November 22, 2025 • 44 mins
Michael Cloonan, CEO of Sionna Therapeutics, shares his insights about leadership in biopharma and how Sionna is working to restore the cystic fibrosis transmembrane conductance regulator for people living with cystic fibrosis.
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John Simboli (00:00):
Mike, what led you to your role as CEO of Siona
(00:03):
Therapeutics?
Mike Cloonan (00:04):
My journey into biotech first started when I was
at Bain, doing strategyconsulting. So I started after
business school, went to Bain inBoston, working on strategy
consulting. And I was working ona number of different industries
at that time, not justhealthcare, but I eventually
started to specialize inhealthcare and pharma and
medical devices, and really gotme energized about that
(00:27):
industry, really because of whatyou can do from a greater good,
from impacting patients andfamilies. I started to feel a
strong connection to thatindustry. And at that time, I
felt like this is the industry Iwant to get into. And I was in
Boston and made the jump intobiotech at that time, which was
back in 2003, and I joinedBiogen, one of the bigger
(00:48):
biotechs, here in Boston andacross the US, and spent 14
years at Biogen. A great run,great opportunity to learn in a
bigger biotech company. Didvarious roles, starting in more
finance and business developmentand strategy, then eventually
switched into the commercialorganization and running
different markets and countries,but really saw, you know, a full
(01:10):
scope of responsibilities acrossmy time at Biogen. And I just
continued to fall in love withthe work that we were doing,
launching medicine, seeing theimpact that it would have on
patients, specifically in areaslike MS, hemophilia, spinal
muscular atrophy. And then,after 14 years there, had this
great experience, I felt like Iwas ready for the next role for
(01:32):
me, which ended up being a ChiefOperating Officer, role in a
more mid sized company, whichwas Sage Therapeutics, which was
also focused on CNS, but more ondepression, postpartum
depression, but still sort of aneurology CNS connection. And I
felt like it was a greatopportunity for me to leverage
all of the things I had learnedat Biogen over the 14 years, but
(01:54):
maybe have a broader impact, youknow, a bigger role, broader
impact, within a more of a midsized company. And spent four
years at Sage and had anothergreat experience there,
experienced some some tremendoushighs and some challenges, as
every biotech does. And havingdone that for four years, then
you sort of start to feel likeyou've been the Chief Operating
(02:15):
Officer, you've had all thispast experience, and do you want
to make that jump? So yourquestion was, what made you want
to be a CEO? And it's throughexperiences that you build up
over time that sort of puts youin a position to decide is that
something you think that wouldbe meaningful? Do you think you
could make an impact? I startedgetting calls from recruiters
(02:37):
about various CEO roles, and,you know, really felt like I was
ready to take that next step andlead a company in that way. And
fell in love with Sionna. Thatultimately was the job that I
took. I joined the company backin 2021 and at the time, it was
a 12 person biotech. Very small,very early stage
research-focused company at thattime, but I saw tremendous
(02:59):
potential of what we could buildand do within Sionna. And so
that's sort of my career arc, asto how I got to where I got to,
and why, and I can get into morewhy I picked Sionna, but it was
a great opportunity, again, toleverage 20-plus years of
experience to really help acompany achieve its goals, to
get patients the medicines thatwe were working on. And you
(03:21):
know, we've seen now, been herefour and a half years, and have
really progressed the company toa point where the excitement
only grows, and what thepotential we have.
My process in joining Sionnawas, the history of Sionna was,
our science spun out of Sanofiback in 2019. So these were
(03:41):
programs that actually go backto Genzyme. So you know, if the
history, Genzyme merged withSanofi, and then these programs
rolled into Sanofi after thatpoint in time. So these, there's
a 15-year history to theprograms that we have at Sionna.
And when we spun out in 2019 wehad two co-founders of the
organization that came out ofSanofi. They had been working on
(04:02):
these programs for a long periodof time, and so they were the
original founders of thecompany. They took some of the
scientific team with them fromSanofi to start Sionna. And it
was at that time that we got theseed capital for the company was
put in, and that was from theCystic Fibrosis Foundation, RA
capital and TPG, and that's howSionna formed. I joined about 18
(04:23):
months after that, so I was notone of the original founders,
but came in very early whenthat, again, the organization
was about 12 people, a group ofscientists that mainly had come
out of Sanofi. And it was at atime when the company felt like
they were starting to turn thecorner on the science. Really
wanted to bring in more of abusiness leader to run the
organization. My background ismore on the business side than
(04:46):
it is on the scientific side,but we had such a strong
scientific foundation withinSionna that bringing in somebody
with my skill set as more of abusiness operator made more
sense at that time. So I came invery early, again. As not as the
original founder of the company,but have seen sort of the growth
and development of the programsand of the company over the four
and a half years that I've thatI've been here.
John Simboli (05:09):
When you were sifting through the various
opportunities that might comeyour way, as you're talking with
with people putting those infront of you, when you were
doing your own research. I'vespoken with several CEOs who
have said there were hundreds ofpossibilities they've looked at.
And then for some, it was acareful winnowing, and then
like, okay, that's when I wantto put my my bet. For others, it
(05:32):
was like falling in love, theway they've described it to me,
and some mixture in between. Sowhat was that like for you? Did
you know? Could you see itpretty clearly that this was the
place?
Mike Cloonan (05:43):
When you start thinking, and I started
contemplating being a CEO, oneof the things that I thought
would be very helpful was tovisualize what that company
could look like. What is thatprofile of the company that
would be the one that you wouldjump for? Because I was happy at
Sage. I liked the work that wewere doing there, and so I
wanted to be selective aroundwhat that first CEO opportunity
(06:04):
would look like. So I had in mymind, sort of a vision of what
that could ultimately be, andinitially. And so you do get a
lot of calls, like you'regetting a lot of recruiters
reaching out. You're gettingdifferent types of CEO
opportunities, and you'relearning through that process
to, sort of, as you said,whittle down what are the ones
that seem more or lessattractive based on your own
(06:26):
interest and where you think youcan add value? Because some
companies are are just more setup for a specific individual to
drive value. But ultimately,with Sionna, it actually
surprised me. When I got thecall from Sionna, actually the
recruiter on the Sionnaengagement, I knew the recruiter
from a past, from our past life.
