , this is gonna suck

31:56

and I'm gonna have to go raise this money , but I

31:58

really believe in this and I really want to

32:00

take this forward , so it's

32:03

awful that way .

32:04

Yeah , and I imagine that would hold some

32:06

weight . Like you

32:08

sit down in a meeting and if you know , if you're fortunate

32:10

enough to be in a meeting with a VC

32:13

group who is tuned in

32:15

to your personality and what

32:17

you're doing there , like why you're there , I

32:20

imagine that has got to hold some

32:22

some weight with them . Versus , you

32:24

know , versus the , the biotech

32:26

BD person , or fundraiser

32:28

, um , who enjoys

32:31

the sport of it , right , like you don't enjoy

32:33

, you don't you know ? I

32:35

almost feel like going into one of these meetings and being like

32:37

listen , guys , I'm not here for the sport of it is probably

32:40

going to set you off on the right foot from the outset

32:42

.

32:43

I think it does . I think we're fortunate

32:45

that we have our

32:48

investors are amazing . I enjoy

32:50

working with them . They're thoughtful

32:52

. I learn things from them . They guide us well

32:55

. Our board meeting we

32:58

take votes at board meetings because you have to

33:00

for meeting minutes and things like that , but

33:02

we've never had to take a board vote

33:04

for anything at Clara so far where

33:07

it's been contentious or people have

33:09

to vote . They're very

33:11

, very smart people and super

33:13

supportive . I

33:21

mean , if you think about when Silicon Valley Bank blew up and all of our money was there , we got calls

33:23

from . It's like we have money . If you need to make payroll , we're here . They were calling

33:25

us on the weekends and just incredibly

33:27

thoughtful and , um , yeah

33:30

, just good people . Yeah , a lot

33:32

of a lot of entrepreneurs have bad stories with

33:34

vcs .

33:35

I I don't have any really yeah

33:37

but I think it's partly that selection

33:39

process yeah

33:41

, you You've mentioned

33:43

you've used the word we

33:45

like in those early days building the company

33:48

fundraising . I want to get

33:50

as sort of an abbreviated

33:52

chronology of the

33:54

we from the outset

33:57

, right . So like it was you and

33:59

these two doctors from Harvard , some

34:01

other folks who were interested , you got

34:03

some VCs on board , started building a board

34:05

. What did the we look like

34:07

then ? The we of ClarisBio , and

34:10

kind of walk us through what the we looks like now

34:12

as you're in the throes of clinical

34:15

activity .

34:18

So we started out it was Ray Z Raisa

34:21

and Sunil and myself initially , and

34:24

then Meredith Fisher at

34:27

Mass General was very helpful

34:29

and

34:32

supportive of us and helping sort of we

34:34

would bounce ideas off of her and she's still

34:36

on our board and an amazing person

34:39

and super thoughtful

34:41

. But that was the

34:43

we at that time . And then , as

34:46

we moved forward , we

34:48

had a legal team and

34:51

so Joe Favors

34:53

is our counsel and again

34:56

, I've worked with him for 15

34:58

years . He's an amazingly smart person

35:01

and very thoughtful

35:03

. But we worked with them . And then , after

35:05

the legal team , our first

35:07

hire was Dr Susan Orr

35:10

. She had done diligence for Alcon on

35:13

Lux Biosciences . So I got to know her through

35:15

that process and we

35:17

just stayed in contact with each other and had great

35:19

respect for her because she was doing

35:21

diligence on the questions

35:23

and the thoughtfulness and

35:26

the integrity was

35:28

very important . So Susan came

35:30

on board Shortly after that . Piotr

35:33

Braila came on as our formulation CMC

35:37

expert and it was funny we

35:39

had mentioned to the VCs that we would

35:41

, or to our investors that we would formulate

35:43

the drug in four months and they were told this all it was funny we had mentioned to the VCs that we would , or to our investors that we would formulate the drug in four months , and they

