Improving Cardiovascular Outcomes With Immediate Therapeutics' Atul Deshpande, Ph.D.

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On this week's episode, Atul Deshpande, Ph.D., CEO at Immediate Therapeutics, talks about partnering with American cities to conduct clinical trials during ambulance rides to the hospital, with the goal of preserving heart function and reducing mortality related to acute cardiovascular events, including heart attacks. Deshpande reflects on his previous experience developing and commercializing Dupixent at Sanofi, describes the history and mechanism of Immediate's glucose-insulin-potassium (GIK) candidate, IMT-358, and explains why there is more to intellectual property than just patents. 

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Episode Transcript

Ben Comer (00:07):
Welcome back to the Business of Biotech.
I'm your host, Ben Comer, chiefeditor at Life Science Leader,
and today I'm pleased to speakwith Atul Deshpande, Ph.
D.
, CEO of Immediate Therapeutics,a clinical stage biotech
focused on delivering therapiesto patients before they arrive
at the hospital that reduceheart muscle damage and improve

(00:28):
outcomes, including mortalityassociated with acute coronary
syndromes.
Atul worked in consultingbefore joining Sanofi, where he,
among other things, worked ondupilumab as it progressed
through clinical trials and thenled global operations for the
Dupixent franchise.
Next, he joined Harbor Biomedas chief strategy officer and

(00:51):
head of US operations, helpingto take the company public in
2020 on the Hong Kong StockExchange, raising $400 million
in the process.
After that, he joined ImmediateTherapeutics as CEO, then left
to work as Chief StrategyOfficer at Peptalogics for
nearly three years and thenreturned last April to Immediate

(01:11):
Therapeutics as CEO, a job hesays he had to take if he wants
to sleep at night.
Atul is not currently taking asalary for his work as CEO at
Immediate.
We'll hear more about why, aswell as learn about the unique
clinical development programImmediate is pursuing the
company's IP strategy for acombination product comprised of

(01:33):
glucose, insulin and potassiumknown as GIK, and what's next
for the company.
Thanks so much for joining me,atul.

Atul Deshpande, Ph.D. (01:41):
Thank you , Ben.
It's a pleasure to be here tool.

Ben Comer (01:47):
Thank you, ben.
It's a pleasure to be here.
You are originally from India.
You got your bachelor's andmaster's degree in Mumbai before
coming to the US for a PhD atUC Irvine in neuroscience and a
postdoc at UCLA.
Then you went into consulting.
What made you decide on theentrepreneurial path a tool
versus becoming an academic or aphysician?

Atul Deshpande, Ph.D. (02:09):
Yeah, ben , fantastic question to start my
journey there.
So, yes, I did my bachelor's inmicrobiology biotechnology back
in Mumbai and did a master's inneuroscience, which is what you
know led me to come to UCIrvine, one of the leading
institutions for neuroscienceresearch, and there I joined the
lab of Jorge Basiglio.

(02:30):
I was working on Alzheimer'sdisease, down syndrome a topic
that is extremely close to myheart, given even now we don't
have any treatments or solutionsfor these patients, and the
numbers seem to be growingrapidly treatments or solutions
for these patients, and thenumbers seem to be growing
rapidly.
Then I did a short postdoc atUCLA with Greg Cole, another
fantastic mentor, and decided toleave academia to go join the

(02:58):
industry as a consultant.
The reason for doing that wastwofold.
One, jorge who you know tilldate remains a mentor and a
close friend actually said hey,you have a mind that is
different than an academician.
You think you know more in termsof what can we do to bring
treatments to patients, and soyou should be pursuing a path
that allows you to do thatrather than just staying in

(03:19):
academia.
Your mind is not built that way, and that's what planted a seed
in my brain to kind of explorethose options.
Eventually, when I went over toGreg's lab at UCLA, there were
some industry collaborationsthat I was already working with
and part of, so that got meexposed to the way the industry
works and what are the keyconsiderations in terms of basic

(03:40):
research versus translationalresearch, and how do we take
drugs through clinical trials tobring them to the patients.
And that's what ignited thespark of, you know, saying, okay
, lab work or bench work is notfor me.
I really want to do.
What I want to do is helppatients, and the sooner I can,
you know, do that, the better itis going to be, which is what

(04:00):
started me on the journey ofgoing into consulting.

Ben Comer (04:04):
Yeah.
So then you went into lifesciences consulting for a few
years and then joined Sanofi.
What experiences stuck out foryou at Sanofi?
What did you learn while youwere there?

