Episode Transcript
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Ben Comer (00:06):
Welcome back to the
Business of Biotech.
I'm your host, Ben Comer, chiefeditor at Life Science Leader,
and today I'm excited to speakwith Joel Latham, president,
CEO, and Director at IncannexHealthcare, a clinical stage
company developing cannabinoidand psychedelic combination
therapies for obstructive sleepapnea, rheumatoid arthritis and
(00:28):
generalized anxiety disorder.
Joel joined Incannix Healthcarein 2016 and became CEO just two
years later, in 2018.
But before that, he worked at adiverse range of companies,
including large multinationals,outside of the life sciences
sector, and he was also aprofessional rugby player.
(00:49):
I'm looking forward to hearingfrom Joel about his journey into
life sciences leadership andthe development programs
Incannex is currently workingon, why he thinks cannabinoids
and psychedelic combinationproducts hold particular promise
for patients, his strategicapproach to fundraising and
providing value to shareholdersas a public company, and what it
(01:10):
took to move the company'soperations from Australia to the
US.
Thanks so much for being here,Joel.
It's a pleasure to be with you,ben.
Thank you for having me.
Absolutely.
You are a professional rugbyplayer I mentioned.
What would you describe as yourfavorite thing about the game?
Joel Latham (01:28):
for people in the
US who may not be as familiar
with it, as I was much youngerand, like many kids, grew up
playing sport and really had alove for rugby league from a
(01:49):
young age, which I think hasprovided the opportunity and the
solid grounding to be able toimplement a lot of things and
traits that I learned being aplayer into my business career.
So rugby league is a uniquesport that we play in Australia
in a very competitiveenvironment and something that I
(02:13):
loved as a child growing up and, as I said, built a lot of
strong foundations for me toreally set me on the path that
I've continued on throughout mycareer.
Ben Comer (02:28):
It's a pretty rough
sport.
I wonder if that's helped you.
You know deal with I don't knowinvestors, errant board members
, regulators.
What are some of the skills,maybe, that you learned in rugby
, that you've brought forward?
Joel Latham (02:43):
It is a very tough
sport.
It made sure that I wasresilient from a very young age,
which is something that I'vebeen able to implement into my
role now and my business career.
But I think one of the mostimportant fundamentals that I
(03:03):
learned was that winning is theonly option, and also working in
a team environment and buildinga competitive nature.
So this has really beengrounding for me and set the
mentality that I wanted to havethroughout my business career,
and I think this is really oneof the reasons why I'm so
(03:24):
competitive still to this dayand I have an unwavering
willingness to ensure thatInconnex is successful.
Ben Comer (03:34):
I mentioned at the
beginning in the intro your
diverse work experience.
You've worked in sportswear andtobacco products, in gaming and
entertainment and as a regionalmanager at Mars, the
multinational confectioner.
How did those experiences helpprepare you for the life
(03:55):
sciences industry?
Joel Latham (03:56):
Yeah, so from a
young age I always had an
entrepreneurial mindset and Iknew that a career in business
was something that I wanted topursue.
I've had a really good groundingfrom a family perspective.
My father was at the samebusiness for 40 plus years,
(04:17):
started there when he was 16years old and gradually worked
his way through the ranks tobecome the CEO of the
organization that he was at andhe was CEO for 20 plus years.
So I always had that solidgrounding growing up, which I
was incredibly thankful andlucky to have.
So I wanted to forge my ownpath in business and I
(04:38):
identified very early on thathaving a diverse range of
experience and learning fromleaders in various different
sectors was the right way for meto set myself up for success
long term.
Thankfully, I was able to gainan immense amount of experience
working with some key globalleaders in multinational
(05:01):
businesses, multi-billion dollarorganisations, working across
both the public and privatesectors.
I was able to learn and pickand choose the key traits that I
wanted to implement in the waythat I was going to run a
business, and I think thatputting all that together has
really set me up on the paththat I'm on now and that unique
(05:25):
experience that I've had to beable to forge a unique way to
look at the way we develop ourunique assets, the way we
disrupt drug development and howwe can really forge our own
path at Inconnex as disruptorsand leaders in the field that
we're in.
Ben Comer (05:46):
Yeah, I want to get
into that, but I'm curious what
was the company that your fatherworked at and led for 20 years?
Joel Latham (05:53):
So it was a company
called Sydney Markets Limited.
So they're basically thelargest fresh food provider hub
in Australia.
So that's a business that hebuilt up over time.
I actually I did part-time workthere from the ages of 13 up,
so I really got to know thatbusiness from the ground level.
(06:16):
So, again, a bit ofdiversification in my experience
, which has helped me get towhere I am today.
Ben Comer (06:26):
And your family is
still in Australia.
You're in the US now, and we'lltalk about that a little bit
later, but is most of yourfamily still in Australia?
Joel Latham (06:34):
Most of the family
is still in Australia, so we
spend obviously a lot of time inthe US.
We have the core part of ourteam within Australia as well,
which I spend quite some time inAustralia with our team.
So, given that we'vetransitioned the business from
Australia to the US,particularly with the focus on
(06:57):
the NASDAQ, that has really beena key component of our strategy
focusing on the North Americanmarket.