35:45

were told this all it was impossible , and

35:48

he did it in four months , so

35:50

it was very good . We were lucky , though , we

35:52

have a good protein that's very stable , and

35:56

then from there it

35:59

was during the pandemic , so

36:02

we were all co-located in different

36:04

places , and so

36:06

Susan had worked with Tom Nidalan , who

36:08

was a clinical expert

36:11

in development , so we

36:13

brought her on and then

36:15

so we were a four-person company for

36:17

a while , and then , about a year

36:19

, year and a half ago , we

36:22

decided to bring on somebody who would be our chief

36:24

business officer , and we were very

36:26

fortunate to that

36:28

was through a recruiter

36:31

and met Henry Routh , and he's

36:33

joined , and we're

36:35

very lucky . We get along very , very well . We

36:38

finish each other's sentences . I

36:41

am a recovering micromanager

36:43

, so I'm on the I think

36:45

, step 11 . And

36:47

so I think that's really helpful for me

36:49

that we've been a virtual company

36:52

for the last couple

36:54

of years , so we don't have tons of meetings

36:56

and everybody's very , very

36:58

good at what they do and very senior , so

37:01

we don't monkey with each other's

37:03

work a lot and

37:05

they have a really good culture , very

37:07

like-minded people . So that's very important because

37:09

I think one of the things I've learned as

37:11

a CEO is culture eats strategy

37:14

for lunch . And if you don't have the

37:16

right culture , it doesn't

37:18

matter how brilliant your strategy is . Yeah

37:22

.

37:23

Yeah , yeah , yeah

37:25

. That's selectivity , again selectivity . You

37:27

mentioned sort of selectivity being a

37:29

theme around the VC

37:32

exercise and I imagine

37:34

that comes to bear pretty heavily

37:36

as well when you're building out your , your C-suite

37:39

.

37:40

Definitely , definitely . And again , I think

37:42

it's that network and the people . You know I've

37:45

I've been into companies with Piotr it's

37:47

my first company with Susan , but I've known her for a very

37:49

, very long time . And then our founders

37:52

. You know our scientific co-founders

37:54

, you know Ray's and Sun , this dramatic allusion

37:56

, you know , to changes in

37:59

the

38:09

standard of care and ophthalmic

38:11

indications .

38:13

How important was it to you from

38:16

the outset that you were looking

38:18

at the potential for sort of changing

38:20

the administration paradigm for potentially

38:22

any number of you know ocular

38:25

indications away

38:27

from perinatal administration

38:30

to topical administration

38:32

? Was that like an important consideration for you or

38:35

was is that just like , oh man , this is really . It's

38:37

a , it's a nice to have .

38:40

So I think from from

38:42

an administration . It was funny because when

38:45

I was at iTech , Dr Chambers

38:47

had told Dr

38:50

Chambers at the time was in charge of the FDA and

38:53

then ophthalmology and

38:55

he had said that you shouldn't really go into

38:57

the human eye with a needle more than four times in a

38:59

person's life . And so

39:01

David Geyer definitely

39:04

changed that paradigm and people go in

39:06

every other month to get

39:08

an injection for

39:11

any VEGF or any of those therapies

39:13

for AMD or DME . But

39:15

for us the

39:17

sort of switch in the paradigm is

39:19

that if you think about it , you still

39:21

hear it from companies today that they're

39:23

only interested in the back of the eye and

39:26

the reason they say that it's code . For

39:28

that's where the value is right , because you

39:31

can charge to preserve

39:33

and actually improve vision at the back

39:36

of the eye . You can charge a significant

39:38

amount of money for that therapy and

39:41

that also sort of wrapped

39:43

up in the intended fact that they're biologics

39:46

In

39:48

the front of the eye . The business

39:50

model has always been volume

39:54

, so the most successful drugs in

39:56

the front of the eye are usually , you know , dry eye

39:58

has been where you see the billion-dollar

40:00

molecules and

40:02

that's what's driven that , I think

40:04

, with the launch of Oxervate , which

40:08

is NGF for an orphan disease

40:10

, that paradigm has shifted

40:12

from proteins in the back of the eye to

40:14

proteins in the front of the eye and people

40:16

see value there and they're

40:19

also , I think , recognizing that there

40:21

are a lot of other indications

40:23

in the front of the eye that have been

40:25

underserved . So usually the front

40:27

of the eye is antihistamines , steroids

40:30

, dry eye . You know cyclosporine

40:32

for the front of the eye and

40:35

I think bringing

40:37

biologics to the front of the eye is

40:40

very exciting and we see several

40:42

indications that we're very interested

40:44

in . That we think would really

40:47

help patients .

