Latest / The BioHub - by Avetix / Episode 114 - Martijn Negen - COO of VarmX

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Episode 114 - Martijn Negen - COO of VarmX · The BioHub - by Avetix

0:04
On this episode of the Biohub podcast, we're joined by Martin
0:07
Nagan, who is the Chief Operating Officer at Varmax.
0:12
Martin, great to have you on the podcast.
0:15
Thanks for coming on and just to thanks.
0:17
For having me. Yeah, no pleasure.
0:21
Just to kick things off, I guess Varmex, you've had a busy past
0:25
year, but maybe for the listeners out there who don't
0:28
know too much about the company, do you want to just start off
0:30
with a quick high level overview of what you guys are all about?
0:35
Yeah, of course, of course. Yeah, Thanks for having me
0:37
again. I'm really great to to be able
0:39
to spend this time with you. We're indeed Varmex.
0:43
We're based in Leiden in the Netherlands and we're all about
0:47
transforming the treatment of inherited and acquired
0:51
coagulation factor disorders that cause either bleeding or
0:55
thrombosis. And our lead asset is called
1:01
VMXCOO 1 and that's all about either preventing bleeding or
1:08
stopping bleeding. The asset has been in
1:12
development for quite a few years.
1:14
Of course, we're now ready for phase three, which we're
1:17
actually in the process of starting up and we're hoping to
1:19
open our first clinical trial site actually on the other side
1:23
of the globe in Australia and New Zealand, right on the other
1:27
side of the of the new year. We're late December now, so
1:32
early January 26th we hope to to launch our first site and then
1:37
of course first get our first patient in.
1:39
And the indication we're after with VMX COO1 is for the
1:44
treatment of patients who are on so-called factor 10A inhibitors,
1:49
Eliquis, Xarelto products like that.
1:52
There's 10s of millions around the world of people who take
1:55
these drugs to prevent blood clotting because they have for
1:59
example atrial fibrillation or other conditions.
2:03
These drugs work fantastic. They prevent a lot of blood
2:05
clots and they're for prevent a lot of lost lives as you prevent
2:11
myocardial infarction, brain infarctions and so forth.
2:16
However, if you're on these blood thinners, as they're also
2:21
called in sort of the public domain and you do require urgent
2:26
surgery, then the surgeon cannot just cut you open because you'll
2:30
just continue to bleed. And these people literally clean
2:33
out the blood bank as they say, a lot of blood transfusion
2:36
needed. There are no indicated
2:40
treatments for for these patients.
2:42
There is nothing that can make these blood thinners, these
2:46
factor ten aid inhibitors stop working.
2:51
There is one asset and Exonet alpha that is partially
2:57
approved, however is just being removed from the market in the
3:00
US by by its producer AstraZeneca.
3:04
And we're waiting what they will do in the rest of the world
3:07
because the recent trials showed that it works well, but it works
3:10
too well. It it, it caused hot clots so
3:15
and there's some other stuff that's used off label.
3:18
Got. You, so the and the other
3:20
indication for this asset is if you have a spontaneous severe
3:23
bleeding either, I don't know, a ruptured aneurysm, a brain
3:27
bleed, a car accident with trauma and bleeding, then you
3:32
also continue to bleed. And our asset is a human
3:37
recombinant factor 10, which functions the same as you and I
3:43
have in our correlation system. And this is a key component of
3:46
blood correlation and it's modified such that these factor
3:51
10A inhibitors that all these patients are on cannot bind to
3:55
it. And as a result, our asset
3:58
bypasses those blood thinners that are in the bloodstream of
4:02
the patients and thereby immediately restore the ability
4:07
to coagulate to clot blood and in that way either allow urgent
4:14
surgery or stop a severe bleed from from from continuing.
4:20
Now of course, we're doing a phase to each demonstrate that
4:24
that indeed works in actual patients.
4:26
But our current healthy volunteer data and also animal
4:30
models that we've done illustrates that it works really
4:33
well and it does not add what's called thrombotic risk.
4:37
So a risk of blood clotting, which you don't need of course,
4:40
in those spacious. Nice.
4:42
So it's restoring the body's normal process, right I think
4:47
there was someone on blood thinners these his as well,
4:49
right family members, friends. So yeah, that's that.
4:53
It's not your first rodeo in the space either, right?
4:56
I mean, just going back a little bit to your own personal
4:59
background. You were with Portola, right?