Atul Deshpande, Ph.D. (04:18):
Yeah.
So the consulting journey was,first of all, interesting.
I did a few years of consulting, then went to London, got my
MBA, which also then opened upthe doors of being able to speak
your language.
You know, as a scientist, I wasalready speaking the language
of science, but now, with theconsulting background and the
business degree, I was able totalk about NTV and I was able to

(04:39):
talk about, you know, what isimportant from a business side
of things as well, and that's avery interesting and unique
combination which allows you tochallenge yourself as well as
challenge the industry from acouple of different perspectives
.
And that, I think, has helpedme tremendously through my
journey, because when I go toinvestors, I can speak both

(05:02):
languages.
I can go and dive deeper intothe signs and the mechanism of
matching and the targets, butalso pull that up to a
60,000-foot level and say, okay,this is how it's going to help
the patients and this is why weneed to look at supply chains or
pricing and reimbursement andhow to bring these drugs
actually to market and not justget, you know, get stuck in the

(05:24):
route of discovery, discovery,discovery.
So, you know, after my MBA, Idid another couple of years of
consulting and I was exposed toemerging markets during those
two years.
So, you know, I'd been in touchwith Sanofi after my MBA and
the conversation reignited whenI was asked to join Sanofi in

(05:45):
Shanghai.
So I was based out of New Yorkat that time and decided to take
this opportunity, which wasvery interesting.
I was asked to head the R&Dstrategy for Asia Pacific and
under that purview I was basedout of Shanghai, but I had Japan
, china, australia, india,russia, southeast Asia high.
But I had, you know, japan,china, australia, india, russia,

(06:07):
southeast Asia, all under my,you know, purview of looking
into what new products from theSanofi portfolio should we bring
to the Asia-Pacific region, andthen, of course, the clinical
trials related to it and so onand so forth.
So that was a fantasticexperience.
We were there for about threeyears and I learned a lot.
I learned a lot in terms of notjust thinking about the
traditional way of drugdevelopment, but I also learned

(06:29):
about, you know, whatconsiderations do you think
about when you're thinking aboutemerging markets?
You know you have Japan andAustralia, which are Western
markets in a sense, and you'relooking at you know how do we,
you know, include them in theglobal clinical trials.
But then you have China in themix and you have India in the
mix, where you know they wanttheir own patients, you know, to
experience the drug before theyapprove anything.

(06:50):
And so you know those might bebridging trials, those might be,
you know, participation inglobal trials.
And then it becomes aconversation of, oh, am I going
to slow down global trials forregional, you know, approval?
And so all of thosecomplexities kind of expose you
and make you think about what isthe optimal drug development

(07:10):
pathway, not just for Westernmarkets, but also making sure
that emerging markets and othermarkets are taken into
consideration.
And we are not only thinkingabout bringing drugs for those
who can afford, but also bringdrugs to market those who cannot
afford, or think about adifferent business model to

(07:31):
bring these drugs to patientswho really need it and can
benefit from it.

Ben Comer (07:33):
Right, had you ever been to China before you landed
in Shanghai?

Atul Deshpande, Ph.D. (07:37):
No, I hadn't.
That was the first time.
And I landed there, one of thefirst things that struck me
there was, visually speaking.
I was passing over one of theflyovers that you know are there
in China, all over the place,and I saw, you know, clothes
hanging outside, you know, todry off apartment buildings, and

(07:58):
I was like, wait, that justreminds me of Mumbai.
And I was like, wait, that justreminds me of Mumbai and that,
just, you know, clicked rightthere.
That, you know, coming fromBombay and having spent my whole
childhood, and you know,growing up in Bombay, I was like
, yeah, I can fit here.
And then, you know, spendingthat all that time in Shanghai,
both my wife and I, we learnedthe local language, you know, we

(08:25):
assimilated as much as we couldinto the local culture and the
ecosystem.
So we, you know, thoroughlyenjoyed our stay there.

Ben Comer (08:28):
Yeah, and then you, after you left Sanofi, you
worked at Harbor Biomed, as Imentioned, helped with the IPO
on the Hong Kong Stock Exchange.
So you know, you have some realexperience, not just in
mainland China, but also in HongKong to some extent.
And this is a prelude to thequestion I wanted to ask, which
is you know what and this isalso separate from the main

(08:51):
discussion we're going to getinto, but I'm just curious
because it's such a hot topicwhat can you say about the
amount of of deal making andinnovation that that's happening
in China's biotech sector rightnow?

Atul Deshpande, Ph.D. (09:03):
Yeah, you know it is a hot topic at this
point in time and you see a lotof these.
You know deals coming throughfor big pharma and the Chinese
biotech ecosystem.
But you know, one of the things, ben, that really helped me as
I was going through this journeyis after I came back from China
still, you know, with Sanofi,to the Bridgewater site in New
Jersey, I was the unitmanagement auditor, which means

(09:28):
managing the operations for theimmunology and immunology
portfolio.
As I was going through thatexperience, I got an opportunity
to work on Dupilumab, which wasone of the leading products in
the immunology portfolio, andthen eventually, given the
combination of languages that Iwas able to speak, as I said
before, science and business andyou know, presenting in the

(09:49):
meetings and everything I wasactually asked to lead the
global operations for the launchof Dupixent, you know, which
then took me from Bridgewater toBoston and, you know, then
responsible for the overalllaunch for the Sanofi Dupixent
franchise.
So that that, again, was afabulous experience.