We had worked together in thepast. And she said to me, this
is the one. This is the one thatyou're going to take. And it's,
(06:48):
I'm telling you, this is theone. I was very pleased to hear
that initially, but also curiousas to what it was and when she
initially described what theopportunity was, which was,
again, this very small, 10 to 12person research organization,
early stage, going after a verychallenging target that had not,
that had long been consideredundruggable, that was sort of
(07:09):
the label that had been attachedto some of the main programs we
were working on. And when Iheard that, I was like, Well,
are you sure you know me?
Because that actually doesn'tsound like the exact right fit
that I was thinking about.
Because as I talked about mycareer arc, a lot of my
background was sort of laterstage, biotech, you know, phase
two and beyond,commercialization experience,
(07:30):
global experience, biggerorganizations. And so, at first,
it didn't seem to sort ofscratch the profile that I was
initially thinking. But as I dugin, that's when I fell in love
with Sionna. What really stoodout for me, for Sionna, was the
fact that you had this smallorganization that you could
build, you know, from thatstage, and grow it. If you went
into a small, a medium sized tobigger company, you already have
(07:53):
a lot of things established. Andso you're inheriting something
as a CEO, rather than buildingit. And so there was a real
appeal to me that I didn'trealize at the time, until I
really started talking to acompany of this size to say,
Gosh, I can really build thisfrom almost the beginning. There
is this history and legacy ofthe programs and the team is
there, but we can really buildthis together. Then the science
(08:16):
was the other part of this. Wehave this very unique target
that we're going after. And ifyou know anything about CF, it's
a monopoly that exists today.
There was a single competitor,and it's an $11 billion market
that is dominated by a singleplayer. We had a very unique
approach to solving the issue inCF through this mechanism called
(08:36):
NBD1. We were the only companyworking on NBD1, and as I had
said, it had the history ofbeing labeled as an undruggable
target. And so I liked thechallenge that that brought, of
we're going after something thatno one else has been able to do.
We've made progress, and if wedo this, we have a potential to
positively disrupt a monopoly.
And so I like competition. Ithrive in that area. And so to
me, when I thought about theability to build a company, to
(08:59):
work with a great scientificteam, to go after a unique
target that, again, couldpositively disrupt and
potentially transform thestandard of care. It all really
started to come together. Like,she was right. This was the
right opportunity for me, andit's that's why I signed up.
John Simboli (09:16):
Your word, visualization, caught my ear
just a second ago. I wasthinking about, quite likely, I
would guess anyway, youvisualized what would be like to
be a CEO, not having been onebefore. And I'm guessing that
some of the things youvisualized turned out the way
you anticipated, and some ofthem didn't. What was that? What
was that blend?
Mike Cloonan (09:34):
When you think about what the experiences
you've gained before being aCEO. You're going to leverage
those experiences, whatever yourpath that's led you there, If
you've come up through thescience or the business side,
you have experiences that aregoing to be very tangible and
relatable to the CEO role. Andso you have a set of skills that
can make you successful. Andthen there's always going to be
(09:55):
things that you didn'texperience. You can't have done
everything prior to being a CEO.
And so the things that I foundwere more of the natural
transition that I felt very goodabout was, you know, the people,
the culture, the development ofthe organization, the hiring and
building out the company, andestablishing, you know, a strong
culture. That was all verytangible and relevant to what
I'd done in the past. There wasalso, you know, developing the
(10:18):
strategy and aligning thefinancial plan with the
strategy, all very comfortable,sort of moving from past life
into that current CEO role. Soagain, there's a lot that you
have to rely on your instinctsand your experience that's going
to set you down a path to besuccessful. The areas that were
new for me was the fundraisingaspect and as a private company.
So I had come from publiccompanies where we had raised
(10:40):
capital and raised money, butgoing to a small private
company, VC funded verydifferent capital raising and
financing aspect than what I hadexperienced in the public realm.
And so you have to becomfortable being uncomfortable,
I think, as a CEO and that youhave to know the things that you
don't know. And I would say,sort of have confident humility.
Because you can't knoweverything, and you have to be
(11:02):
able to rely on your team whomight have expertise in a
certain area, your board ofdirectors, who are a great
resource that we had here atSionna. And then you know
outside experts that you can tapinto help you get through it. So
you learn as you go through thisprocess, just like anything,
you're going to pick up so manyskills, and once you do it, you
know, once you build up moreexpertise and more knowledge and
(11:24):
more comfort with it. But Ithink one of the biggest things
with the CEO role was, again,really being, understanding
yourself, having a selfawareness around what you know
you di well. What are the thingsyou either haven't had a chance
to do yet, or it's not yourexpertise, and you've got to
rely on the team or experts,like I said, and then you
acquire them, you build thoseskill sets, and it becomes a
(11:46):
little bit like muscle memorythat you build that into your
overall, you know, tool kit thatyou have as a professional. And
the second time you go throughit, it makes you that much
stronger. And every situation isdifferent. That's the other part
of biotech. The macroenvironment could be very
different, like the politicalenvironment could be very
different. And so learning tonavigate through that, where
(12:08):
situations could be verydifferent than what you might
have experienced in the past,and having a flexibility and a
nimbleness in terms of how youoperate, that's one of the keys
in a small biotech.
John Simboli (12:22):
That word nimbleness certainly makes me
think of the BioBoss that justpublished. He was talking about
bobbing and weaving, and as faras, navigating, and I had
thought at first he meant like,like a boxer, or like closing.
And he said, No, it's not somuch about avoidance. It's about
nimbleness. It's about footwork.
I thought that's interesting.
Mike Cloonan (12:43):
Yeah, pivoting. I think pivoting is the word you
would hear quite often. Just theability, the scenario you might
have envisioned playing outdoesn't play out exactly, and
you have to have that ability topivot to a slightly different,
and sometimes even a muchdifferent scenario. But you've
sort of envisioned what thatother scenario is before it
happens. You're trying toanticipate. You're trying to see
(13:05):
around corners and really thinkin multiple scenarios. You may
have your preferred path or yourbase plan, but really trying to
think through what else couldhappen and when it does happen,
you're already prepared topivot, because you envisioned
it. Because you planned for it,it could have happened that way.