40:48

Yeah , you mentioned

40:50

Oxervate and we

40:52

talked about this the last time we spoke , so I'm hoping

40:54

we can spend a little bit of time talking about drawing some

40:56

, you know , sort of contrasting

40:58

what you're working on versus the

41:00

approach there Is

41:03

. That is

41:07

the approach there .

41:09

Oxervate is used to treat NK correct .

41:16

That's its indication and it's the first biologic to be approved

41:19

for use in a topical front of the eye condition ? Would that be considered the standard

41:21

of care right now ?

41:23

I think it's rapidly growing to become the standard

41:25

of care . I think if you think

41:28

about the treatment of patients with

41:30

NK , the first stage is always

41:32

to look at are you treating that

41:34

patient with any other topical

41:36

drug or even systemic

41:38

drug that could damage

41:41

the front of the eye , so a typical

41:43

drug with a preservative

41:45

in it ? You definitely take a patient

41:47

off of that . Then you move into

41:50

therapies that are not proven in

41:53

large clinical trials . So you could do serum

41:56

, you could do platelet-derived factors

41:59

you could look at . Insulin

42:01

is sometimes used . And

42:04

then you go to the sort of more surgical

42:06

like a tessera

42:09

fee , where you sew a portion of the eye closed

42:11

so that the lid covers the wound

42:13

and protects it and hopefully helps

42:15

heal it . And then

42:18

the other thing is amniotic membrane

42:20

, so you can put an amniotic membrane on the surface

42:22

of the eye . So those are sort

42:24

of the gamish of things that were used

42:26

prior and I think OxyVeid

42:28

, because of its efficacy

42:30

, has

42:33

come to be the standard of care in neurotrophic

42:35

keratitis .

42:36

Yeah , efficacy . However

42:39

, the

42:41

I guess DIY

42:44

formulation of

42:46

the therapy struck me the last

42:48

time we spoke . Maybe

42:50

it didn't strike me as much as

42:52

what you just mentioned sewing part of the

42:54

eyelid shut to cover the wound . That sounds sort

42:57

of barbarian . Maybe effective , I

42:59

don't know , but it sounds like we

43:01

could move away from that if science allows . It

43:03

sounds like we could move away from that if science

43:06

allows . But

43:15

in the case of Oxervate , I believe you told me

43:17

it was like a multi , like in the teens step process for the patient

43:19

to self-administer this drug and that just sounded untenable

43:21

to me , particularly in a patient population that is largely elderly , I

43:23

would assume .

