January 27, 2024 • 39 mins
Mike Gaffney, CEO of Cellphire Therapeutics, shares his thoughts with BioBoss host John Simboli about leadership in biopharma and how Cellphire is working to save lives by bringing novel hemostatic products to patients in need.
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John Simboli (00:00):
Today I'm speaking with Mike Gaffney, CEO at
(00:03):
Cellphire Therapeutics,headquartered in Rockville,
Maryland. Welcome to BioBoss.
Mike.
Mike Gaffney (00:09):
Thanks, John, delighted to be here.
John Simboli (00:11):
Mike, what led you to role as CEO of Cellphire
Therapeutics?
Mike Gaffney (00:15):
It's certainly been an interesting journey. As
my wife highlighted, when Ijoined the company, everything
I've done before this, in hermind kind of aligns to what
we're doing here. Cellphire isdeveloping, hopefully, life
saving cellular therapeuticsmade from platelets; it stops
bleeding. And we'll talk alittle bit later about the
potential impact we might have.
But we're solving what I thinkpeople had concluded was an
(00:37):
intractable problem. And we'reexcited about that. So there's a
real opportunity to have a bigimpact, which is quite important
to me. My journey here, way backwhen I was a naval officer,
served in the Submarine Force,and I have engineering training
as well as that militaryservice. You're at the pointy
end of the spear, and it can bekind of scary. And then I spent
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the last 25 years in a varietyof different roles, helping to
build businesses, and buildingbusinesses is about, as this
podcast is a bit aboutleadership. To the "boss" side,
it's easy to say the leadershipand the human component of that
is the stuff that's quiteimportant and understanding,
technically—process, how do youget stuff done? How do you get
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from here to there. It's alwaysa journey. You can say, here's
where I want to get to, but atthe end of the day, it aligns to
a couple of key principles,which was the other part that I
thought was relevant to mejoining Cellphire. I can see,
from the outside looking at areally good team, some really
good people and an opportunityto help a lot of people with our
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technologies, though they werestruggling with some key natural
growth elements. Where do youwant to spend our time and focus
organizationally on the thingsthat will have the biggest
impact. We were really good atthe science, we had lots of
interesting scientific insightsand paths we could go down, but
there wasn't a sense ofdirection we identified. In all
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these cases, I found people thatare key. The quality of the
talent, the quality of the team,and their alignment engagement
with what you're trying toachieve. And we talk about phase
appropriate in pharma, kind oflifecycle appropriate for a
company and its journey,bringing people from large
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pharma into a small ventureStage Company. Talent, maybe
their insight, maybe theirunderstanding . . . you know, I
don't have a team of 20, who aregoing to execute X, Y, and Z, I
need to roll up my sleeves. AndI need to be excited about that,
though, it may be challenging atpoints in time. These are some
of the components that I bringto Cellphire, which is all part
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of my journey. How do youattract talent? How do you focus
a talented, committed team,focused on an objective, and
then attract the partners,capital partners, and the right
collaborators to be successful.
That's what I've built my careerround. And I'm excited to bring
that here.
John Simboli (03:06):
From what I understand of the Cellphire
technology, if you do get theapprovals that you're hoping to
get, it could help a lot ofpeople. Some of those people,
the portion that are at thepointy end of the spear, that
must have a special resonancefor you, I would guess.
Mike Gaffney (03:25):
Absolutely. And what's interesting, there's a
history here around the militaryuse case. Deployed people who
are in harm's way, and we wantto make sure they have, and the
people helping them have thetools that they need to save
lives and avoid the sort ofchallenges that otherwise
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happen. We've all seen Mash andthings like that. And that's
pretty scary stuff. What isreally exciting is this is a
universal problem, that we'refocused on the availability of
hemostatic agents, platelets arethe only one that really exists
that does primary and secondaryhemostasis. But that's the only
tool that's available. That toolhas material limitations. And we
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think we can solve that problembecause of our technology to
create an allogeneic, shelf,stable, hemostatic agent that
you could put in your backpack,that you could store on your
ship, that you could take tothird world countries that don't
have the infrastructure toaddress and solve this problem.
Because it's a reallycomplicated supply chain, and
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it's really hard to do. And sothat affects people like my
sister. She's in Poteau,Oklahoma, it's a very, very
rural market. And the closesthospital that has platelets on
the shelves is in Tulsa, fourhours away. So if there's a car
accident, if there's a you know,a delivery, maternal hemorrhage,
and the like, that is a massiveopportunity to help a lot of
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people in a lot of differentmarkets. And it's interesting
that in a first world economylike the United States, 33% of
the hospitals don't haveplatelets on the shelves. We can
solve that problem when we getour products approved. And
that's what we talk about everyday with our team, and how that
will help. Moms, rural areas,third world countries, patients
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who are fragile and otherwisemight have challenges, as well
as folks at the pointy end ofthe spear. And have a big
impact, we hope, onlife-threatening trauma, and the
like, that would be material forthe broader clinical needs that
are out there.
John Simboli (05:31):
Can you recall what it was about Cellphire that
made you say, I think I reallywant to pursue this one?
Mike Gaffney (05:35):
This was the one that I could see a big impact,
John Simboli (05:36):
Did you ever go through that phase where you
fit all of the things that Iwanted to do, as well as the
thought, Well, I really want tolead this company, but I'm not
path that I saw the companywould need to take. I could be a
really helpful player, a personwho could provide the let's
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figure out what we ought tofocus on. Where do we want to
spend our time? And had a lot ofexperience around. It was also a
challenge. I've been executivechairman or CEO of lots of
sure I want to be the CEO, ordid you know from the beginning,
different companies. Lifesciences is something that I've
had some exposure to. When theboard approached me about this,
we all said, Okay, this is whatI'm good at, I can lead, I can
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help get us focused, again,raise capital. I can work with
and build a team. I can attractcollaborators and team members.
And all that other stuff withthe team has been interesting.
Not being the expert for them,is been really helpful, because
no, this only makes sense if I'mthe CEO?
I can just ask questions, andthat's the sort of stuff that
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made it, for me, something thatI was excited to get involved
with. For two years into thejourney, and we made a lot of
progress to achieve our "We savelives" vision, we feel good
about that. But it's been,certainly a leadership
challenge. And in a lot ofinteresting ways.
Mike Gaffney (07:08):
For this company, this is how I've always thought
about it, I did a lot ofathletic things throughout my
life, particularly in highschool and college. I wasn't
particularly good at many ofthem. But I really enjoyed the
challenges of being on a team.
We're setting out to try andachieve these objectives. And
there's some lessons there thatalso relate to business, because
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they're human lessons ofdetermining, what are we about?
How do we treat each other? Howdo we think about values in that
context, and allow ourselves tofocus on getting the people in
the right spot in a preparedway. I looked at this company
and the thing they were missingthe most was principled,
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values-oriented leadership, thatwould unlock the technical
insights, the energy of the teamand people, as well as the
opportunity to have a bigimpact. Because we were spending
a lot of time on science and weweren't thinking about what is
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the end in mind. More about usand what we're about. And, you
know, service in leadership is,I think the only way to be
successful. You don't doanything. When I was in the
Navy, I talked about, with myteam, there were only two things
I was allowed to do. I couldoperate a periscope, and I could
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use a pen. And otherwise I wasnot allowed to touch anything.