I do think sometimesorganizations can get caught if
you don't envision it. It takesyou a second when an outcome
(13:27):
happens that maybe you didn'tplan for. It can take a little
while for you to come to gripswith what the scenario is before
you can actually act on it. AndI think if you can plan ahead
and see around corners likethat, it just does allow you to
pivot that much more quickly.
John Simboli (13:42):
I spoke with a CEO who had been at the company
prior to becoming CEO, he'd beenon the business development
side. He said he'd become verygood at trying to develop
various scenarios to present tothe CEO and the executive team,
kind of like what you're talkingabout. But he said when he got
in the role it was a surprise tohim, because he hadn't yet made
(14:04):
that transition. He said, in oneof the very first meetings, he
said, you know, guys and ladies,we could do this or this, or
this or this. And he said therewas a long pause, and someone on
the team said, Yeah, but whichone are we going to do? So you
can't arbitrarily make adecision. You have to involve
your team. But that is an aspectof being the CEO that is
different from being a member ofthe executive team in another
(14:25):
way, correct?
Mike Cloonan (14:26):
Yeah, absolutely, you are the leader of the team.
But the way you know everyleader is going to have their
own philosophy, their own howthey want to be a leader, how
they run the team. And to me, itdoes come down to the team
orientation. That is, to me, oneof the biggest parts of where a
collection of individuals, butwe all have a common vision or
mission at Sionna. Our goal isto deliver highly impactful
(14:49):
medications to people livingwith CF that could fundamentally
change their lives and the livesof their families. That's your
North Star. And so as a leader,you have to ground yourself and
what your philosophy is on howyou're going to lead the team.
And a lot of what we talk aboutas a team, we are a team first.
Our individuals and ourfunctions kind of come second.
(15:10):
It's the leadership team that weare focused on first, and how we
can best help the organization.
And so my ask of all of myleadership team members is you,
as we come in as a team, yousort of take your functional hat
off, like you're not the financeperson, you're not the BD
person. You are an executiveleader, first of the company.
And we really want people whocan think from an enterprise
(15:30):
level. That they can thinkacross the organization, again,
not just in their function ortheir swim lane. And to me, if
you have a team that embracesthat concept. This is where you
can get into the scenarioplanning that is complex, and
you can think, get the contextand get the thinking of the
entire team that's going to helpyou build an even better roadmap
(15:51):
as to how to be successful. Butit does come from this, the
spirit of the company, the teamis first. The function is
second. I'm an enterprisethinker, and I think that really
works well. That's been part ofmy philosophy that I subscribe
to, and I think it helpscompanies be very successful. If
you can do it.
John Simboli (16:10):
It's in the nature of biotech and biopharma that
it's data driven, and the datachange. In a world where you're
trained to be a decision maker,you're trained to follow the
science, follow the data, Iremember talking with a CEO who
said I had to learn thatsometimes I wasn't going to make
the right decision, but often Icould fix it.
Mike Cloonan (16:27):
Well, when you're asking the question, I started
to think about, you're right. Imean, there is it's biotech is
hard to predict at time. Andwe've talked about the scenario
planning and trying to thinkahead, and you can still get
surprised. But one of the thingsthat we, that I do embrace, and
the team here does embrace, it'ssimilar to what you're talking
about, but I would call itstrategic optionality. That's
(16:50):
one of the frameworks that wereally believe in, which is it's
different than scenarioplanning. It's really trying to
best enable multiple ways towin, if you will. And so that
could be how you build yourportfolio of assets. That could
be how you invest your capitaland your resources. With
biotech, it's always abouttrying to get to that next stage
of development, which will thende-risk the compound that much
(17:12):
further, or the program thatmuch further. But until you have
that, the more optionality thatyou have, and you do it in still
a what I would call capitalefficient way. We only have a
finite amount of resources. Wecan't have infinite strategic
optionality. But it's veryimportant, in my mind, when you
think about biotech, is that tohave multiple options, multiple
ways to win, it enables you topivot more quickly if have
(17:35):
different options, differentassets. And it's complicated,
though. The more strategicoptionality you build into the
organization, it createscomplexity. Because, as you were
saying, you're not actuallymaking a decision today. You're
keeping options open, but sothat's your decision you're
making. You're making thedecision to keep options open
instead of making the decisionto go down this specific path.
(17:57):
And so it's actually just adifferent decision making
framework of you're still makingdecisions, but it's, in essence,
the decision to keep things openuntil we have more data. Then we
can be data driven and we cannarrow the options and start to
go down a more defined path. Butit's all about leveraging. You
know what happens in biotechwith data, the de-risking, more
(18:17):
certainty comes into play, andit just gives yourself a better
chance to make the bestdecision, as opposed to, too
early, maybe narrowing it down,and it might lead you down a
different path.
John Simboli (18:28):
You probably smiled when you saw this
question about when you wereeight or nine years old, did you
have any image of what lifewould be like? It's surprising
to me when I've asked that a fewtimes here, when I've had
answers like, No, I was trainedto be a classical pianist, and
then I realized . . . So whatwas your image, or what you
Mike Cloonan (18:47):
you're thinking, but I definitely was at that
What is the unmet need? Youbegan to talk thought?
time thinking I wanted to playfor the Boston Celtics or the
Boston Red Sox. There was noquestion in my mind I was going
to be a professional athlete,and that was a big part of my
identity growing up. I lovesports. Still do, but you know,
as I when I take that now andreally think about maybe what
(19:09):
you're trying to get at in termsof why I asked that question,
you know, what I learned, veryearly on, having that mindset of
an athlete is that, you know,having a common vision of what
you want to accomplish, and whatdoes success look like? And the
team aspect. The team first, theindividual success comes later.
And those are parts of myleadership philosophy that I
(19:31):
talked about earlier, aboutthings that I still have today.