(10:13):
I mean, you know, very fewpeople honestly get that
exposure to launching a drug andwhat it takes to launch a drug.
I was right in the mix of itright from the get-go,
understanding the clinical trial, because I was a global project
manager for a year or so beforeI jumped into the commercial

(10:33):
side of things.
So, again, bringing thatscientific curiosity and data
and positioning into theconversations that are now
pricing, reimbursement,marketing, how do we position
this, what the competition lookslike, what are they talking
about, and so on and so forth.
So, again, a fantastic exposure.
I was there right from theget-go of the launch

(10:54):
preparations, launch readiness.
I set up the whole operationsaround launch readiness.
Fortipixent launched atopicdermatitis, the first indication
.
Fortipent in the US and 52other countries.
So you know, managing all ofthose operations.
And then, you know, eventuallywe got through the launch of

(11:14):
Depixent for asthma in the US,prepared Europe for the launch,
and then I was, like you know,exhausted at that point.
You know, like I said, you knowvery few people get the
experience of launch readinessand launching a drug.
I was fortunate enough to havethat two times in two different
environments, if you will,because with atopic dermatitis,

(11:37):
you're creating and shaping themarket.
It was the first drug coming tothe market.
So it's a very differentconversation, whether it's with
pairs or KOLs, or you knowphysicians or even patients.
So it's a very differentconversation, whether it's with
pairs or KOLs, or you knowphysicians or even patients.
That's a very different, youknow level of engagement.
And then you're launchingAsthma, which is, you know, we
were fifth to market at thatpoint in time.
It's an already establishedmarket.
And now you're thinking aboutokay, how do I position myself,

(11:59):
how do I differentiate myselffrom what is already there in
the market, but also what thecompetition looks like.
You know behind me.
And then you know, is that away to grow the whole pie and
then take a small you know pieceof it, or am I just going to
get into the mix and just fightfor the same patients?
And so those learnings wereamazingly, amazingly critical
and you know, learned a lot overthose three years or so.

(12:22):
And so after I did that, youknow I was in true sense
exhausted to a certain pointbecause, managing global
operations, the only point thatI would have, you know, a minute
for myself would be down in thebasement of the car park, which
is the only place where I wouldnot receive any signal on my

(12:45):
cell phone.
But you know, it was a lot offun and I really appreciate it
and I still keep in touch withall the colleagues that you know
work with me and I work with interms of the Depixent launch.
It was a fantastic team and afantastic experience that I
carry close to my heart again.
So, after I decided to, youknow, kind of put a stop on the
PIXIN story and then move on tosomething else, a friend of mine

(13:08):
had, you know, started thiscompany, harvard Biomed, and he
and I, you know, always used tokeep in touch.
He was out in China, used totravel back, and he and I
actually had worked together inthe Sanofi office.
So he was the head of SanofiChina at that point in time,
jingxiong Wang, and I was, ofcourse, the strategy officer or

(13:30):
R&D strategy, and so, keepingthat connection alive, we used
to pass based on what'shappening with his company,
what's happening with theoverall environment and the
direction of research andbringing new drugs to market.
And so one of theseconversations, you know, I was
like you know, I'll be lookingfor something else, you know, in

(13:52):
a time period soon, and he waslike well, if you are going to
be looking for something else.
It would be fantastic for youto come join you know, harvard
Biomed as the chief strategyofficer.
Given the experience that youhave and you have, and given
what we aim to build, I think itwould be a fantastic match to
do so, and so, in 2019, Iprecisely decided to do that
joined Harbor Biomed as thechief strategy officer.

(14:16):
When I joined the company, itwas primarily a platform company
with a couple of differentmouse models that were capable
of generating human antibodies,and there were a couple of other
small drugs different mousemodels that were capable of
generating human antibodies, andthere were a couple of other
small drugs in the portfolio,primarily from in-licensing.
The internal pipeline was stillgrowing at that point, and so

(14:40):
what I did over the next two anda half years or so with Harbor
Biomed was basically focus andpush through assets into the
clinical portfolio, therebybuilding the overall portfolio
for the company, which is whatthen allowed us to kind of make
a name for ourselves in thebroader market, but then also

(15:00):
justified the valuation when wedecided to go into fundraising
in 2020, both through the VCchannels as well as ended up
doing the IPO, as you mentionedbefore, at the end of 2020.
So we raised about $400 millionthrough those rounds.
$180 came from venture capitalfunds with quick succession.

(15:24):
So one round closed in March, Ibelieve, and then another one
in June, collectively for that180.
And then we went on to do theIPO in the Hong Kong exchange
for $220 million, given thatpretty much all the operations
were in China.
We had a small lab here inCambridge and then operations in
China.

(15:44):
We had a small lab here inCambridge and then operations in
Netherlands, and I was managingboth Europe and US.
At that point, it obviouslymade sense for us to go to the
Hong Kong Stock Exchange.
One of the things that we alsodid notice, at least at that
point in time and the picturemight be a little bit different
now is the Hong Kong market wasquite hungry for IPO and

(16:10):
companies with our profile, andso we were able to really make
those connections, build therapport that we needed with
investors in the Hong Kong StockExchange, which gave us a
successful IPO that we wereplanning for.

Ben Comer (16:25):
That's excellent background.
Thank you so much for that,atul.
We could probably spend somemore time talking about Hong
Kong and the Hong Kong StockExchange, but let's bring it up
to immediate therapeutics, yournext step after Harbor Biomed.
What circumstances led you intothat CEO role at immediate
therapeutics initially?