Those are the things I canoperate. The other stuff you
guys have to do well. My job isto help you be successful,
remove obstacles, make sure wehave the right training and
talent and resources. And if wedon't have them, I've got to go
get them. That was the thingthat I saw Cellphire was
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missing, creating the, alllright, here's what we ought to
go do. Here's the things thatwe're probably not going to go
do therefor,e and how do we getthere together and recruit in
those internal or externalinsights, or leaders tend to
make that stuff happen?
John Simboli (09:16):
Could you imagine, in the early steps when you're
first looking at Cellphire, oneof the reasons this is
interesting to me is because itmay or may not be
differentiated, in terms ofproducts it can create someday?
Mike Gaffney (09:27):
From the outside looking in with Cellphire, the
differentiation related simplyto the unmet need around
hemostatic agents. Plateletavailability is a global
problem. Platelets are notavailable in first world
markets, much less second andthird world markets across the
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globe. Someone was just tellingme today, China is in a crisis,
post-COVID And we've seen thisin lots of countries, but you
know, interesting in a verylarge population, very dense
population and one with, a fairbit of command and control that
will allow you to say, hey,everybody's going to donate,
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rather than the volunteer thingthat might happen in United
States. And they have a bigproblem related to how long can
you store this stuff. It's asupply chain issue. And you can
only store this stuff sevendays. If you think of the
engineering problem of how do Imanage the logistics from
donation of an allogeneicproduct to delivery or use
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clinically, and I've got sevendays to work with, it'd be, I
don't have the analogy for this.
It'd be like building a housewith something that only lasts
seven days, it's kind of likebuilding the ice bars, that are
really cool, but they melt veryquickly. And so you've got a
very narrow window. And sounless somebody is paying a lot
of money, it's hard to makesense of that business. And
that's the need in themarketplace. What we do is we
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make shelf-stable hemostaticagents from platelets, with a
three to five year, depending onthe technology, shelf life. So
you take seven days, and youcreate a huge time window that I
can now do things with, toaddress that supply chain issue.
That was the thing that kind ofchecked the box early for me.
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There is a really importantthing, if we're successful, that
we can address. What's beeninteresting, differentiation was
about time. That has somebenefits to it, but you also run
into the Okay, really, how muchvalue do you add other than you
can stick this stuff on theshelf? In my early investigation
engagements with the team aswe're working through the "What
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do we want to spend our time on?
And how do we best position theinitial products for success?"
was teasing out and starting tosee and help the group see, the
potential differentiation thatthere is with our products. And
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how do we improve thedifferentiation. Our freeze
dried product, we call thetechnology freeze dried platelet
derived hemostat, FPH. Actually,because of the process and the
various components, we takeplatelets, we batch them up and
then we manufacture in a processand we lyophilize, the freeze
dry them, because of the impacton the cells in that process. We
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actually have an amplificationof certain components that will
deliver some interestingtherapeutic effects. And that
differentiation, in addition toshelf life, is in very
significant populations, wethink we can have a big, big,
big impact. So I was talkingearlier about the military use
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case, maternal hemorrhagecontext, rural markets, trauma,
and there are lots of people onanti-platelet therapies, 10
million people United States areon anti-platelet therapies. If
they have an urgent or even justa regularly scheduled procedure,
that's hard for a surgeon, aclinical team to address. It
turns out that our stuff, FPH,in that context, actually
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performs better in vitro, by along way, compared to liquid
stored platelets. And havingthat come to the forefront for
the team, we had the data, wehad the science, there was kind
of a this was an interestingexperiment. We've also got some
really interesting experimentsabout the potential impact on
intracranial hemorrhage, wherethere are no therapeutics. And
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both of those are categorieswhere there aren't great
solutions, there are not tools.
Surgeons talk all the time aboutif someone's on anti-platelet
therapy, it's really hard tostop the bleeding in a surgical
procedure or even a traumaticevent, it's even worse. Brain
hemorrhage. similarly, I don'thave great tools. We're solving
a problem that people have kindof just accepted as intractable.
And now we think we can solve itand have a huge impact from a
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differentiation perspective. Andas we're talking to investors or
collaborators, we'rehighlighting, not only is this
stuff shelf stable for threeyears, and easy to administer,
but also here are populationswhere we've got millions of
people with significant diseaseor clinical burdens. And the
science is telling us we candifferentiate in the material
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way. That's really exciting. Ididn't know that when I got
here. But that's part of theventure journey is let's look at
the data and see what it says.
Having the team highlight thatfor me, being I don't know, dumb
enough or smart enough, orsomewhere in between, to say
that's interesting, let's learnmore about that, has been, I
think, an important part of thecompany journey. That
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willingness to listen isleadership is an important part
of that service.
John Simboli (14:47):
Can you talk to me about differentiation in the
sense that, my understanding isthat currently, blood has to be,
of course, accounted for eachperson's blood type. Your
product, potentially, has a, Idon't know if the word
universality is the right word,but has that much broader
application? Is that true? Do Ihave that right?
Mike Gaffney (15:06):
Yes, in the in the context of our product and its
universal use, that makes itsimpler to go to the shelf and
say, Okay, I just need to grabthat. That said, the blood banks
who manage most of theseproducts, they do an excellent
job of matching components.
What's relevant to us is we cando both things, we can establish
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universality in a shelf stableway so it's very well
understood. And then, differentfrom the blood banks, because we
do a batch process, we canactually test to confirm that.
Rather than I've typed you,John, I've typed Mike. And then
I also need to test you forviral contaminations, everything
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else, but if something happenslater, that I find out about,
oh, gosh, you had COVID, andthat creates issues as a donor,
then I've got to pull it back. Avery complicated supply chain
that the blood banks have tomanage. We can address that
upfront with our ability to takesmall samples from the batch,
just like any biopharmaceuticalbatch, and do the testing and
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the quality control upfront. Sothere are some benefits from a
safety perspective, that onceapproved, we think our product
will bring to the market, fromthe differentiation. And that's
important because you know, wewant to improve what we're
doing. We want improve thebroader solutions that are
available, because otherwise,why are we doing this?
John Simboli (16:30):
When you meet someone, let's say through a
family connection, and perhapsthey don't really know much
about biopharma, or they don'tknow much about what Cellphire
is doing? They may say, well,what are you doing? What's your
job like? How do you explainthat in the terms of what I do
all day? How do you say it? Anddo they understand it?
Mike Gaffney (16:53):
The simple, declarative answer is, I have a
lot of meetings. I have a lot ofphone calls. So that doesn't
resonate with anybody at all,because that's just not
exciting. It's not aninteresting thing. And in those
meetings, every day, you'retrying to make a little bit of
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incremental improvement. There'sno big aha or big event. There's
very few seminal events. It'sincremental improvement. I was
talking about when I was aventure capitalist, about the
difference between a very goodmanagement team, and just an
okay, or good management team is10%. 10%, every day. If you can
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make a 10% improvement everyday, be 10% better. At the end
of the day, you're going tobuild a really interesting,
successful company. And that'swhat we strive for, in that
context. So the tactical orspecific answer is I have a lot
of meetings. And it's with allthe things that you would
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expect, our existing team, whatare what are we spending our
time on strategy? How are wegetting stuff done? Accounts
payable, accounts receivable,all that sort of stuff. I
generally don't talk about that.