You can trace back to, again,sort of that very early age of
what you thought you wanted tobe, but was it the actual what
you wanted to be or who youwanted to be? And that's what I
think about when I reflected onthis question. There were things
It really comesdown to when you think about
that, again, I could take fromthat of who I wanted to be, part
of a team, doing something verymeaningful, again, the
(19:52):
opportunity to be successful andgo after a championship, and in
biotech that's getting a drug tolaunch and getting it to
patients. So there is a strongconnectivity between thinking
back now and reflecting of whymaybe I landed where I did
today. But I did fast forwardlike, you know, when I did a
little bit more okay, beyondthat very early stage, when did
(20:13):
I start to think about, youknow, why I landed in biotech
and my early, when I went toundergrad, I started off as a
chemistry major. So I alwaysloved science, and thought that
where the bar is today. As wesaid, a third of patients who
would be something that I wantto do as a career. But then I,
you know, as I did more of thescience, and I started taking
some business classes, Iactually pivoted. And I pivoted
to business as my major. Butwhat I found out later in life
(20:35):
is, having done the scienceearly, pivoting to business and
then sort of building yourcareer on the business side,
biotech is the intersection ofscience and business. I mean,
that's really what the businessmodel is. And so when I look
back now, I'm not surprised thatthis is where I landed based on
what sort of my two academicaspirations or interests were in
college, and sort of how Imorphed them back together later
(20:57):
in life.
are on the standard of care havenormal CFTR function. So that
(21:55):
means two thirds do not havenormal CFTR function, and that
(22:41):
means that their quality of lifeis not where it needs to be.
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Their life expectancy is notwhere it is, and just their
(24:12):
overall how they live, their dayto day life, can be improved.
(25:00):
And so what we are focused on isdriving as many patients with a
(25:50):
dual combination to a betterthreshold or better level of
(26:35):
CFTR function, all the way tonormal for as many patients as
(27:22):
possible. And if we can do that,the downstream implications for
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patients are significant interms of their quality of life,
(28:57):
potentially life expectancy. Allof those things feed into this.
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And the other part of it is notonly trying to raise the
(30:31):
efficacy bar and get morepatients to normal. The other
(31:14):
part of this, we're doing itwith two drugs, as compared to
(32:00):
the standard of care, which isthree drugs. And that standard
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of care has already anestablished tolerability
(33:24):
profile, but we believe with twocompounds, one that's a
(34:08):
differentiated one in NBD1, wemay have the potential to
(34:52):
deliver a differentiatedtolerability profile for
(35:30):
patients as well. So the firstgoal is drive the efficacy and
(36:18):
improve that CFTR function. Butthere could also be a corollary
(37:00):
CF is a large rare disease. Ithas about 100,000 patients
worldwide that have CF. And soit is one of the largest rare
diseases that exist. And alsospeaks to the market size. As we
benefit to this, of having atolerability improvement, if it
said, It's $11 billion marketsize that is growing to 15
billion in the not too distantfuture. And so for folks today,
we could talk about lifeexpectancy being in that mid
50s, as I said today, that's animportant framework to think
(37:23):
about. How can we improve thelives of CF patients? There is
exacerbations to the diseasethat could put them into the
hospital, where their lungs arenot functioning in the way that
they want. The mucus is stillbuilding up. And so, we've made
a lot of progress in the lastdecade in terms of CF, but those
are the things we can take evento a better level, with
(37:44):
potentially NBD1 being thebackbone of a dual combination
that can provide incrementalbenefits than what they see
today. And that's the goal. Andjust to get having more options
does what we think it can do.
for patients, as I've talkedabout, it does create, not every
medicine works for everypatient, and that's the case in
every disease. The more optionswe have, patients respond
differently to options, and sothat's our goal. We believe
(38:07):
patients deserve more options inCF and that's our goal, is to
deliver them new, potentiallymore efficacious options that
could even have a differentiatedtolerability profile.
John Simboli (38:17):
A lot of my work, just by chance, has been with
people who companies are workingin the rare disease side and
having a normal life, thensuddenly having your world
upside down, and then havingthis incredible opportunity to
have your life back again. It'salmost beyond words.
Mike Cloonan (38:31):
That's why we work in biotech, right? To see the
impact that you can potentiallymake on people living with that
disease. It's impacts thefamilies, because everyone is
sort of involved with that. Andso it really is unique, not only
to biotech, but again, tocertain disease areas, where you
could see fundamentally gamechanging improvement in the
lives of people living with thedisease, and their families, for
(38:55):
sure.
Just to summarize so it's veryclear, Sionna is going after a
new approach for CF. And CF is amonopoly, as we've talked about,
where there's a single playerthat has dominated the space for
a long time. And as we know, thevast majority of patients are
not getting to normal CFTRfunction. So our mission is to
drive as many patients aspossible to normal CFTR
(39:15):
function. We're going after thatto solve the unmet need that
exists, and we're going toleverage this very new, first in
class target called NBD1, whichis not, it's not a new target,
per se, in terms of beingstudied. It's a new target in
that, for the first time,somebody is in the clinic with
NBD1. And it really is the keyto unlocking more CFTR function.
(39:36):
It helps fully correct theprotein. And if you can fully
correct the protein, you canfully normalize its function.
And one of the ways we are goingto get there and to drive that
incremental benefit for patientsin a clinically meaningful way,
is to combine NBD1 with oneother complementary mechanism
that we have in our portfolio.
And when we do that as part of adual combination, we have the
(39:56):
potential to raise the efficacybar and deliver meaningful
clinical improvement forpatients living with CF.
We talked a lot about thestrategic optionality. That's a
big part of what we're building.
Our portfolio has strength anddepth, both across many
dimensions. We're entering a keypoint in our life cycle at
Sionna, where we're enteringphase two with this add-on to
(40:17):
the standard of care, proof ofconcept, while at the same time
running this dual combinationhealthy volunteer study with
SION 451. And one thing wedidn't talk about is we will
have data from both of thosestudies in the middle of 202o.
So a very impactful less than 12months now for Sionna, and we're
in a very fortunate financialposition because we recently
(40:37):
completed our IPO, as you mayhave seen back in February of
this year, where we raised over$200 million. It has provided a
lot of financial flexibility toexecute that strategy that we've
talked about. And so veryimportant year, a
transformational year forSionna. But we've put ourselves
in the position, through verystrong execution, to be here and
to turn those cards over in themiddle of 2026
John Simboli (41:01):
Mike, thanks for speaking with me today.