Ben Comer (07:11):
Yeah, and, like I
said, I definitely want to talk
to that or talk about that injust a little bit, but I'm
curious about how you know youor, I guess, why you wanted to
come into life sciences.
What were the circumstances,you know that led you to Incanex
Healthcare, which I believe wascalled Impression Healthcare
Limited, maybe what up until2020?
Joel Latham (07:30):
That's correct.
So initially, impressionHealthcare, now known as Incanex
, was listed on the ASX back in2016.
So what led me to the businessis quite unique circumstances.
Actually, I was an investor inthe business prior to becoming
an employee, so I believed inthe business initially.
(07:51):
I liked the path and thetrajectory the business was on
and I invested my own money atthat point in time, which was
back in 2015.
Once the company was public, Icome on board as the general
manager at the time and reallystarted to play a key role in
collaboration with our board ofdirectors that we had at the
(08:13):
time.
Who I have?
Some great leaders in their ownright Mr Troy Valentine, who is
our company's chairman, hasgreat capital markets experience
with over 30 years, and hasbeen a great sounding board and
guide as we've continued todrive this business forward.
And also Mr Peter Widows, whohas been a board member since
(08:36):
that period of time, so he wasactually the CEO of Heinz HJ
Heinz so 20,000 employees, $2billion in revenue.
So he comes from a reallystrong background as well.
So at that time, we had somegreat guidance with those two
particular board members and nowwe've continued to build the
(08:57):
business out and have some newboard members that have joined
over the past three to fiveyears that have obviously played
key roles in the development ofour business as well.
Ben Comer (09:12):
So you were an
investor in the company and you
were looking at it and thinking,well, maybe I can help this
thing take off.
You had some ideas, I wouldimagine, about it.
What was Impression HealthcareLimited working on when you
first joined?
Joel Latham (09:26):
So Impression
Healthcare were a dental
business a dental healthcarebusiness at the time, but
collectively with the board andseveral advisors at the time, we
saw an opportunity within themarket that we thought was
relatively untapped, and thatwas to be able to look at novel
(09:47):
drug assets that were targetingindications that had limited or
no treatment options available.
We saw a significant gap withinthe market.
We saw an opportunity and wedecided to pivot the business
from the ASX, at the time beinga dental business, into the
(10:07):
business that we are now.
We built a world-leading team atthe time and we've continued to
drive and evolve the uniquestrategy that we implemented at
the time and that was, as I said, to look at indications that
had limited or no treatmentoptions available.
(10:27):
That provided us with potentialfast-tracked approval with the
FDA and also allowed us to forma strong and robust IP position,
ensuring that our unique andproprietary combination products
had the commercial protectionlong term.
(10:49):
Not only that, we wanted to dosomething a little bit different
to a lot of our peers and ourcompetitors products that target
two different mechanisms ofaction simultaneously,
potentially providing us withthe opportunity to have an
(11:09):
enhanced therapeutic benefit,and I'm pleased to report that
across our three lead assets.
We've been able to validatethat and justify our strategy
with continued positive resultsand positive milestones that we
have delivered to the markettime after time.
So we're in a really strongposition at the moment,
(11:30):
particularly when looking at ourthree lead assets and the
positive outcomes that we'vebeen able to provide to the
market more recently.
Ben Comer (11:39):
You're clearly an
ambitious leader of the company,
Joel.
There are a number of drugmechanisms and substances out
there.
You chose combination productsand combinations that utilize
cannabinoids and psychedelics,which is somewhat
non-traditional.
(12:00):
There are a number of companiesobviously working in
psychedelics development.
Now I don't know of many thatare working in combinations of
cannabinoids and psychedelics.
What kind of drew you to thatparticular space and this was, I
guess, what 2020, when youfirst brought in these assets
and started preclinical work?
(12:21):
Is that accurate?
Joel Latham (12:22):
That's correct.
That's correct.
That's correct.
So, in conjunction with ourboard and some key advisors at
the time, we identified theseemerging markets and really
thought that both thecannabinoid and the psychedelic
sectors had been somewhatuntapped.
We knew that there was anextensive amount of existing
(12:43):
research on not onlycannabinoids but also
psychedelic compounds, and thatreally did fit into that
overarching drug developmentstrategy that we had in place.
One thing that we have alwaysprided ourselves on, not only as
a company but me personally, isto be disruptive and to lead
(13:03):
new markets and new sectors.
And this is where we identifiedboth the cannabinoid and
psychedelic sectors as a uniqueopportunity, because we were
able to target indications,being able to utilise
cannabinoids and psychedelicsand really lead the way.
And I truly believe that we'vebeen able to do that.
(13:24):
We've been able to disrupt bothsectors and we've been able to
validate the hypothesis behindeach of our programs, with the
results that we've been able todeliver to the market.
Ben Comer (13:37):
Now, when you say
that you've been able to disrupt
both sectors, you're talkingabout cannabinoids and
psychedelics.
What do you mean by that?
How have you been able todisrupt those?
Joel Latham (13:47):
Well, not only
cannabinoids and psychedelics,
but the overarching drugdevelopment industry in its
entirety, where we're utilizingcannabinoids and psychedelics in
combination.
