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February 10, 2025 • 45 mins

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From the JP Morgan Healthcare Conference in San Francisco, Peter Anastasiou, CEO of Capsida Biotherapeutics, discusses his journey from big pharma to biotech and the challenges he's faces on the leading edge of first-gneration gene therapies. Anastasiou discusses the in-house manufacturing quality advantage, how building that capacity opened the door to important partnering opportunities, the company's preparation for clinical trials and IND submissions, and more. From mastering in-house manufacturing to forging strategic partnerships, Capsida aims to redefine genetic medicine.


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Transcript

Episode Transcript

Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Matthew Pillar (00:04):
Peter Anastasiou got his start in big pharma
with the likes of Lilly and BMS,but before too long, he
followed the siren song ofbiotech and never looked back.
I'm Matt Pillar.
This is the Business of BiotechJPN 2025 edition, and I'm here
with Peter, who is now CEO atCapsida Biotherapeutics.

(00:24):
Peter had a few stops along theway and those stops are on the
agenda for our talk about thelead up to his tenure at Capsida
and how he's navigating theebbs and flows of the gene
therapy space.
Peter, it's great to see youagain.
Nice seeing you too.
Thanks, man.
I appreciate you taking thetime out of a very busy, busy
week to spend with the businessof biotech.
Yeah.

Peter Anastasiou (00:44):
I'm looking forward to it.
It's going to be fun.

Matthew Pillar (00:46):
Yeah.
So I want to start with you andget a little bit of background
on where you came from and whatyou've done prior to CapSeda.
You got your start, like I said, in big pharma and in sales and
marketing, so tell us a littlebit about that and tell us about
when you sort of moved fromsales and marketing and
transition to a manager.

Peter Anastasiou (01:04):
Yeah, absolutely so.
As you said, I had a fairlytraditional start to my career
Big Pharma, lilly and BMS.
I was a Lilly 12 years, bmsthree years, and started always
on the commercial side of things.
But even when I was incommercial, in most of that time
at Lilly and all the time atBMS, I was really embedded in

(01:25):
working cross-functionally withRD.
At Lilly I was embedded into adrug development team that was
focused on coming up with asuccessor for Prozac.
Prozac was the biggest drug forLilly at the time.
So we had this.
It was like a Manhattan projectto get a successor to the
important franchise that wasalready created.
So I got a deep exposure to drugdevelopment, even though I

(01:47):
represented the commercialfunction by being embedded in
that team, and I saw the valueof what we were doing in terms
of commercializing a product wasonly possible if we had
products to commercialize.
So the discovery team, all thepreclinical work that was going
on, the clinical work certainlyregulatory is what enabled us to

(02:10):
ultimately commercialize thoseproducts.
And so I had a desire, as mycareer progressed, to want to be
involved more broadly in drugdevelopment and later
commercialization and not justcommercialization.

Matthew Pillar (02:24):
I imagine that having that experience in
commercialization, you know theallure of building is great.
But when you do that you sortof give up the rush and
excitement and adrenaline ofsuccess right Of
commercialization.
Was there any kind of push-pullgoing on there?

Peter Anastasiou (02:43):
No, because there's a different level of
adrenaline, and you know so as Imoved later on in my career to,
you know, even being moreinvolved in drug development and
eventually overseeing all theoperations.
For later, when I was atLundbeck in North America, there
was a different level ofenthusiasm and adrenaline.
You know, every time a studywould be in, blinded and looking

(03:06):
at the study results.
Or even, you know, making theshift from phase two to phase
three.
And how do you design, you know, a phase three program that
captures all the importantelements of phase two and not
makes a lot of changes, becauseobviously the more changes you
make, the more risk you takethat the phase three won't
repeat.
But at the same time you learnthings from phase two.
So it's that knife's edge ofhow do you, you know, make the

(03:29):
necessary change without makingtoo many.
So there were always thesesources of adrenaline,
excitement, enthusiasm.
You know regulatory, you knowthe negotiating labels with the
FDA and what you know can youget into the label which then
enables you to uh, to tell yourstory commercially.
All of those things weredifferent levels of uh, of a

(03:51):
rush, yeah, uh, but at the endof the day, you know, uh, all
that stuff that we do is to geta medicine to patients, and so
there's a lot of those pointsthat create a lot of enthusiasm,
sometimes some tears.
There's a lot of failures alongthe way, but it helped me all

(04:11):
of that.

Matthew Pillar (04:12):
Yeah, yeah, so was Lundbeck the first stop
post-Big Pharma.