Atul Deshpande, Ph.D. (16:45):
Yeah, into that CEO role at Immediate
Therapeutics initially.
Yeah, so while I was doingHarvard Biomed, I was introduced
and then got associated withMassBio, which is a three-year
organization here and that runsa program which is a mentoring
program.
So you know, through MassBio Idid, and still do, mentor
several companies that you knowcome in through that program.
Most of them are early stagecompanies, and so you know

(17:07):
there's a conversation aroundnot just you know the research
piece of it, but then also thelong-term value and have you
thought about you know themarket and where are you going
to position the drugs, and so onand so forth.
So a team of us sits down withthe founders and the CEOs of the
company and discuss thesethings.
That allows them to thinkbeyond.
Hey, this is just excitingscience, right.
And so, as I was doing that,there was this new program that

(17:32):
MassBuy started to bring in somelate stage companies into the
mix, and immediate therapeuticswas the first that came in.
And so, again, a few of ussitting around the table every I
believe it was Thursday morningwith the founder and his team,
you know kind of pressure,testing what has been done, what

(17:52):
needs to be done.
Have they thought about this,have they thought about that?
And so got really engaged andinvolved with the mentoring
process.
And so, you know, with thementoring process, got
introduced to Harry Selker,who's the founder of the company
.
What I was very, very, veryimpressed with was the data that

(18:12):
Harry had in his hand at thatpoint in time.
And so when he first came in,you know, the initial
conversation was like oh, thisis an academician, you know
who's done a clinical trial?
Harry's actually, you know,based out of Tufts Medical
Center.
And so we were just sittingthere waiting to hear you know

(18:34):
what this story is all about,and after a few slides, he
showed us the data of theimmediate one trial and I was
taken aback, you know.
From that point, you know I'lltell you the data in a minute.
But, you know, through thatconversation, through those
engagements, I started thinking,you know, I really have to, you

(18:54):
know, find an opportunity toeither help Harry or work on it
myself, to bring this asset topeople, because it's going to be
a game changer.
It's going to save, you know, Ibelieve, millions of lives and
have a positive impact onpatients, but then also the
society in general, and that'swhat got me excited to work on
this.
So at one point in time, as wewent through Harvard Biomed and

(19:17):
I was thinking about, the IP wasdone, the portfolio is
established, what are my nextsteps?
One of the things that Istarted exploring was whether I
could, you know, work with Harryto bring this disrupt the
market, and that's what you knowagain got the conversation
started, and so, in April of2021, I decided to, you know, to

(19:41):
quit Harvard Biomed and joinimmediate therapeutics as the
CEO.

Ben Comer (19:46):
Right, excellent.
And then you left for a littlewhile and I do want to get back
to you know that data thatreally caught your eye and you
know what you think theopportunity is.
We'll get into GIK, but youleft and came back to immediate
therapeutics as CEO.
Can you talk a little bit aboutyou know that decision.

Atul Deshpande, Ph.D (20:05):
Absolutely so.
You know, when I joined inApril May of 2021, you know I
joined it with a lot ofexcitement.
I was like you know, the datais amazing.
It should be a no-brainer forus to raise the monies that we
are looking for in, you know, inthis stage of the company so
being a late stage, you know,phase three ready asset I was

(20:27):
like you know, this is perfect,this is what we should be doing.
It's significantly de-riskedand has a lot of support.
It should not be that difficultto bring this through the
investor channel, get theinvestment and start the
clinical trial soon.
But, you know, as fate wouldhave it, timing is everything

(20:48):
and we were coming out of thefunding boom of 2020 and early
2021.
So, as we prepared and startedhitting the market, the funding
started to trickle down.
And so, you know, when I joinedthe company, the company had
already raised $40 million innon-dilutive funding and had
used up all of that money forthe phase two clinical trial

(21:12):
immediate one.
And so when Harry was, you know, pitching this at the MassBio
events, the company did not haveany money.
But I had a lot of convictionin the data and so the risk that
I had taken was to joinimmediate therapeutics without a
salary, just on the basis ofequity, using my own runway also

(21:36):
, you know, with a little bit ofinvestment going back to the
company to keep the operationsrunning.
And so that was a decision thatyou know my wife fully
supported and helped me with.
Uh, she was like you know, uh,you're, you seem very passionate
about it.
I can hear it in your voice.
You should go do what you wantto do, but make sure there's a
deadline to it.
And this, you know, we can'tjust keep going for forever.

(21:58):
So we had mapped out uh, youknow, to give this everything
that we have for a year, and uh,so we tried, we tried all
possible.
You know, to give thiseverything that we have for a
year, and so we tried, we triedall possible.
You know avenues in terms offundraising for that one whole
year.
We had really interestingconversations with pharma
partners, strategics.
We had very engagingconversations with venture
capitals, but just themacroeconomic environment and

(22:20):
funding cycles were such that wewere not able to close the
round that we were looking forfor the clinical trial.
And so, come May of 2022,that's where, you know, I had to
take the hard fall and astrategic decision for myself as
well as the company, to put iton a strategic pause, put it on

(22:41):
the side for now and you know,and find something else that is
going to again allow me to bringin the salary that would allow
me to make sure I have enoughcash to pay my bills.