So, from the cannabinoidperspective, we're utilising
cannabinoids in combination withother pharmaceutical products
(14:10):
and combining them in uniquelyformulated novel drug products.
So this is something thathasn't been done previously, and
we've been able to form astrong and robust IP position
and we've been able to show that, combining cannabinoids with
other pharmaceutical products,we're able to achieve enhanced
(14:31):
research outcomes and we're ableto have both compounds act
synergistically, and this hasbeen demonstrated through the
results that we've delivered tothe market previously results
that we've delivered to themarket previously.
Ben Comer (14:47):
Well, let's talk
about your three clinical
programs.
Maybe we could just start withan overview, just in terms of
what the combinations are andthen what the various stages of
development that they're in foreach of the three.
Joel Latham (15:01):
Yeah, so our lead
asset is called IHO426, which is
targeting obstructive sleepapnea Significant opportunity
for us as a company.
There are no primary registeredpharmaceutical treatments for
obstructive sleep apneacurrently available.
Our goal is to have the firstorally pharmaceutical treated
(15:27):
obstructive sleep apneaopportunity.
We're well on our way to beingable to do that.
We have a combination productof dronabinol and ezetizolamine,
so both of these compoundstarget two different mechanisms
for reducing obstructive sleepapnea simultaneously.
We've been able to prove synergyin both of our Phase 2 clinical
(15:52):
trials.
More recently we completed aPhase 2 trial, so this was a
multi-site trial within the USunder an open IND, and I'm
pleased to report that wedelivered positive results that
exceeded our expectations.
So we're really pleased withthose results that we've been
(16:13):
able to deliver to the market.
We saw a reduction on ourprimary endpoint of up to 83%
reduction in the AHI, which isthe apnea hypopnea index, the
gold standard for measuring anddiagnosing obstructive sleep
apnea.
So on our most efficacious dose, being able to achieve up to an
(16:40):
83% reduction was an extremelypleasing result for us.
It has validated the hard workand effort that we have put into
this program to get it to whereit is, and it's justification
for a lot of shareholders aswell.
We have an extensive shareholderbase that have backed us
(17:02):
continually from the time thatwe've developed this asset right
up until when we've deliveredthese positive results.
So it was really justificationfor these shareholders as well
that have shown confidence in us, and we know that this is
another building block to get usto where we need to be, and
(17:23):
that is to commercialisation andpartnership for this exciting
asset.
So next steps for us for IHL4.2x we continue to engage and
have favourable conversationswith the FDA.
We're continuing to do that andwe expect to be in a position
in due course to be able toprovide an update to the market,
(17:46):
which we hope to be an excitingupdate, because I know a lot of
our shareholders are lookingforward to this update, and I
just want to let everyone knowthat this is our focus.
We're working on this every dayand we continue to make good
progress, and this next step forus is a pivotal time for the
business as we continue toexpand with the rapid
(18:09):
development of this excitingasset.
Ben Comer (18:13):
Now the standard of
care for obstructive sleep apnea
?
Is it the?
What are the machines called?
Like the IPAP machines?
Yeah, sorry.
Joel Latham (18:24):
Sorry to cut you
off there.
Yes, it's cut you off yet there, yes, it's a c-pap machine, so
it's a device.
Um, it's the gold standard ofcare at the moment.
Ben Comer (18:32):
Um, unfortunately,
nobody likes using nobody, I I
would.
I would submit no one likes touse a c-tap, uh, c-pap machine.
So yeah, if you could produce aproduct that could deliver
those kind of results, I wouldimagine that that would open up
a huge global market.
Joel Latham (18:51):
It does.
It provides us with theopportunity to open up a
significant market.
The CPAP device has beenextremely successful over
previous years.
There are companies within thisspace is there are companies
within this space their marketcaps are in excess of $30
billion that are providing thesedevices to patients.
(19:13):
Unfortunately, there is anextremely high non-compliance
rate with these devices, but wesee this as an opportunity for
us to provide an alternativesolution for patients that find
these devices unbearable incertain situations.
(19:33):
But it also provides us with anopportunity to be able to use
our drug product in combinationwith these devices.
In combination with thesedevices.
So, whilst our goal is to seewe see this as a monotherapy,
without a shadow of a doubt, andIHL-4-2X, we see this being as
a one-stop shop treatment forobstructive sleep apnea, but
(19:57):
there is also the possibilitywhere we could potentially look
to see IHL-4-2X in combinationswith other therapies as well,
which again opens up many doorsfor us as a company.
Ben Comer (20:13):
And what are the two
active ingredients in IHL-4-2X?
Joel Latham (20:18):
So it's dronabinol
and ezetizolamide.
Ben Comer (20:22):
Okay, all right, and
which one of those is the
cannabinoid, that's dronabinol,dronabinol.
And what is the other one, theazetazolamide?
Azetazolamide Is that a nowgeneric drug that's patent has
expired at this point.
That's correct.
Yes, okay, and so maybe justquickly, if you don't mind, joel
(20:44):
, what is your IP holding forthis particular product?
What does that look like, giventhat it's two drugs that now
kind of exist in the publicdomain?
Joel Latham (20:55):
It's two drugs that
now kind of exist in the public
domain.