Peter Anastasiou (04:17):
No, so I was at.
After BMS I actually joined amed tech startup.
That was my firstentrepreneurial experience.
So it's not quite biotech butvery similar venture backed.
You know, cash strapped, youknow having to do things on a on
a shoestring budget.
But we developed a productfirst of its kind in the CNS

(04:37):
space, got it FDA approved andthen launched it.
So you know being part of thatwhole journey FDA approved and
then launched it.
So you know being part of thatwhole journey.
And then at Lundbeck.
So Lundbeck is a hundred yearold company.
But in the US Lundbeck didn'thave any presence.
They had always sold theirproducts through other companies

(04:58):
, primarily forestpharmaceuticals.
So I got joined as part oftheir concerted effort to build
out into the US.
So at first I came on board tobe the head of a business unit,
to create a business unitactually from scratch, which we
did.
Then I became the chiefcommercial officer across all
the commercial functions and allthe products and then became
the president of US and thenlater North American operations.

Matthew Pillar (05:17):
Yeah, so we're going to get into some of the
more scrappy entrepreneurialexperiences.
But did Lundbeck set you up forwhat was to come?
Or do you feel like I was justkind of curious about how well
resourced, being an old company,established company overseas,
how well resourced you were herein the state?

Peter Anastasiou (05:38):
It was very similar to like a biotech.
I mean, we were setting upthings from scratch, setting up
processes, setting up systems,slps, and building things from
scratch.
And the way I think about it iswe had one venture investor and
that venture investor was theheadquarters in Copenhagen that
funded our build out in the US.

(05:59):
We had to deliver for theinvestors.
We had to report back to theinvestors.
So it was a very similarexperience of going from very
little kind of a little bit ofan embryo and then growing and
building and the growing painsthat come from that.
And all of that has beenapplicable to the kind of stuff
that we're doing at Capsula.
And so I love that experienceand I wanted to get back to an

(06:25):
experience like that, which isultimately what drove me to to
capsule.

Matthew Pillar (06:29):
Yeah, so Lundbeck didn't didn't
necessarily feel like it camewith a safety net.
No, well, not necessarily.

Peter Anastasiou (06:35):
I mean, you know, we had investors that
expected us to perform, andthose investors were the
headquarters, and so anytime wehad a you, we had a company, we
wanted to buy a partnership, wewanted to do, if we wanted to do
, a DTC campaign, which is ahuge investment all that had to
be aligned with the maininvestor back in Copenhagen.

(06:57):
So a lot of parallels andsimilarities that I really
learned from and that I applyevery day in what I'm doing at
Capsida.

Matthew Pillar (07:06):
Yeah.
Did you go from Lundbeckdirectly to Capsida?
I did, okay, and you've beenthere for three years, yeah.
So what have you observed inthat time that you've been at
the helm at Capsida in terms ofsort of the macroeconomic
environment that you've dealtwith?
I mean, you know you can drawyour own assumptions.

Peter Anastasiou (07:30):
You think about the past three years in
biotech, but tell us about youknow firsthand perspective.
Yeah, you know it's reallyinteresting.
My timing, not for Capsa Capsahas been great, but for the
micro macro environment, mytiming couldn't have been worse.
You know, I was joining Capsain January 2022, right off of
2021, which was the best year inbiotech ever, arguably.
The fundraising environment wasgreat, the investments people

(07:53):
were making, the progress thatpeople were appreciating,
investors were appreciating,because of the COVID pandemic
our industry and what we do andwe're willing to put money
behind it.
And then that kind of came to ascreeching halt in 2022, right
around the time I was joiningCapsa.
So that was a challenge to dealwith and we navigated through

(08:15):
it very successfully, and a bigpart of the way we navigated
through it was we have greatinvestors in Westlake and Burson
, great support and greatguidance that they give us.
But also we embarked on apartnering effort and so
throughout 2022, we talked to alot of companies but all ended
up towards the end of 22 andbeginning of 23, consummating

(08:36):
new partnership relationshipswith Lilly and then expanded
partnership with AbbVie, and sothose were great validation of
the work we do, but also were animportant source of capital for
us to not only support theirprograms that we just partnered
on, but also the other work wewere doing in terms of building
capabilities and moving our ownprograms forward.

Matthew Pillar (08:57):
Yeah, tell us a little bit about what you can
share, about how you establishedthose partnerships, like what
mechanisms went into makingthose partnerships happen.

Peter Anastasiou (09:07):
Yeah, well, I think it all starts with having
something that people want andthat comes from solving
challenges that exist.
So we're in the geneticmedicine space, specifically
gene therapy.
And gene therapy has had somuch promise and some really
good successes with, like theold Algensma and Alvedis with
you know, and DMD with Sareptabut also had a lot of challenges

(09:30):
too, some safety issues,underperformance, issues in
terms of efficacy, but alsocommercial performance.
And so what we do is we existto solve the challenges that
some of those, many of thosefirst generation gene therapies
space, and so the partneringeffort really is by starting, by

(09:51):
having a solution to a problemthat exists.
And so, specifically, what wefocus in on is delivery.
So, you know, a lot of thesegene therapies are using
naturally occurring viruses,like wild type, like AAV9.
And for certain tissue targetsthat's great, like if you're
targeting the liver, youinjected IV and most of it

