Latest / The BioHub - by Avetix / Episode 72 - Nick Manusos - CEO of Kenai Therapeutics

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Episode 72 - Nick Manusos - CEO of Kenai Therapeutics · The BioHub - by Avetix

0:05
So welcome back to the episode of the Bio Hub.
0:07
Today, we're delighted to welcome Nick Manusos, who's the
0:10
founding CEO of Kenai Therapeutics, a company at the
0:14
forefront of developing precision therapies for
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neurodegenerative diseases. Nick has dedicated his work to
0:21
bring in bridging cutting edge science with business strategy
0:24
to bring transformative treatments to patients.
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Now at the helm of Kenai, Nick's leading efforts to harness
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ground breaking research in neuroscience and cell therapy
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and building partnerships and driving innovation aimed at
0:38
tackling some of the most pressing challenges in medicine.
0:41
So join us today as we'll talk through the CNS space company
0:45
company culture in early stage biotech, as well as the
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inspiration behind Key and I. So Nick, thanks so much for
0:52
coming on. How are you?
0:54
Doing great. Thank you.
0:55
Thank you for having me. Yeah, it's a pleasure.
0:58
So let's just start off with a little bit about your journey
1:01
then. So your career spans everything
1:03
from big pharma to early stage biotech.
1:06
What originally drew you into the life sciences space, and how
1:10
did that journey lead you to starting your own company?
1:14
Yeah, thank you. 40 years, it happened.
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It happened fast. You know, you dial back the
1:21
clock to 40 years ago coming out of undergrad and my career
1:25
ambitions, I grew up in Northern Illinois.
1:29
There just happened to be, for me, very fortunate, just
1:32
happened to be a company that solved multiple ambitions for
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me, one being life sciences and the other being a career
1:41
opportunity to grow. And that was Abbott
1:43
Laboratories. Abbott Laboratories pre split,
1:46
mind you. So it was a diversified
1:49
healthcare company, diagnostics, pharma, hospital products, a
1:54
very diversified company. And I was lucky enough to join
1:59
and get in a fair at the time, a fairly prestigious manufacturing
2:02
training program where you immersed yourself in four
2:07
different jobs over 2 years, every six months.
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And this is the foundation for me of how you immerse yourself
2:14
quickly in a start up like mentality and make a difference
2:18
in a short period of time. When I had to do that four times
2:22
in in two years, I believe that training program is still in
2:26
existence today. But from there, the other great
2:29
thing about Abbott Laboratories, I had mentors and executives,
2:33
things like John Landgraf and Joe Nemers who would invest in
2:38
you without any experience to help as a as a identified as a
2:41
future leader in Abbott Laboratories.
2:43
They invested in me and they gave me chances at positions
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theoretically I wasn't qualified for.
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So again, start up like transition of being, being able
2:54
to jump in and do new things and succeed and and be successful
2:59
with new things. And so I had a very diversified
3:01
career in manufacturing, commercial sales, global general
3:06
manager, full PNL very lucky to have those kind of experiences.
3:10
Again, if you think about that works well in the start up world
3:13
translating over to other companies like Takeda, I built
3:17
Takeda's U.S. business developments organization
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initially from not not scratch, but almost scratch.
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I did build the alliance management function from
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scratch. I did build the search and
3:30
evaluation company that initiated the search and
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evaluation competency within the company.
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And then later I led the integration office in Zurich,
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Switzerland for the $13 billion acquisition of Nycomed.
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If you think of all these things, they're all big company
3:44
things, but they all transition nicely into adapting for me
3:48
anyhow, personally into a start up world.
3:52
An example, an example of how that translates well is we've
3:57
identified one of the strengths of Kenai is what I call our
4:00
ecosystem. It's a very powerful ecosystem.
4:04
And together myself and Howard Federoff, doctor Howard Federoff
4:07
were able to build this ecosystem within Kenai.
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And one of one, like for example, one pillar in the
4:12
ecosystem is our manufacturer, one of the world's leading
4:17
induced pro potent cell manufacturers because we're
4:21
we're a neuron cell replacement therapy, we're going to restore
4:24
what Parkinson's disease has stolen from patients.
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But anyhow that proprietary induced pro potent stem cell
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manufacturing platform, we've locked that up in a partnership
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with Fujifilm, Sire Dynamics, FCDI.