Yeah, so it's a combinationtherapy that we've been able to
basically manufacture here, sothe combination therapy of the
two drugs combined to treatobstructive sleep apnea.
So we have a position over thecombination of the both products
.
So methods of use, and thenthere's also various items that
(21:19):
we have around the formulationdevelopment of the product.
So, yeah, we have quite anextensive IP position.
You can't just go and combinethese two products, given the
fact that we have coverage overthat at all the escalating doses
.
So we've been able to.
(21:39):
We've been working on this IPposition for the past five years
and have ensured that we've putourselves in extremely strong
position to have protection overthese two compounds in
combination when treatingobstructive sleep apnea.
Ben Comer (21:57):
Got it, Got it Okay.
And then your second program isIHL 675A, and that one's
targeting rheumatoid arthritiscorrect.
Joel Latham (22:07):
That's correct.
So IHL 675A was originallydeveloped as a platform drug
because we saw the benefitsacross multiple inflammatory
conditions.
So when we first hypothesisedand built the program around
(22:29):
this being a platform, apotential inflammatory platform
treatment drug, a potentialinflammatory platform treatment
drug, we completed extensivepreclinical and early clinical
studies to really de-risk andvalidate this particular product
.
We were able to see fantasticresults in irritable bowel
(22:54):
disease, pulmonary inflammationand, more importantly,
rheumatoid arthritis.
Not only was IHL 675Aefficacious across those three
indications, but it was alsoextremely safe, which was very
pleasing for us.
(23:14):
It got to the point where wedelivered positive phase one
results and we really needed toensure that we're allocating our
resources effectively andefficiently.
So instead of launching thethree individual assets that we
had tested in a pre-clinicalsetting into larger stage phase
(23:37):
two clinical trials, weidentified to push forward
rheumatoid arthritis first,which is exactly what we have
done.
There's a significantaddressable market in excess of
$50 billion and it's primed tobe disrupted $50 billion and
(24:02):
it's primed to be disrupted.
So we've decided to moveforward with the phase three
component of rheumatoidarthritis and we're in the
process at the moment ofgenerating the required
documents to open our IND withthe FDA and once that IND is
opened we will be commencingphase two studies within the US.
For this exciting asset.
Ben Comer (24:24):
What are the active
drugs that are in IHL675A, the
constituent parts of thecombination?
So?
Joel Latham (24:33):
it's CBD, which is
the cannabinoid, and
hydroxychloroquine.
So again, we've been able tocombine these two products that
target the different factors ofreducing inflammation within the
body simultaneously.
Ben Comer (24:51):
Now,
hydroxychloroquine is one of
these kind of drugs that havebeen politicized by by covid um,
you know, for for a number ofreasons I don't need to get into
here, I, but I am curious ifyou get questions about that, if
it has any bearing, or or oranything else with potential
investors.
I mean, do people ask you, youknow why hydrochloroquine, or
(25:15):
why you're using this particulardrug, or you know what you know
does it?
Does it put you on, you know,one political side or another to
even be developing thiscompound?
I'm just curious about that.
Joel Latham (25:28):
Yeah, so back
during the COVID times it was
something that was raisedbecause it was extremely
politicized at the time.
But the answer and the view issimple from us it's about
providing the best therapeuticoutcome for our patients and
having a patient-focusedapproach.
Regardless of how politicizedhydroxy hydroxychloroquine has
(25:51):
been, there is an existing bodyof research that shows how
efficacious that this drug, thiscompound, has been over time
and we've been able to justifythat in our earlier stage
clinical trials as well.
So, taking the political sideof hydroxychloroquine out, we
(26:11):
look at it from apatient-centric focus.
We focus on the patient andwhat is going to be the best
outcomes for the patient, andthe combination of these two
compounds is what's going toprovide, in our view, the best
outcome.
Hence why we've progressed withthis combination.
(26:32):
Product of IHL 675A.
Ben Comer (26:35):
Safety and efficacy.
Data trumps politics is whatI'm hearing you say.
Unlike obstructive sleep apnea,rheumatoid arthritis does have
a number of marketed treatments.
Now there's obviously, you know, biosimilar.
Humira is available now.
How do you see this particularproduct differentiating itself
(26:57):
from what's currently on themarket?
Joel Latham (27:00):
Yeah, we see
ourselves we're going to be in a
unique position, similar to allof our assets.
We enter into markets with theaim and the goal to disrupt.
That's what we want to do.
So there is a $50 billionaddressable market that we're
coming in to disrupt.
We want to provide a unique andfavourable alternative solution
(27:24):
for patients within therheumatoid arthritis space, and
the combination ofhydroxychloroquine and CBD
potentially provide that in theunique soft gel capsule that
we've been able to developinternally.
So the ease of use, the safetyprofile and how potentially
(27:44):
efficacious our drug can be iswhat's going to set us apart
from other potential treatmentsthat are on the market currently
.
Ben Comer (27:54):
Got it.
And then your third program,PSX-001,.
This is your psychedeliccombination therapy for
generalized anxiety disorder, Ibelieve.
What would you tell us aboutthat development program?
Joel Latham (28:09):
So, again, this is
another exciting asset, hence
why it's one of our three leads,and we've been able to
significantly de-risk thisproduct given that we've
recently announced positivephase two results.
