April 24, 2024 • 26 mins
Listen in on our conversation with Rob Etherington, CEO of Clene Nanomedicine, a company pioneering nanotherapeutics for neurodegenerative diseases like ALS, multiple sclerosis, and Parkinson's.
Rob discusses Clene's unique approach to improve mitochondrial function through a novel nanotherapeutic called CNM-au8, which has shown promising outcomes in clinical trials. He highlights the challenges in drug development, including funding and FDA approval processes, and underscores the importance of resilience, continuous learning, and strategic partnerships in advancing biotech innovations. The episode also touches on Rob's personal philosophy on leadership and the importance of women in leadership roles.
https://clene.com/
https://www.linkedin.com/in/rob-etherington-431718/
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https://www.qualio.com/
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https://www.qualio.com/from-lab-to-launch-podcast
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Episode Transcript
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(00:01):
Hi there! Welcome to the FromLab to Launch podcast by Qualio,
where we share inspiring storiesfrom the people on the front
lines of life sciences.
Tune in and leave inspired tobring your life saving products
to the world.
Meg Sinclair (00:17):
Greetings, everyone.
Thank you for tuning in to thefrom lab to launch podcast
brought to you by Qualio.
I'm Meg, your host, and I'mdelighted to be here with you
today.
Before we dive into today'sepisode, we'd love it if you
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And if you're interested inbeing a guest on the show.
(00:37):
Please check out the applicationin the show notes.
Today we're excited to welcomeRob Etherington on the show
today.
Rob is the CEO of clean atrailblazer in the field of
nanotherapeutics for neuroneurodegenerative diseases, such
as ALS, multiple sclerosis andParkinson's.
Rob has over 30 years of sales,marketing, and leadership
(00:59):
experience in biotech, and asfounding CEO of Clene has helped
raise over 250 million infunding.
And under his leadership, Clenehas completed multiple phase two
studies and long term open labelextension studies.
For now, let's jump in and getstarted.
As someone who has had a lovedone affected by LS.
I'd love to hear more about thisamazing nanotechnology being
(01:22):
developed and how it can improvepatient outcomes.
So I'm really happy to welcomeyou today to lab to launch Rob.
Rob Etherington (01:29):
Thanks, Meg.
It's a pleasure to be here.
And sorry about that news, whichI didn't know before you just
said it about your loved onewith ALS, a devastating disease.
Uh, let me explain a little bitof context for your listeners
about kind of what we're doingand how we're doing it.
The human nervous system iscomplex and highly metabolically
active.
Uh, just putting that intocontext, our brain is about two
(01:52):
to 5 percent of our body weight,depending upon who we are, but
it is responsible, frankly, forAbout 25 percent of my energy
utilization every day, day andnight, uh, 20 percent of my
oxygen consumption, 20 to 25percent of my glue glucose
utilization.
So it's highly, you know,highly, highly metabolically
(02:15):
active and the neuronsthemselves depend upon the
mitochondria for all of theenergy.
that they require to do what youand I take for granted to move
and walk and to talk and eat andto chew and breathe.
All of these things that you andI just do and have been doing
since childhood.
But in neurodegenerativediseases, including ALS, these
(02:36):
essential aspects of life thatwe count on start to be taken
away.
And why that happens is becausethese mitochondria that produce
energy, there's a number ofprocesses going on that underpin
that neurotransmission and theseneurotransmission signal as I
just said, how we eat and talkand move and walk and think and
breathe.
(02:57):
And so what clean is doing issomething totally unique and
novel.
Uh, we've taken, I'm holding itup here in my hand, your
listeners only can't see it, uh,you've, your viewers can.
This is a 60 mil suspension ofour nanotherapeutic, we call
cinema you eight.
Uh, patients drink this everymorning in the clinical studies
that we're organizing.
(03:18):
Uh, if I was to be blindfolded,uh, and to drink a glass of room
temperature water, or cinema,you wait, I would not be able to
tell the difference.
In fact, our asset.
Uh, what we do for placebo inall of our clinical studies is,
is literally purple coloredwater.
Sinemauate, because of the goldnanotherapeutic in it, uh, reads
(03:38):
as purple to the eye.
And why this is so relevant isbecause the World Health
Organization predicts that, uh,these neurodegenerative diseases
of which I speak, not just ALS,but MS, multiple sclerosis,
Parkinson's, and I can go on,there's a lot of them.
They will become the second mostprevalent cause of death in the
next 20 years.
(03:59):
And so it's pretty obvious thata therapeutic breakthrough is
urgently needed.
Uh, and, and what we're doingwith our asset is pioneering
catalytic nanotherapeutics totreat these diseases.
And what I mean by that is wereally target the improvement of
the mitochondrial function, andwe do that via the catalytic
(04:20):
active of our asset to improvenicotinamide, iodine, and
dinucleotide to reduce reactiveoxygen species, which are to,
um, a byproduct of energyproduction and an essential
energy metabolite and takentogether.
This is really pioneering a newway to restore and to protect
the way the neurons work.
Meg Sinclair (04:41):
A first of its kind.
Pioneers.
Rob Etherington (04:43):
Yeah, it is.
It's actually important to, tohighlight that for a second.
So most drug development issmall molecule chemistry.
That's how it was for basicallya hundred years nearly.
Then in the last, uh, number ofdecades, biologics have taken
also their Their progress aside,small molecule clean is doing
(05:05):
neither of these, uh, what we'redoing is intersecting physics
and material science, basicallya therapeutic elemental metal at
physics scale.
So we're talking atomic scale.
We're talking nano scale.
We're talking small enough tocross the blood brain barrier
scale.
And we're doing that to driveenergy into the neuron.
Meg Sinclair (05:26):
Amazing technology.
Amazing.
So, um, what are some of thecurrent and potential
applications, um, for all ofthese vast, uh, uh,
neurodegenerative,neurodegenerative diseases?