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We also have the other pillar within the ecosystem, a gold
4:43
standard device manufacturer, the the device company clear
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point know who's going to deliver our cells to patients.
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You know the bar right now from from cell and gene therapy
4:55
delivery into the brain. And then the final piece of the
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ecosystem is the three centers of excellence we built to
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actually treat patients that we've on borrowed.
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And so you, you take all these things together and take those
5:08
years, 40 years of experience that translates into knowing how
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to build an ecosystem, a powerful ecosystem like we have
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at Kenai Therapeutics. Nice.
5:17
What was the initial spot behind the founding of Kenai
5:20
Therapeutics and how did you experience it?
5:23
Some of the companies that you just mentioned shape that
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vision. Yeah, absolutely.
5:30
I would say it's not one spark. I would call it 3 sparks.
5:34
I was Chief Operating Officer at Fuji Film Star Dynamics FCDI and
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at the time I was there, the brilliant scientists at FCDI
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generated very powerful preclinical data in a, in a HEMI
5:49
parkinsonian model that in powerful data, what I mean
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powerful behavior change using our cells generated behavior
6:00
preclinically and, and, and very powerful compared to other
6:04
similar companies in our space, very powerful preclinical data
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in uniquely A dose dependent manner.
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So we had that we generated that data.
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That's one spark. The next spark was Jonathan Yay
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from Syse Ventures and serial self therapy entrepreneur and
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gene therapy entrepreneur Carter Cliff got together and they came
6:26
in and they started investigating our Parkinson's
6:29
disease program as a potential spin out and and Jonathan Yay,
6:34
by the way, goes on and sites. The adventures go on to seed us
6:38
and take us all the way through the Series A.
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The third spark and the final spark was our scientific
6:43
founders, Howard Federoff, Doctor Howard Federoff, who's
6:45
now on our team as chief medical officer, scientific founder of
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the company. I got to know Howard when he was
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at Aspen, when he was CEO at Aspen.
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We we created a good professional friendship.
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I knew his capabilities. And then doctor Jeff Cordover,
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Jeff oversaw the preclinical program, not only for our
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preclinical program that generated that powerful data.
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He did other preclinical programs and Jeff always thought
7:11
ourselves were different. So Jeff and Howard got together
7:15
scientific founder. So there's the three Sparks
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scientific founders, serial entrepreneurs, seed company,
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Jonathan Yay and that power complete clinical data that
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kicked things off. Now what my learnings from my
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other experiences translate into Kenai is first and foremost the
7:37
power of a patient driven mission, right?
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Our, our goal is to restore, as I mentioned, what Parkinson's
7:45
has lost in Parkins, what Parkinson's has stolen from
7:49
patients with our neuron cell replacement therapy.
7:54
Getting behind that, whether it's Opsis or Sentry or these
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other companies I participated in the start up of our Iota
8:00
having rallying around that patient driven mission is
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critical and that we have with, with the we were focused right
8:09
away on that patient driven mission.
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And then the final thing I would say for me personally that I
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learned as I go back through those companies is my own
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personal relationships and collaborations with the
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scientific or engineering innovators and how to take that
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partnership that I have with them and translate that in to
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getting our organization and our milestones going in line with
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the patient driven mission. Michelle Maharbis, Jose Carmena
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Diota Doctor, David Gam at OPSIS and now Howard and Jeff Cordova
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are at Kenai. My relationship with them keys
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to success for the future and so far so good.
8:52
Nice. That's good to hear.
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And just to delve in, so you guys are focused within CNS,
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which I know is considered one of the more difficult areas of
9:00
biotech. What makes you believe that now
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is the right time to go after the disorders that you're
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targeting? And how is Kenai doing it
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differently versus others? So when I say when you look
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about now, it's not so much about 2025 now it's more of
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where cell therapy as an approach is whether it's
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diabetes, neurodegen, cancer, the field we're getting better
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and better at understanding the field and the promise field of
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of cell therapy, including neurodegenerative diseases where
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we're actually human clinical data now being generated that
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demonstrates the promise of cell therapy.
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Now for us in in Parkinson's disease, cell therapy is
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different than current standards of care.
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Current standards of care in Parkinson's modify they do not
9:58
modify disease, they only address symptoms.
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Cell therapy is a disease modifying approach actually can
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change the course of the disease.