So this is a combination ofpsilocybin, which is a
psychedelic compound, incombination with psychotherapy.
(28:33):
So this is a world firstclinical program that we've been
able to develop here at Inconex.
So it is a combination therapy,something that is quite unique
in itself because there isn't acombination therapy that has
been registered with the FDA asyet.
So, similar to what I've talkedthrough previously our goal
(28:56):
around disruption and breakingdown barriers and doing things
that companies haven't donepreviously and this program
really fits within ourwheelhouse.
So we're combining psilocybinin combination with
psychotherapy to treatgeneralized anxiety disorder.
So, similar to our other assets, it's providing our company and
(29:19):
our shareholders with asignificant commercial
opportunity if we're able tocontinue to justify, validate
and have successful clinicaltrial results and have favorable
interactions with theregulators.
So, again, an exciting assetthat we've been able to
significantly de-risk in a phasetwo 72 patient clinical trial
(29:44):
and we released the results tothe market a couple of weeks ago
and the feedback has beenoverwhelmingly positive.
Ben Comer (29:53):
This is a synthetic
psilocybin.
Do you have like a compositionof matter patent on that
particular piece of thecombination or is your ip
protecting the, the combinationproduct, as a single kind of
compound?
Joel Latham (30:06):
so it is a.
It is a synthetic version ofpsilocybin and our provisional
ip position sits across thecombination of the therapy in
combination with the syntheticpsilocybin.
Ben Comer (30:22):
Now and with this
development program, you're
trialing this drug incombination with psychological
support, correct?
Can you maybe just explain ordescribe what that psychological
support would look like to apatient who's participating in
the trial?
Joel Latham (30:41):
Well, it's
extremely important for us to
put the patient first, as youmay have gathered throughout a
lot of our conversation today,and nothing changes in relation
to PSX001.
We put the patients first andthe discussion that we've had
with the FDA given that therehasn't been a combination
(31:01):
therapy and a psychedeliccompound registered with the
agency previously we've adoptedan approach where we need to
ensure that we put the patient'ssafety first.
We look at the results thatwe've been able to generate from
our Phase 2 study and it'sclear that our protocol put the
patient's safety first.
We look at the results thatwe've been able to generate from
our phase two study and it'sclear that our proprietary
(31:22):
protocol that we have been ableto develop, where we go through
psychological therapy with thepatients, it shows the enhanced
safety outcomes that we havebeen able to generate compared
to some of our peers in thepsychedelic sector.
So, with the psychotherapysupport that we provide to our
(31:45):
patients, we're able to ensurethat our patients are in a safe
environment, a guided, safeenvironment, with our therapists
that have gone through anextensive training regime to be
able to deliver the protocols asa part of our package to these
(32:06):
patients.
So this is something thatreally does set us apart from
most other companies within thisspace.
Ben Comer (32:15):
And so that therapy
component obviously improves the
safety and efficacy of theproduct, or you wouldn't have it
right.
That's correct.
Yeah, as most of the businessof biotech listeners will
remember or know, lycosTherapeutics developed a
therapy-assisted MDMA candidatefor PTSD.
(32:36):
The FDA ultimately did notaccept that for approval for a
number of reasons.
But I've heard other executivesworking in this space, joel,
such as Sereni Rao at Atai LifeSciences, has argued that you
know, therapy orperson-to-person psychological
support has no place on a druglabel since the FDA doesn't or
(33:01):
hasn't traditionally regulatedtherapy and Serenity, I remember
, pointed to Spravato J&J's nowblockbuster S-cadamine product
as an example.
The RIMS requirement forSpravato, I believe, requires
healthcare provider oversight,you know, for at least two hours
(33:22):
.
But it's more of a safetymonitoring, not necessarily an
interventional therapy.
But you know what could you sayabout, you know, that decision
to incorporate that activepsychological support?
You know you've referenced someconversations, some engagement
with FDA.
Do you feel pretty confidentthat the agency is ready to
(33:44):
accept this and potentiallyapprove therapy as a component
ultimately of the label?
Joel Latham (33:51):
Well, I am
confident if we're able to
continue on the trajectory thatwe're on and we're able to have
overwhelmingly positive resultsthrough our next stages of
development.
There's no denying howbeneficial our therapy could be
(34:13):
to patients suffering from thisdebilitating anxiety disorder.
So it comes with complexities,but again, that's why we're
comfortable in what we're doing,because we're disrupting a
market, so a lot of our peerssteer away from the
(34:35):
psychological support with thenarrative that they push out
publicly, because there are alot of complexities around that
component of what we're doing.
With what we're doing, becausewe've seen real world benefits
(34:58):
of how that provides a betteroutcome to these patients, to
the patients that we're lookingto support, and with our
patient-centric approach, safetyis first and foremost at the
forefront of what we're doingand we need to ensure that.
And we've been able todemonstrate that and this is a
(35:18):
path that we're going tocontinue to go down, whether or
not our peers are doing it ornot.
We are unique and we are goingto do this in the right way to
ensure that we get the mostefficacious result and ensure
that we have the safest therapythat is potentially on the
market to treat anxietydisorders.
Ben Comer (35:39):
And you would be the
first company to receive
approval for a product pairedwith therapy that's in the US.