Mike Cloonan (41:04):
Thank you, John.
It's been a real pleasure. Ireally appreciate the time and
being able to talk about Sionna.
Mike, what led you to your role as CEO of Siona
(00:03):
Therapeutics?
Mike Cloonan (00:04):
My journey into biotech first started when I was
at Bain, doing strategyconsulting. So I started after
business school, went to Bain inBoston, working on strategy
consulting. And I was working ona number of different industries
at that time, not justhealthcare, but I eventually
started to specialize inhealthcare and pharma and
medical devices, and really gotme energized about that
(00:27):
industry, really because of whatyou can do from a greater good,
from impacting patients andfamilies. I started to feel a
strong connection to thatindustry. And at that time, I
felt like this is the industry Iwant to get into. And I was in
Boston and made the jump intobiotech at that time, which was
back in 2003, and I joinedBiogen, one of the bigger
(00:48):
biotechs, here in Boston andacross the US, and spent 14
years at Biogen. A great run,great opportunity to learn in a
bigger biotech company. Didvarious roles, starting in more
finance and business developmentand strategy, then eventually
switched into the commercialorganization and running
different markets and countries,but really saw, you know, a full
(01:10):
scope of responsibilities acrossmy time at Biogen. And I just
continued to fall in love withthe work that we were doing,
launching medicine, seeing theimpact that it would have on
patients, specifically in areaslike MS, hemophilia, spinal
muscular atrophy. And then,after 14 years there, had this
great experience, I felt like Iwas ready for the next role for
(01:32):
me, which ended up being a ChiefOperating Officer, role in a
more mid sized company, whichwas Sage Therapeutics, which was
also focused on CNS, but more ondepression, postpartum
depression, but still sort of aneurology CNS connection. And I
felt like it was a greatopportunity for me to leverage
all of the things I had learnedat Biogen over the 14 years, but
(01:54):
maybe have a broader impact, youknow, a bigger role, broader
impact, within a more of a midsized company. And spent four
years at Sage and had anothergreat experience there,
experienced some some tremendoushighs and some challenges, as
every biotech does. And havingdone that for four years, then
you sort of start to feel likeyou've been the Chief Operating
(02:15):
Officer, you've had all thispast experience, and do you want
to make that jump? So yourquestion was, what made you want
to be a CEO? And it's throughexperiences that you build up
over time that sort of puts youin a position to decide is that
something you think that wouldbe meaningful? Do you think you
could make an impact? I startedgetting calls from recruiters
(02:37):
about various CEO roles, and,you know, really felt like I was
ready to take that next step andlead a company in that way. And
fell in love with Sionna. Thatultimately was the job that I
took. I joined the company backin 2021 and at the time, it was
a 12 person biotech. Very small,very early stage
research-focused company at thattime, but I saw tremendous
(02:59):
potential of what we could buildand do within Sionna. And so
that's sort of my career arc, asto how I got to where I got to,
and why, and I can get into morewhy I picked Sionna, but it was
a great opportunity, again, toleverage 20-plus years of
experience to really help acompany achieve its goals, to
get patients the medicines thatwe were working on. And you
(03:21):
know, we've seen now, been herefour and a half years, and have
really progressed the company toa point where the excitement
only grows, and what thepotential we have.
My process in joining Sionnawas, the history of Sionna was,
our science spun out of Sanofiback in 2019. So these were
(03:41):
programs that actually go backto Genzyme. So you know, if the
history, Genzyme merged withSanofi, and then these programs
rolled into Sanofi after thatpoint in time. So these, there's
a 15-year history to theprograms that we have at Sionna.
And when we spun out in 2019 wehad two co-founders of the
organization that came out ofSanofi. They had been working on
(04:02):
these programs for a long periodof time, and so they were the
original founders of thecompany. They took some of the
scientific team with them fromSanofi to start Sionna. And it
was at that time that we got theseed capital for the company was
put in, and that was from theCystic Fibrosis Foundation, RA
capital and TPG, and that's howSionna formed. I joined about 18
(04:23):
months after that, so I was notone of the original founders,
but came in very early whenthat, again, the organization
was about 12 people, a group ofscientists that mainly had come
out of Sanofi. And it was at atime when the company felt like
they were starting to turn thecorner on the science. Really
wanted to bring in more of abusiness leader to run the
organization. My background ismore on the business side than
(04:46):
it is on the scientific side,but we had such a strong
scientific foundation withinSionna that bringing in somebody
with my skill set as more of abusiness operator made more
sense at that time. So I came invery early, again. As not as the
original founder of the company,but have seen sort of the growth
and development of the programsand of the company over the four
and a half years that I've thatI've been here.
John Simboli (05:09):
When you were sifting through the various
opportunities that might comeyour way, as you're talking with
with people putting those infront of you, when you were
doing your own research. I'vespoken with several CEOs who
have said there were hundreds ofpossibilities they've looked at.
And then for some, it was acareful winnowing, and then
like, okay, that's when I wantto put my my bet. For others, it
(05:32):
was like falling in love, theway they've described it to me,
and some mixture in between. Sowhat was that like for you? Did
you know? Could you see itpretty clearly that this was the
place?
Mike Cloonan (05:43):
When you start thinking, and I started
contemplating being a CEO, oneof the things that I thought
would be very helpful was tovisualize what that company
could look like. What is thatprofile of the company that
would be the one that you wouldjump for? Because I was happy at
Sage. I liked the work that wewere doing there, and so I
wanted to be selective aroundwhat that first CEO opportunity
(06:04):
would look like. So I had in mymind, sort of a vision of what
that could ultimately be, andinitially. And so you do get a
lot of calls, like you'regetting a lot of recruiters
reaching out. You're gettingdifferent types of CEO
opportunities, and you'relearning through that process
to, sort of, as you said,whittle down what are the ones
that seem more or lessattractive based on your own
(06:26):
interest and where you think youcan add value? Because some
companies are are just more setup for a specific individual to
drive value. But ultimately,with Sionna, it actually
surprised me. When I got thecall from Sionna, actually the
recruiter on the Sionnaengagement, I knew the recruiter
from a past, from our past life.