Ben Comer (22:55):
Yeah right.

Atul Deshpande, Ph.D. (22:57):
And that's when I decided to join
Peptalogics.
So again, a great journey withPeptalogics.
No-transcript.

(23:29):
We had to fundraise and youknow again the last couple of
years of you know kind ofstressful fundraising
environment we had to kind of,you know, revisit strategies and
think about how do we positionourselves and things like that.
So you know, earlier, this event, earlier this year, then I
decided, you know, that we wereable to make some progress with

(23:52):
PeptoLogix.
So I decided to, you know, kindof take a close on the
PeptoLogix story, because it wasat a position where I could,
you know, kind of step back andthey would, you know, continue
to move forward.
Which is when I decided, hey,you know, the ecosystem seems to
be changing a little bit.
There seems to be again, seemsto be a little bit of money

(24:15):
freeing up from all theseinvestments that VCs have done
and, given the stage of theasset that we have, I think it
would be a really good time togo back to the market and see
what we can do about it.
And so, in April of this year,I decided to again take a plunge
back into immediatetherapeutics and see where we
can do about it.
And so in April of this year, Idecided to again, you know,
take a plunge back intoimmediate therapeutics and see

(24:35):
where we can go with it, again,with the blessings of my wife,
with a runway towards till theend of the year to again keep it
going and give it everythingthat we have.

Ben Comer (24:45):
Well, if you can convince your wife and family to
allow you to work, you know,without a salary, then I think
you're probably in good shape.
You know, with investors aswell.
Let's talk about glucose,insulin, potassium, gik, three
substances commonly associated,you know, with the metabolic
system, specifically diabetes.
What is the history of thistriple combination?

(25:08):
And heart disease?
Because it goes back a numberof years.

Atul Deshpande, Ph.D (25:12):
Absolutely , and actually, if you look at I
believe it was a 2023 reviewwhich Harry, who's the founder
of the company, and the chiefscientific officer.
Jim Udelson, who's the head ofcardiology at Tufts Medical but
is also the chief medicalofficer for immediate
therapeutics, and Gene Braunwald, who I believe a lot of people

(25:34):
in the cardiovascular world knowas potentially a godfather of
cardiovascular.
He's with the group up at MGHand he was the one who had
initially done these experimentsabout 50 years ago, and so in
2023, they wrote a review, youknow, altogether capturing what
has been done about this in thelast 50 years, and there's a lot

(25:56):
actually that has been done inthe last 50 years.
There actually were severaltrials that were done in Europe
with GIK that were started inpatients that you know had ACS
symptoms or had a cardiac arrestand you know were brought to
the hospital symptoms or had acardiac arrest and you know were
brought to the hospital.

(26:17):
Now we have data from about20,000 of these patients that
had been exposed to GIK and oneof the biggest difference about
what immediate one was comparedto the previous trials that had
been done, was the timing ofadministration, and so you know,
all the previous trials thatwere done were done after the
patients arrived at the hospital, which was, you know, six,

(26:40):
seven hours, three, four hourstypically from the onset of the
symptoms of ACS, of acutecoronary syndrome, whereas
immediate the trial, the way itwas done, was done in the
pre-hospital setting, so in theambulance, which is where you
are reducing or minimizing theamount of damage that is being

(27:01):
done to the heart.
So it is a very interestingmechanism of action.
The way the combination workshas shown to be extremely safe,
like I said, not just in ourtrial but then also the previous
trials that have been done.
But the efficacy was what wewere able to show in our
immediate one trial and theefficacy was sorry, go ahead.

Ben Comer (27:23):
No, go ahead.
No, I was just going to saythat it seems like what you're
saying is that the keydifferential is when it's when
the drug is administered.
You mentioned the studies, thatsome studies that have been
conducted in Europe that youknow weren't necessarily as
strong as the data that I thinkyou saw in the immediate one
trial.
Is that what you're getting to?
That it has to be administeredvery quickly, you know after the

(27:47):
onset of symptoms, and then youknow that becomes tricky in
terms of how you conduct a trialthat captures those patients.

Atul Deshpande, Ph.D (27:56):
Absolutely .
And again, going back to, youknow, not just my immediate
faith of timing is everything.
With immediate timing iseverything.
And so you know the combination, the way it works.
And let's talk about thepatient journey a little bit
before we get into how the drugworks.
Right, imagine you and I arehaving this conversation and you

(28:17):
know I start having some minor,you know chest pain.
Most of the time people tend toignore those kinds of things,
assuming that it's, you know,indigestion or anxiety or
something else.
They'll try some home remedies,you know, for the first 30
minutes, even an hour, beforethey actually think, oh, this is
something serious and I need todo something medically about it
.
Once they realize, you know,they end up calling 911 or

(28:41):
decide to drive to the nearesthospital themselves, even though
it is not recommended to do so.
About 50% of the patients drivethemselves to the hospitals.
Of the patients drivethemselves to the hospitals.
If the ambulance comes in, orif you do, you know, reach the
hospital, the first thing thatthey're going to do is, you know