Instead, I talk about, thepotential impact, and what's the
problem, because that's thestuff that matters to people.
And I think it's important forour team and me, when we're
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having those meetings, we'retrying to be 5% and, hopefully
10% better, that we have a senseof here's where we're going.
That's hard to do, because youget involved in day to day,
people challenges, you gettired, you get hungry, whatever
it might be. And it's importantto me to focus on that. So I
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answer the question around,here's what we're trying to do.
As opposed to what do I do?
John Simboli (18:48):
As you can recall being a young person, eight or
nine or 10, or whatever is thecorrect appropriate age for you,
and you've tried to remember Oh,yeah, when I grew up, I want to
be, and for most of us, that waslike, what would my parents
think I should be when I grow upkind of stuff. Can you recall
what that image was? And does ithave anything to do with what
you're doing today,professionally?
Mike Gaffney (19:08):
Quick answer was, well, I want to be a nuclear
physicist. which is like, Okay,you're eight or nine? As I look
at that, one, it's silly, itsounds egocentric, or how smart
am I and everything else, butwhat I was really saying is I
want to do something that'shard. And I want to do something
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that has some technicalchallenges to it. And that has,
in my mind at that time, and Ithink it's still consistent, has
an important element of service.
Because my dad was a submarineofficer, as well. And he
actually studied nuclearengineering when he was at the
Naval Academy. I think that wasthe derivative way to say those
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things. There's somethin aboutthat impact and what he was
about from a serviceperspective, what his friends
were about. And those threecomponents of do something hard,
do something that has some realtechnical challenges to it, and
would have a bit of positiveservice benefit, was really what
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I was saying. I didn't know Iwas saying that at the time. But
I think that was, as I lookback, how I interpret that eight
or nine thing.
John Simboli (20:27):
When you look at other companies that may be
looking to solve similarproblems, do you see others? If
you do see others, do see yourapproach being a different way
of looking at the problem?
Mike Gaffney (20:40):
There are always competitors. And they fall into
two categories, folks who arepursuing very small, incremental
improvements to the existingsource or supply, So going from
seven days to 14 days, thingslike that. And then there's a
number of others. And I totallyunderstand where this comes
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from, that are doin "This isreally cool science, we're going
to make these things frommesenchymal stem cells, or we're
going to make an artificial one.
And it's going to be made up ofnanobots and all sorts of
stuff." And ultimately thatstuff will work. We are doing
the, which appeals to myengineering brand, we are doing
the practical thing. Let's makethis stuff shelf stable. It's
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not going to be sexy science.
But when we're successful, it'sgoing to save a lot of lives. So
we don't have that sexy, wow,this is cool sort of platform
sizzle to it. But we know whatwe're trying to get done. And
it's going to impact millions oflives around the world when
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we're successful.
John Simboli (21:44):
Let's say you're at an investor conference, and
you give a description, more orless like what you just told me,
but of course, in an expandedformat, and then you're going
toi get probably some people whosay, Oh, I see, you're like the
first group that you mentioned,the incremental group, or some
other investors might say, Oh, Isee. You're in the the sexy
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scientific platform approach.
And then you probably spend sometime saying, well, actually,
this is where we are. Is there apattern in which people might
pigeonhole incorrectly? And thenhow do you help them get back on
track?
Mike Gaffney (22:22):
The biggest pigeonhole challenge the company
has relates to the broaderbiopharmaceutical market
environment, is scientificallydriven. And it should be because
at the end of the day, it'sscientific developments really
where the technology sparks. Thechallenge for Cellphire and the
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investors kind of taking a lookat it is, it's not going to be
sexy. And it's not just sciencethat is going to allow us to be
successful. It's being smartabout where do we focus our
clinical development forapproval? It's going to do that
with a mind to where are the bigunmet needs and differentiation,
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where we talked about earlier,but also, how do we supply
against the demand from a supplychain and production
perspective, in a way thatachieves an attractive economic
outcome for both customers, thepatients as well as for the
company. Which is different, itcertainly falls in the
psychotherapeutic world, wherethat has become much clearer
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over the last 10 to 15 yearsthat that's an important part of
that successful business model.
But a lot different than smallmolecule, or even stem cell
production solution sets whereyou have no constraints on how
you think about your productionprocess and everything else. So
that's a different thing. Sohelping them understand that and
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also understand that's actuallya relatively low risk
proposition. It's not does itwork or not? It's how do you
execute against all thosecomponents to be successful?
Bringing that technology that,does it work or not, in these
clinical settings, to market.
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That's where the risk sits. Andwe're so far advanced around
understanding the science andwhere our products are, from a
developmental perspective,they're in phase two, that for
us, it's about folks who arewilling to spend enough time and
are interested in how we mighthave that sort of impact from a
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commercial perspective. We'renot sexy. And how do you then
get over the sales challenge ofeverybody wants sexy science.
That that's the problem orchallenge that I have in
communicating and representingthe company and what we're about
doing, what we're looking toachieve and where we need
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capital and investors support tobe successful.
John Simboli (25:04):
At this point, do you allow yourself, personally
or in your meetings, to todescribe how it's going to
affect the lives of people?
Military, it seems prettystraightforward. People can
maybe grasp that. Maybe in termsof Emergency Room needs and
things like that. How big a dealis this if your drugs get
approved?
Mike Gaffney (25:23):
So it's, it's a very big deal. It falls into
multiple categories. So I'llkind of pick one or two. So my
daughter, my oldest daughter,Claire, she goes to business
school in New England, and hasan internship in Seattle. So she
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drove in three days, from NewEngland, to Seattle, and my wife
and I spent the whole timeworrying about that. Pictures I
actually show our team, I won'tshow them here, but it's a
horrific car crash on the sideof a rural road. And you look at
that and say, Oh, my gosh, thelikelihood of those people
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surviving without great care isvery, very small. And the
statistic is American Red Crossserves half of the hospitals in
the United States. 33% of themdon't have platelets on the
shelves. So, okay, Claire, makesure when you get into that
accident, if it happens, you'rewithin 10 miles of that hospital
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that has that liquid stored,platele on the shelves until we
get our products approved.
That's the sort of impact we canhave. There are patients who
have immune reactions toreceiving transfusions. And
because of those immunereactions, that has significant
clinical effects andparticularly fragile patients,
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where there aren't goodsolutions, we can solve those
problems for them. Maternalhemorrhage is one of the largest
killers of women globally. Andthe only tool or the best tool
that exists, and there are anumber of folks who tried to
solve this problem, isplatelets. But most third world
countries don't even haveplatelets, anywhere much less,
you know, kind of on the shelf.
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So the impact we can have in ourday to day lives in ways that
touch all of us is significant.
What's interesting is, peoplejust accept what we have.
Because the solution set that'savailable is either that really
cool science that's 30 yearsaway from ever getting to the
shelves, or incrementalimprovement that doesn't address
this massive gap of safety,efficacy, and availability.