We had worked together in thepast. And she said to me, this
is the one. This is the one thatyou're going to take. And it's,
(06:48):
I'm telling you, this is theone. I was very pleased to hear
that initially, but also curiousas to what it was and when she
initially described what theopportunity was, which was,
again, this very small, 10 to 12person research organization,
early stage, going after a verychallenging target that had not,
that had long been consideredundruggable, that was sort of
(07:09):
the label that had been attachedto some of the main programs we
were working on. And when Iheard that, I was like, Well,
are you sure you know me?
Because that actually doesn'tsound like the exact right fit
that I was thinking about.
Because as I talked about mycareer arc, a lot of my
background was sort of laterstage, biotech, you know, phase
two and beyond,commercialization experience,
(07:30):
global experience, biggerorganizations. And so, at first,
it didn't seem to sort ofscratch the profile that I was
initially thinking. But as I dugin, that's when I fell in love
with Sionna. What really stoodout for me, for Sionna, was the
fact that you had this smallorganization that you could
build, you know, from thatstage, and grow it. If you went
into a small, a medium sized tobigger company, you already have
(07:53):
a lot of things established. Andso you're inheriting something
as a CEO, rather than buildingit. And so there was a real
appeal to me that I didn'trealize at the time, until I
really started talking to acompany of this size to say,
Gosh, I can really build thisfrom almost the beginning. There
is this history and legacy ofthe programs and the team is
there, but we can really buildthis together. Then the science
(08:16):
was the other part of this. Wehave this very unique target
that we're going after. And ifyou know anything about CF, it's
a monopoly that exists today.
There was a single competitor,and it's an $11 billion market
that is dominated by a singleplayer. We had a very unique
approach to solving the issue inCF through this mechanism called
(08:36):
NBD1. We were the only companyworking on NBD1, and as I had
said, it had the history ofbeing labeled as an undruggable
target. And so I liked thechallenge that that brought, of
we're going after something thatno one else has been able to do.
We've made progress, and if wedo this, we have a potential to
positively disrupt a monopoly.
And so I like competition. Ithrive in that area. And so to
me, when I thought about theability to build a company, to
(08:59):
work with a great scientificteam, to go after a unique
target that, again, couldpositively disrupt and
potentially transform thestandard of care. It all really
started to come together. Like,she was right. This was the
right opportunity for me, andit's that's why I signed up.
John Simboli (09:16):
Your word, visualization, caught my ear
just a second ago. I wasthinking about, quite likely, I
would guess anyway, youvisualized what would be like to
be a CEO, not having been onebefore. And I'm guessing that
some of the things youvisualized turned out the way
you anticipated, and some ofthem didn't. What was that? What
was that blend?
Mike Cloonan (09:34):
When you think about what the experiences
you've gained before being aCEO. You're going to leverage
those experiences, whatever yourpath that's led you there, If
you've come up through thescience or the business side,
you have experiences that aregoing to be very tangible and
relatable to the CEO role. Andso you have a set of skills that
can make you successful. Andthen there's always going to be
(09:55):
things that you didn'texperience. You can't have done
everything prior to being a CEO.
And so the things that I foundwere more of the natural
transition that I felt very goodabout was, you know, the people,
the culture, the development ofthe organization, the hiring and
building out the company, andestablishing, you know, a strong
culture. That was all verytangible and relevant to what
I'd done in the past. There wasalso, you know, developing the
(10:18):
strategy and aligning thefinancial plan with the
strategy, all very comfortable,sort of moving from past life
into that current CEO role. Soagain, there's a lot that you
have to rely on your instinctsand your experience that's going
to set you down a path to besuccessful. The areas that were
new for me was the fundraisingaspect and as a private company.
So I had come from publiccompanies where we had raised
(10:40):
capital and raised money, butgoing to a small private
company, VC funded verydifferent capital raising and
financing aspect than what I hadexperienced in the public realm.
And so you have to becomfortable being uncomfortable,
I think, as a CEO and that youhave to know the things that you
don't know. And I would say,sort of have confident humility.
Because you can't knoweverything, and you have to be
(11:02):
able to rely on your team whomight have expertise in a
certain area, your board ofdirectors, who are a great
resource that we had here atSionna. And then you know
outside experts that you can tapinto help you get through it. So
you learn as you go through thisprocess, just like anything,
you're going to pick up so manyskills, and once you do it, you
know, once you build up moreexpertise and more knowledge and
(11:24):
more comfort with it. But Ithink one of the biggest things
with the CEO role was, again,really being, understanding
yourself, having a selfawareness around what you know
you di well. What are the thingsyou either haven't had a chance
to do yet, or it's not yourexpertise, and you've got to
rely on the team or experts,like I said, and then you
acquire them, you build thoseskill sets, and it becomes a
(11:46):
little bit like muscle memorythat you build that into your
overall, you know, tool kit thatyou have as a professional. And
the second time you go throughit, it makes you that much
stronger. And every situation isdifferent. That's the other part
of biotech. The macroenvironment could be very
different, like the politicalenvironment could be very
different. And so learning tonavigate through that, where
(12:08):
situations could be verydifferent than what you might
have experienced in the past,and having a flexibility and a
nimbleness in terms of how youoperate, that's one of the keys
in a small biotech.
John Simboli (12:22):
That word nimbleness certainly makes me
think of the BioBoss that justpublished. He was talking about
bobbing and weaving, and as faras, navigating, and I had
thought at first he meant like,like a boxer, or like closing.
And he said, No, it's not somuch about avoidance. It's about
nimbleness. It's about footwork.
I thought that's interesting.
Mike Cloonan (12:43):
Yeah, pivoting. I think pivoting is the word you
would hear quite often. Just theability, the scenario you might
have envisioned playing outdoesn't play out exactly, and
you have to have that ability topivot to a slightly different,
and sometimes even a muchdifferent scenario. But you've
sort of envisioned what thatother scenario is before it
happens. You're trying toanticipate. You're trying to see
(13:05):
around corners and really thinkin multiple scenarios. You may
have your preferred path or yourbase plan, but really trying to
think through what else couldhappen and when it does happen,
you're already prepared topivot, because you envisioned
it. Because you planned for it,it could have happened that way.