(29:01):
, check for ECG and once theysee an abnormal ECG, you're
qualified as a suspected ECSpatient, which is when you are,
you know, driven back to thehospital and then starts you
know, the whole process journeyof blood work, imaging, and then
eventually the therapy whichcomes in the form of you know
the whole process journey ofblood work, imaging, and then
eventually the therapy whichcomes in the form of, you know,
a balloon or a stent, orpotentially a bypass, depending
on where the clots are, how manythere are and how bad the

(29:22):
arteries might be clogged.
And so, from the time that theACS onset happens which is the
minor, you know, chest pain thatyou experience, which is when
the heart is actually callingout for help through the time
that you actually get anytherapeutic intervention, it
could be anywhere between threeto four hours in urban settings

(29:42):
and it could be even more inrural settings, because the
ambulance just takes time tocome in and take you back to the
relevant hospital.
Now, in that period of time, theonly thing that is a typical
standard of care is aspirin andsaline, and both of them don't
really protect the heart in anyway.
It's just hydration.
And aspirin, we know, does workto a certain extent in terms of

(30:05):
dissolving the clot, but not tothe extent that it's really
going to help the heart get thenutrition and the oxygen that
it's looking for when it'schoking on the blood supply, and
so that timing plays a criticalrole in terms of the amount of
damage that the heartexperiences over that three to
four hours.
And so the combination that wehave tested and come up with,

(30:29):
it's a combination of glucose,potassium, insulin, and the way
it works, in a very simplisticway, is glucose, you know, it's
energy for the cells.
We all know that you're makingit available in the simplistic
forms that the heart muscle canreally absorb very quickly, and
so keep on doing its regularfunction.
Potassium, in this case, isanti-arrhythmic and so that you

(30:54):
know, for Lehman's term is themessenger that heart muscle uses
to talk to each other.
And so, because you havepotassium in the right quantity
reaching the heart, in thatscenario the heart muscle, you
know, communicates and keeps onbeating in the rhythm that it
needs to for the heart to keepon functioning.
And so that becomes, you know,a kind of communication channel

(31:14):
for the heart muscle to keepdoing what its usual job is.
And then, last but not the least, one of the critical components
here is insulin, and insulin,in this scenario, is given at a
supraphysiological level, andthis is important because I'll
talk about one of the reasonswhy, you know, we also have a
good and this is importantbecause I'll talk about one of
the reasons why we also have agood support down the line is,

(31:35):
at these supraphysiologicallevels, insulin actually acts as
an anti-apoptotic, through theAKT pathway, and as an
anti-inflammatory.
So when the cells are understress, insulin gets there and
tells the heart muscle dude,it's okay, don't die, I'm going
to help you.
And for the amount of damage onthe heart muscle that has been

(31:59):
done, when the immune system isgetting activated to come clean
it up, you know it's alsotelling the immune system it's
okay, I got the heart undercontrol, I'm going to help it
survive.
Do not over-activate or do notdo anything rash or crazy, I'm
here to control the situation.
And so in that kind of amechanism of action, it does
give the heart muscle what it'slooking for.

(32:21):
Even if small amounts of bloodis reaching, because the
concentration of these threecomponents is that high at
supraphysiological level, eventhat small amount of blood is
able to deliver what the heartneeds at that point in time.
And that's why the timing ofadministration is critical and
really important in terms of,you know, giving that heart
muscle the chance to survive andnot, you know, go through a

(32:44):
huge infarct size, and this wasthen visible in the data that we
have shown.
So immediate one.
The trial that we ran wasactually done, as you know, kind
of a phase three clinical trial.
So it was, you know, placebo,randomized, double-blinded,
everything that you would lookfor in a placebo-controlled
trial.

(33:04):
It had 891 patients sorry, 871patients enrolled in the trial
and what we were able to show asa result of this trial that we
did in a placebo-controlledenvironment was a 50% reduction
in cardiac arrest, a 50%reduction in all-cause mortality
in the hospital within sevendays and an 80% reduction in

(33:27):
infarct size.

Ben Comer (33:29):
Wow, yeah, that's definitely eyebrow-ra.
I can see why you know itcaught your attention in that
initial meeting.
Immediate's GIK candidate isIMT358.
We've been talking aboutImmediate 1, which is a phase
two trial.
It was completed in 2012.

(33:53):
You've just mentioned some ofthe results and a fairly large
number of patients were enrolledin this trial.
Can you talk a little bit abouthow the founders of the company
managed to do that?
I'm just curious about how youyou know how you enroll patients
.
You know ahead of having someyou know heart attack symptoms,

(34:15):
right.