(10:14):
accumulates in the liver, sothat's no problem.
But for other targets, like thebrain, where there's biological
barrier, like the blood-brainbarrier, it's really tough to
get to the brain.
And so what we do is weengineer capsids, we take those
viruses, we engineer them to beable to cross the blood brain
barrier and we're not just CNSfocused those are elite programs

(10:37):
but any tissue that has abiological barrier, which most
do.
So getting tropism to where youwant to go and, at the same
time, engineering them to notaccumulate where you don't want
it to go, and in this instance,the liver.
So, and as a result of that,we're able to deliver IV.
So it all starts with thesolution that we're offering to
the problems of first-generationgene therapies that a lot of

(10:59):
these pharma companies have had.
So that's what enabled us toget a lot of meetings.
We kicked off at this meeting,jpmorgan 2022, a partnering
process, and it was because ofthat solution that we have that
we were able to get thosemeetings.
We showed them the progress wewere making.
We had a great CBO who hasgreat relationships and managed

(11:20):
a beautiful process, and that'show we ended up having not just
one partnership, but two thatcame out of that effort in 2022.

Matthew Pillar (11:26):
Yeah, all right.
So without getting toopropeller head on me, can you
talk a little bit about theengineering that enables this,
because you know there have been, it seems like for years
there's been discussion around,you know outside the liver,
right, so can you share with usjust a little bit on like sort

(11:48):
of the fundamentals, I guess, ofthat in a very high?

Peter Anastasiou (11:50):
level way.
So the first, the technologythat we're based on, comes from
caltech.
There's a woman named bibianabradinaru who has a lab in
caltech.
Two of the people in her lab,nick flintanus and nick godin uh
, together we call them theKnicks, so I may refer to them
as the Knicks during this call.
The three of them are thescientific co-founders.

(12:11):
So what they did was they takethat virus and manipulate the
amino acid sequence on thesurface of the capsid and that
creates literally billions ofvariants.
By doing that, manipulationcreates literally billions of
variants.
By doing that, you knowmanipulation.
You use directed evolution tocreate billions of capsid
variants.
And then what we have built isa screening process using

(12:34):
robotics and that automationthat can filter and screen, you
know, all the different nhptissues.
The important part is we'redoing all our work in NHPs and
in human cells, not just in mice, and so we go from the billions
of capsids down to thousands ofcapsids, down to dozens of
capsids, down to the one thathas the criteria we're looking

(12:56):
for for each disease.
So for any disease you set outin advance, almost like a target
product profile, like you wouldfor, let's say, a clinical
stage product.
Here we create what's calledthe target capsid profile and
say, okay, if we want to get toParkinson's, here's the cells we
need to impact, here's thebrain regions we need to get to.

(13:19):
And so we set up that criteriain advance and that filtering
process, screening process,allows us to get down and
identify that capsid.
So that's hopefully that wasn'ttoo-.

Matthew Pillar (13:30):
No, no offense to the propeller end.

Peter Anastasiou (13:34):
Yeah, propeller end.
Oh, that's great.
Yeah, but hopefully thatexplains the secret sauce.
And so that is our platform,but that platform has been
productive.
That is our platform, but thatplatform has been productive.
And now that platform hascreated assets that are on the
cusp of going to the clinic andhelping to treat patients that
have our target diseases.

Matthew Pillar (13:53):
Yeah, Then that process.
Is it a very time-consumingprocess?

Peter Anastasiou (13:59):
It started.
You know it's almost like I'mnot in the software world, but
you know they say that once youhave your first software, every
successive version goes quicker.
The turnaround time is quicker.
It's the same sort of thing.
So the first time we did ittook a little longer and every
single time that process hasshrunk down now to the point

(14:20):
where it's, you know, in theweeks and not months.

Matthew Pillar (14:23):
Yeah, that's a ML to AI enabled process?
I'm assuming no.

Peter Anastasiou (14:29):
I mean, no, it's mostly robotics and
automation.
Okay, yeah, you know, for uscertainly AI and all of that has
great promise in our industry.
But for what we're doing, doingbiological screening, we think,
is the best way to get the endresult that we're looking for
versus modeling it.

Matthew Pillar (14:48):
Or, you know, ai and silico approaches, yeah, so
we talked a little bit aboutthe macroeconomic environment in
22.
And I mean, if you're able topull through that, you know
you've got a leg to stand on.
There's a foundation.
And then, in this field ofgenetic medicine, there is a
microeconomic environment.

(15:08):
And on any given day.
You know, don't ask me whatinvestors are thinking the
partner you're looking for, butyou've got to differentiate
right.
You've got to create somethingthat keeps genetic medicine in
the you know therapeutic du jour.
Tell me about that, like,what's that been for you and

(15:29):
what levers and buttons do youhave control over to navigate
that?