I do think sometimesorganizations can get caught if
you don't envision it. It takesyou a second when an outcome
(13:27):
happens that maybe you didn'tplan for. It can take a little
while for you to come to gripswith what the scenario is before
you can actually act on it. AndI think if you can plan ahead
and see around corners likethat, it just does allow you to
pivot that much more quickly.
John Simboli (13:42):
I spoke with a CEO who had been at the company
prior to becoming CEO, he'd beenon the business development
side. He said he'd become verygood at trying to develop
various scenarios to present tothe CEO and the executive team,
kind of like what you're talkingabout. But he said when he got
in the role it was a surprise tohim, because he hadn't yet made
(14:04):
that transition. He said, in oneof the very first meetings, he
said, you know, guys and ladies,we could do this or this, or
this or this. And he said therewas a long pause, and someone on
the team said, Yeah, but whichone are we going to do? So you
can't arbitrarily make adecision. You have to involve
your team. But that is an aspectof being the CEO that is
different from being a member ofthe executive team in another
(14:25):
way, correct?
Mike Cloonan (14:26):
Yeah, absolutely, you are the leader of the team.
But the way you know everyleader is going to have their
own philosophy, their own howthey want to be a leader, how
they run the team. And to me, itdoes come down to the team
orientation. That is, to me, oneof the biggest parts of where a
collection of individuals, butwe all have a common vision or
mission at Sionna. Our goal isto deliver highly impactful
(14:49):
medications to people livingwith CF that could fundamentally
change their lives and the livesof their families. That's your
North Star. And so as a leader,you have to ground yourself and
what your philosophy is on howyou're going to lead the team.
And a lot of what we talk aboutas a team, we are a team first.
Our individuals and ourfunctions kind of come second.
(15:10):
It's the leadership team that weare focused on first, and how we
can best help the organization.
And so my ask of all of myleadership team members is you,
as we come in as a team, yousort of take your functional hat
off, like you're not the financeperson, you're not the BD
person. You are an executiveleader, first of the company.
And we really want people whocan think from an enterprise
(15:30):
level. That they can thinkacross the organization, again,
not just in their function ortheir swim lane. And to me, if
you have a team that embracesthat concept. This is where you
can get into the scenarioplanning that is complex, and
you can think, get the contextand get the thinking of the
entire team that's going to helpyou build an even better roadmap
(15:51):
as to how to be successful. Butit does come from this, the
spirit of the company, the teamis first. The function is
second. I'm an enterprisethinker, and I think that really
works well. That's been part ofmy philosophy that I subscribe
to, and I think it helpscompanies be very successful. If
you can do it.
John Simboli (16:10):
It's in the nature of biotech and biopharma that
it's data driven, and the datachange. In a world where you're
trained to be a decision maker,you're trained to follow the
science, follow the data, Iremember talking with a CEO who
said I had to learn thatsometimes I wasn't going to make
the right decision, but often Icould fix it.
Mike Cloonan (16:27):
Well, when you're asking the question, I started
to think about, you're right. Imean, there is it's biotech is
hard to predict at time. Andwe've talked about the scenario
planning and trying to thinkahead, and you can still get
surprised. But one of the thingsthat we, that I do embrace, and
the team here does embrace, it'ssimilar to what you're talking
about, but I would call itstrategic optionality. That's
(16:50):
one of the frameworks that wereally believe in, which is it's
different than scenarioplanning. It's really trying to
best enable multiple ways towin, if you will. And so that
could be how you build yourportfolio of assets. That could
be how you invest your capitaland your resources. With
biotech, it's always abouttrying to get to that next stage
of development, which will thende-risk the compound that much
(17:12):
further, or the program thatmuch further. But until you have
that, the more optionality thatyou have, and you do it in still
a what I would call capitalefficient way. We only have a
finite amount of resources. Wecan't have infinite strategic
optionality. But it's veryimportant, in my mind, when you
think about biotech, is that tohave multiple options, multiple
ways to win, it enables you topivot more quickly if have
(17:35):
different options, differentassets. And it's complicated,
though. The more strategicoptionality you build into the
organization, it createscomplexity. Because, as you were
saying, you're not actuallymaking a decision today. You're
keeping options open, but sothat's your decision you're
making. You're making thedecision to keep options open
instead of making the decisionto go down this specific path.
(17:57):
And so it's actually just adifferent decision making
framework of you're still makingdecisions, but it's, in essence,
the decision to keep things openuntil we have more data. Then we
can be data driven and we cannarrow the options and start to
go down a more defined path. Butit's all about leveraging. You
know what happens in biotechwith data, the de-risking, more
(18:17):
certainty comes into play, andit just gives yourself a better
chance to make the bestdecision, as opposed to, too
early, maybe narrowing it down,and it might lead you down a
different path.
John Simboli (18:28):
You probably smiled when you saw this
question about when you wereeight or nine years old, did you
have any image of what lifewould be like? It's surprising
to me when I've asked that a fewtimes here, when I've had
answers like, No, I was trainedto be a classical pianist, and
then I realized . . . So whatwas your image, or what you
Mike Cloonan (18:47):
you're thinking, but I definitely was at that
What is the unmet need? Youbegan to talk thought?
time thinking I wanted to playfor the Boston Celtics or the
Boston Red Sox. There was noquestion in my mind I was going
to be a professional athlete,and that was a big part of my
identity growing up. I lovesports. Still do, but you know,
as I when I take that now andreally think about maybe what
(19:09):
you're trying to get at in termsof why I asked that question,
you know, what I learned, veryearly on, having that mindset of
an athlete is that, you know,having a common vision of what
you want to accomplish, and whatdoes success look like? And the
team aspect. The team first, theindividual success comes later.
And those are parts of myleadership philosophy that I
(19:31):
talked about earlier, aboutthings that I still have today.