43:25

Correct . Yes , the average age

43:27

of the patient in neurotrophic keratitis

43:29

is roughly around 65 years of age

43:32

, and I think so

43:34

we were blessed with a

43:36

very stable molecule . Ngf

43:40

is neurotrophic growth factor , which

43:42

is the active ingredient in oxirvate is

43:45

relatively unstable and

43:48

so the drug has to be formulated by the

43:50

patient , and

43:52

that has a . It's

43:55

inconvenient for the patient , it's inconvenient

43:57

for the

44:00

prescriber , because they have to teach the patient

44:02

or their caregiver how to formulate the drug

44:04

and then from there

44:07

it also limits the use of

44:09

the drug . So we've had conversations in our

44:11

market research where physicians

44:13

have said if my patient's not an A-type personality

44:16

, or they're not their caregiver's not an A-type

44:18

personality , I won't even prescribe

44:20

the drug , because I know that they won't

44:22

follow through with the compounding

44:24

of the drug on a daily basis . So

44:27

I think that's an important differentiator

44:29

for us . We have our

44:31

drugs delivered in single-use containers

44:34

and preservative-free

44:36

, and right

44:39

now we know that we will be able to deliver

44:41

it to the patient refrigerated

44:44

, but then from there the patient

44:46

has three months at room temperature in

44:49

which they can use the drug , so there will be no formulation

44:51

. That's important

44:54

because it's convenient for the patient , but I

44:56

think it will also expand the number of patients

44:58

who can use the drug . And

45:00

then I think the other aspect of

45:02

the drug that we're very excited about our drug is

45:05

that it seems to be very safe . We

45:09

obviously don't know the

45:13

absolute data from our trial because we're masked

45:15

so we don't know who's on drug

45:17

and vehicle . But if we look at the overall

45:20

side effect profile , we're seeing that

45:22

profile is very consistent with

45:24

the vehicle arm in the Dompe

45:28

study . So we're very happy . It's

45:31

a great safety profile and I think that's very

45:33

, very helpful . Ngf

45:35

itself is a pro-inflammatory

45:38

molecule and so the patients

45:40

do exhibit pain upon

45:42

installation and so

45:45

we don't see that . So I think that's going

45:47

to be another benefit . But I think the coolest

45:50

thing about our drug is we do see that Swiss

45:52

Army knife . So I think if

45:54

we see , we not only see

45:56

a potential for the

45:58

treatment of neurotrophic keratitis and

46:01

the resolution of the

46:03

wound , which is the primary endpoint , but

46:05

there may be other aspects of the

46:07

drug where we see reductions in

46:09

scarring which would

46:11

end up in improvements in vision for the patients

46:14

. We

46:27

may also see improvement in sensation with the drug because we do grow nerves . So there's a lot

46:30

of reason to believe we bring more to the patients with this disease and then other diseases

46:32

as well .

46:35

Yeah , yeah , I mean , it all sounds like upside

46:37

.

46:39

We have to prove it though . We have to prove it Right

46:41

, right .

46:42

Yeah , you got to prove it . You got to . Yeah , of course

46:45

, as far as proving it goes , I

46:47

mean , if you prognosticate

46:50

for a moment on , you know , I

46:52

mean part of your job is to obviate

46:54

, to see what could be

46:56

coming around the bend to thwart your progress

46:59

that perhaps you know was

47:01

unexpected . I

47:04

think that's what obviate meansba , means right , expect , somehow foreseeing

47:06

the , the unexpected and being ready

47:08

to deal with it . Maybe loose

47:10

definition , um , what

47:13

, what do you ? I mean , can you , can you

47:15

pinpoint anything

47:17

that that could

47:19

stand in the way ? Like that you're

47:21

that , you're concerned about

47:25

I .

47:26

I wake up every night thinking about these things . I'm

47:28

sorry , I'm sorry , no , no

47:31

, no , no , no , it's , it's , it's , it's , it's the

47:33

other part of the job . I , I think . For

47:35

me , I think , the the being

47:38

being we're second to

47:41

this disease , we

47:43

rely on what's

47:45

gone before us for powering

47:48

the trials , and

47:52

so we're conservative people . So we've

47:54

chosen the

47:56

vehicle arm . In the two trials

47:58

that Oxervate did , that did the

48:00

best . So they saw complete healing at week eight at roughly 30%

48:02

in the vehicle arm . So we're using that as our baseline in the best . So they saw complete

48:04

healing at week eight at roughly 30% in the vehicle arm . So we're

48:06

using that as our baseline in

48:09

the trial . So if that's different , in

48:11

their second trial it was around

48:14

19% . So if

48:16

it's different but it could be different in 40%

48:18

, you know , we could see 40% healing . That's

48:21

a concern . So that to

48:23

me is the major concern

48:26

. I think I believe our drug will

48:28

work . From the animal studies

48:30

, from

48:33

the work that's been done before

48:35

, I think it will work . It's

48:37

an endogenous protein that we make to

48:41

perform this function in other parts of our

48:43

body and the eye as well . It's produced

48:45

in the eye . It's produced in the eye , it's produced in the lacrimal

48:48

glands , it's

48:50

produced in the cornea , and

48:52

so it's there . It's there for a reason

48:54

. We're just providing more of it . So it

48:56

should work . But for me that's the

48:58

main concern what our vehicle arm is going to do . Vehicle

49:01

arm is going to do .

49:04

So , speaking of the production of HGF , how is

49:06

it produced and manufactured

49:08

? At Kringle , I'm assuming

49:11

.