5:02
For. Yeah, that's correct.
5:04
That's correct. Yeah.
5:05
So if I, if I go a little bit farther back, I, I did start in
5:08
the in on the science side, medical, medical laboratory
5:12
technology, medical biotechnology and then ended up
5:17
on the commercial side in, in pharma.
5:19
So I spent quite a few years in big pharma companies.
5:23
As I just mentioned AstraZeneca, I worked for Eli Lilly,
5:26
Bristol-Myers Script Genentech, worked in in in several
5:30
countries in Europe, at the European level, also lived and
5:34
worked in the US East and West Coast amongst Rich Genentech in
5:39
the Bay Area and also worked in global roles.
5:42
And eventually ended up back in the Netherlands and worked as a
5:46
general manager for a company, indeed that was called Portola,
5:51
which developed and launched the product I mentioned before,
5:55
Andexanet Alpha. So this was really the first
5:59
asset in this space of managing patients on a factor 10A
6:03
inhibitor that either require urgent surgery or suffer from a
6:07
spontaneous severe bleed. They did a really great job as a
6:12
sort of the trailblazer in the in the space.
6:16
But the product, yeah, is just not delivering on its on its
6:20
promise. And hence the decision of
6:22
AstraZeneca, who now owns the products after Portola was
6:25
acquired by Alexion and Alexion, as you may recall, was acquired
6:29
by AstraZeneca, they have now decided to, to, to discontinue
6:35
the products, at least in the US for now.
6:37
I was a general manager with them launching in in Europe, so
6:41
part of the European leadership team in the late teens, early
6:44
20s, including some some, some some COVID time, which was
6:48
interesting and LED the Nordics, Benelux and later also the
6:54
Alpine region. So yeah, I have I have some
6:57
background in this space and more broadly, I think my
7:01
background is not only, but in the last few years it has
7:05
focused there in the intra hospital setting, which is in my
7:09
view a very different game, if you will.
7:11
Then then for example, buy and bill or or General practitioner
7:15
setting as well as in the urgent care, either ICU or ER, urgent
7:23
surgery and so forth setting, which sets itself apart from
7:28
your general, let's say, rheumatoid arthritis patient
7:32
that just has an appointment to come see the physician in the
7:34
hospital for job. So that's, and then I think the
7:38
additional pieces, the, the biotech background that I, that
7:42
I have all assets I've worked on in the last, I don't know,
7:47
decade or more, maybe almost all have been biotech.
7:51
So proteins that are produced by living organisms.
7:56
Yeah. Nice.
7:57
Yeah. I think it's interesting that
7:58
you touched on the intra hospital space.
8:00
Yeah, it's very different like you say, someone coming into the
8:04
doctors for their general appointment versus someone
8:07
potentially bleeding out on the surgery table.
8:09
It's pretty stark difference for sure.
8:13
Yeah, really testing environment.
8:15
I mean you, I think you also did some consulting work between
8:18
there with Target who've also been on the podcast as as well,
8:22
right. Are you when Varmex came along,
8:26
you touched on the reason that the on that she has not
8:29
obviously been withdrawn from the US market.
8:33
What stood out with your program like science or yeah, mode of
8:40
action? Yeah.
8:41
What's something that drew you into to Varmex?
8:45
It's interesting that you that you asked that I did not come
8:51
across pharma by by accident. It was because of my background
8:54
with this Portola and knowledge in the in the space.
8:58
After Portola got bought by Alexion and Alexion was going to
9:02
get bought by AstraZeneca. I left Alexion for AM Pharma,
9:06
which is a company and you tracked in the Netherlands level
9:11
that is active in in also urgent care and critical care, ICU care
9:20
there as it was in phase three, but that failed for futility.
9:24
The only endpoint you don't want to hit, we hit it at AM Pharma
9:28
and the company is now on track to in an adjacent indication
9:33
finalize a phase two trial and and hopefully go from there.
9:38
Once I left AM Pharma because we've reduced the organization
9:41
where I was a commercial lead from 30 plus to I believe 3.
9:45
So it was a significant downsize.
9:49
My intention was to come back into a ideally sea level role in
9:56
a startup biotech. Those roles of course are not
9:59
widespread, certainly not in the Netherlands or near the
10:02
Netherlands. So I started doing different
10:05
projects with companies where I could help with my expertise,
10:08
background, network and so forth with the aim of eventually
10:12
ending up in a role. One company, as you mentioned
10:15
was Target Indeed, with Christopher Kreis, who also was
10:18
on the podcast and worked with a couple of other companies and
10:23
through a venture capital firm that was looking at Farmax.