Rob Etherington (05:39):
Well, the, the good question, the hallmarks of
neuronal death converge onmitodysfunction and these
nicotinamide adeninedinucleotide pathway deficits
that I, I mentioned earlier.
And there's a whole series of,um, pathogenic insults that kind
of converge.
to cause the stress on theneuron.
(06:00):
And the result of that ismitodysfunction.
And, uh, again, as I mentioned,a whole bunch of other things.
So what we're doing is we're,we're focused on ALS first
amyotrophic lateral sclerosis,um, uh, sometimes called Lou
Gehrig's disease after thefamous baseball player who,
contracted this disease and wentquite public with it in the
1930s.
(06:21):
Unfortunately, it took 60 yearsfor the very first drug to be,
uh, approved by the U.
S.
FDA.
That drug, now called Rileazol,is a generic.
It was approved in the mid 90sand is available mostly around,
pretty much everywhere aroundthe world.
But there's been, despite a lotof science, a lot of money and a
(06:41):
lot of attention, very few othertrue breakthroughs.
And there's been a lot of, um,consternation about this,
including in the last few monthswith, uh, um, the failure of
some major phase three studies.
But so we started at ALS.
We also, um, have a multiplesclerosis project underway, uh,
because our same asset can beused in MS.
(07:03):
And we've also concluded oneParkinson's program, And that is
just the beginning.
We think there's theopportunity.
For a number of these, uh,neurodegenerative diseases, uh,
to be attacked, um, uh, or to bereally helped.
That is probably more preciselysaid by CNMA.
Meg Sinclair (07:23):
Terrific.
Well, we'll have to stay tunedon what, what else comes down
the pipeline for clean.
So far, what are the mostsignificant challenges you face
in developing new therapies forthese neurodegenerative diseases
and how have you overcome them?
Rob Etherington (07:37):
First, the challenge always is funding,
finding enough money to dosomething completely new.
I'm fond of a statement that thefamed author Stephen Covey said,
that there's never abreakthrough without a break
with, and he means break withconvention.
So we had to, you know, reallyhelp others understand what a
(07:59):
clean surface nanotherapeuticsuspension is, uh, and I say
clean surfaced because we use nosynthetic chemistry in our
process, none, we had to pioneerand create this process.
process ourselves.
It was organic to clean.
Uh, the founder Mark Mortensonand chief science officer is the
one who came up with this.
I still work alongside Marktoday.
(08:19):
And Mark had the idea, um, sometime ago actually, uh, to figure
out how to shave Adam's Of oftherapeutic metals often and
self aggregate them in a watersuspension so that they could be
taken by mouth orally.
And he did this with 150 presentto date and counting patents
(08:41):
that he applied for andreceived.
And then we've also done anumber of trade secrets.
So, so, so first funding toanswer the question we had to
start, uh, Helping otherscapture this vision of what this
could be.
The second thing we had to do ishelp the U.
S.
Food and Drug Administration,which has been our primary focus
as a United States basedcompany, understand the safety
(09:02):
aspects of this.
We theorized from the beginningthat, uh, clean surfaced, uh,
nanotherapeutic Atomic scale, 13nanometers in size.
That is remarkably small.
Um, so small that again, therecan be a crossing of the blood
brain barrier, which isdifficult to achieve and we
theorize that we would haveclean toxicity and that is
(09:24):
indeed been the case.
We're grateful for that.
But that took many years for usto help persuade the FDA about
that.
We had to do.
Work in, um, mice and, and ratand mini pig and dog and then to
human phase one work.
And that took many years and alot of cash to basically Compile
a compelling safety database andgratefully, you know, knock on
(09:47):
collective wood here.
We have now over 600 years ofcollective subject exposure
across the ALS, MS andParkinson's landscape of our
disease clinical studies withoutidentified safety signals.
What that means is we have not asingle serious adverse event
related to CMAU8 that's beenconsidered severe or life
(10:08):
threatening or resulted indeath.
And our drug is remarkably safe.
Um, has a remarkably hightolerability, meaning, uh, if
patients can drink, uh, a glassof water or put that water if
they have ls and they've lostthe ability to drink into their
feeding tube, then they can takeour asset without very many side
effects.
(10:29):
Uh, just to inform yourlisteners, sometimes we see some
adverse events that aretransient or mild, such as a
headache or GI, but patientsdon't complain about these on
balance.
And we're, we are routinely toldby the clinicians that are
involved in our clinical studiesthat our drug is amongst the
easiest to take.
So there's two things that wehad to sort through, it took
many years, cash to get this newnovel concept up and running,
(10:50):
um, safety.
to prove so that we could, um,have the US FDA let us proceed
into phase two clinical studies.
Uh, then we had to identify anddevelop our targets, um, how we
would tackle the diseases andwhat clinical endpoints we would
use.
And that has not been smooth.
It never is in clinical drugdevelopment.
(11:13):
Uh, we've missed some primaryendpoints and yet we've seen
other things occur that wedidn't expect that now have
completely pivoted our focus,namely survival benefits that we
saw in ALS.
Now we've seen it across threecompletely different types of
patient programs, but we didn'texpect we'd see that survival at
the beginning.
We thought we'd see moreclassically functional change.
(11:34):
Um, but the reality of whatwe're doing is it takes, um,
Some time for our director tostudy state.
So on short studies, we don'tsee functional change as much,
but we do see survival.
And so that was another.
learning.
And then a fourth is how toreliably manufacture this to get
to scale.
Um, that's always a challengewith a new drug, uh, how to, um,
(11:57):
be able to, uh, achieve what iscalled the CMC aspects of drug
development, chemistry,manufacturing, and controls so
that the FDA is satisfied, uh,that what we do is.
Reliable and, um, yeah, that'sgood.
Replicability.
Uh, in other words, we do thesame thing every time.
(12:20):
The asset, uh, is always thesame for patients to drink.
Meg Sinclair (12:24):
Well, that kind of leads me into my next question.