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That's the thing that will havea big impact at the end of the
day. That's where I have tostart the conversation because
otherwise people don't get,Okay, it's not cool science, why
did you choose to spend time onit? Let me just tell you a
story, Claire driving driving toSeattle in three days, which is
nuts. But that's Claire, youknow, what were her parents
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doing? We were hoping she wasdriving by hospitals that have
platelets on the shelves,knowing that in South Dakota,
knowing that in Idaho and otherstates, there's not a lot on the
shelves, and we're just going tohope she doesn't get into an
accident there.
John Simboli (28:08):
For the two products categories that you
have right now, can you justdescribe them for a little bit
in broad terms, and maybe talkperhaps about how the pipeline
expresses your vision for whatyou're setting out to do with
the company?
Mike Gaffney (28:20):
We talked about two technologies. We have a
cryopreserved or frozen. Andthen we have the freeze
dried.The cryopreserved isabout, we're working closely
with the army on this, they'vebeen a great funding partner,
addressing availability asquickly as we can, from a
timeline or approvalperspective. We're doing some
things, technically, that wethink will expand that market to
(28:42):
a degree but it's cryopreserved,it's frozen, so you have to have
a cold chain, we think we canimprove the product. So the cold
chain would actually includeyour home freezer, John, so you
can have a unit on the shelf orthe hospital can in a rural
market, because they don't havean ultra cold chain.. And we're
targeting somewhere on the 27-28timeframe for approval. That
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will be a nice and importantimpact, near term, on that
availability, rural markets, aswell as the military use case.
But you can't put a frozenplatelet unit in your backpack.
You can't do that as easily inrural ane in third world
hospitals. That's where thefreeze dried platelet
haemostatic technology comesfrom. As I mentioned earlier,
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we're starting to tease out andwe've done, I think a good job
as a team, where can we reallyhave an impact and what is that
differentiation? It's not justavailability, but it's about
efficacy and clinical impact.
And there's three categories: one, which we're really excited (29:37):
undefined
about is the ability to help anorphan or ultra orphan
population that is very fragilebecause they have genetic
platelet disorders and in theirdisease progression, there's a
lot of challenges. Oneparticular category Hermansky
(29:58):
Pudlak Disease, put likedisease, and most of those
within a particular geneticallele will require a lung
transplant by the time they're40 or 45. So transfusion
reactions, events related tothat will make them ineligible,
will disqualify them. We cancontrol and match the product to
(30:21):
those particular patient'simmune situation so that doesn't
create any issues. What thisindustry calls an HLA match. For
the that population, we put iton the shelf, it's available to
their clinicians, they pull itoff, and not only say, Okay,
this is something that will beuseful and stop your bleeding,
(30:42):
like some of the products thatare out there, but it also is
matched to you. This is John'scategory of folks from a disease
perspective, we call that orphangenetic product. And an HLA
matched impact is something thatclinicians are very excited
about, because they do not havethat alternative easily today.
You can do it, it's hard, incertain circumstances. The blood
(31:04):
banks do a good job within thelimits of what they're able to
do. We can address that on aglobal basis. The bigger ones
that are really interesting, interms of the broader impact,
relate to we'll call it genericFPH for perioperative use,
trauma,surgery, emergencydepartment use, folks who are on
(31:24):
anti platelet therapy. In thatcontext, there's there's
probably a million a year thatcould benefit from a product
like this. And this would fitinto the hemostatic agent tool
that's available to a clinicianand an important one, where they
can say, Gosh, this will be bestfor this patient in this
circumstance. And then, furtherdown the pipeline is one related
(31:47):
intracranial hemorrhage. I willshare that we've got a
collaborator at UCSF, Dr.
Shibani, Pati, who's got somereally impactful videos of
internal post trauma, brainbleeds within mice, controlled
(32:08):
cortical injury. And every timeI show these, these images, she
has one with and without, onewith an injury and with our
product, with an injury andwithout our product, and we're
both of an age you rememberthis, War on Drugs, what is your
brain on drugs? It looks likescrambled eggs. That's what the
(32:30):
injury without our product lookslike. And then you look at the
same injury, in the mouse, withour product, it looks like the
eggs are whole. And you go oh,my gosh, the clinicians, they
jump up and they sort of runaround the room and talk to you
about oh, my gosh. We have tocall them down and say, Okay, we
have a preclinical model, itseems to have a really big
(32:52):
impact. All the other therapiesthat Dr. Pati has studied have
not had this sort of an impact.
But we've got a road to go hereabout approval. But those are
the kind of key things in ourpipeline, and hopefully a bit
about the passion that we havein terms of the potential human
and clinical impact that we canhave.
John Simboli (33:09):
Several of those three categories or portions of
those three categories as itsounds to my ear just hearing
for the first time, is they arereally unmet medical needs. It's
not like an a first line. Secondline. Third line is just there
is no line for some of those,correct?
Mike Gaffney (33:25):
That's correct.
That's absolutely right. Andthat's that kind of intractable,
there isn't a good solution. Andwe just kind of assume we can't
do it. In our team, not me, theChief scientists, all the
scientists who've been here for10-15 years. They're the ones
that brought it here, right. Andmy job and our job now is to get
it approved so we get in thehands of clinicians. And there
(33:47):
are some very significant unmetneeds that are in front of us
that we hope to have an impacton.
John Simboli (33:55):
Going back to the early part of our conversation
about when the you made thatchoice to be the leader at
Cellphire, how did you or thecompany go about choosing where
to have the headquarters belocated and where to where to
focus your activity?
Mike Gaffney (34:10):
So the company, as it predated me, is in Rockville,
Maryland, not far from NIH,National Cancer Institute and
all that sort of stuff. Sothere's a nexus of science that
kind of makes sense.
Importantly, two fundingpartners for the company
historically and today are alsonearby. The Army up at Fort
Dietrich in Frederick Maryland,has been an important partner
(34:34):
along the journey for thecompany in developing both the
cryopreserved and now actuallyhelping out on the freeze-dried
program. And then the other isBARDAm an entity within Health
and Human Services, which Idescribed as when I talked to
people who aren't in theindustry as DARPA for biologics,
and they've been a wonderfulpartner. So being in the
(34:57):
Maryland area, it makes a ton ofsense. What you get here is a
lot of great scientists and alot of folks who are passionate
about impact, military peopleand the like. So all those
things are good. The area talksabout itself as number three, or
number four in the biotechworld. But the difference
between number three and numberfour and number one, and number
(35:18):
two, is massive. So thechallenge you have here is you
have a lot of really smartscientists and a lot of people
who are passionate, you have alot less of an ecosystem of
people who have the experienceof taking science all the way
through and being successfulwith that. What is that
ecosystem of executives,regulatory people, people with
(35:41):
CMC experience, people with allthe clinical development and
clinical execution experience,investors, all those things are
necessary to success. And ourchallenge, being here, is
building on those strengths withthe government science, those
relationships from anon-dilutive funding and
(36:02):
engaging external to ourparticular market with those
people and organizations thatcan be helpful to us as we go on
our journey.
John Simboli (36:13):
Mike, thanks for speaking with me today.
Mike Gaffney (36:15):
John. It's been a pleasure. And BioBoss is doing
great things for the industry.
So that said, thank you for theopportunity.
Today I'm speaking with Mike Gaffney, CEO at
(00:03):
Cellphire Therapeutics,headquartered in Rockville,
Maryland. Welcome to BioBoss.
Mike.
Mike Gaffney (00:09):
Thanks, John, delighted to be here.