Peter Anastasiou (15:34):
Yeah, I think everybody understands the
potential of gene therapies andgenetic medicines more broadly
and we've seen some of thosesuccesses, but we've also seen a
lot of failures, and so I dothink genetic medicines in some
ways have fallen out of favor inthe marketplace and people are

(15:54):
certainly excited about thingslike obesity and immunology, but
we exist to solve thechallenges that led to this
falling out of favor.
So I think what's fallen out offavor is some of those
generation one therapies thatare using, you know, aav9 and
can't be delivered IV withoutaccumulating the liver or you

(16:17):
have to do direct braininjection, and so all the things
that have made geneticmedicines, at least in our space
and gene therapy, fall out offavor is why we exist to solve
those challenges.
So sometimes it's a littlefrustrating that we get swept up
in that broad view, but theimportant part is that the
progress that we're making andit's tangible progress, I think

(16:39):
will certainly help continue todifferentiate us out of the pack
of the group that has kind ofbeen a little bit laggards.
But I also hope we're going tobe at the forefront, or the tip
of the spear, of helping bring anew set of enthusiasm and a new
era of enthusiasm to what we'redoing.

Matthew Pillar (16:59):
Yeah, I get the sense that some of the
enthusiasm around cell and genetherapies both cell and gene
therapies Some of thatenthusiasm gets quelled by the
complexity of manufacturingsupply chain, last mile supply
chain, if you will deliverypatients.

(17:20):
Big challenges there.
How does Capsida approach oraddress some of those kind of
back-end challenges?

Peter Anastasiou (17:28):
That's a super important point.
So, in addition to what I wasdescribing about our
differentiation around Capsidaengineering and getting to where
you want to go and not going towhere you don't want to go, one
of the other challenges thathas set back a lot of gene
therapies is quality ofmanufacturing.
So thanks to our investorsagain Westlake and Burson, who

(17:50):
understood that and were willingto make an investment in our
own manufacturing facility, sowe have a 15,000 square foot
manufacturing facility that's inour same building where our
research labs are in ThousandOaks in Thousand Oaks, and so we

(18:12):
have complete control overtimelines, cost, quality through
that manufacturing facility andon top of that we build in
manufacturing screen room thatscreening process that I talked
about, going from the billionsdown to the one.
Not only are we looking in thatscreening process for capsids
that meet the profile that we'relooking for, but we're also
looking for capsids that aremanufacturable at least in as
much quantity and scale and easeas AAV9.

(18:34):
So that's one of the earlyscreens that we do to help us
select the capsid and thatwouldn't be possible if we were
using a CDMO or if we didn'thave that capability and I'm
sure there's great CDMOs outthere no criticism.
Or if we didn't have thatcapability, we would and I'm
sure there's great CMOs outthere no criticism.
But you lose control andanytime you do a tech transfer,
you introduce risks and youcan't have the screening as

(18:56):
early in the process as youwould like and you don't have
that collaboration of being inthe same building between the
research team and themanufacturing.
For all those reasons, we madethe decision to invest in that
facility and it's been awonderful decision.
And not only has it enabled ourprograms but, quite frankly,
we're enabling our partners'programs.
So I mentioned the partnershipsthat we have at Vietlili.

(19:18):
We also have a partnership withCRISPR and Stally, but we just
got an option as an example,opt-in for one of the lead
programs from the AbbVieCollaboration in
Neurodegeneration.
We are going to be themanufacturer for that program,
so that's a great validation.
But not only did building thatfacility enable our programs,

(19:39):
but it's enabling the AbbVieprogram to go forward.
We have a relationship with asister portfolio company in the
Westlake Burson portfolio calledKate Therapeutics, and they
don't have a manufacturingfacility and we do.
So we've created a relationshipin 2023 where we would be a
manufacturer for them.

(20:00):
Novartis bought them and nowthey're a Novartis company and
they're going to continue to useus as the manufacturer.
So that capability has beengold for Capsida, but it's
proving to be that for the Abbeyprogram and hopefully other
programs from Abbey and forthese now Novartis programs.

Matthew Pillar (20:22):
Yeah, did that manufacturing facility come
online under your watch, or wasit does that?

Peter Anastasiou (20:28):
It was.
It was built.
It came online just as I wasjoining yeah, so I joined in
January of 2022 and that's whenit was coming online.
But the decision to make thatinvestment was made just prior
to when I well, about a yearprior to when I came and the
great manufacturing team that wehad built that out.

Matthew Pillar (20:50):
Our friends at Alston and Byrd set us up with
some amazing space to recordduring JPM week.
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(21:10):
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Alston Byrd represents lifesciences companies and their

(21:33):
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Learn more at alstoncom andtell them you learned about them
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On the business of biotech, doyou have any insight into what

(21:54):
kind of a heavy lift it took toconvince investors that
manufacturing analysis is theway to go.

Peter Anastasiou (22:01):
It was not cheap.
I certainly won't quote what itis that it costs, but I've
certainly heard the discussionswith our investors and with our
team and it was expensive but itwas worth it for all the
reasons that I mentioned.
It would be way more expensiveif we had all the reasons that
you even brought up.
The question is, if we havethese great programs and they

(22:24):
weren't manufacturable on theright scale or quantity and we
had to then go to another CDMOand do a tech transfer and then
you know a delay in our programsor you know hopefully you know
having any kind of not havingany quality issues or the FDA
shutting you down because ofyour quality issues would have
been way more expensive thanmaking that initial investment.