I am a quality professionalmyself, and given that we do
quality management systems hereat Qualio with the complexities
and high stakes of.
What you've been developing andon the front lines of innovation
with the FDA, what strategieshave you used as the CEO to
maintain and improve quality asyou've been going from the lab
(12:46):
to market distribution?
Rob Etherington (12:49):
Um, so we're, we're not a market distribution,
of course, yet we don't have anapproved drug, but we're, we're,
we're preparing for that.
Um, so that has been, you know,that, that, that.
80 percent of the people atclean have been involved in that
process, either manufacturing S.
O.
P.
S.
Standard operating procedures,uh, regulatory C.
(13:10):
M.
C.
requirements.
Um, and in all of that, about 80percent of our team has been
completely focused on that piecebecause, uh, that was A big
piece of oversight that theagency wanted to, um, be certain
of all of our early meetingswith them were all about how we
could make certain we had thequality and we could replicate,
(13:32):
uh, this and, uh, that sometimesis tedious, um, work.
Uh, it's, it's a lot ofpaperwork.
It's a lot of T crossing and Idotting.
And then also, since we werepioneering this from scratch, we
had to figure out how to buildit from the ground up.
Was one aspect to develop ouractive pharmaceutical
(13:53):
ingredient, but then to movethat to scale and to human dose
and to sufficient concentrationwas a whole bunch of other work.
That's actually one of thereasons why we have chosen not
to do any manufacturing with acontract manufacturing
organization.
It's just so complicated that wewanted to, in our case, we
wanted to have, um, it underour, uh, our purview and within,
(14:17):
uh, you know, our responsibilityentirely.
But also we wanted to keepsecret what we do with a series
of trade secrets so that, uh,somebody couldn't just go
replicate it, um, you know,outside the door.
So that, that, what that enablesus to do is we have our patent,
um, But we also have, uh, theability, we think, to, uh, keep
(14:37):
trade secrets and, uh, make itvery difficult for somebody even
post patent expiry to comebehind us.
Meg Sinclair (14:45):
Very strategic, um, in your, uh, Roll there.
Um, so now I'm curious.
You've helped raise asignificant amount of capital
for clean to be able toaccomplish all these milestones.
What has been challenging foryou, especially in the current
economy?
Um, and what advice would yougive for people trying to raise
(15:06):
capital?
Rob Etherington (15:08):
Yeah, since 21 when, uh, you know, we kind of
peaked in biotech 22 even still4.
has been remarkably complicatedfor pre revenue biotech
companies.
Um, uh, we have the goodfortune, which many of my peer
base does not, that we stilltrade above our enterprise
value, which to say our, ourcash, um, on hand and the length
(15:30):
of cash we have money for, um,our market cap is still above
that number.
So many companies in theneurodegenerative space and
elsewhere have struggled,struggled, struggled to, We're
going to raise the capital, uh,since there's been this flight
out of biotech in the last, um,two and a half years, but I, I
sense it changing.
Uh, we, since J.
(15:50):
P.
Morgan in January of this year,uh, I think there's been, um,
uh, continued, uh, refocusingand investment beginning back in
the space, uh, still companiesthat are a dream or a thesis as
opposed to a clear path tocommercialization, uh, still are
struggling and that wouldinclude clean, um, which is the
(16:12):
reason why, you know, we'reworking hard to see if we can
get all of our solving Datatogether to consider the
possibility of acceleratedapproval of the agency.
We had a meeting with them lastyear and They gave us marching
orders and we're, um, uh, seeingif we can accommodate a number
of questions they had to getback on track for a new drug
application.
But also too, we're preparingnow for two phase three studies.
(16:35):
We have a phase three readyasset that has been completely
de Been de risked safety wiseand is ready to go.
Uh, and so, um, that brings meto, uh, what do we also do?
Well, one leans into partnering.
Um, there's, there's been adearth of, uh, good assets in
many of the big pharma pipelinesor even medium and small pharma.
And so small, innovativebiotechs like clean, uh, and you
(16:58):
know, we, we enable theopportunity to, uh, bring
something completely outside thebox that could be.
Markedly complimentary to, um,you know, the drugs in, in, in
these pipelines.
And we have a number of pharmacompanies now looking at clean,
considering exactly that idea.
Meg Sinclair (17:17):
Can you tell us anything more about those
partnerships or collaborationsare still too early to share?
Rob Etherington (17:22):
No, too early.
Uh, and anything publicly, uh,but we have said that, uh, we
are open to partnering.
We have welcomed, uh, otherpharma companies to come under
the hood under a confidentialdisclosure agreement and look,
really look at our data.
And, uh, we're doing this in twoways, uh, ALS and MS.
Uh, we've not spoken much aboutMS or ALS clinical data yet, um,
(17:44):
but in both cases, we havesomething very novel and unique
that the marketplace, uh, webelieve definitely requires for
either the ALS or the MSpatient.
Meg Sinclair (17:56):
They sure need, um, all the treatments and
support they can get, um, toimprove their outcomes.
So it's terrific.
And I love that creating anecosystem of partnerships and
collaboration to really move theneedle for patients.
So terrific.
For our aspiring scientists andinnovators listening to the
podcast, what advice would yougive those looking to make a
(18:18):
significant impact innanotechnology or just biotech
at large?
Rob Etherington (18:23):
Well, uh, there's infinite number of
roadblocks and hurdles that oneeither has to push through or
jump over, push through theroadblock and jump over the
hurdle.
And so there's a resilience, um,that is obviously requisite with
this work.
Um, uh, so that, that's onething, uh, is to just keep
(18:43):
pressing forward.
If your science is solid.
And if you're seeing progress,then to count all the victories
and push through the defeats.
And again, clean clean has hadto figure out a number of these
things.
We had to make sure we had.
Um, a stable asset that had roomtemperature stability.
That took a lot of work.