Atul Deshpande, Ph.D. (34:16):
Yeah, this was a very innovative way
of you know running the trialhonestly, ben, because you know
doing pre-hospital settingtrials is one of the most
difficult things that you can doin a, you know, in a clinical
trial environment.
And so you know this was runout of Tufts Medical Center with
both Harry and Jim, you know,involved in running the clinical

(34:38):
trial.
The other thing that iscritical in running this kind of
trial is, you know you don'thave sites that are hospitals in
running this kind of trial.
You have cities that are sitesin running this kind of trial.
Because imagine, you know I'msitting here and you know I have
this onset of the event.
I'm not going to tell theparamedic, take me to this

(35:00):
hospital because it's a site forIMT358.
Or the paramedic is not goingto recommend that I take you to
a hospital five miles away whenthere's another one three miles
away because that is a site forIN2358.
So the way the trial wasdesigned and done was we had to
buy in all the hospitals and allthe ambulance services in a

(35:21):
specific city and we had 13cities that bought into running
this clinical trial.
So we had Boston all the wayfrom Boston down to Dallas, all
the way up to Alaska.
You know we had these 13 citiesthat participated in this
clinical trial and, given thesafety profile of IMT358, we
were able to convince the IRBthat it should be started as

(35:46):
early as possible.
And, in terms of consent fromthe patient, we were able to
work with the IRL to get oralconsent in the ambulance setting
that you know they're okay tomove forward with this
administration of IMT35A andthen sign the actual paperwork
once they are stabilized andonce everything is done down at
the hospital.
So by doing so we were able to,you know, get the consent, get

(36:07):
the patients enrolled and getthe treatment going as quickly
as possible.
The other thing that we also didwas we had an algorithm that we
had developed internally withinimmediate, that's called ACI
TIPI.
Now this ACI TIPI, incollaboration with, you know,
stryker and a couple of othercompanies, was installed in the
defibrillators that is, in theambulances, and so what it does

(36:29):
is it will look at the ECG inreal time setting and give you a
probability of that ACSconverting into a full, you know
, heart attack.
And if you, you know, kind oflook at the number and it says
75% or higher, then you knowthat there's a very high
likelihood that this ACS patientis going to, you know, convert
into a full-blown heart attackand would benefit from this kind

(36:51):
of administration of IMT358.
And those were the patientsthat we enrolled in the trial,
giving them the background ofIMT358, the safety of it and how
it could potentially help them.
And, you know, that is theresult that we saw from the
clinical trial.

Ben Comer (37:07):
Yeah, it's a very impressive operation.
I mean, not only did you getthe 13 cities on board and the
hospitals in the 13 cities, butalso the, you know, the EMTs and
getting into the even in, youknow, into the ambulances that
are then delivering patients,and then you know kind of I
don't know, is that a novelprocess of getting that initial
consent and then signing afterstabilization.

(37:29):
Was that?
Is that unprecedented, or isthat done in other, you know,
with other types of medicinesthat are used in a kind of
ambulatory setting?

Atul Deshpande, Ph.D. (37:37):
I?
You know, honestly I don't knowthe answer to it.
I haven't looked at, you know,too many drugs that were in that
setting, but we did face.
You know from what I hear fromHarry and Jim, you know there
was a lot of apprehension, ifyou will, in the initial
conversation.
But once we showed them, youknow the data from all these
clinical trials, the safety ofthe drug and everything else,

(37:59):
and you know the ACI-TP,combined, you know, with
identifying the right patientsthat would be enrolled in the
clinical trial, then theconversation got a lot more
easier, where they were likeyeah, these are the patients
that are obviously going tobenefit and the safety profile
looks extremely good.
You know this is the way to doit.

Ben Comer (38:16):
Yeah, and helpful too .
I'm sure that these are threekind of known entities.
You know they've been widelyresearched for a number of years
and so I you know there couldbe some confidence in the safety
profile which I'm sure helps,you know, ease that operation of
delivering it in that kind ofunique setting.
So the founders conducted thistrial, had incredible data, took

(38:39):
it to the FDA.
What happened?
What happened next?

Atul Deshpande, Ph.D. (38:45):
Yeah, you know everybody was excited.
This data was then presented atthe ACC meeting as a
late-breaker, you know, session,and you know, then Harry and
Jim proceeded to go back to theFDA to have a conversation about
a phase three clinical trial.
Now, one of the things thathappened before immediate one or

(39:09):
during immediate one was thetrial initially.
Immediate one initially wasdesigned as a trial.
You know, that would have about15,000 patients.
It was supposed to be done bothin the emergency room setting
or the ER setting and theambulance.
But you know, given thecomplexity of this enrollment
that we just touched upon, youknow the enrollment started as a

(39:31):
slower recruitment rate.
Now, this trial was also, youknow, funded by the NHLBI, part
of the NIH at that point in time, to a tune of $40 million.
And so, as we were reviewing,you know how quickly the trial
was moving one of thesuggestions that came on board
from the NIH or NHLBI was hey,why don't you focus on the
ambulance setting instead of,you know, both the ambulance and

(39:53):
the ER and reduce the number ofpatients?
Because that's where you'll beable to get to the patients
fastest and you know, you willsee whether this actually helps
the patients or not, and so thetrial number was reduced.
But, you know, when INITIAT-1was originally designed, the
primary endpoint was progressionto AMI, and when the trial

(40:15):
design was changed, after, youknow, conversation with the NIH
and the FDA, one of the thingsthat Harvey and Jim missed on
doing was changing the endpointfrom progression to AMI to the
three pre-specified secondaryendpoints that we already had
accounted for.
So, you know, the primaryendpoint in the big trial, the
15,000 patient trial, wasprogression to AMI.