Is that also true in Australia?
Are there any products thathave been approved to be kind of
co-administered with therapy inAustralia?
Joel Latham (35:58):
co-administered
with therapy in Australia, so
Australia is a little bit of adifferent landscape.
So the TGA, the equivalent tothe FDA in the US, has allowed
for psychedelics to beprescribed to patients here
within Australia, which hasallowed us as a company to be
able to, has allowed us as acompany to be able to utilize
(36:22):
the decision from the TGA to beable to open a psychedelic
psychotherapy clinic so we'reable to generate real world
experiences in Australia withpatients that are suffering from
different conditions, wherethey can go through guided
experiences and guided treatmentprotocols when being prescribed
psychedelics.
So this is why we're so firmlyset on our strategy and why we
(36:45):
believe it is the best pathforward, because it's not just
results that we've been able todeliver in a clinical setting,
which has been favorable results.
We have realworld experience ina clinic that we have built
from the ground up in Melbourne,australia, and we've seen long
and real, lasting changes inpatients when being prescribed,
(37:09):
with patient support.
So that's why we have such astrong view on this.
Ben Comer (37:18):
I want to ask a
question about just kind of
handling and manufacturingscheduled drugs, whether it's
cannabinoids or psychedelics.
Have there been challenges thatyou've had to overcome in order
to manufacture and administercontrolled substances in
(37:38):
clinical trials?
What's that experience beenlike?
So, in clinical trials, yes'sthat experience been like.
Joel Latham (37:42):
So in clinical
trials, yes, there are extra
layers and complexities, but ourteam is extremely well-versed.
I look at our team and, underthe guidance of Dr Mark Bleakley
, our Chief Scientific Officer,and Dr Luke Barbato, our Chief
Medical Officer, we've built outa world-leading team that we've
(38:03):
been able to manage theend-to-end process here.
There are complexities aroundscheduled products, particularly
psychedelics and Schedule 1products.
There are extra processes withpermits, shipping, storage and
distribution and licensing attrial sites.
So that's something that we'vecontinued to manage over time,
(38:29):
but we haven't had many issuesin that regard.
So, no teething, notinsurmountable, yeah, no, no.
And I think that the credit isreally to go down to the team
that we have here at Inconnexwho have managed that so well.
And I think it's worth notingas well for our lead asset,
ihl-426, targeting obstructivesleep apnea.
It is our goal and our viewthat that product will be, if
(38:54):
successful when registered, aSchedule 3 product, so removes a
lot of the additional layers ofcomplexity if we're able to
continue to be successful withthat asset.
Ben Comer (39:09):
Right, that seems to
be the approach that has been
taken in the US Previously.
There have been at least oneproduct that I know of that is a
cannabis-based product.
That was a Schedule 1 up untilit was approved by the FDA and
then it transitioned intoSchedule 3.
But there's also this ongoingrulemaking process at the US
(39:34):
Justice Department and the DEAabout reclassifying cannabis in
general from Schedule 1 toSchedule 3, although it appears
to have kind of stalled at themoment.
And you know, based on whatyou've just said, I suspect your
answer to this question isgoing to be no.
But I'm curious you know whatthat decision to reschedule from
(39:55):
Schedule 1 to Schedule 3 forcannabis generally?
Would that have any impact, anysort of meaningful impact on
your business in any way?
You know, good or bad Not?
Joel Latham (40:05):
particularly
because, as I mentioned, our
goal is to have IHL-426 as aSchedule 3 product.
Ihl-675a, our othercannabinoid-related product, is
also classified as a Schedule 3.
So limited impact for us, but Ithink it's good for the sector
(40:25):
in its entirety.
Again, looking at it from apatient-focused approach, there
are benefits to cannabinoids andI'm sure that it's going to
assist other companies out therethat are looking to develop
cannabinoid-based assets andfollow our lead to a certain
degree.
Ben Comer (40:43):
Great.
I want to ask about fundingnext, Joel.
I wonder if you could describeyour funding strategy as a
public company and how you thinkabout providing shareholder
value.
Joel Latham (40:57):
So for us.
We are quite a unique company.
We always have shareholdersfront of mind.
We run this business asshareholders for shareholders.
So myself and our other boardmembers are all major
shareholders within the businessand have participated in
capital raises from the very,very early days of being listed
on the Australian Stock Exchangeback in 2016.
(41:20):
So that is a very, veryimportant point and what I
firmly believe sets us apartfrom some of our peers and other
companies in similar sectors.
So we've always been verystrategic in relation to our
capital management and how we'velooked to raise capital.
Over previous years, we'veadopted a strategy where it is
(41:41):
vitally important that we lessendilution and minimize the
impact of dilution wherever wecan, whilst ensuring that the
company is being adequatelyfunded to be able to deliver on
the key milestones and thecatalysts that we have for each
of our three lead assets.
So we've run the businessextremely efficiently and only
(42:05):
looked to raise capital overprevious years when we've needed
to to ensure the rapid,advanced development of our
three lead assets.
So we've been able to utilizean ATM facility with our banking
partners over the past sixmonths, which has put us in a
(42:26):
position to be able to ensurethat we're funded into the next
stages of development for ournext three assets.