Uh, we've had to pivot, uh,from, uh, clinical endpoints
(19:06):
that we didn't meet intoclinical endpoints that we did,
and then build new clinicalstudies off of these we've had
to understand biomarker paths,uh, that, uh, are, are very
relevant in our respectivespaces that, uh, You know, one
biomarker in particular, that'skind of a very critical
biomarker and, uh, ALS calledneurofilament light, uh, as the
(19:27):
neuron is attacked, it kind ofleaves, uh, this said kind of
colloquially, a debris field inthe serum and the plasma of the
blood and I can measure it.
And, uh, if that neuron is underextraordinary attack, then that
neurofilament, um, light, andit's not light like sunlight,
but rather light, like molecularweight, uh, it can be measured.
And we.
High levels of neural filamentlight in the serum is indicative
(19:49):
of a massive attack on theneuron, which is exactly what
happens in ALS disease.
So I frankly had never heard ofneural filament light when we
started clean and now we talkabout it all the time and we
explore it exhaustively.
So that's another example is onehas to be in constant learning
mode of of our respective spacesto make progress.
So, so resilience.
(20:11):
Uh, constant learning andfiguring out how to, to solve
the infinite number of problemsthat develop along the path.
Meg Sinclair (20:18):
Infinite number of problems.
No big hurdles, no problems.
That's great advice though.
Um, so switching the gears alittle bit, we saw in your bio
that you have seven daughters.
Can you tell us a little bitabout your personal philosophy
when it comes to leadership,especially women in leadership,
which we hear a lot about thesedays.
Rob Etherington (20:39):
Good question.
The first I've ever been askedthat one.
Um, seven daughters.
Indeed.
uh, the last two are now incollege.
The other five are all eitherconcluded.
I have one daughter that has aspecial needs as well.
That didn't go to college, butis actually, um, nonetheless,
uh, an assistant manager, at heroffice and, uh, despite no
(20:59):
college degree, uh, shows up,does the work and leads her
peers and, uh, she can becounted upon expressly to, uh,
despite her special needs.
And so I think that is just one,you know, one example.
Um, uh, but women in leadershipare critical.
Uh, I actually have had, uh,strong women who do amazing
(21:21):
work, uh, alongside me at, uh,at.
Pfizer, uh, where I was first atnine years.
At Octillion, where I was for 13and then here at clean for 11.
Um, and, uh, I've, I've workedfor women.
Uh, I find most of my keyopinion leaders actually are
female physicians.
In fact, Um, I was just with thetop doctor in Canada last night,
(21:44):
um, returned back from Montrealthis morning.
Um, she's an extraordinary womanwho has done tremendous
progress.
And the number one a LS doc inthe country by most people's
argument is merit.
Sovich, also a woman.
So I, I love, um, actually theinsight that, that women bring
and that, uh, women lead out.
And as a dad of only girls,seven of them as I, as you
(22:07):
noted.
Um, it's, it's been fun to watchthem thrive and lead and learn
and make their place in theworld.
And it's critical that we, uh,as Sheryl Sandberg says, uh,
lean in to female leadership.
Meg Sinclair (22:26):
That's terrific.
And you're in good company.
My dad was a, it was a dad offour daughters.
So, um, I'm sure he, he canrelate there.
So, and I think he brought upsome strong women as well.
So,
Rob Etherington (22:39):
um, our last special, any dad that
specializes in girls is a truedad.
Yeah.
Meg Sinclair (22:46):
Yeah.
True Dad.
I like that real badge of, ofhonor there for dads.
Um, our last question to closethis out is a bit of a fun one,
though.
I already got you with asurprise question there with the
daughters.
We love to ask each of ourguests, if we ran into you at a
bookstore at a Barnes and Noble,um, the library, what section
would we find you in?
Rob Etherington (23:05):
I love historical biographies.
Um, love them, um, and alldifferent types.
Uh, uh, one of my passions isactually working in my yard.
Um, I spend a ton of time in theyard, uh, gardening, um, raising
flowers, uh, et cetera.
I like to be out in nature.
And while I'm there, I listenedto a lot of podcasts or when I'm
(23:25):
on planes, I listened to, um, Iwould rather I read, uh,
historical biographies.
So, uh, and again, wide ranging.
I just finished the Elon Muskbook.
I'm presently, um, listening tothe Barbra Streisand book and on
the plane just this morning, Iwas learning about the history
of food in the White House fromGeorge Washington, all the way
to the present era and theimportance of state dinners.
(23:48):
So, as you can see, that's avery wide, um, slice, uh, but,
uh, in any, any historicalbiography, Um, thrills me, uh,
whether it's Churchill or, uh,or Hamilton or Benjamin Franklin
or I can go on and on.
Meg Sinclair (24:04):
All right.
Well, you're in good companythere as well.
I'm a big historical fan havingread, uh, Catherine the Great
and Hedy Lamarr's biographiesrecently.
So, um, yeah.
History is always a fun one.
Well, thanks Rob so much forjoining us.
It was really exciting to hearabout all of your work with
Clene and all the work you'redoing for patients with ALS, MS,
(24:24):
and Parkinson's, and hopefullymore.
Rob Etherington (24:28):
Thank you, Meg.
If we're right with this thesis,we think we're seeing a survival
benefit for ALS that'sdesperately needed that patients
are able to live longer.
And if we're right with thisthesis in multiple sclerosis, we
believe that we are seeing datathat is improving vision and
cognition on top of standard ofcare DMT.
And that's never happenedeither.
(24:49):
So, in both cases, a survivalbenefit and an ALS and a
functional benefit of vision andcognition improvement in MS
would be a major breakthrough.
And we're thankful for all theInvestors and patients that, um,
and clinicians that, uh, worktogether with Clene on this
potential mission to develop agold nanocrystal suspension as
(25:09):
the very first cellularenergetic catalyst.
And we're grateful for how theyhelp us do this.
And we're grateful for theopportunity to talk with you,
Meg, about it today.
Meg Sinclair (25:18):
Well, thank you, Rob.