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What we, what we like to say our ambitions with cell therapy is
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the three Rs. First, replace what has been
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lost. Second, repair the neuro
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circuitry, the connectivity with the cells that are in the space.
10:25
And lastly, restore, restore function or as I mentioned,
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restore what Parkinson's has stolen.
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So from an approach standpoint that's different.
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Within the approach, our cells are different, they're unique,
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going all the way back to FCDI generating that powerful
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preclinical data. FCDI was able to get there
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because they had a very iterative approach to developing
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the cells, a proprietary iterative approach.
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They have been manufacturing neurons for 10 years before they
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even got into cell therapy to for research purposes to cell to
11:03
industry. Now they start cell therapy and
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so often they've had years and years of cryopreservation
11:10
experience, years and years of manufacturing experience before
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they even started cell therapy. Now they're tweaking and
11:16
iterating on that potency and testing it in animals and
11:19
optimizing it for efficacy. So at the end of the day, our
11:23
cells are unique. They perform differently
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preclinically and and it's proprietary.
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We have a proprietary approach. So again, first approach, then
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our cells and then finally are are features of our cells
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cryopreserved allogeneic off the shelf delivery of cells.
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There are other companies that have autologous versions, but
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there's 1,000,000 Parkinson's patients in the US, 90,000 new
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patients in the US every year, 10 million globally.
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We have, we have a, we have features that allows us to
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steadily deliver in a reproducible, consistent fashion
12:08
cells for patients and we have the ability to reach those
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patients in a safe and hopefully a safe and colourable manner.
12:16
Nice. And I think so, Kenai, you guys
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recently announced your 82,000,000 Series A RAM, which
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is impressive given how the market is at the moment.
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Can you walk us through what it took to get there and what are
12:30
some of the key milestones the company have achieved so far?
12:35
Well, as you know, in this, in this market, it's, it's, it's
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challenging. You have to be resilient, right?
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So in addition to, I mean, what we do as a biotech company, what
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we do cutting edge biotech company, what we do every day in
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our day jobs is hard, right? We solve technical challenges.
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We, we seek opportunities. We, we try to explore those
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opportunities and challenges technically.
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We try to get around those obstacles every day in addition
13:04
to that in a challenging fundraising market.
13:07
So yeah, you have both of these things.
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So you have to be really resilient.
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And, and I always had the phrase my, my team, the key.
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And I team hears me say this all the time.
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You have to get back up, dust yourself off and get back at it.
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And we had to do that many times.
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So it takes resilience from a financing standpoint.
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It also took a set of investors who embraced that preclinical
13:31
technology, preclinical data that I mentioned and the promise
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and translate that preclinical data and and could see the hope
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for for Parkinson's patients in that patient driven mission that
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I talked about before to restore what Parkinson's has taken away.
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So you put those two things together and boy, we have a
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great set of investors very fortunate to have the column
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group cure Ventures Alaska current fund, not only great
14:00
investors, value added investors, not just check
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writers, value added investors and a great and a great a great
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board. So those are the those are the
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things that are important that were important and for us to get
14:15
the series Series A done now milestones what we've done.
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Think about this. We're, we're three, a little
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over three years old and a Series A company 3 years old and
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we are on the cusp of going into the clinic.
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That's, that's remarkable from, from a milestone standpoint.
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We created that ecosystem I mentioned.
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We've manufactured enough devices and we've manufactured
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enough IPS cells to get us through all the way through that
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and the end of Phase one and B and beyond.
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We, we obtained enough funds that Series A also gets us
14:53
through the Phase one and and beyond.
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We've cleared all the major regulatory barriers and we've
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set up, we've set up those almost completed those three
15:06
centers of excellence. Someone is on boarded already
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and the other two are just right there to be on boarded from a
15:13
center of excellence to deliver a promising therapy for
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patients. Wow, excited and congratulations
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for almost getting in the clinic.
15:23
And Zucchini sits at the intersection of the platform and
15:27
the lead asset model. How do you think about the
15:29
commercial strategy, platform leverage and long term value
15:34
creation from that? Yeah.
15:37
So it's the classic biotech dilemma, right?
15:40
You have a strong proprietary platform and you have a
15:45
compelling lead asset. It's a, it's a every biotech
15:49
board, every biotech management team goes through the, the
15:51
dilemma of word optimize, optimize for the platform,
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optimize for the lead asset. And we have a powerful pipeline.