49:12

Yes , so our partner in Japan , kringle

49:14

, manufactures the drug . They use

49:16

Chocell's traditional biological

49:20

manufacturing and together

49:23

we're developing a new process at Catalan

49:25

to

49:28

scale to a much larger yield than

49:31

currently Kringle has and

49:34

that process is going very well . So we're

49:36

very happy and we'll be introducing that

49:38

API from that in a further

49:42

as we move forward into the clinic .

49:44

Yeah , the

49:48

effort at Catalan does also show

49:51

cell Correct .

49:52

It's using their GPEX lightning show

49:55

cell and it's a much more modern

49:57

process and a more

50:00

advanced cell .

50:04

So as far as clinical

50:06

supply right now , you're content

50:08

with your clinical supply right now . But that move

50:10

is it to advance into

50:13

broader clinical studies or is it anticipation

50:15

of serving a larger patient

50:17

population ? What sort of precipitated the need

50:19

to turn to Catalan and look

50:22

at scaling that up ?

50:25

I think several things . One is

50:27

we're advancing to commercialization

50:30

. So

50:33

I think , looking at that perspective from a commercial perspective and having a more robust

50:35

process I think the

50:38

process that Kringle has is very

50:40

robust . When

50:43

we get the certificates of

50:45

the COAs from Kringle

50:47

and we test the drug as we have to , it

50:50

always hits the numbers right on the spot

50:52

. The Japanese manufacturers of

50:54

drugs do a very , very good job , so

50:56

there's never been a question of that . But

50:58

I think as we move into commercial

51:00

, we're going to need more drug and

51:03

it's always good to have two sources . So

51:05

those are the two main reasons .

51:07

Yeah , yeah , okay

51:10

. So give us a clinical update

51:13

when are we right now in terms of clinical

51:15

activity and then maybe

51:17

not to bait you into a forward-looking

51:20

statement , but what might be coming next

51:22

in terms of clinical activity for

51:24

CLARIS ?

51:34

So we have completely enrolled our current trial and we will have a readout in the

51:36

latter part of July . So that's very exciting , nerve-wracking

51:39

but exciting at the same time . And

51:41

then from there we have initiated

51:44

two open label

51:46

trials . One

51:49

is in a reversal of scar . So

51:52

in the animal work we were excited

51:54

by the ability

51:56

to look at preformed scars

51:58

and see if we can reverse them . And

52:00

we've been able to show that in two animal

52:02

models that I've mentioned . And

52:04

so we're very excited to

52:06

see if we can do that in

52:09

the human model , as it were . And

52:11

so we've enrolled five

52:13

patients to date in open-label trials

52:16

and we're seeing

52:18

some interesting effects . So we're

52:21

very , very happy with that . That

52:23

would be a completely new indication . There's currently

52:25

no therapy approved for the reversal of

52:27

scars , and so that would

52:29

be it's terra incognita from

52:32

a regulatory perspective , so

52:34

that'll be , but it's

52:36

a great area to actually go in and

52:38

remove scars from people that

52:41

have that in their central

52:43

vision . I think it would be a huge benefit

52:45

.

52:46

Yeah , just curious

52:48

, just to stay there real quick before we move on

52:50

to the other indication . When

52:52

you talk about the reversal of scar

52:54

tissue , healing scar tissue , you

52:57

know , does that open

52:59

up like am I thinking of this correctly or too

53:01

simply ? Like that opens up an

53:03

entire , like it

53:05

could be I'm

53:07

not sure how to phrase the question Like

53:10

scarring can be caused by any

53:12

manner of things right , disease , infection

53:15

, trauma . So

53:17

are all those on the table when we talk

53:19

about scarring ?