John Simboli (00:11):
Mike, what led you to role as CEO of Cellphire
Therapeutics?
Mike Gaffney (00:15):
It's certainly been an interesting journey. As
my wife highlighted, when Ijoined the company, everything
I've done before this, in hermind kind of aligns to what
we're doing here. Cellphire isdeveloping, hopefully, life
saving cellular therapeuticsmade from platelets; it stops
bleeding. And we'll talk alittle bit later about the
potential impact we might have.
But we're solving what I thinkpeople had concluded was an
(00:37):
intractable problem. And we'reexcited about that. So there's a
real opportunity to have a bigimpact, which is quite important
to me. My journey here, way backwhen I was a naval officer,
served in the Submarine Force,and I have engineering training
as well as that militaryservice. You're at the pointy
end of the spear, and it can bekind of scary. And then I spent
(00:58):
the last 25 years in a varietyof different roles, helping to
build businesses, and buildingbusinesses is about, as this
podcast is a bit aboutleadership. To the "boss" side,
it's easy to say the leadershipand the human component of that
is the stuff that's quiteimportant and understanding,
technically—process, how do youget stuff done? How do you get
(01:21):
from here to there. It's alwaysa journey. You can say, here's
where I want to get to, but atthe end of the day, it aligns to
a couple of key principles,which was the other part that I
thought was relevant to mejoining Cellphire. I can see,
from the outside looking at areally good team, some really
good people and an opportunityto help a lot of people with our
(01:41):
technologies, though they werestruggling with some key natural
growth elements. Where do youwant to spend our time and focus
organizationally on the thingsthat will have the biggest
impact. We were really good atthe science, we had lots of
interesting scientific insightsand paths we could go down, but
there wasn't a sense ofdirection we identified. In all
(02:03):
these cases, I found people thatare key. The quality of the
talent, the quality of the team,and their alignment engagement
with what you're trying toachieve. And we talk about phase
appropriate in pharma, kind oflifecycle appropriate for a
company and its journey,bringing people from large
(02:25):
pharma into a small ventureStage Company. Talent, maybe
their insight, maybe theirunderstanding . . . you know, I
don't have a team of 20, who aregoing to execute X, Y, and Z, I
need to roll up my sleeves. AndI need to be excited about that,
though, it may be challenging atpoints in time. These are some
of the components that I bringto Cellphire, which is all part
(02:46):
of my journey. How do youattract talent? How do you focus
a talented, committed team,focused on an objective, and
then attract the partners,capital partners, and the right
collaborators to be successful.
That's what I've built my careerround. And I'm excited to bring
that here.
John Simboli (03:06):
From what I understand of the Cellphire
technology, if you do get theapprovals that you're hoping to
get, it could help a lot ofpeople. Some of those people,
the portion that are at thepointy end of the spear, that
must have a special resonancefor you, I would guess.
Mike Gaffney (03:25):
Absolutely. And what's interesting, there's a
history here around the militaryuse case. Deployed people who
are in harm's way, and we wantto make sure they have, and the
people helping them have thetools that they need to save
lives and avoid the sort ofchallenges that otherwise
(03:46):
happen. We've all seen Mash andthings like that. And that's
pretty scary stuff. What isreally exciting is this is a
universal problem, that we'refocused on the availability of
hemostatic agents, platelets arethe only one that really exists
that does primary and secondaryhemostasis. But that's the only
tool that's available. That toolhas material limitations. And we
(04:09):
think we can solve that problembecause of our technology to
create an allogeneic, shelf,stable, hemostatic agent that
you could put in your backpack,that you could store on your
ship, that you could take tothird world countries that don't
have the infrastructure toaddress and solve this problem.
Because it's a reallycomplicated supply chain, and
(04:30):
it's really hard to do. And sothat affects people like my
sister. She's in Poteau,Oklahoma, it's a very, very
rural market. And the closesthospital that has platelets on
the shelves is in Tulsa, fourhours away. So if there's a car
accident, if there's a you know,a delivery, maternal hemorrhage,
and the like, that is a massiveopportunity to help a lot of
(04:54):
people in a lot of differentmarkets. And it's interesting
that in a first world economylike the United States, 33% of
the hospitals don't haveplatelets on the shelves. We can
solve that problem when we getour products approved. And
that's what we talk about everyday with our team, and how that
will help. Moms, rural areas,third world countries, patients
(05:15):
who are fragile and otherwisemight have challenges, as well
as folks at the pointy end ofthe spear. And have a big
impact, we hope, onlife-threatening trauma, and the
like, that would be material forthe broader clinical needs that
are out there.
John Simboli (05:31):
Can you recall what it was about Cellphire that
made you say, I think I reallywant to pursue this one?
Mike Gaffney (05:35):
This was the one that I could see a big impact,
John Simboli (05:36):
Did you ever go through that phase where you
fit all of the things that Iwanted to do, as well as the
thought, Well, I really want tolead this company, but I'm not
path that I saw the companywould need to take. I could be a
really helpful player, a personwho could provide the let's
(05:56):
figure out what we ought tofocus on. Where do we want to
spend our time? And had a lot ofexperience around. It was also a
challenge. I've been executivechairman or CEO of lots of
sure I want to be the CEO, ordid you know from the beginning,
different companies. Lifesciences is something that I've
had some exposure to. When theboard approached me about this,
we all said, Okay, this is whatI'm good at, I can lead, I can
(06:20):
help get us focused, again,raise capital. I can work with
and build a team. I can attractcollaborators and team members.
And all that other stuff withthe team has been interesting.
Not being the expert for them,is been really helpful, because
no, this only makes sense if I'mthe CEO?
I can just ask questions, andthat's the sort of stuff that
(06:40):
made it, for me, something thatI was excited to get involved
with. For two years into thejourney, and we made a lot of
progress to achieve our "We savelives" vision, we feel good
about that. But it's been,certainly a leadership
challenge. And in a lot ofinteresting ways.
Mike Gaffney (07:08):
For this company, this is how I've always thought
about it, I did a lot ofathletic things throughout my
life, particularly in highschool and college. I wasn't
particularly good at many ofthem. But I really enjoyed the
challenges of being on a team.
We're setting out to try andachieve these objectives. And
there's some lessons there thatalso relate to business, because
(07:30):
they're human lessons ofdetermining, what are we about?
How do we treat each other? Howdo we think about values in that
context, and allow ourselves tofocus on getting the people in
the right spot in a preparedway. I looked at this company
and the thing they were missingthe most was principled,
(07:53):
values-oriented leadership, thatwould unlock the technical
insights, the energy of the teamand people, as well as the
opportunity to have a bigimpact. Because we were spending
a lot of time on science and weweren't thinking about what is
(08:17):
the end in mind. More about usand what we're about. And, you
know, service in leadership is,I think the only way to be
successful. You don't doanything. When I was in the
Navy, I talked about, with myteam, there were only two things
I was allowed to do. I couldoperate a periscope, and I could
(08:37):
use a pen. And otherwise I wasnot allowed to touch anything.
Those are the things I canoperate. The other stuff you
guys have to do well. My job isto help you be successful,
remove obstacles, make sure wehave the right training and
talent and resources. And if wedon't have them, I've got to go
get them. That was the thingthat I saw Cellphire was
(08:58):
missing, creating the, alllright, here's what we ought to
go do. Here's the things thatwe're probably not going to go
do therefor,e and how do we getthere together and recruit in
those internal or externalinsights, or leaders tend to
make that stuff happen?