What I like about the ATMfacility facility is the company
is in complete control.
We can determine when and howmuch we can use as a part of
(42:47):
that ATM and we use a verystrategic approach.
Where it doesn't impact, weensure that there's as little
impact on the share price andthe trading volume as possible.
We announced to the market amonth or two ago that we had $50
million in the bank.
We were able to uniquely managethe ATM during those times to
(43:12):
put ourselves in this position.
And again, another positivepoint of the ATM facility there
are no attaching warrants andother potentially toxic terms
that come with the use of theATM when we have used it.
So that's another reason why wehave looked to adopt the ATM
(43:35):
facility as a strategy toefficiently and strategically
manage our capital requirements.
Ben Comer (43:43):
moving forward, and
how are you able to set that up?
I'm hearing the voices oflisteners saying, well, yeah, of
course we don't want to takedilutive funding if we can help
it, but given the state of justgeneral investment in biotech,
the past couple of years hasbeen incredibly difficult for
(44:04):
you know a number of companies,particularly early stage
companies.
How did you?
Is there anything more youcould say, joel, just about how
you managed to set that up?
And for listeners who aren'tfamiliar with the ATM structure,
if you wouldn't mind, just youknow, providing a quick overview
of that.
Joel Latham (44:22):
Yeah, so we're able
to set this up quite
efficiently with our bankingpartners.
I see having an ATM facility inplace as good and standard
housekeeping for listedbusinesses.
It allows companies to remainagile and it allows companies to
remain efficient when managingtheir capital requirements.
So the way the ATM works is thecompany is in complete control
(44:49):
of how it is used and providesinstructions to their banking
partners on how much the ATM isto be used.
So, for example, we can headinto, we can see how the stock
is trading during the day andprovide instruction to the
banking partner to be at 5% ofthe trading volume once they're
(45:13):
online and trading and not toadd to any downward pressure.
The company can provide clearinstructions, essentially so for
us when it has been used.
We're not like other companieswhere companies provide a set
number of shares or a setpercentage of volume that is
(45:33):
being traded.
We monitor and manage on areal-time basis how the stock
had been trading and look tomanage how the ATM is
implemented and in use when wehave had it active previously.
Ben Comer (45:51):
Excellent.
Thank you for that.
I want to ask about in CanXHealthcare's move or
re-domiciled from Australia tothe US.
I believe that happened in 2023.
Could you talk a little bitabout what prompted that move
and what challenges existed thatyou had to overcome to
(46:13):
successfully do it Well, first,and foremost, the strategy
behind the move was to providepotentially the greatest
opportunity for shareholders inthe long run.
Joel Latham (46:28):
That was the goal.
We saw the NASDAQ beingdomiciled as the NASDAQ as the
greatest opportunity for us tobe able to succeed as a business
, to be able to tap intostrategic ways to be able to
raise capital, which has come tofruition over the past couple
of years.
But we thought that it was thebest opportunity to maximise the
(46:50):
value of our business.
We saw peers in both thecannabinoid and psychedelic
fields that were trading atmultiples of where we were at,
and we firmly believed that wewere undervalued compared to
some of our peers, particularlygiven our assets and the results
that have underpinned the valueof those assets over time.
(47:14):
So we wanted to focus ourattention on one market, that
being the NASDAQ, rather thanbeing duly listed on both stock
exchanges.
We saw that there was greateropportunity to increase
liquidity on the NASDAQ, whichwe have experienced, and seen
that to also come to fruitionover time, and we're really
(47:37):
pleased to be able to completethat process because it was an
extensive one.
So to the second part of yourquestion what was involved in
the transition from the ASX todomicile in the US.
It was a long process.
We had to go throughshareholder approval so it was
overwhelmingly voted through infavour at our EGM Extraordinary
(48:02):
General Meeting to vote throughthe concept to be able to
re-domicile to the US.
We then had to go through thecourt system here within
Australia to be able toessentially have the strategy
validated as a part of theprotocols that take place, which
(48:23):
we then achieved, and then wehad to go through what was an
extensive process to transitionall stockholding from the ASX
over to the NASDAQ.
So we had to take on a lot ofthat onus ourselves as a company
.
There were easy paths that wecould have taken, but we decided
to take on a lot of that onusourselves as a company.
There were easy paths that wecould have taken, but we decided
(48:44):
to take the path that was asleast impact for our
shareholders as possible.
So, fast forward, a couple ofyears now, we've been able to
ensure that the company isadequately funded.
The company is extremely liquidin how it trades, which is
something we would never haveexperienced on the ASX.
(49:06):
The thought of being able toraise the funds to ensure that
our lead assets were adequatelyfunded we firmly believe that
wouldn't have been able to beachieved on the ASX, given
market conditions in Australia.
So, whilst our share priceisn't where we want it to be
right now, we know that thefundamentals are stronger than
(49:32):
ever and we know that, as wecontinue to push this company
forward, we're confident thatour true value will be realised
over time.
Given our lead assets areadequately funded through the
next stages of development,which is extremely exciting for
us as a business.
Ben Comer (49:51):
Pardon my ignorance
on this question, but what are
the downsides of being duallisted, like if you were to stay
on the ASX and come on to theNASDAQ?
What's the downside of doingthat?