(22:48):
And, like I said, we have greatinvestors that had enough
wisdom and willingness to makethat investment.
I'm thankful that they did.

Matthew Pillar (22:57):
Yeah, the previous episode to this one was
with Stefan Scherer from 3T.

Peter Anastasiou (23:04):
So we have a common investor in Wesley Right?
Yep, yeah, he spent some timethere.

Matthew Pillar (23:06):
A common investor in Wesley Right?
Yep, yeah, he spent some timethere.
I believe, in fact, thatdiscussion sort of centered
around the shape-shifting thatyou know an R&D focused company
moving into the clinic has toendure, or you know the
decision-making that a CEO needsto make about personnel and
where resources are allocated.
Obviously they are notmanufacturing in-house, but I

(23:27):
would imagine that would be apretty big sort of shape shift,
not only to do in the firstplace but to maintain.
So three years in now, as CEO,tell me about how you're
maintaining expertisequalification momentum in that
manufacturing facility.

Peter Anastasiou (23:45):
Yeah, well, first of all we have a great
great team that's superexperienced.
They've been making biologicsfor literally a lot of 30 years,
Super experienced team, andthey're committed to our cause
and our mission.
They're a really great teamthat has a lot of them have

(24:05):
worked together for a long timeand kind of came over as a team
and they've been great for therest of the organization as well
in terms of culture, and sothey are pretty self-motivated.
But yes, of course there's afew, you know, pivots that you
make.
You kind of pivot from being aplatform to having assets, from

(24:28):
having assets to getting theminto the clinic, which that's
the state we're at and goingfrom, let's say, on the
manufacturing side, kind ofvector production, small scale
for animal experience, to thenexpanding to suspension,
broad-based manufacturing forhumans, and it's different

(24:48):
quality level of specifications,and so all those have been
super exciting pivots that we'vemade successfully up until this
point.
And the next and most importantpivot we're making is filing
INDs, which we'll do here in thefirst half of the year.
Two INDs one for our program,developmental and epileptic

(25:11):
encephalopathy caused by aspecific mutation, by the STXBP1
mutation, and then aParkinson's program caused by
GPA mutations.
Both of those knock on woodwill be submitted and approved
INDs in the first half of theyear and hopefully we'll be
treating our first patients inQ3 for both programs.

(25:31):
So all of those have beenexciting evolutions, next steps
that, at the end of the day, youknow, one of the things that
we've talked about is the greatscience that we have isn't just
for science sake.
We're not an academicinstitution, we created the

(25:54):
science.
So then it helps in the serviceof patients, and so that's also
been kind of a North star forall of us, whether it be the
research team, manufacturingteam, certainly the clinical
team why all of us are here, andso it's a really exciting time
for us making that big, bigpivot.
Will that manufacturingfacility support clinical trial

(26:15):
supply, gmp?
Actually, we just finished theGMP manufacturing for our first
program, the STX BP-1 program,and we're in the middle of
finalizing our GMP for theParkinson's program, and so that
is at the FDA's quality specs.
We've had pre-ID meetings wherewe've submitted the data that

(26:37):
we have and we got positive orsupportive feedback from the FDA
.
But yeah, so this is a clinicaland commercial grade
manufacturing facility.

Matthew Pillar (26:49):
Yeah, I ask that question in part because some
of the you know, so often whenwe think about genetic medicine
we think like rare disease,ultra-rare disease.
Some of the indications thatyou guys are looking at are not
so rare, certainly notultra-rare.
So it seems to me there's adifferent sort of capacity
requirement, potentially as youmove the products.

Peter Anastasiou (27:11):
We certainly have the capacity to do the
upcoming clinical trials.
But as those programs progressand as our partners programs
progress, I hope we'll be in asituation that we need to expand
our facility.
We have the capability toexpand our facility in our
current footprint.
That would be a wonderfulsituation to be in.
Yeah, so you were talking aboutlike indications.

(27:32):
We purposely picked indicationsthat would well, first of all,
that have an unmet need that wethink we can help these patients
.
That's first and foremost.
But we selected them to be kindof bookend.
So if, to your, to your point,in gene therapy a lot of the
traditional programs are inpediatrics, ultra-rare or small
diseases.

(27:52):
So the STX-BP1 program iscertainly not ultra-rare but it
is considered rare it's about5,000 patients in the US and
Europe and in pediatricpopulation, that's kind of the
traditional place gene therapiesare played.
And on the other end we selectedParkinson's, gba, adult
population, neurodegeneration,bigger patient population, about

(28:18):
300,000 patients in the US andEurope.
So we, you know we wanted toshow the bookends of what's
possible with our capsids, withour cargo optimization
capabilities, everything, and sothat's why we picked those two
as elite programs.
And it also, to your point,showcases what's possible on the
manufacturing side too, to beable to accommodate both of

(28:41):
those adult patients thatrequire more and broader
populations as well as you know,the rare condition in the spin
a younger patient population.
So I think those indications,besides those programs, besides
being best in class to helppatients who are desperately
suffering, also are a greatshowcase of what's possible

(29:02):
through our technology.