John Simboli (09:16):
Could you imagine, in the early steps when you're
first looking at Cellphire, oneof the reasons this is
interesting to me is because itmay or may not be
differentiated, in terms ofproducts it can create someday?
Mike Gaffney (09:27):
From the outside looking in with Cellphire, the
differentiation related simplyto the unmet need around
hemostatic agents. Plateletavailability is a global
problem. Platelets are notavailable in first world
markets, much less second andthird world markets across the
(09:49):
globe. Someone was just tellingme today, China is in a crisis,
post-COVID And we've seen thisin lots of countries, but you
know, interesting in a verylarge population, very dense
population and one with, a fairbit of command and control that
will allow you to say, hey,everybody's going to donate,
(10:11):
rather than the volunteer thingthat might happen in United
States. And they have a bigproblem related to how long can
you store this stuff. It's asupply chain issue. And you can
only store this stuff sevendays. If you think of the
engineering problem of how do Imanage the logistics from
donation of an allogeneicproduct to delivery or use
(10:35):
clinically, and I've got sevendays to work with, it'd be, I
don't have the analogy for this.
It'd be like building a housewith something that only lasts
seven days, it's kind of likebuilding the ice bars, that are
really cool, but they melt veryquickly. And so you've got a
very narrow window. And sounless somebody is paying a lot
of money, it's hard to makesense of that business. And
that's the need in themarketplace. What we do is we
(10:57):
make shelf-stable hemostaticagents from platelets, with a
three to five year, depending onthe technology, shelf life. So
you take seven days, and youcreate a huge time window that I
can now do things with, toaddress that supply chain issue.
That was the thing that kind ofchecked the box early for me.
(11:18):
There is a really importantthing, if we're successful, that
we can address. What's beeninteresting, differentiation was
about time. That has somebenefits to it, but you also run
into the Okay, really, how muchvalue do you add other than you
can stick this stuff on theshelf? In my early investigation
engagements with the team aswe're working through the "What
(11:41):
do we want to spend our time on?
And how do we best position theinitial products for success?"
was teasing out and starting tosee and help the group see, the
potential differentiation thatthere is with our products. And
(12:04):
how do we improve thedifferentiation. Our freeze
dried product, we call thetechnology freeze dried platelet
derived hemostat, FPH. Actually,because of the process and the
various components, we takeplatelets, we batch them up and
then we manufacture in a processand we lyophilize, the freeze
dry them, because of the impacton the cells in that process. We
(12:28):
actually have an amplificationof certain components that will
deliver some interestingtherapeutic effects. And that
differentiation, in addition toshelf life, is in very
significant populations, wethink we can have a big, big,
big impact. So I was talkingearlier about the military use
(12:50):
case, maternal hemorrhagecontext, rural markets, trauma,
and there are lots of people onanti-platelet therapies, 10
million people United States areon anti-platelet therapies. If
they have an urgent or even justa regularly scheduled procedure,
that's hard for a surgeon, aclinical team to address. It
turns out that our stuff, FPH,in that context, actually
(13:14):
performs better in vitro, by along way, compared to liquid
stored platelets. And havingthat come to the forefront for
the team, we had the data, wehad the science, there was kind
of a this was an interestingexperiment. We've also got some
really interesting experimentsabout the potential impact on
intracranial hemorrhage, wherethere are no therapeutics. And
(13:35):
both of those are categorieswhere there aren't great
solutions, there are not tools.
Surgeons talk all the time aboutif someone's on anti-platelet
therapy, it's really hard tostop the bleeding in a surgical
procedure or even a traumaticevent, it's even worse. Brain
hemorrhage. similarly, I don'thave great tools. We're solving
a problem that people have kindof just accepted as intractable.
And now we think we can solve itand have a huge impact from a
(13:59):
differentiation perspective. Andas we're talking to investors or
collaborators, we'rehighlighting, not only is this
stuff shelf stable for threeyears, and easy to administer,
but also here are populationswhere we've got millions of
people with significant diseaseor clinical burdens. And the
science is telling us we candifferentiate in the material
(14:21):
way. That's really exciting. Ididn't know that when I got
here. But that's part of theventure journey is let's look at
the data and see what it says.
Having the team highlight thatfor me, being I don't know, dumb
enough or smart enough, orsomewhere in between, to say
that's interesting, let's learnmore about that, has been, I
think, an important part of thecompany journey. That
(14:43):
willingness to listen isleadership is an important part
of that service.
John Simboli (14:47):
Can you talk to me about differentiation in the
sense that, my understanding isthat currently, blood has to be,
of course, accounted for eachperson's blood type. Your
product, potentially, has a, Idon't know if the word
universality is the right word,but has that much broader
application? Is that true? Do Ihave that right?
Mike Gaffney (15:06):
Yes, in the in the context of our product and its
universal use, that makes itsimpler to go to the shelf and
say, Okay, I just need to grabthat. That said, the blood banks
who manage most of theseproducts, they do an excellent
job of matching components.
What's relevant to us is we cando both things, we can establish
(15:26):
universality in a shelf stableway so it's very well
understood. And then, differentfrom the blood banks, because we
do a batch process, we canactually test to confirm that.
Rather than I've typed you,John, I've typed Mike. And then
I also need to test you forviral contaminations, everything
(15:46):
else, but if something happenslater, that I find out about,
oh, gosh, you had COVID, andthat creates issues as a donor,
then I've got to pull it back. Avery complicated supply chain
that the blood banks have tomanage. We can address that
upfront with our ability to takesmall samples from the batch,
just like any biopharmaceuticalbatch, and do the testing and
(16:09):
the quality control upfront. Sothere are some benefits from a
safety perspective, that onceapproved, we think our product
will bring to the market, fromthe differentiation. And that's
important because you know, wewant to improve what we're
doing. We want improve thebroader solutions that are
available, because otherwise,why are we doing this?
John Simboli (16:30):
When you meet someone, let's say through a
family connection, and perhapsthey don't really know much
about biopharma, or they don'tknow much about what Cellphire
is doing? They may say, well,what are you doing? What's your
job like? How do you explainthat in the terms of what I do
all day? How do you say it? Anddo they understand it?
Mike Gaffney (16:53):
The simple, declarative answer is, I have a
lot of meetings. I have a lot ofphone calls. So that doesn't
resonate with anybody at all,because that's just not
exciting. It's not aninteresting thing. And in those
meetings, every day, you'retrying to make a little bit of
(17:15):
incremental improvement. There'sno big aha or big event. There's
very few seminal events. It'sincremental improvement. I was
talking about when I was aventure capitalist, about the
difference between a very goodmanagement team, and just an
okay, or good management team is10%. 10%, every day. If you can
(17:36):
make a 10% improvement everyday, be 10% better. At the end
of the day, you're going tobuild a really interesting,
successful company. And that'swhat we strive for, in that
context. So the tactical orspecific answer is I have a lot
of meetings. And it's with allthe things that you would
(17:57):
expect, our existing team, whatare what are we spending our
time on strategy? How are wegetting stuff done? Accounts
payable, accounts receivable,all that sort of stuff. I
generally don't talk about that.