10:27
I got to speaking to them and was introduced to the Farmax
10:30
team who were on the brink of either doing a series C
10:36
investment round or in some other way from the company so
10:40
that they could execute the phase three, the CMC work and
10:43
other things that that needs to happen in the coming years to
10:46
bring the product to to commercialization.
10:49
And that that it was interesting because it, it was really first
10:52
it was like, oh, we did this market research.
10:54
Can you have a look at it and tell us what you think?
10:57
We need another project that you maybe run that for us.
11:00
Somebody got sick. He maybe take over his role for
11:03
a little bit. And so it's snowballed into a
11:06
role that got bigger and bigger and now, you know, Long story
11:11
short, and now the I need the CEO and I'm wearing a couple of
11:16
other hats at the same time as well.
11:18
Yeah, I was going to say you essentially CBO is well right in
11:23
all but. Yeah.
11:25
Well, yeah, yes, yes and no. The, the, the business
11:29
development piece, we, we really did as a team where our CEO,
11:34
John Glasspool, our CFO Paul Rose and myself, we were sort of
11:39
the core, but you, you do these things together because that's,
11:42
that's what you need in the end. I'm also the, the commercial
11:46
lead. So in, in we'll get to this, I
11:48
guess later on in building our equity story going into phase
11:53
three, we really needed a firm story and strategy around, OK,
11:59
how are we going to commercialize this thing once it
12:01
gets through phase three, What is required?
12:04
What are the barriers, what are the opportunities?
12:07
How do you go about it? And we needed to do some, some
12:10
research and work with an external consultant firm to, to
12:14
put that story together. And I, I LED that effort as
12:16
well, given my, my commercial background.
12:19
And now that we're in a collaboration, which we'll also
12:21
get to no doubt, Callum, I'm also part of the alliance
12:26
management. So there's different hats that I
12:28
get to wear, which is all of fun, Yeah.
12:30
Nice. Yeah, it's a, it's a good segue
12:32
in one time as well. So I mean you joined back in mid
12:36
2024, right? And was the Series C announced
12:40
quite soon after that? When was When was that?
12:44
Yeah, Yeah. So my, my sort of my initial
12:46
projects were already well before middle of 2024, but
12:51
indeed and we already started building the the commercial
12:55
piece of the equity story for that as well began indeed in the
13:01
middle of 2024. John Glaspool joined us our our
13:05
CEO. He's a very experienced first
13:09
big pharma and now several startup biotech executive with a
13:17
ton of of experience and network and also in business
13:21
development. And with him and the rest of the
13:25
team. We really initially sat down and
13:28
say, OK, we need this company funded to execute the phase
13:32
three CMC and other things we need to do.
13:34
What do we need for that was just under 200 million.
13:37
We went for 185 million and we could either do a Series C
13:42
through venture capital or some other combination working with
13:47
also potential strategic partners and that's what we went
13:50
about doing. So we first sat down and said,
13:52
OK, what should our equity story look like?
13:56
How do we make this essentially one company, one asset company
14:01
with a couple of other assets in the early pipeline relevant and
14:08
interesting enough for either venture capital investors or or
14:11
strategic partners? And then so that's why you
14:13
really need to start because of course you're in the end,
14:16
you're, you're, you're selling a company, you're selling an
14:19
asset, you're selling an opportunity for investors or
14:23
whoever they may be, at least that's the way I look at it.
14:26
And so BD in that sense is for me is, is very much like a sales
14:30
process which I've lived and breathed for years in, in bigger
14:33
pharma. So that's also how I look at it.
14:36
And it's, it's very much as John tends to say, kissing as many
14:40
frogs as possible and then one, one will turn into a Prince.
14:44
So we built that, that equity story and we did two things.
14:47
We then started reaching out to venture capital firms that we
14:52
felt might be interested in, in, in our products and our and our
14:56
company. And there were a couple of
14:58
criteria. I think 11 is we need a
15:00
significant cash 200 million and you don't want to get AV CS.
15:05
We will all chip, chip in a little bit.
15:08
You want a couple of big ones and maybe some smaller ones.