Matthew Pillar (29:04):
Yeah, we talked a bit about the investment
community and its appetite forgenetic therapies.
You know, like I said, giventhat so much of the nucleus of
activity in this space has beenin ultra rare, what's different
sort of compare and contrast forme?
What's different in terms ofyour approach to the partner
investment community in broaderindications than what you know,

(29:28):
these small like ultra rareindication developers are
experiencing?
Is there a difference?

Peter Anastasiou (29:37):
Well, so we've had a receptive audience from
the investment community, justlike we have from the pharma
community, because, again, we'redoing things, we're solving
problems that exist andcertainly, just like pharma
companies you know, some areinto rare diseases, some are not
, some are into broader diseases.

(29:57):
There's investors that have athesis and you know, and each
can, and so you know everybodythey have to be focused on where
they invest, so they can'tinvest in everything, but it's
been a receptive conversation.
I think you know even the raredisorders.
I mean, look at a company likeSarepta and the success they've
had.
I just saw that they announcedthat they're performing ahead of

(30:20):
their plan in the commercialuptake of their product.
All that creates great momentumfor the types of things we do.
And while there have beenchallenges in CNS, even on the
or I'm sorry, not in CNS in genetherapy, on the
commercialization side, in theCNS part of gene therapy,
there's been some good successeswith, you know, avexis,

(30:42):
navivartis and Zolgensma andSarepta and what they're doing
with Elbetis, and we think we'regoing to have similar success
even in the rare population andcertainly in the broader
population with the nerdygeneration program.

Matthew Pillar (30:58):
Yeah, yeah, you've talked a bit about what
Capsida is doing to change theparadigm in gene therapy and you
bear a responsibility to dothat, apparently.
What do you see across thegreater landscape Like?
What does the rest of the fieldI don't mean to you know make
it an us?

Peter Anastasiou (31:16):
versus them, kind of thing.

Matthew Pillar (31:17):
But from your perspective, what does the rest
of the field need to do to bringgene therapy back to the
development stage that it needsto be at right, to bring gene
therapy back to the developmentstage that it needs to be at
right.

Peter Anastasiou (31:32):
Yeah, I think we you know the field needs to
be more selective about you knowwhat indications we're pursuing
, what technology you use.
Like I said, certain diseases,it's perfectly fine to use
AAV-based therapies because youcan easily get to certain
tissues, but for those you know,more difficult tissues to get
to, like the brain and like manyother organs, I mean, the
kidney has biological barriers,the lung has biological barriers

(31:56):
, the eye has biologicalbarriers.
So, just being smart about theindications, being smart about
the delivery technology that'sbeing used, and then, of course,
cargo and things like that.
But I really think that, again,I'm quite hopeful that, with
some of the successes that arehappening, particularly in some
of the CNS gene therapies that Imentioned, but also progress

(32:19):
we're making and, quite frankly,others are making as well, I
think will help, I hope, but Ithink will help to restore some
of the momentum and enthusiasmBecause at the end of the day,
it's undeniable the benefit thatgene therapies can have for
patients if they're done right.
I mean if you have a cleargenetic cause of a disease and

(32:39):
you can fix that genetic cause,whether it be through a gene
therapy or, you know, a geneediting approach.
Those are disease modifying andpossibly curative, so the power
is undeniable.
These aren't symptomatictreatments, you know.
Like you know, in ourParkinson's program I mean,
levodopa is so critical buteventually it wears out.

(33:04):
I mean it's a symptomatictreatment.
What we're trying to do isalter the course of the
Parkinson's caused by the GBAmutations.
That's just so powerful, and Ithink there's a lot of companies
that understand that.
That's why there's many thatare still quite engaged in gene
therapy and there's a lot ofinvestors that see that.

(33:25):
So then it's incumbent upon usand others to deliver on that
promise, and that's why we exist.

Matthew Pillar (33:31):
Yeah, yeah, what is the?
What is the greater genetherapy landscape in CNS
disorders look like?
Is it a competitive space?
Do you find a lot of peopleworking there or people moving
toward CNS?