It was a pleasure.
Please check out the show notesto get more details about Rob
and Clene.
Thanks so much.
Thank you for listening to thisweek's episode of From Lab to
(25:42):
Launch, brought to you byQualio.
If you like what you've heard,please subscribe and give the
show a positive review.
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For more information aboutQualio, our guest today, or to
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Until next time.
Hi there! Welcome to the FromLab to Launch podcast by Qualio,
where we share inspiring storiesfrom the people on the front
lines of life sciences.
Tune in and leave inspired tobring your life saving products
to the world.
Meg Sinclair (00:17):
Greetings, everyone.
Thank you for tuning in to thefrom lab to launch podcast
brought to you by Qualio.
I'm Meg, your host, and I'mdelighted to be here with you
today.
Before we dive into today'sepisode, we'd love it if you
could take a moment to rate andshare the podcast with your
circle of science enthusiasts.
And if you're interested inbeing a guest on the show.
(00:37):
Please check out the applicationin the show notes.
Today we're excited to welcomeRob Etherington on the show
today.
Rob is the CEO of clean atrailblazer in the field of
nanotherapeutics for neuroneurodegenerative diseases, such
as ALS, multiple sclerosis andParkinson's.
Rob has over 30 years of sales,marketing, and leadership
(00:59):
experience in biotech, and asfounding CEO of Clene has helped
raise over 250 million infunding.
And under his leadership, Clenehas completed multiple phase two
studies and long term open labelextension studies.
For now, let's jump in and getstarted.
As someone who has had a lovedone affected by LS.
I'd love to hear more about thisamazing nanotechnology being
(01:22):
developed and how it can improvepatient outcomes.
So I'm really happy to welcomeyou today to lab to launch Rob.
Rob Etherington (01:29):
Thanks, Meg.
It's a pleasure to be here.
And sorry about that news, whichI didn't know before you just
said it about your loved onewith ALS, a devastating disease.
Uh, let me explain a little bitof context for your listeners
about kind of what we're doingand how we're doing it.
The human nervous system iscomplex and highly metabolically
active.
Uh, just putting that intocontext, our brain is about two
(01:52):
to 5 percent of our body weight,depending upon who we are, but
it is responsible, frankly, forAbout 25 percent of my energy
utilization every day, day andnight, uh, 20 percent of my
oxygen consumption, 20 to 25percent of my glue glucose
utilization.
So it's highly, you know,highly, highly metabolically
(02:15):
active and the neuronsthemselves depend upon the
mitochondria for all of theenergy.
that they require to do what youand I take for granted to move
and walk and to talk and eat andto chew and breathe.
All of these things that you andI just do and have been doing
since childhood.
But in neurodegenerativediseases, including ALS, these
(02:36):
essential aspects of life thatwe count on start to be taken
away.
And why that happens is becausethese mitochondria that produce
energy, there's a number ofprocesses going on that underpin
that neurotransmission and theseneurotransmission signal as I
just said, how we eat and talkand move and walk and think and
breathe.
(02:57):
And so what clean is doing issomething totally unique and
novel.
Uh, we've taken, I'm holding itup here in my hand, your
listeners only can't see it, uh,you've, your viewers can.
This is a 60 mil suspension ofour nanotherapeutic, we call
cinema you eight.
Uh, patients drink this everymorning in the clinical studies
that we're organizing.
(03:18):
Uh, if I was to be blindfolded,uh, and to drink a glass of room
temperature water, or cinema,you wait, I would not be able to
tell the difference.
In fact, our asset.
Uh, what we do for placebo inall of our clinical studies is,
is literally purple coloredwater.
Sinemauate, because of the goldnanotherapeutic in it, uh, reads
(03:38):
as purple to the eye.
And why this is so relevant isbecause the World Health
Organization predicts that, uh,these neurodegenerative diseases
of which I speak, not just ALS,but MS, multiple sclerosis,
Parkinson's, and I can go on,there's a lot of them.
They will become the second mostprevalent cause of death in the
next 20 years.
(03:59):
And so it's pretty obvious thata therapeutic breakthrough is
urgently needed.
Uh, and, and what we're doingwith our asset is pioneering
catalytic nanotherapeutics totreat these diseases.
And what I mean by that is wereally target the improvement of
the mitochondrial function, andwe do that via the catalytic
(04:20):
active of our asset to improvenicotinamide, iodine, and
dinucleotide to reduce reactiveoxygen species, which are to,
um, a byproduct of energyproduction and an essential
energy metabolite and takentogether.
This is really pioneering a newway to restore and to protect
the way the neurons work.
Meg Sinclair (04:41):
A first of its kind.
Pioneers.
Rob Etherington (04:43):
Yeah, it is.
It's actually important to, tohighlight that for a second.
So most drug development issmall molecule chemistry.
That's how it was for basicallya hundred years nearly.
Then in the last, uh, number ofdecades, biologics have taken
also their Their progress aside,small molecule clean is doing
(05:05):
neither of these, uh, what we'redoing is intersecting physics
and material science, basicallya therapeutic elemental metal at
physics scale.
So we're talking atomic scale.
We're talking nano scale.
We're talking small enough tocross the blood brain barrier
scale.
And we're doing that to driveenergy into the neuron.
Meg Sinclair (05:26):
Amazing technology.
Amazing.
So, um, what are some of thecurrent and potential
applications, um, for all ofthese vast, uh, uh,
neurodegenerative,neurodegenerative diseases?
Rob Etherington (05:39):
Well, the, the good question, the hallmarks of
neuronal death converge onmitodysfunction and these
nicotinamide adeninedinucleotide pathway deficits
that I, I mentioned earlier.
And there's a whole series of,um, pathogenic insults that kind
of converge.
to cause the stress on theneuron.
(06:00):
And the result of that ismitodysfunction.
And, uh, again, as I mentioned,a whole bunch of other things.