Instead, I talk about, thepotential impact, and what's the
problem, because that's thestuff that matters to people.
And I think it's important forour team and me, when we're
(18:19):
having those meetings, we'retrying to be 5% and, hopefully
10% better, that we have a senseof here's where we're going.
That's hard to do, because youget involved in day to day,
people challenges, you gettired, you get hungry, whatever
it might be. And it's importantto me to focus on that. So I
(18:40):
answer the question around,here's what we're trying to do.
As opposed to what do I do?
John Simboli (18:48):
As you can recall being a young person, eight or
nine or 10, or whatever is thecorrect appropriate age for you,
and you've tried to remember Oh,yeah, when I grew up, I want to
be, and for most of us, that waslike, what would my parents
think I should be when I grow upkind of stuff. Can you recall
what that image was? And does ithave anything to do with what
you're doing today,professionally?
Mike Gaffney (19:08):
Quick answer was, well, I want to be a nuclear
physicist. which is like, Okay,you're eight or nine? As I look
at that, one, it's silly, itsounds egocentric, or how smart
am I and everything else, butwhat I was really saying is I
want to do something that'shard. And I want to do something
(19:31):
that has some technicalchallenges to it. And that has,
in my mind at that time, and Ithink it's still consistent, has
an important element of service.
Because my dad was a submarineofficer, as well. And he
actually studied nuclearengineering when he was at the
Naval Academy. I think that wasthe derivative way to say those
(19:55):
things. There's somethin aboutthat impact and what he was
about from a serviceperspective, what his friends
were about. And those threecomponents of do something hard,
do something that has some realtechnical challenges to it, and
would have a bit of positiveservice benefit, was really what
(20:18):
I was saying. I didn't know Iwas saying that at the time. But
I think that was, as I lookback, how I interpret that eight
or nine thing.
John Simboli (20:27):
When you look at other companies that may be
looking to solve similarproblems, do you see others? If
you do see others, do see yourapproach being a different way
of looking at the problem?
Mike Gaffney (20:40):
There are always competitors. And they fall into
two categories, folks who arepursuing very small, incremental
improvements to the existingsource or supply, So going from
seven days to 14 days, thingslike that. And then there's a
number of others. And I totallyunderstand where this comes
(21:00):
from, that are doin "This isreally cool science, we're going
to make these things frommesenchymal stem cells, or we're
going to make an artificial one.
And it's going to be made up ofnanobots and all sorts of
stuff." And ultimately thatstuff will work. We are doing
the, which appeals to myengineering brand, we are doing
the practical thing. Let's makethis stuff shelf stable. It's
(21:22):
not going to be sexy science.
But when we're successful, it'sgoing to save a lot of lives. So
we don't have that sexy, wow,this is cool sort of platform
sizzle to it. But we know whatwe're trying to get done. And
it's going to impact millions oflives around the world when
(21:43):
we're successful.
John Simboli (21:44):
Let's say you're at an investor conference, and
you give a description, more orless like what you just told me,
but of course, in an expandedformat, and then you're going
toi get probably some people whosay, Oh, I see, you're like the
first group that you mentioned,the incremental group, or some
other investors might say, Oh, Isee. You're in the the sexy
(22:08):
scientific platform approach.
And then you probably spend sometime saying, well, actually,
this is where we are. Is there apattern in which people might
pigeonhole incorrectly? And thenhow do you help them get back on
track?
Mike Gaffney (22:22):
The biggest pigeonhole challenge the company
has relates to the broaderbiopharmaceutical market
environment, is scientificallydriven. And it should be because
at the end of the day, it'sscientific developments really
where the technology sparks. Thechallenge for Cellphire and the
(22:46):
investors kind of taking a lookat it is, it's not going to be
sexy. And it's not just sciencethat is going to allow us to be
successful. It's being smartabout where do we focus our
clinical development forapproval? It's going to do that
with a mind to where are the bigunmet needs and differentiation,
(23:07):
where we talked about earlier,but also, how do we supply
against the demand from a supplychain and production
perspective, in a way thatachieves an attractive economic
outcome for both customers, thepatients as well as for the
company. Which is different, itcertainly falls in the
psychotherapeutic world, wherethat has become much clearer
(23:32):
over the last 10 to 15 yearsthat that's an important part of
that successful business model.
But a lot different than smallmolecule, or even stem cell
production solution sets whereyou have no constraints on how
you think about your productionprocess and everything else. So
that's a different thing. Sohelping them understand that and
(23:54):
also understand that's actuallya relatively low risk
proposition. It's not does itwork or not? It's how do you
execute against all thosecomponents to be successful?
Bringing that technology that,does it work or not, in these
clinical settings, to market.
(24:16):
That's where the risk sits. Andwe're so far advanced around
understanding the science andwhere our products are, from a
developmental perspective,they're in phase two, that for
us, it's about folks who arewilling to spend enough time and
are interested in how we mighthave that sort of impact from a
(24:37):
commercial perspective. We'renot sexy. And how do you then
get over the sales challenge ofeverybody wants sexy science.
That that's the problem orchallenge that I have in
communicating and representingthe company and what we're about
doing, what we're looking toachieve and where we need
(25:01):
capital and investors support tobe successful.
John Simboli (25:04):
At this point, do you allow yourself, personally
or in your meetings, to todescribe how it's going to
affect the lives of people?
Military, it seems prettystraightforward. People can
maybe grasp that. Maybe in termsof Emergency Room needs and
things like that. How big a dealis this if your drugs get
approved?
Mike Gaffney (25:23):
So it's, it's a very big deal. It falls into
multiple categories. So I'llkind of pick one or two. So my
daughter, my oldest daughter,Claire, she goes to business
school in New England, and hasan internship in Seattle. So she
(25:44):
drove in three days, from NewEngland, to Seattle, and my wife
and I spent the whole timeworrying about that. Pictures I
actually show our team, I won'tshow them here, but it's a
horrific car crash on the sideof a rural road. And you look at
that and say, Oh, my gosh, thelikelihood of those people
(26:04):
surviving without great care isvery, very small. And the
statistic is American Red Crossserves half of the hospitals in
the United States. 33% of themdon't have platelets on the
shelves. So, okay, Claire, makesure when you get into that
accident, if it happens, you'rewithin 10 miles of that hospital
(26:25):
that has that liquid stored,platele on the shelves until we
get our products approved.
That's the sort of impact we canhave. There are patients who
have immune reactions toreceiving transfusions. And
because of those immunereactions, that has significant
clinical effects andparticularly fragile patients,
(26:46):
where there aren't goodsolutions, we can solve those
problems for them. Maternalhemorrhage is one of the largest
killers of women globally. Andthe only tool or the best tool
that exists, and there are anumber of folks who tried to
solve this problem, isplatelets. But most third world
countries don't even haveplatelets, anywhere much less,
you know, kind of on the shelf.
(27:08):
So the impact we can have in ourday to day lives in ways that
touch all of us is significant.
What's interesting is, peoplejust accept what we have.
Because the solution set that'savailable is either that really
cool science that's 30 yearsaway from ever getting to the
shelves, or incrementalimprovement that doesn't address
this massive gap of safety,efficacy, and availability.