15:11
Our internal investors will also willing to to provide further
15:15
funding. So that gives you a sort of a
15:18
focus of what group of venture capital firms you want to be
15:22
focusing on. And then you want friends who
15:25
are interested and and possibly active already in the sort of
15:30
inter hospital biotech acute care space.
15:33
And there's not that many venture capital firms around
15:36
that are particularly the focus there.
15:40
But with our network, with John's network mind Paul's, but
15:43
also our our board, the chairman of who is John Erstrom, who used
15:48
to be the CEO of the company and has a a ton of network and
15:51
experience in the space. And of course use our our
15:55
support from our own board members, which which are our
15:59
current venture capital investors who have their own
16:03
network. We were able to to cast the net
16:07
pretty wide. And so we spoke, I haven't
16:10
counted, but it must be more than 60, maybe even close to 100
16:13
venture capital firms that we presented at least our non
16:16
confidential deck 2. And from there you know there
16:21
were all series you were interested and got into due
16:24
diligence and went into a data room and did more analysis and
16:28
so forth. In parallel, we also went down
16:31
the strategic partnership track and we started by looking for a
16:35
strategic partner, a Co development partner, we called
16:38
it in Japan and Co developments. I call it because we were
16:43
looking for someone who could help us develop the asset in
16:46
Japan from a clinical trial perspective, provide funding to
16:51
impart at least support our our, our effort.
16:54
And then of course, obtain rights to commercialize the drug
16:58
once it were approved in in Japan.
17:00
And that on the strategic side really created a a domino effect
17:06
or or snowball. Maybe I don't know what you what
17:08
you want to call it. We got, you know, word gets
17:11
around you speak to companies and who are active in Japan.
17:14
You can think of it yourself as Stella's, Takeda companies like
17:19
that Shinogi, but they, they all at least these also have global
17:25
presence, right? So they start talking to their
17:27
colleagues in, in, in, in other regions and work that out to
17:31
other companies. So then we got a company who was
17:34
interested for potentially a European deal and that was one
17:38
that was interested in potentially AUS deal.
17:42
And so then we had all these permutations on the table or
17:45
combinations that we could go down.
17:48
And that then led to a a lot of conversation between US and what
17:54
we called our, I believe it was called the investment committee,
17:57
which was us and a couple of members of our board to really
18:01
weigh our options and see where do we have most traction?
18:04
Where do you have the biggest chance of getting the best, the
18:06
best deal, not only for us as a company, but also for our
18:10
current investors who didn't homework diluted too much and
18:13
you get all these dynamics that come into play.
18:16
Yeah, absolutely. And I guess you guys for sure
18:19
feel like you've you've found that best deal with the the CSL
18:23
collaboration, right? I mean, it's, yeah, pretty
18:27
sizable return for the investors, I guess.
18:31
But also it gives you not necessarily the freedom, but
18:35
yeah, the backing to, yeah, step into that registration trial
18:40
like you say. And also it's for, is it for
18:43
that asset only? It's only for your lead asset.
18:45
Do you have the rights to the other assets within that deal?
18:49
Yeah. So maybe more so than a couple
18:52
of years before where you know companies get would get funded
18:57
with very little data and we're able to raise very significant
19:02
amounts and that's no longer the case.
19:04
I think the pendulum is is swinging back a little bit now,
19:06
but there still is is caution in the in the market.
19:11
So we had several companies, VC firms that were interested.
19:15
We were, we have talked about terms, we never got a, a, a firm
19:20
term sheet on the table. So but on the other hand we had
19:24
several term sheets from, from strategic potential strategic
19:28
partners, regional and one global.
19:31
And the Global 1 is what we ended up going with which was
19:35
CSL who are headquartered in in Melbourne, Australia, but they
19:40
have also got offices in Zurich and then on the East Coast of of
19:44
the United States and so forth. And they are very versed in the
19:48
hospital space. They have actually have a
19:51
competing products to our assets in this space of managing
19:56
patients who are on a factor 10A inhibitor.
19:59
And so they have the commercial footprints, they have this their
20:05
background and working with blood products and so forth.
20:09
They have very significant CMC experience, which is very
20:13
helpful for an asset like ours where COGS is.
20:16
This is not just a monoclonal antibody.
20:19
Which has been commoditized at least the production of which
20:23
that the COGS are are usually not that much of an issue.