So what we're doing is we're,we're focused on ALS first
amyotrophic lateral sclerosis,um, uh, sometimes called Lou
Gehrig's disease after thefamous baseball player who,
contracted this disease and wentquite public with it in the
1930s.
(06:21):
Unfortunately, it took 60 yearsfor the very first drug to be,
uh, approved by the U.
S.
FDA.
That drug, now called Rileazol,is a generic.
It was approved in the mid 90sand is available mostly around,
pretty much everywhere aroundthe world.
But there's been, despite a lotof science, a lot of money and a
(06:41):
lot of attention, very few othertrue breakthroughs.
And there's been a lot of, um,consternation about this,
including in the last few monthswith, uh, um, the failure of
some major phase three studies.
But so we started at ALS.
We also, um, have a multiplesclerosis project underway, uh,
because our same asset can beused in MS.
(07:03):
And we've also concluded oneParkinson's program, And that is
just the beginning.
We think there's theopportunity.
For a number of these, uh,neurodegenerative diseases, uh,
to be attacked, um, uh, or to bereally helped.
That is probably more preciselysaid by CNMA.
Meg Sinclair (07:23):
Terrific.
Well, we'll have to stay tunedon what, what else comes down
the pipeline for clean.
So far, what are the mostsignificant challenges you face
in developing new therapies forthese neurodegenerative diseases
and how have you overcome them?
Rob Etherington (07:37):
First, the challenge always is funding,
finding enough money to dosomething completely new.
I'm fond of a statement that thefamed author Stephen Covey said,
that there's never abreakthrough without a break
with, and he means break withconvention.
So we had to, you know, reallyhelp others understand what a
(07:59):
clean surface nanotherapeuticsuspension is, uh, and I say
clean surfaced because we use nosynthetic chemistry in our
process, none, we had to pioneerand create this process.
process ourselves.
It was organic to clean.
Uh, the founder Mark Mortensonand chief science officer is the
one who came up with this.
I still work alongside Marktoday.
(08:19):
And Mark had the idea, um, sometime ago actually, uh, to figure
out how to shave Adam's Of oftherapeutic metals often and
self aggregate them in a watersuspension so that they could be
taken by mouth orally.
And he did this with 150 presentto date and counting patents
(08:41):
that he applied for andreceived.
And then we've also done anumber of trade secrets.
So, so, so first funding toanswer the question we had to
start, uh, Helping otherscapture this vision of what this
could be.
The second thing we had to do ishelp the U.
S.
Food and Drug Administration,which has been our primary focus
as a United States basedcompany, understand the safety
(09:02):
aspects of this.
We theorized from the beginningthat, uh, clean surfaced, uh,
nanotherapeutic Atomic scale, 13nanometers in size.
That is remarkably small.
Um, so small that again, therecan be a crossing of the blood
brain barrier, which isdifficult to achieve and we
theorize that we would haveclean toxicity and that is
(09:24):
indeed been the case.
We're grateful for that.
But that took many years for usto help persuade the FDA about
that.
We had to do.
Work in, um, mice and, and ratand mini pig and dog and then to
human phase one work.
And that took many years and alot of cash to basically Compile
a compelling safety database andgratefully, you know, knock on
(09:47):
collective wood here.
We have now over 600 years ofcollective subject exposure
across the ALS, MS andParkinson's landscape of our
disease clinical studies withoutidentified safety signals.
What that means is we have not asingle serious adverse event
related to CMAU8 that's beenconsidered severe or life
(10:08):
threatening or resulted indeath.
And our drug is remarkably safe.
Um, has a remarkably hightolerability, meaning, uh, if
patients can drink, uh, a glassof water or put that water if
they have ls and they've lostthe ability to drink into their
feeding tube, then they can takeour asset without very many side
effects.
(10:29):
Uh, just to inform yourlisteners, sometimes we see some
adverse events that aretransient or mild, such as a
headache or GI, but patientsdon't complain about these on
balance.
And we're, we are routinely toldby the clinicians that are
involved in our clinical studiesthat our drug is amongst the
easiest to take.
So there's two things that wehad to sort through, it took
many years, cash to get this newnovel concept up and running,
(10:50):
um, safety.
to prove so that we could, um,have the US FDA let us proceed
into phase two clinical studies.
Uh, then we had to identify anddevelop our targets, um, how we
would tackle the diseases andwhat clinical endpoints we would
use.
And that has not been smooth.
It never is in clinical drugdevelopment.
(11:13):
Uh, we've missed some primaryendpoints and yet we've seen
other things occur that wedidn't expect that now have
completely pivoted our focus,namely survival benefits that we
saw in ALS.
Now we've seen it across threecompletely different types of
patient programs, but we didn'texpect we'd see that survival at
the beginning.
We thought we'd see moreclassically functional change.
(11:34):
Um, but the reality of whatwe're doing is it takes, um,
Some time for our director tostudy state.
So on short studies, we don'tsee functional change as much,
but we do see survival.
And so that was another.
learning.
And then a fourth is how toreliably manufacture this to get
to scale.
Um, that's always a challengewith a new drug, uh, how to, um,
(11:57):
be able to, uh, achieve what iscalled the CMC aspects of drug
development, chemistry,manufacturing, and controls so
that the FDA is satisfied, uh,that what we do is.
Reliable and, um, yeah, that'sgood.
Replicability.
Uh, in other words, we do thesame thing every time.
(12:20):
The asset, uh, is always thesame for patients to drink.
Meg Sinclair (12:24):
Well, that kind of leads me into my next question.
I am a quality professionalmyself, and given that we do
quality management systems hereat Qualio with the complexities
and high stakes of.
What you've been developing andon the front lines of innovation
with the FDA, what strategieshave you used as the CEO to
maintain and improve quality asyou've been going from the lab
(12:46):
to market distribution?
Rob Etherington (12:49):
Um, so we're, we're not a market distribution,
of course, yet we don't have anapproved drug, but we're, we're,
we're preparing for that.