Peter Anastasiou (33:46):
Yeah, I think there are people working in it.
Certainly I think, again, theunmet need, the problems that
exist are undeniable, so itcertainly attracted some
interest.
You know I'm quite proud ofwhere we're at and the programs
that we have are all the venturewould be best in class.
Again, we're about to be in theclinic and so you know I'm a

(34:09):
believer, like when I thinkcompetition brings the best out
of people.
You know, fear competitionthat's.
You know, the old saying is thebest thing that ever happened
to Coke was Pepsi.
And so there is something abouthaving.
You know, all boats rise when acouple of members are in a
category and are workingtogether.
You know, working together butare working towards solving

(34:32):
problems.
It just brings a little bit ofvigilance and a little extra
something from all of us.
But I wish you know anybodywho's in this space.
I want the whole field tosucceed Because again, it'll
bring momentum back to the field, it'll bring more investors in,
it'll bring even more pharmacompanies in and ultimately
it'll just help more patients.
So that's how I kind of thinkabout the competition field.

(34:55):
Yeah.

Matthew Pillar (34:56):
Give us a snapshot of where Capset is
today in terms of that marchtoward competition field.
Yeah, give us a snapshot ofwhere CAPSET is today in terms
of that march toward the clinic.

Peter Anastasiou (35:03):
Yeah.
So I mean we're very much inexecution mode to get ready for
our IND filings.
You know we've done all the INDenabling work that needs to be
done for those two programs.
We've had pre-IND meetings withthe FDA, we've done dose range
finding studies, we've dosed ourGLP-THOT studies and we've done
manufacturing scale-up for oneof the programs or almost done

(35:25):
with the other.
So now we're just waiting forthe final results of those
studies and then we'll packagethose INDs both in the first
half of this year and inparallel we're preparing for the
clinic.
So we have a great chief medicalofficer who's hired, a great
team and also a network of youknow CROs and outside
consultants that are busytalking to sites and getting

(35:48):
those sites up and ready.
You know we don't want to startthat process after the IND is
approved.
We started that process monthsago so that we're ready as soon
as the IND is approved that wecan start.
You know, planning for andfirst patients to get treated.
So that's what our focus hasbeen.
I mean this has been thecompany's been around five years
.
This has been the and actuallythe people at Caltech were

(36:12):
working on for many years before.
This is the culmination of thework that's gone on for many
years is to get to this point,to help patients.

Matthew Pillar (36:21):
Yeah, yeah.
It's always interesting to meto have a conversation around
sort of that metering of theshape shifting of the growth of
the hires.
You know, pre-ind we need toput a clinical team into place.
You know there's all this riskinvolved in that right Like
planning for the next step andbuilding for the next step.

(36:42):
Give us some insight, I don'tknow advice, if you will, to
aspiring biotech builders onthat element of it, like
obviating for the next stepbeing a step ahead and embracing
the risk of being ready for thenext step.

Peter Anastasiou (36:57):
Yeah, I think you have to have the passion for
building and you have to havethe tolerance for risk and you
have to understand thatinnovation is not a straight
line.
It's usually like this but aslong as you're heading upward,
then you're doing well.
But if we're all foolingourselves and we think it's
going to be a completelystraight line, no setbacks,

(37:22):
that's just not reality.
But I think it's a mindset thatsomeone needs to have.
You were asking about my careerearlier.
Even though it was a little bitdifferent, it was the same kind
of experience that I had atLundbeck.
So, when we were building andtaking on risks of, you know,
developing products, licensingproducts, buying companies all

(37:43):
of those take risk.
All of those have setbacks.
You know you're building newcapabilities.
You know you have SOPs.
You know you make some mistakesand you learn from those
mistakes.
It's all you know, very similaras you know the capabilities.
It's all you know, very similaras you know the capabilities
we're building.
You know building a clinicalregulatory team building.

(38:04):
You know all the moving from.
You know a new phase ofmanufacturing, moving into the
GMP scale.
All of those are exciting, fun.
There's challenges you run intothat you have to overcome and I
think you have to be ready forthat ride.
And then the other thing I wouldsay is, especially as a CEO I

(38:25):
mean, sometimes people expectthe CEO to be an expert at
everything I personally thinkthe best CEOs are those that
understand what they're expertat and hire people who are
expert of the things thatthey're not and creating a clear
strategy, creating a clear setof objectives and goals, that
they hold people accountabletowards delivering, inspecting

(38:48):
on what's happening but at thesame time, and holding people
accountable but at the same timegiving people the latitude to
exert the expertise you hirethem for latitude to exert the
expertise you hire them for.
And also, as a CEO, to be thebiggest champion, storyteller of

(39:10):
the company, chief, fundraiser,all of those things.
So, for those who areinterested in a career or aspire
to become a biotech CEO, Ithink those are some of the
thoughts I would share.

Matthew Pillar (39:16):
Yeah, no, they're all good thoughts.
Now level with us and tell uswhat's not fun.

Peter Anastasiou (39:25):
Well, the inevitable setbacks are not fun.
The funding environment hasn'tbeen fun, even though we've
navigated it well.
We're a five-year-old companyand still the only equity route
we raised was the originalSeries A.
All the rest of the funding hascome through pharma partnering
and we've been very successfulat that, but not having the kind

(39:49):
of momentum in themacroeconomic environment and
kind of biotech or the momentumbehind gene, genetic medicines
and therapy.
Those things haven't been fun.