20:26
They're very smart and how we produce our assets so that we
20:29
minimize the cost of goods sold and so they can be a great
20:33
partner there. So we we've partnered with them
20:37
and they provided us with an with an upfront that has given a
20:44
initial return to our investors. They have committed to funding
20:48
the entire program as we were also pitching to venture capital
20:52
firms. So that's 185,000,000 which
20:55
allows us to execute a phase three trial, also execute a
20:59
single arm phase two trial and an adjacent indication to your
21:03
question earlier, it allows us to further develop the pipeline
21:07
assets that we that we have. It importantly allows us to get
21:13
to commercial scale with our CMC program and also look for
21:17
optimization to minimize the, the COGS once we get to market.
21:23
And they've also committed outside the deal to, to help us
21:28
with commercial readiness activities.
21:32
And so that's, that's really great.
21:35
So we can now execute the the plans that we that we have.
21:39
We do that in close collaboration with them.
21:42
So we have a governance structure where we have a joint
21:44
steering committee and a a joint CMC clinical development and and
21:49
commercial committee. I get to Co lead the the latter
21:52
as well. And I'm also the alliance lead
21:54
together with someone on the CSL side.
21:56
So that's where my multiple hats come into come into play.
22:01
And that said, we are as a company, we're still an
22:05
independent entity. And as such, we are in the lead.
22:09
We do it collaboratively. But in the end, if Bush comes to
22:13
shove, we take the decision today to go left.
22:15
If they want to go right, for example, we haven't gotten
22:18
there. And I, I don't think that we
22:20
will, but if we need to, then, then we could go there.
22:24
So that's really good. So we have that, that autonomy,
22:27
if you will, still as as an organization.
22:30
But you know, we want to of course benefit as much as we can
22:33
from our, our partner in all functions that we that, that,
22:38
that we operate because they have a tonne of resource
22:43
knowledge and, and capability that we can benefit from.
22:46
We're only 23 people I think right now.
22:49
So you know, we don't, we don't, we don't have much bandwidth.
22:52
Yeah, for sure. And like you said, I guess that
22:55
existing particularly CMC experience within CSLI mean it
23:00
gives you the best chance of, yeah, reducing those COGS like
23:03
you say, but are equally getting the product to patients as
23:08
quickly as. Possible, certainly, yes.
23:10
CMC as I talked about it's also clinical operations like for
23:14
example, we are now as we get into the startup of our phase
23:17
three, we're looking to, to to work in 150 to 165 clinical
23:25
trial sites. So hospitals worldwide, US,
23:27
Europe, New Zealand, Australia, Japan.
23:32
And since CSL has boots on the ground and institutional
23:36
knowledge in these hospitals, it can be extremely helpful for
23:40
them to give us feedback on the list of hospitals that we've
23:44
selected. The principal investigators that
23:47
we might be working with in those hospitals get us entry
23:51
points if we can find them, suggest other hospitals that we
23:54
may not have considered for, for whatever reason.
23:58
And so there's a lot of knowledge there that that we can
24:01
we can tap into. That's helpful.
24:04
And on the commercial side as well, an example, CSL have a
24:09
product that failed their phase three, I think it was early last
24:13
year, 24 in acute myocardial infarction.
24:18
That drug is used in the emergency was to be used in the
24:22
emergency room. They were at the end of the
24:24
phase 3A ton of their commercialization work or pre
24:28
launch commercialization work had already been done.
24:31
There's a lot of knowledge there that is very applicable to what
24:36
we're going to be looking at for for VMX, COO1 as well.
24:40
So in all those different ways you can benefit from from a
24:43
large partner like that. Yeah, 100% and mutually
24:47
beneficial as well, right. Like you say, they have a
24:49
competing product. So yeah, I can certainly see.
24:54
Yeah. So maybe Callum, if I can, I can
24:56
finish on that piece where they fund the 185 And then once the
25:01
Phase 3 is finalized, they then get to decide whether or not
25:05
they want to require Pharmax at a already agreed price, which
25:12
was part of the deal. And then after that, there are a
25:15
whole series of commercial milestones that that were
25:17
brought in as well. These deals seem to be becoming
25:22
a little bit more popular across the industry.
25:25
But Martin, I mean, what's your take on that?
25:27
Do you see that becoming more and more of an option for for
25:30
big pharma I guess? Yes, I, I would see two drivers,
25:38
one and one is as you suggest is more of an option for big
25:41
pharma. We were already in conversations
25:43
with CSL when the, when, when, when they announced that they
25:47
were going to going to divest a bunch of their R&D and focus
25:51
more on partnering. There are more and more
25:53
companies out there that, that, that do that.