Um, so that has been, you know,that, that, that.
80 percent of the people atclean have been involved in that
process, either manufacturing S.
O.
P.
S.
Standard operating procedures,uh, regulatory C.
(13:10):
M.
C.
requirements.
Um, and in all of that, about 80percent of our team has been
completely focused on that piecebecause, uh, that was A big
piece of oversight that theagency wanted to, um, be certain
of all of our early meetingswith them were all about how we
could make certain we had thequality and we could replicate,
(13:32):
uh, this and, uh, that sometimesis tedious, um, work.
Uh, it's, it's a lot ofpaperwork.
It's a lot of T crossing and Idotting.
And then also, since we werepioneering this from scratch, we
had to figure out how to buildit from the ground up.
Was one aspect to develop ouractive pharmaceutical
(13:53):
ingredient, but then to movethat to scale and to human dose
and to sufficient concentrationwas a whole bunch of other work.
That's actually one of thereasons why we have chosen not
to do any manufacturing with acontract manufacturing
organization.
It's just so complicated that wewanted to, in our case, we
wanted to have, um, it underour, uh, our purview and within,
(14:17):
uh, you know, our responsibilityentirely.
But also we wanted to keepsecret what we do with a series
of trade secrets so that, uh,somebody couldn't just go
replicate it, um, you know,outside the door.
So that, that, what that enablesus to do is we have our patent,
um, But we also have, uh, theability, we think, to, uh, keep
(14:37):
trade secrets and, uh, make itvery difficult for somebody even
post patent expiry to comebehind us.
Meg Sinclair (14:45):
Very strategic, um, in your, uh, Roll there.
Um, so now I'm curious.
You've helped raise asignificant amount of capital
for clean to be able toaccomplish all these milestones.
What has been challenging foryou, especially in the current
economy?
Um, and what advice would yougive for people trying to raise
(15:06):
capital?
Rob Etherington (15:08):
Yeah, since 21 when, uh, you know, we kind of
peaked in biotech 22 even still4.
has been remarkably complicatedfor pre revenue biotech
companies.
Um, uh, we have the goodfortune, which many of my peer
base does not, that we stilltrade above our enterprise
value, which to say our, ourcash, um, on hand and the length
(15:30):
of cash we have money for, um,our market cap is still above
that number.
So many companies in theneurodegenerative space and
elsewhere have struggled,struggled, struggled to, We're
going to raise the capital, uh,since there's been this flight
out of biotech in the last, um,two and a half years, but I, I
sense it changing.
Uh, we, since J.
(15:50):
P.
Morgan in January of this year,uh, I think there's been, um,
uh, continued, uh, refocusingand investment beginning back in
the space, uh, still companiesthat are a dream or a thesis as
opposed to a clear path tocommercialization, uh, still are
struggling and that wouldinclude clean, um, which is the
(16:12):
reason why, you know, we'reworking hard to see if we can
get all of our solving Datatogether to consider the
possibility of acceleratedapproval of the agency.
We had a meeting with them lastyear and They gave us marching
orders and we're, um, uh, seeingif we can accommodate a number
of questions they had to getback on track for a new drug
application.
But also too, we're preparingnow for two phase three studies.
(16:35):
We have a phase three readyasset that has been completely
de Been de risked safety wiseand is ready to go.
Uh, and so, um, that brings meto, uh, what do we also do?
Well, one leans into partnering.
Um, there's, there's been adearth of, uh, good assets in
many of the big pharma pipelinesor even medium and small pharma.
And so small, innovativebiotechs like clean, uh, and you
(16:58):
know, we, we enable theopportunity to, uh, bring
something completely outside thebox that could be.
Markedly complimentary to, um,you know, the drugs in, in, in
these pipelines.
And we have a number of pharmacompanies now looking at clean,
considering exactly that idea.
Meg Sinclair (17:17):
Can you tell us anything more about those
partnerships or collaborationsare still too early to share?
Rob Etherington (17:22):
No, too early.
Uh, and anything publicly, uh,but we have said that, uh, we
are open to partnering.
We have welcomed, uh, otherpharma companies to come under
the hood under a confidentialdisclosure agreement and look,
really look at our data.
And, uh, we're doing this in twoways, uh, ALS and MS.
Uh, we've not spoken much aboutMS or ALS clinical data yet, um,
(17:44):
but in both cases, we havesomething very novel and unique
that the marketplace, uh, webelieve definitely requires for
either the ALS or the MSpatient.
Meg Sinclair (17:56):
They sure need, um, all the treatments and
support they can get, um, toimprove their outcomes.
So it's terrific.
And I love that creating anecosystem of partnerships and
collaboration to really move theneedle for patients.
So terrific.
For our aspiring scientists andinnovators listening to the
podcast, what advice would yougive those looking to make a
(18:18):
significant impact innanotechnology or just biotech
at large?
Rob Etherington (18:23):
Well, uh, there's infinite number of
roadblocks and hurdles that oneeither has to push through or
jump over, push through theroadblock and jump over the
hurdle.
And so there's a resilience, um,that is obviously requisite with
this work.
Um, uh, so that, that's onething, uh, is to just keep
(18:43):
pressing forward.
If your science is solid.
And if you're seeing progress,then to count all the victories
and push through the defeats.
And again, clean clean has hadto figure out a number of these
things.
We had to make sure we had.
Um, a stable asset that had roomtemperature stability.
That took a lot of work.
Uh, we've had to pivot, uh,from, uh, clinical endpoints
(19:06):
that we didn't meet intoclinical endpoints that we did,
and then build new clinicalstudies off of these we've had
to understand biomarker paths,uh, that, uh, are, are very
relevant in our respectivespaces that, uh, You know, one
biomarker in particular, that'skind of a very critical
biomarker and, uh, ALS calledneurofilament light, uh, as the
(19:27):
neuron is attacked, it kind ofleaves, uh, this said kind of
colloquially, a debris field inthe serum and the plasma of the
blood and I can measure it.