Matthew Pillar (40:01):
Right.

Peter Anastasiou (40:01):
But we've navigated through that.

Matthew Pillar (40:02):
Yeah, so what's on the agenda here at JPMorgan25
?
And it's an interestingquestion to ask because you know
there's the obvious Well, I'mhere to meet with investors and
find partners, but there'salways some nuance in the
response that I get to thatquestion.
So specific to Capsida what areyou doing?

Peter Anastasiou (40:19):
Yeah, well, first and foremost, we have a
speaking slot at the conference,which is great, and so it's.
You know, this is the biggestmeeting of the year and kicks
off the year and couldn't bebetter timing for us because of
the transition we're about tomake from, you know, preclinical
to clinical, and it really isthat transition, in addition to

(40:42):
the presentation that we'recommunicating here to pharma
companies, to investors, aboutthe progress that we made and
getting these lead programs onthe cusp of being in a clinic
and treating patients.
So it's mostly awarenessbuilding around the progress
We've always maintained andworked hard to maintain

(41:04):
relationships with pharmacompanies, investors, et cetera,
and make sure that they knowwhat we're up to and the
progress that we're making.
I'm a big believer that youdon't just show up to somebody
when you're looking forsomething, whether it be a
partnership or an investment.
I think telling our story,building awareness, creating a
base of knowledge for thosecommunities of what we're up to,

(41:29):
just makes it so much more easywhen there is something
specific or tangible that you'reworking on, whether it be with
pharma companies or withinvestors.
So it's mostly awarenessbuilding about, as you used, a
phase shift that the prettysignificant one we're about to
embark.

Matthew Pillar (41:49):
Yeah, very cool.
I want to ask another questionabout the meeting, the JPM
meeting, right, I was justhaving a conversation about this
with a colleague of mine andI've sat in on a number of them
and I see what happens on stageand we talked about we're just
having a sort of a speculativeconversation about how important
what happens off stage might be.
So I'm curious if you can giveour listeners some insight into

(42:12):
the mechanics of that meeting.
So I'm assuming you'll bepresenting, yeah, I'll be
presenting, you'll be presenting.
Now did you bring?
So you'll present you'll.
You know, you'll do the pitchdeck, you'll hope that you got
all the right points right.
A lot of prep that goes intothat.
Now, did you bring like asupport team?
They got some more morescientists that go on propeller
cut floats, who are going to,you know, kind of take questions

(42:34):
off stage Like what does thatkind of look like?

Peter Anastasiou (42:37):
Yes.
So the short answer is yes, Ourchief medical officer, our
chief technology officer and ourchief research and innovation
officer, as well as othermembers of the leadership team,
will be there, but they'll bepart of the Q&A at the end.
But it's interesting when yousay off stage, my time on stage
is total of 25 minutes and we'rehere for five days, Right, so

(43:00):
most of the action that is forus, but almost everybody, is not
even related to the specificconference.
It's the magnet, the conferencethat has attracted all these
people that are here.
So it's really outside of theconference that we're having.
Well, this conversation talkingto pharma companies, talking to

(43:21):
investors, meeting with ourcurrent partners.
You know we have thepartnerships with Abbey, Lilly
and CRISPR.
So we're taking advantage ofthe fact that we're here and
working with them, meeting withthem, update on the programs,
the progress meeting with ourown investors, programs, the
progress meeting with our owninvestors.
Since we're all in the sameplace, it's an opportunity to

(43:43):
make sure to communicate, stayconnected with our current
investors.

Matthew Pillar (43:53):
So that's how we're spending our time and
again, I think for everybody,most of the action's outside the
conference.
Yeah, yeah, for sure.
Yeah, stefan earlier talkedabout how it's like an 8 to 11
day.
That's probably conservative.
Yeah, certainly it, for sure.
Yes, stefan earlier talkedabout how it's a.
It's like an eight to 11 dayyou know that's, that's probably
conservative.

Peter Anastasiou (44:02):
Yeah, certainly it was yesterday.
I mean first night with all thereceptions that most people
have.
You know, quieter tonight butbusy all day long, and busy all
day long tomorrow as well, yeah,and then, and then Thursday,
and then, you know, kind of inthe afternoon on Thursday.
I guess If I had hair I wouldsay I could let my hair down on
Thursday afternoon.

Matthew Pillar (44:23):
Well, I wish you luck in the presentation.
That's a great achievement.
I'm sure it'll go swimminglyand I really do appreciate you
taking time out of this superbusy week to spend.
Yeah, thanks for theopportunity.
Yeah, happy to be a part of it.

Peter Anastasiou (44:35):
Yeah, it was fun.
I wish you all the best withall your podcasts throughout the
year.

Matthew Pillar (44:39):
Thank you All right, so that is Capsula CEO
Peter Anastasiou.
I'm Matt Piller.
This is the Business of BiotechJPM edition.
We drop every Monday, so we'llsee you next week.
Thanks for listening day.
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