25:57
And so that's, that's one driver.
26:00
The other driver I think is the, the, the limitations in, in that
26:08
they're currently are in getting startup companies like Pharmax,
26:13
but also others certainly when it's earlier stage funded.
26:18
I spoke about that earlier a little bit already, But there's
26:22
not that many options if you, if you can't get a venture capital,
26:26
if there's not a path to IPO, which is like been, I mean,
26:30
there's been so few these the last year, then there, you know,
26:36
and you still want to stay afloat and keep your, keep your
26:40
company going. And then, you know, strategic
26:43
partnering is, is one option. We, I think I've been lucky or
26:50
maybe we did well in doing it in such a way and being able to
26:53
find a partner such that we, you know, we weren't backs to the
26:58
wall in that sense, if you will. But there's plenty of companies
27:02
out there that are and that's, you know, do a deal, but may not
27:07
do a deal that is great for either the founders and or the
27:11
current investors just because they they need to keep the
27:14
company going. Yeah, for sure.
27:17
I think like you say, you rightly point out is, I mean
27:20
early phase development, if you've not got any clinical
27:24
data, it's been super hard to get fund the past couple of
27:28
years. I mean, like you touched on
27:29
during COVID, that was a different story.
27:32
But hopefully next year. I mean, we've probably said this
27:35
at the same time last year, but there's a bit more hope moving
27:38
into 2026. I mean, by the time this comes
27:41
out, it will be already January. But yeah, what's your take on
27:45
the market moving into the new year?
27:48
Should we say, do you think the signs of.
27:52
Yeah, early stage investment coming back?
27:54
I think on the face of it, there looks to be.
27:58
Yeah. But what I, what I read in sort
28:00
of your, your general news feeds, that seems to be the
28:03
case. I'm not the, the biggest expert,
28:06
expert in the earlier stage investment.
28:08
So when I when it's preclinical like like like C Series A and so
28:12
forth. So I may not be the best, the
28:14
best person to, to ask when you speak to, to VC firms, when I
28:19
speak more to the, the, the growth funds rather than those
28:23
earlier stage funds, then they seem to be seeing more and more
28:29
activity. There's still, it's not
28:31
necessarily then reluctance maybe, but there's some caution.
28:35
And you know, there's quite a bit of consideration and
28:38
analysis being done and, and very significant deep dive due
28:44
diligence before investment committees are willing to, to
28:48
take a dive into a new company. Also for reasons I I mentioned
28:52
earlier a part because they need to be sure that they can keep
28:56
their current investment companies going because
28:58
otherwise it's like, you know, filling, filling 1 hole about
29:02
the other is created. So that that is hopefully going
29:08
to to continue. But there's of of of course,
29:12
always macroeconomic factors that, that, that, that you don't
29:16
control and are hard to foresee that may that may disrupt that.
29:21
But, you know, it looks like there's a trend in the right
29:24
direction. Yeah, absolutely.
29:26
I, I guess it's deals like yours, for example, that keep
29:30
the cogs turning in that sense, right?
29:31
That keep the returns to the investors going and then it's
29:34
all a cycle, right? And it can go back to those
29:36
early stage. Investment around it so.
29:40
It's awesome. I mean you're starting phase
29:42
three in January and what's the timeline for the trial?
29:46
When can we expect some some first news on how you guys are
29:50
getting on? Yeah.
29:51
So it's a good question. So we as said, we are opening
29:56
our first sites early January, then the US will will follow.
30:00
We'll have around 20 sites probably there.
30:04
And then the the EU is always a little bit of a longer timeline
30:07
because you have this CTIS system that you need to get all
30:11
the countries into and it just takes time.
30:13
So that'll follow around the summer and into the back end of
30:17
of 26, we will be recruiting 400 patients a minimum where we
30:23
compare VMX with usual care which in our space is and
30:29
Dexanet was mentioned, but the off label drug that is most used
30:33
is 4 factor PCC. And so physicians can choose
30:38
whatever they want, but the majority will likely be 4 factor
30:41
PCC at 400 patients. We'll then look at what the the
30:45
data shows and if our statistical calculations go to
30:49
wait every think they are are likely to go, then we might stop
30:54
the trial there for efficacy. We have built it and funded it
30:58
such though that if needed we can go to 600 or even to 800
31:02
patients and we'll have a futility check at 100 patients,
31:06
but that will just be a go, no go.