And, uh, if that neuron is underextraordinary attack, then that
neurofilament, um, light, andit's not light like sunlight,
but rather light, like molecularweight, uh, it can be measured.
And we.
High levels of neural filamentlight in the serum is indicative
(19:49):
of a massive attack on theneuron, which is exactly what
happens in ALS disease.
So I frankly had never heard ofneural filament light when we
started clean and now we talkabout it all the time and we
explore it exhaustively.
So that's another example is onehas to be in constant learning
mode of of our respective spacesto make progress.
So, so resilience.
(20:11):
Uh, constant learning andfiguring out how to, to solve
the infinite number of problemsthat develop along the path.
Meg Sinclair (20:18):
Infinite number of problems.
No big hurdles, no problems.
That's great advice though.
Um, so switching the gears alittle bit, we saw in your bio
that you have seven daughters.
Can you tell us a little bitabout your personal philosophy
when it comes to leadership,especially women in leadership,
which we hear a lot about thesedays.
Rob Etherington (20:39):
Good question.
The first I've ever been askedthat one.
Um, seven daughters.
Indeed.
uh, the last two are now incollege.
The other five are all eitherconcluded.
I have one daughter that has aspecial needs as well.
That didn't go to college, butis actually, um, nonetheless,
uh, an assistant manager, at heroffice and, uh, despite no
(20:59):
college degree, uh, shows up,does the work and leads her
peers and, uh, she can becounted upon expressly to, uh,
despite her special needs.
And so I think that is just one,you know, one example.
Um, uh, but women in leadershipare critical.
Uh, I actually have had, uh,strong women who do amazing
(21:21):
work, uh, alongside me at, uh,at.
Pfizer, uh, where I was first atnine years.
At Octillion, where I was for 13and then here at clean for 11.
Um, and, uh, I've, I've workedfor women.
Uh, I find most of my keyopinion leaders actually are
female physicians.
In fact, Um, I was just with thetop doctor in Canada last night,
(21:44):
um, returned back from Montrealthis morning.
Um, she's an extraordinary womanwho has done tremendous
progress.
And the number one a LS doc inthe country by most people's
argument is merit.
Sovich, also a woman.
So I, I love, um, actually theinsight that, that women bring
and that, uh, women lead out.
And as a dad of only girls,seven of them as I, as you
(22:07):
noted.
Um, it's, it's been fun to watchthem thrive and lead and learn
and make their place in theworld.
And it's critical that we, uh,as Sheryl Sandberg says, uh,
lean in to female leadership.
Meg Sinclair (22:26):
That's terrific.
And you're in good company.
My dad was a, it was a dad offour daughters.
So, um, I'm sure he, he canrelate there.
So, and I think he brought upsome strong women as well.
So,
Rob Etherington (22:39):
um, our last special, any dad that
specializes in girls is a truedad.
Yeah.
Meg Sinclair (22:46):
Yeah.
True Dad.
I like that real badge of, ofhonor there for dads.
Um, our last question to closethis out is a bit of a fun one,
though.
I already got you with asurprise question there with the
daughters.
We love to ask each of ourguests, if we ran into you at a
bookstore at a Barnes and Noble,um, the library, what section
would we find you in?
Rob Etherington (23:05):
I love historical biographies.
Um, love them, um, and alldifferent types.
Uh, uh, one of my passions isactually working in my yard.
Um, I spend a ton of time in theyard, uh, gardening, um, raising
flowers, uh, et cetera.
I like to be out in nature.
And while I'm there, I listenedto a lot of podcasts or when I'm
(23:25):
on planes, I listened to, um, Iwould rather I read, uh,
historical biographies.
So, uh, and again, wide ranging.
I just finished the Elon Muskbook.
I'm presently, um, listening tothe Barbra Streisand book and on
the plane just this morning, Iwas learning about the history
of food in the White House fromGeorge Washington, all the way
to the present era and theimportance of state dinners.
(23:48):
So, as you can see, that's avery wide, um, slice, uh, but,
uh, in any, any historicalbiography, Um, thrills me, uh,
whether it's Churchill or, uh,or Hamilton or Benjamin Franklin
or I can go on and on.
Meg Sinclair (24:04):
All right.
Well, you're in good companythere as well.
I'm a big historical fan havingread, uh, Catherine the Great
and Hedy Lamarr's biographiesrecently.
So, um, yeah.
History is always a fun one.
Well, thanks Rob so much forjoining us.
It was really exciting to hearabout all of your work with
Clene and all the work you'redoing for patients with ALS, MS,
(24:24):
and Parkinson's, and hopefullymore.
Rob Etherington (24:28):
Thank you, Meg.
If we're right with this thesis,we think we're seeing a survival
benefit for ALS that'sdesperately needed that patients
are able to live longer.
And if we're right with thisthesis in multiple sclerosis, we
believe that we are seeing datathat is improving vision and
cognition on top of standard ofcare DMT.
And that's never happenedeither.
(24:49):
So, in both cases, a survivalbenefit and an ALS and a
functional benefit of vision andcognition improvement in MS
would be a major breakthrough.
And we're thankful for all theInvestors and patients that, um,
and clinicians that, uh, worktogether with Clene on this
potential mission to develop agold nanocrystal suspension as
(25:09):
the very first cellularenergetic catalyst.
And we're grateful for how theyhelp us do this.
And we're grateful for theopportunity to talk with you,
Meg, about it today.
Meg Sinclair (25:18):
Well, thank you, Rob.
It was a pleasure.
Please check out the show notesto get more details about Rob
and Clene.
Thanks so much.
Thank you for listening to thisweek's episode of From Lab to
(25:42):
Launch, brought to you byQualio.
If you like what you've heard,please subscribe and give the
show a positive review.
It really helps us out.
For more information aboutQualio, our guest today, or to
be a guest on a future episode,please refer to the show notes.
Until next time.
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