Or, I guess, why did you decidenot to do that?
Joel Latham (50:07):
So we did do that
initially.
So we were a duly listedbusiness from 2021.
And we were duly listed forquite some time before making
the pivot to list all of ourshares onto the NASDAQ and be a
NASDAQ domiciled company.
So we saw back in 2021 theupside potential of being listed
(50:32):
on the NASDAQ.
However, being a duly listedcompany being domiciled on the
ASX, we never truly got thebenefits of being listed on the
NASDAQ.
We didn't have the liquiditythat you would expect.
We were being front run and ledby the ASX, given we were
(50:52):
domiciled here and we'reessentially an ASX listed
company with no benefits of theNASDAQ.
We hadn't raised capital on theNASDAQ at that period of time,
so we didn't have any liquiditytrading in the NASDAQ.
When we were duly listed andwhilst we had an extremely
(51:13):
compelling story, we worked veryhard in building up
relationships with investorshigh net worth, significant
funds within the US and theyloved the story and it really
resonated but it often got putin the too hard basket because
(51:34):
of the complexities around beingduly listed and there was no
liquidity on the NASDAQ.
So to buy into Inconex theywould have to go buy ASX shares
and for a lot of US investors.
Why would they do that, whenthey trade on the NASDAQ and the
(51:55):
NYSE on a daily basis andthere's no complexities around
owning shares in Australia?
So for us it was aroundsimplifying that structure,
removing all of those barriersto entry and ensuring that our
compelling story continued toresonate with US investors
(52:17):
without the complexities tonavigate around the Australian
Stock Exchange, potential taxcomplications and being able to
have an Australian stock andthen transition it back onto the
NASDAQ.
It was just far too complex andwe wanted to completely
simplify that for US investors.
That for US investors.
Ben Comer (52:40):
Got it Great.
I wanted to ask a questionabout your leadership style,
which I think I'm getting a bitof a sense of.
You are not afraid to take ondifficult challenges.
You, in fact, may seek them outto some degree.
I wonder how you would describeit though, your leadership
style and the kinds of valuesyou look for in employees or try
(53:03):
to imbue in your workforce.
Joel Latham (53:06):
Yeah, so my
leadership style is
entrepreneurial.
I look at it as an old schoolapproach.
I pride myself on being thehardest worker in the room.
I pride myself on leading byexample and I pride myself on
ensuring that our company is ina position where we can disrupt
(53:30):
multi-billion dollar addressablemarkets and really forging a
path that is going to leave along and lasting impact on these
sectors that we're working in.
So those are things that Ipride myself on and I am
unbelievably motivated to ensurethat this company is successful
.
I have skin in the game.
(53:52):
I'm an investor.
I mean, I am an investor and Iwant this company to be
successful and I drive myselfand this company every day to
ensure that we're in a positionto do that.
So, when looking at it from amarket perspective, shareholders
can feel confident that theyhave a CEO that is in place that
(54:16):
will outwork everyone and toensure and continue to drive for
a successful outcome, and thisis something that I like to
instill with our employees.
So, whilst the hours that Iwork are quite unique and long,
I don't necessarily expect thatfrom our employees, but I expect
(54:40):
our employees to have the samemindset, that entrepreneurial
mindset, to break down barriers,to not take no for an answer
and to think in unique andinnovative ways to ensure that
we're providing favorableoutcomes for our shareholders
and patients alike.
So it's about disruption, it'sabout working hard and it's
(55:04):
about finding ways that we canshorten our path to
commercialization and liquidityevents for our shareholders.
Ben Comer (55:16):
Final question, Joel
what are your top priorities for
the rest of this year?
Joel Latham (55:22):
question Joel, what
are your top priorities for the
rest of this year?
Top priorities for the rest ofthis year is to provide a clear
path for our shareholders fornext steps for IHL 4.2x, psx,
0.0.1, and 6.7.5a.
We continue to advance therapid development of each of
these assets on a daily basisand when we're in a position to
(55:46):
provide a regulatory update forthese assets, we look forward to
providing that to the market.
I know the market is andshareholders are anticipating
these updates, but I just wanteveryone to understand this is
our sole focus.
We work on this day in, day outand we're ensuring that we're
(56:08):
putting ourselves in the bestpossible position to succeed and
provide the most favourableoutcome in the long run.
So our goals are to continuewith the rapid development of
these assets and provide a clearpath forward.
But again, I want everyone toknow that this is something that
we're close to being able to doand it is anticipated, and
(56:32):
we're going to continue to drivethis company forward.
So we're excited, I'm extremelyexcited, and we'll continue to
go down this path.
Ben Comer (56:44):
Well, thank you so
much for coming on the show.
Joel Latham (56:46):
No, thank you, ben,
it was an absolute pleasure.
Ben Comer (56:50):
We've been speaking
with Joel Latham, president, ceo
and Director at IncanexHealthcare.
I'm Ben Comer and you've justlistened to the Business of
Biotech.
Find us and subscribe anywhereyou listen to podcasts and be
sure to check out new weeklyvideocasts of these
conversations every Monday underthe Business of Biotech tab at
lifescienceleadercom.
(57:11):
We'll see you next week andthanks, as always, for listening
.
We'll see you next time.