31:09
There's no data there that will be be seen by anybody.
31:13
And then if we hit the 400 patients efficacy endpoint, then
31:19
with hopefully a well, at least we already have a fast track
31:23
designation and we would look for launch by early 29 in the,
31:31
in the US, shortly followed by the by the EU and, and
31:34
potentially Japan even coming before that.
31:37
Because we, which is interesting, if I can mention
31:40
this, we've applied for the phase one PMDA waiver.
31:45
And I've been given that waiver as well, which means that where
31:49
you usually and in the past always had to do a phase one in
31:53
Japanese subjects to show your PKPD and so forth in those
31:56
Japanese subjects, you can now get a waiver and embed in your
32:02
phase 3 Japanese subjects and also do your PKPD as part of
32:06
that. So it's sort of an integrated
32:08
piece. And we got that waiver.
32:09
So we might be able to get through the Japanese market even
32:12
before US and EU, which has pricing benefits as well,
32:17
because there's reference pricing and so forth that come
32:19
into play there. So that's really cool.
32:21
And, and in the end, you know, the drug 4 factor PCCI mentioned
32:26
has never been researched and proven to, to work, but
32:28
physicians use it because there's some perception and
32:31
belief it works. And in these space, you got to
32:34
do something. It's really difficult to sell to
32:37
a family. And, you know, I didn't do
32:38
anything because I couldn't. That's, that's just really tough
32:41
for a physician. And Dexanet has mentioned is,
32:43
is, is looking to disappear from the from the market and our
32:47
asset will be specific for this indication.
32:51
It will be approved for this indication.
32:54
It bypasses and restores coagulation rather than reverses
33:00
and battles it out with this the factor 10A inhibitor.
33:03
We we don't touch the inhibitor. So regardless of which which
33:06
factor 10A inhibitor, it works. It works instantaneously.
33:12
It can be administered in just a 10 second push with a single
33:15
dose, whatever the patient, which is very convenient in a in
33:19
an urgent care situation where there's a lot going on of
33:23
course. And it can be used with other
33:28
medications that are being used in these patients like for
33:30
example, heparin, which is not the the effector or efficacy of
33:35
which is not affected by our VMXC or OO1 or vice versa.
33:41
So physicians don't need to think about can I use this stuff
33:44
together and do I need to manage anything?
33:47
There's no management required. So effective, safe, as
33:51
mentioned, no thrombotic effect is expected and very convenient.
33:56
So we we trust that that's a really good position to be in
34:02
once the the product comes to market.
34:04
Yeah, absolutely. But look, it sounds like it's
34:07
going to be a busy, busy year ahead.
34:09
You have second one by the end of it my time, I'm sure.
34:12
But yeah, looking forward to tracking the progress and and
34:16
thanks again for coming on. I guess we'll wrap up with the
34:19
the standard by hub question, which is, yeah, if you were to
34:23
have a dinner with one scientist or entrepreneur, past or
34:28
present, it can be anyone you'd like.
34:30
Who would it be and and why? Yeah, yeah, interesting.
34:35
I was doubting between Watson and Crick who, who indented or
34:40
who discovered DNA, the structure of DNA, which they did
34:44
in Cambridge. And I lived and worked in
34:47
Cambridge during my studies when Stephen Hawking was alive and I
34:51
went to see him when he was not speaking anymore.
34:54
He spoke through his, his computer already at the time.
34:57
And so I think it would have been Stephen Hawking and the,
35:00
the, the level of thinking and the way that he was able to look
35:04
at the, the world or the, the, the, the Galaxy, the universe
35:09
that we are in in such a different way than any anyone
35:13
did before as just fascinating. It's, it's still fascinates me
35:18
think about that kind of stuff as well.
35:19
And just having his type of thinking applied to, to to our
35:26
biotech business, for example, would have been, would have been
35:28
fantastic. So that would be the one.
35:30
Yeah, that is a good choice. I can't argue that one.
35:33
Yeah, totally for. Thank you.
35:35
Awesome. Well, look, thanks for coming on
35:37
again. Really appreciate it.
35:38
And yeah, all the best for 2026 and beyond.
35:42
Thank you so much, Kyle. I'm really nice to be here and
35:45
thanks for having me.