15:58
We have plans to address unmet needs in inherited, not only the
16:05
pathic forms of the disease, but inherited forms of the disease,
16:08
inherited forms of Parkinson's patients, 10% make up inherited
16:12
forms of the disease. And we have in the very near
16:15
future plans enter the clinic to address patient needs.
16:19
And from an inheritance standpoint, we have a plans to
16:22
address patients that have injured or dying cells through
16:28
gene editing. We have other plants through
16:29
gene editing to address patients with enzymatic deficiency.
16:33
So we have a powerful pipeline, but make no mistake our focus
16:39
right now is on our as a company right now is on our phase one
16:43
replace trial. Again the replace name for
16:46
replacing the cells that Parkinson's disease has taken
16:50
away and then repair and restore.
16:53
So that's our phase one trial. That's what we're focused on and
16:56
and meet meeting the patients that are the needs of the
16:59
patients that are enrolling in that trial.
17:01
We are clear, clearly focused on that mission right now.
17:06
Good, And so you've helped scale and sell companies previously,
17:11
but founding from scratch is a whole different ball game.
17:15
What's been the biggest surprise in building Kenai from?
17:18
From zero, yeah. So again as I mentioned, I like
17:23
to think my big some lot of my big company experience helps me
17:26
with that build from scratch model.
17:29
You know when we completed the IPO for Century that was in 2021
17:35
and then when we completed the Big pharma partnership with
17:38
OPSIS, OPSIS by the way similar patient focused mission to
17:43
restore sites. So when we complete that was
17:48
2021 the peak, you know kind of the peak of the last good times
17:55
in the in the biotech capital markets, private public capital
18:00
from a private and public capital market standpoint.
18:04
When we started Kenai in 2022, we knew things were going to be
18:08
different from that standpoint, but I did not know, I didn't no
18:14
one knew how long this was going to last.
18:16
And here we are when we started the journey in 2022, here we are
18:20
in 2025 and we're still in that macro market that challenge.
18:25
So we did not anticipate be. So that was kind of the biggest
18:29
surprise for me is where we're at from a from a macro
18:32
standpoint. That said, we're we're ready for
18:35
it. We've built a nimble around that
18:39
ecosystem, A nimble flexible business model for the company,
18:44
efficient business model. We don't have to build a bricks
18:48
and mortar plant and employ it. We have that already with our
18:51
great partner and and both partners, our device and
18:54
ourselves manufacturing partners.
18:56
We don't have to build big infrastructure so we can stay
19:00
lean and efficient in spite of the market.
19:03
And frankly, this is where we should be anyhow.
19:05
I embrace it. I'm, I'm wired for it based on
19:10
my, my 40 years of history and so far the company could is
19:14
hitting all those milestones that I mentioned before on this
19:17
lean business from a lean business model standpoint.
19:23
Nice. I was going to say, if you can
19:25
make a company work in probably one of the worst biotech markets
19:29
ever, then surely the only way is up for you guys.
19:33
We, we believe. We believe so, yeah.
19:38
Good. And I guess culture, company
19:41
culture tends to make or break particularly early stage
19:45
biotech. How are you thinking about
19:47
culture that scales with the science?
19:52
Really, really important. Not only does culture need to
19:56
scale with the science, but it also needs to be dynamic, A
20:02
dynamic and fluid culture. Because as as we know, we
20:07
discussed obstacles. I worked at big companies, but
20:13
start up world is not for everyone who's worked at big
20:17
companies. There are people who worked at
20:18
big companies that like. Their cubicles and like to be
20:22
focused where they focus, but that's not not the start up
20:26
mentality. We have a San Diego team right
20:30
now that we had initially hired on a great group of people in
20:33
San Diego. Initial team you hired that no
20:36
sooner than we hired them, then we asked them to do things
20:38
differently that were in their job description.
20:41
They embraced it. They didn't fight it, they
20:44
didn't complain about it and they embraced it and they
20:46
executed well and helped us hit those milestones that I
20:48
previously mentioned. So when you're hiring, when
20:53
you're building that culture, it's really, really important
20:57
early in your, in your company formation that you build that
21:00
right team, not only one that can scale with the cities, but
21:03
one that can scale with the dynamics of what, what's, what's
21:07
about to happen to you as a company.