(27:32):
That's the thing that will havea big impact at the end of the
day. That's where I have tostart the conversation because
otherwise people don't get,Okay, it's not cool science, why
did you choose to spend time onit? Let me just tell you a
story, Claire driving driving toSeattle in three days, which is
nuts. But that's Claire, youknow, what were her parents
(27:53):
doing? We were hoping she wasdriving by hospitals that have
platelets on the shelves,knowing that in South Dakota,
knowing that in Idaho and otherstates, there's not a lot on the
shelves, and we're just going tohope she doesn't get into an
accident there.
John Simboli (28:08):
For the two products categories that you
have right now, can you justdescribe them for a little bit
in broad terms, and maybe talkperhaps about how the pipeline
expresses your vision for whatyou're setting out to do with
the company?
Mike Gaffney (28:20):
We talked about two technologies. We have a
cryopreserved or frozen. Andthen we have the freeze
dried.The cryopreserved isabout, we're working closely
with the army on this, they'vebeen a great funding partner,
addressing availability asquickly as we can, from a
timeline or approvalperspective. We're doing some
things, technically, that wethink will expand that market to
(28:42):
a degree but it's cryopreserved,it's frozen, so you have to have
a cold chain, we think we canimprove the product. So the cold
chain would actually includeyour home freezer, John, so you
can have a unit on the shelf orthe hospital can in a rural
market, because they don't havean ultra cold chain.. And we're
targeting somewhere on the 27-28timeframe for approval. That
(29:02):
will be a nice and importantimpact, near term, on that
availability, rural markets, aswell as the military use case.
But you can't put a frozenplatelet unit in your backpack.
You can't do that as easily inrural ane in third world
hospitals. That's where thefreeze dried platelet
haemostatic technology comesfrom. As I mentioned earlier,
(29:26):
we're starting to tease out andwe've done, I think a good job
as a team, where can we reallyhave an impact and what is that
differentiation? It's not justavailability, but it's about
efficacy and clinical impact.
And there's three categories: one, which we're really excited (29:37):
undefined
about is the ability to help anorphan or ultra orphan
population that is very fragilebecause they have genetic
platelet disorders and in theirdisease progression, there's a
lot of challenges. Oneparticular category Hermansky
(29:58):
Pudlak Disease, put likedisease, and most of those
within a particular geneticallele will require a lung
transplant by the time they're40 or 45. So transfusion
reactions, events related tothat will make them ineligible,
will disqualify them. We cancontrol and match the product to
(30:21):
those particular patient'simmune situation so that doesn't
create any issues. What thisindustry calls an HLA match. For
the that population, we put iton the shelf, it's available to
their clinicians, they pull itoff, and not only say, Okay,
this is something that will beuseful and stop your bleeding,
(30:42):
like some of the products thatare out there, but it also is
matched to you. This is John'scategory of folks from a disease
perspective, we call that orphangenetic product. And an HLA
matched impact is something thatclinicians are very excited
about, because they do not havethat alternative easily today.
You can do it, it's hard, incertain circumstances. The blood
(31:04):
banks do a good job within thelimits of what they're able to
do. We can address that on aglobal basis. The bigger ones
that are really interesting, interms of the broader impact,
relate to we'll call it genericFPH for perioperative use,
trauma,surgery, emergencydepartment use, folks who are on
(31:24):
anti platelet therapy. In thatcontext, there's there's
probably a million a year thatcould benefit from a product
like this. And this would fitinto the hemostatic agent tool
that's available to a clinicianand an important one, where they
can say, Gosh, this will be bestfor this patient in this
circumstance. And then, furtherdown the pipeline is one related
(31:47):
intracranial hemorrhage. I willshare that we've got a
collaborator at UCSF, Dr.
Shibani, Pati, who's got somereally impactful videos of
internal post trauma, brainbleeds within mice, controlled
(32:08):
cortical injury. And every timeI show these, these images, she
has one with and without, onewith an injury and with our
product, with an injury andwithout our product, and we're
both of an age you rememberthis, War on Drugs, what is your
brain on drugs? It looks likescrambled eggs. That's what the
(32:30):
injury without our product lookslike. And then you look at the
same injury, in the mouse, withour product, it looks like the
eggs are whole. And you go oh,my gosh, the clinicians, they
jump up and they sort of runaround the room and talk to you
about oh, my gosh. We have tocall them down and say, Okay, we
have a preclinical model, itseems to have a really big
(32:52):
impact. All the other therapiesthat Dr. Pati has studied have
not had this sort of an impact.
But we've got a road to go hereabout approval. But those are
the kind of key things in ourpipeline, and hopefully a bit
about the passion that we havein terms of the potential human
and clinical impact that we canhave.
John Simboli (33:09):
Several of those three categories or portions of
those three categories as itsounds to my ear just hearing
for the first time, is they arereally unmet medical needs. It's
not like an a first line. Secondline. Third line is just there
is no line for some of those,correct?
Mike Gaffney (33:25):
That's correct.
That's absolutely right. Andthat's that kind of intractable,
there isn't a good solution. Andwe just kind of assume we can't
do it. In our team, not me, theChief scientists, all the
scientists who've been here for10-15 years. They're the ones
that brought it here, right. Andmy job and our job now is to get
it approved so we get in thehands of clinicians. And there
(33:47):
are some very significant unmetneeds that are in front of us
that we hope to have an impacton.
John Simboli (33:55):
Going back to the early part of our conversation
about when the you made thatchoice to be the leader at
Cellphire, how did you or thecompany go about choosing where
to have the headquarters belocated and where to where to
focus your activity?
Mike Gaffney (34:10):
So the company, as it predated me, is in Rockville,
Maryland, not far from NIH,National Cancer Institute and
all that sort of stuff. Sothere's a nexus of science that
kind of makes sense.
Importantly, two fundingpartners for the company
historically and today are alsonearby. The Army up at Fort
Dietrich in Frederick Maryland,has been an important partner
(34:34):
along the journey for thecompany in developing both the
cryopreserved and now actuallyhelping out on the freeze-dried
program. And then the other isBARDAm an entity within Health
and Human Services, which Idescribed as when I talked to
people who aren't in theindustry as DARPA for biologics,
and they've been a wonderfulpartner. So being in the
(34:57):
Maryland area, it makes a ton ofsense. What you get here is a
lot of great scientists and alot of folks who are passionate
about impact, military peopleand the like. So all those
things are good. The area talksabout itself as number three, or
number four in the biotechworld. But the difference
between number three and numberfour and number one, and number
(35:18):
two, is massive. So thechallenge you have here is you
have a lot of really smartscientists and a lot of people
who are passionate, you have alot less of an ecosystem of
people who have the experienceof taking science all the way
through and being successfulwith that. What is that
ecosystem of executives,regulatory people, people with
(35:41):
CMC experience, people with allthe clinical development and
clinical execution experience,investors, all those things are
necessary to success. And ourchallenge, being here, is
building on those strengths withthe government science, those
relationships from anon-dilutive funding and
(36:02):
engaging external to ourparticular market with those
people and organizations thatcan be helpful to us as we go on
our journey.
John Simboli (36:13):
Mike, thanks for speaking with me today.
Mike Gaffney (36:15):
John. It's been a pleasure. And BioBoss is doing
great things for the industry.
So that said, thank you for theopportunity.
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