53:22

Almost all of them . I think initially

53:24

we're looking at the initial

53:26

patients , that we're looking at largely

53:28

microbial keratitis or

53:31

microbial infection , but

53:33

we will include viral and we

53:35

will include I think we have already included

53:37

one mechanical injury patient as well . So

53:39

I think , yeah , you're absolutely right , all of those

53:42

things on the table , we

53:44

would be successful in all of them . I don't know , but

53:46

we're going to look at as many as we can

53:49

. And

53:52

the other indication is limbal

53:54

stem cell deficiency . We

53:57

have enrolled in our trial

53:59

, in our neurotrophic keratitis trial

54:01

. About

54:04

20% of our patients have limbal

54:06

stem cell deficiency and

54:09

we've seen some . Obviously we

54:11

don't know if they're on drug or vehicle , but

54:13

for somebody to have an improvement in that area

54:16

is rare , and so we're

54:18

starting to see that as well in

54:20

some of our patients , and

54:23

so that's given us the

54:26

impetus to move forward and look at

54:28

that as a separate disease . So

54:31

we'll begin enrolling patients

54:34

this week actually who

54:37

have that lymphocytes cell deficiency

54:39

, and that's a brand

54:41

new indication that we're very , very excited

54:44

about , because there is no pharmaceutical treatment for

54:46

those patients . Most

54:48

patients actually have to be treated with a

54:51

transplant , a stem cell transplant , the

54:53

current therapy .

54:55

Yeah , that's

54:57

pretty fascinating work . What

55:00

haven't I asked you , Clark that is

55:02

central to the story that I should

55:04

have asked you if I were

55:06

better at my job .

55:09

I think you've done an incredible job of asking

55:12

really , really good questions and I thank you for that

55:14

. I appreciate that , yeah .

55:17

What's next for you ? I

55:19

mean , like I mentioned from the outset , you've been plugged

55:22

into this space for going on 20

55:24

years . There's

55:26

a lot of work to be done at Claris . I'm

55:29

not going to ask you to tell us where you're going next , but

55:31

I'm assuming you're going to plug in at Claris

55:33

and remain committed to the task

55:35

for now . But

55:37

any imminent plans for what Clark

55:40

does next , whether at

55:42

Claris , or otherwise .

55:45

I think for me right now , claris

55:48

is everything and

55:50

we're very much focused

55:52

on the next stage . So we're preparing

55:55

for the next trials and we've manufactured

55:57

drug for that . We've been

55:59

fortunate enough to speak to a lot of interested

56:02

venture groups

56:04

that would join our Series B and we're

56:06

planning to

56:09

move the company forward into an IPO

56:11

. So I think that all of those things

56:13

are main focused

56:16

, I think , for me personally . I think

56:18

the joy of being

56:21

in this space is that if you

56:23

do a good job , um and and

56:25

by that I don't mean necessarily if

56:27

you were the drug doesn't always work

56:29

. Sometimes it does and sometimes

56:31

it doesn't , but as long as you gave

56:33

it the best chance and you , you get

56:36

a result that everybody can sit around and say

56:38

, yeah , this is the truth . What we found

56:40

is the truth that I think you're fortunate

56:42

enough to do it again and again and you

56:44

get that opportunity .

56:45

So yeah Well

56:48

, very good , I uh I appreciate the time that you've

56:50

spent with us . Very thoughtful conversation

56:52

, uh , our initial conversation

56:54

was so . That's what inspired me to want to have you on

56:57

the on the podcast . I just enjoy the

56:59

uh , the transparency , the

57:01

humility , uh behind your approach

57:03

and your personality and I I'm glad you came

57:05

on to spend some time with us , clark .

57:08

Oh , thank you . Thank you very much , I appreciate

57:10

it .

57:11

We'll do it again . We'll you know . You've got you've got

57:13

a readout coming up in July . You got a lot of

57:15

exciting stuff coming down down the pike , so we'll

57:17

stay in touch and we'll have you back on when

57:20

there's , when there's more to report on . Thank

57:26

you very much . I look forward to that . All right , so that's Claris Bio founding

57:29

CEO , Clarke Atwell . I'm Matt Pillar . You just listened

57:31

to the Business of Biotech . Listen and

57:33

subscribe wherever you listen to podcasts

57:35

. Sign up for our Business of Biotech newsletter

57:37

at bioprocessonlinecom

57:39

. Backslash . B-o-b . Drop

57:42

us a line with your guest and topical

57:44

suggestions . Be sure to get in touch and

57:46

let us know which episodes you're picking and

57:48

which you're panning . And , in the meantime

57:50

, and as always , thanks for listening

57:52

.

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