You can trace back to, again,sort of that very early age of
what you thought you wanted tobe, but was it the actual what
you wanted to be or who youwanted to be? And that's what I
think about when I reflected onthis question. There were things
It really comesdown to when you think about
that, again, I could take fromthat of who I wanted to be, part
of a team, doing something verymeaningful, again, the
(19:52):
opportunity to be successful andgo after a championship, and in
biotech that's getting a drug tolaunch and getting it to
patients. So there is a strongconnectivity between thinking
back now and reflecting of whymaybe I landed where I did
today. But I did fast forwardlike, you know, when I did a
little bit more okay, beyondthat very early stage, when did
(20:13):
I start to think about, youknow, why I landed in biotech
and my early, when I went toundergrad, I started off as a
chemistry major. So I alwaysloved science, and thought that
where the bar is today. As wesaid, a third of patients who
would be something that I wantto do as a career. But then I,
you know, as I did more of thescience, and I started taking
some business classes, Iactually pivoted. And I pivoted
to business as my major. Butwhat I found out later in life
(20:35):
is, having done the scienceearly, pivoting to business and
then sort of building yourcareer on the business side,
biotech is the intersection ofscience and business. I mean,
that's really what the businessmodel is. And so when I look
back now, I'm not surprised thatthis is where I landed based on
what sort of my two academicaspirations or interests were in
college, and sort of how Imorphed them back together later
(20:57):
in life.
are on the standard of care havenormal CFTR function. So that
(21:55):
means two thirds do not havenormal CFTR function, and that
(22:41):
means that their quality of lifeis not where it needs to be.
(23:28):
Their life expectancy is notwhere it is, and just their
(24:12):
overall how they live, their dayto day life, can be improved.
(25:00):
And so what we are focused on isdriving as many patients with a
(25:50):
dual combination to a betterthreshold or better level of
(26:35):
CFTR function, all the way tonormal for as many patients as
(27:22):
possible. And if we can do that,the downstream implications for
(28:11):
patients are significant interms of their quality of life,
(28:57):
potentially life expectancy. Allof those things feed into this.
(29:47):
And the other part of it is notonly trying to raise the
(30:31):
efficacy bar and get morepatients to normal. The other
(31:14):
part of this, we're doing itwith two drugs, as compared to
(32:00):
the standard of care, which isthree drugs. And that standard
(32:48):
of care has already anestablished tolerability
(33:24):
profile, but we believe with twocompounds, one that's a
(34:08):
differentiated one in NBD1, wemay have the potential to
(34:52):
deliver a differentiatedtolerability profile for
(35:30):
patients as well. So the firstgoal is drive the efficacy and
(36:18):
improve that CFTR function. Butthere could also be a corollary
(37:00):
CF is a large rare disease. Ithas about 100,000 patients
worldwide that have CF. And soit is one of the largest rare
diseases that exist. And alsospeaks to the market size. As we
benefit to this, of having atolerability improvement, if it
said, It's $11 billion marketsize that is growing to 15
billion in the not too distantfuture. And so for folks today,
we could talk about lifeexpectancy being in that mid
50s, as I said today, that's animportant framework to think
(37:23):
about. How can we improve thelives of CF patients? There is
exacerbations to the diseasethat could put them into the
hospital, where their lungs arenot functioning in the way that
they want. The mucus is stillbuilding up. And so, we've made
a lot of progress in the lastdecade in terms of CF, but those
are the things we can take evento a better level, with
(37:44):
potentially NBD1 being thebackbone of a dual combination
that can provide incrementalbenefits than what they see
today. And that's the goal. Andjust to get having more options
does what we think it can do.
for patients, as I've talkedabout, it does create, not every
medicine works for everypatient, and that's the case in
every disease. The more optionswe have, patients respond
differently to options, and sothat's our goal. We believe
(38:07):
patients deserve more options inCF and that's our goal, is to
deliver them new, potentiallymore efficacious options that
could even have a differentiatedtolerability profile.
John Simboli (38:17):
A lot of my work, just by chance, has been with
people who companies are workingin the rare disease side and
having a normal life, thensuddenly having your world
upside down, and then havingthis incredible opportunity to
have your life back again. It'salmost beyond words.
Mike Cloonan (38:31):
That's why we work in biotech, right? To see the
impact that you can potentiallymake on people living with that
disease. It's impacts thefamilies, because everyone is
sort of involved with that. Andso it really is unique, not only
to biotech, but again, tocertain disease areas, where you
could see fundamentally gamechanging improvement in the
lives of people living with thedisease, and their families, for
(38:55):
sure.
Just to summarize so it's veryclear, Sionna is going after a
new approach for CF. And CF is amonopoly, as we've talked about,
where there's a single playerthat has dominated the space for
a long time. And as we know, thevast majority of patients are
not getting to normal CFTRfunction. So our mission is to
drive as many patients aspossible to normal CFTR
(39:15):
function. We're going after thatto solve the unmet need that
exists, and we're going toleverage this very new, first in
class target called NBD1, whichis not, it's not a new target,
per se, in terms of beingstudied. It's a new target in
that, for the first time,somebody is in the clinic with
NBD1. And it really is the keyto unlocking more CFTR function.
(39:36):
It helps fully correct theprotein. And if you can fully
correct the protein, you canfully normalize its function.
And one of the ways we are goingto get there and to drive that
incremental benefit for patientsin a clinically meaningful way,
is to combine NBD1 with oneother complementary mechanism
that we have in our portfolio.
And when we do that as part of adual combination, we have the
(39:56):
potential to raise the efficacybar and deliver meaningful
clinical improvement forpatients living with CF.
We talked a lot about thestrategic optionality. That's a
big part of what we're building.
Our portfolio has strength anddepth, both across many
dimensions. We're entering a keypoint in our life cycle at
Sionna, where we're enteringphase two with this add-on to
(40:17):
the standard of care, proof ofconcept, while at the same time
running this dual combinationhealthy volunteer study with
SION 451. And one thing wedidn't talk about is we will
have data from both of thosestudies in the middle of 202o.
So a very impactful less than 12months now for Sionna, and we're
in a very fortunate financialposition because we recently
(40:37):
completed our IPO, as you mayhave seen back in February of
this year, where we raised over$200 million. It has provided a
lot of financial flexibility toexecute that strategy that we've
talked about. And so veryimportant year, a
transformational year forSionna. But we've put ourselves
in the position, through verystrong execution, to be here and
to turn those cards over in themiddle of 2026
John Simboli (41:01):
Mike, thanks for speaking with me today.
Mike Cloonan (41:04):
Thank you, John.
It's been a real pleasure. Ireally appreciate the time and
being able to talk about Sionna.
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