21:09
So what I always say from building our team, especially
21:12
our initial team is your, your technical competence, whether
21:16
it's scientific, engineering, accounting, legal, your
21:20
technical competence and proof of that is the ticket to getting
21:25
the interview. But will, what will set you
21:28
apart is demonstration of resilience, demonstration of
21:33
teamwork, demonstration of flexibility and open mindedness,
21:38
and, and if you will, an internal champion to go take on
21:41
what the startup world brings to you every day.
21:46
But despite all those challenges, working in the
21:49
startup is addicting, which is why I keep doing it over and
21:51
over again. And why could people like me
21:53
keep doing it over and over again?
21:54
Because it's an it's an exciting place to work.
21:56
So again, summarizing where I'm at, build that early team with
22:00
that culture that I just mentioned higher for not only
22:05
the hard skills, but the soft skills and that EQ.
22:09
And when you build that, that will scale with the science and
22:12
it will scale with the obstacles and opportunities that are
22:14
presented with you along the way.
22:18
Nice, and this is a question we always finish with on the Bio
22:22
Hub. I know I wanted to give you a
22:23
bit of a heads up with it, but if you were to have dinner with
22:26
three people, past or present, who would it be and why?
22:29
Doesn't necessarily need to be a biotech innovator, although it
22:33
can be if you like. But yeah.
22:36
Yeah, interestingly enough, none of my three are biotech
22:39
innovators, interestingly enough, and, and and none of
22:43
them are with us right now, but I still probably give an
22:47
increased reason for admiration. The first one is an industry
22:51
leader, ex CEO, ex boss of mine by the name of Bob Parkinson.
22:57
Bob is no longer with us. He was CEO of Baxter and I knew
23:00
him going back to my Abbott days.
23:03
He was what I would call from an industry standpoint of a full
23:07
package leader, strategic, tactical, culturally sensitive,
23:13
mission oriented, get got the organization going extremely
23:18
well between the guardrails. I always like to work for Bob
23:22
and I always like being part of his organization.
23:25
I think you had over 11 years of Baxter creating shareholder
23:27
value and you did a great way. And boy, I would I would love to
23:30
have dinner with Bob again. My next one is completely
23:36
outside of the industry, but it's but someone that I admire
23:39
for different reasons. I grew up in Northern Illinois,
23:44
die hard Chicago Bears fan and right now that's that's hard.
23:49
That's hard to do. But Walter Payton, when I was a
23:53
young man, was one of the best players in the NFL.
23:58
His work ethic and his skills were phenomenal.
24:01
But that's not the reason why I would like to have dinner with
24:04
him now. The reason I would like to have
24:05
dinner with him now is there's an award named after him that
24:09
has nothing partially to do with his skills as an NFL football
24:13
player. But mostly what it's known for
24:16
is the player of the year award. The Walter Payton Player of the
24:18
Year award is, is pay it philanthropic, pay it forward
24:24
contributions to the community. So it's not only being good at
24:27
what you are and being phenomenal at what you are, but
24:31
also paying it forward. And he's got an award named
24:34
after him for that. But I'd love to have dinner with
24:38
with Walter and, and even go deeper on how we how we got
24:42
there. The last one person I recently
24:45
lost, I lost my dad recently, but again, I, I don't want to
24:49
from this from, from a point of this podcast.
24:52
It's not the reason I want to have dinner with him.
24:54
I not because he's my dad. I always want to have dinner
24:57
with my dad, but he was a leader.
24:59
I, when I was a young man, I watched my father lead and I
25:03
watched how he lead and I learned a lot from how he led
25:07
people and how his team rallied around him at the right time and
25:11
how he could, he got his team going in the right direction and
25:15
his sort of leadership pillar. So I learned a lot from him.
25:19
So phenomenally, if I get them all three at the table at the
25:22
same time, those three would be a phenomenal dinner and that
25:28
would be great. So those, those are my my three
25:30
people I'd like to have dinner with.
25:32
Nice, but three. I love those.
25:35
All of those answers, particularly the last one.
25:38
And yeah, thanks so much for coming on and helping us out
25:41
with this. It sounds like you're doing an
25:43
amazing job with keen eye and building it where it is today
25:46
and beyond. So I look forward to following
25:49
your guys progress in the future.
25:50
And yeah, thanks again for helping us out with this.
25:54
Thank you, Thomas. Enjoying it.
25:55
Thank you.