(40:36):
The secondary endpoints wascardiac arrest mortality and
infarct size.
They were predefined, so therewas nothing that was done ad hoc
in terms of the review.
But because these weresecondary endpoints, when they
went back to the FDA, the FDAwas like, you know, the data
looks really interesting.
But one question that we have isdoes infarct size really

(40:58):
linearly, you know, correlatewith the number of heart attacks
that people have?
And so that was a big questionthat Harry, jim and a few other
collaborators that worked withthem including Greg Stone, you
know, had to answer.
And so, after 2012, they had,you know, conversations with the
FDA in 2013, 2014, and theneventually, 2015, 2016,.
The whole team worked on a big,you know, project that was, you

(41:25):
know, kind of in-depthmeta-analysis of multiple,
multiple studies that were done,looking at infarct size and
looking at, you know, impact oncardiac arrest and mortality and
everything else.
And so, in 2016, they came outwith a publication that showed
that, yes, infarct size isdirectly correlated with, you
know, eventual cardiac arrestand mortality, and which is when

(41:46):
they were able to go back tothe FDA, showed them that, okay,
there's a direct correlationand we should be able to use
cardiac arrest, mortality andinfarct size as the primary
endpoints for this next trial.
So that was a very interesting,engaging conversation and you
know, as you may know, ben, ifyou don't meet your primary
endpoint in your phase twoclinical trial, typically

(42:09):
companies don't, you know, keeppursuing it, thankfully for us.
You know Harry and Jim both werevery insistent that you know
the way the drug works.
There is a path forward.
They went back, they engagedwith the FDA and the FDA was
better receptive to, you know,the safety profile and the data
that they had seen here.
So not only did the FDA engage,but what they were able to

(42:33):
achieve, what Harry and Jim wereable to achieve with the FDA
was to get a special protocolassessment from the FDA.
Now, what does special protocolassessment mean?
It's basically, you know, thatthe FDA and the team, the
sponsor, look at and design thetrial together to a certain
extent, and so you know theprimary endpoints are

(42:55):
well-defined the timing ofadministration, where we are
going to do the trial, how weare going to do it.
The trial design is already allagreed upon under the SPAR, so
there's not going to be anysurprises when you get to the
far end of actually conductingthe clinical trial.
The other thing that we wereable to work with the FDA was,
you know, given the delta thatwe had between the placebo arm

(43:15):
and the treatment arm of, youknow, 50% and 80% that I
mentioned before, the trialactually is a very small trial.
It's only a 1,600-patient trialcompared to, you know, tens of
thousands of patients.

Ben Comer (43:27):
For most cardiovascular trials?
Yeah, much larger.

Atul Deshpande, Ph.D. (43:30):
Most cardiovascular trials exactly.
So this is only a 1, for mostcardiovascular trials, yeah,

(43:55):
much larger interim readout at900 patients, and if the data
for cardiac arrest and mortalitylooks the same as we have in
the phase two, it does notreally make sense to continue
exposing people to placebo.
We should be converting theminto a treatment arm, and so the
FDA agreed with it, and what wehave right now is, under the
SPAR, we have this, you know,1600 patient trial, but also an
interim readout at 900 patients,and if we are able to show the
same data as we had, we wouldget pretty much a full approval

(44:18):
or an accelerated approval tobring IMT358 to market as
quickly as possible, and then,depending on what the data looks
like, we may, you know,continue to run the remaining
700 patients and then followthese patients for a period of
two years to understand thelong-term effects and the
benefits of IMT-358.

Ben Comer (44:35):
And IMT-358 has also received a breakthrough therapy
designation from the FDA.
I guess what are the biggestbenefits that you see with that
designation?

Atul Deshpande, Ph.D. (44:46):
Right.
So the breakthrough designationhas been really, really helpful
for us, because what it allowsus to do is, you know, have a
constant engagement with the FDA.
Whatever questions we may have,you know it's where they.
You know they're reallyreceptive and looking to work
with the sponsors for, you know,for these breakthrough
therapies, because they reallybelieve that these could have a

(45:08):
significant impact on patientlives.
These could have a significantimpact on patient lives, and so
it's a lot more collaborative,congealed conversation that we
have with the FDA that we havecontinued to this day.
And the other thing that italso gives us is a shorter
review period.
So, instead of a year-longreview that the FDA typically
takes for NDAs or BLAs, thiswould be a six-month review

(45:30):
period for bringing this drug tomarket.

Ben Comer (45:33):
Got it.
And then I want to get to thephase three trial and your
upcoming plans for this product,how you're going to get that
trial completed.
But I had one more questionabout IMT358, which it's been
given a BLA pathway.
It's considered a biologic,which is interesting.
Can you explain why?
Because typically, as you know,Atul and, as we talked about,

(45:58):
insulin has not been considereda biologic historically, and
neither is potassium and glucose.
How were you able to get a BLApathway and have this drug be
considered a biologic?

Atul Deshpande, Ph.D. (46:11):
Right.
So there's a couple of piecesof that story there.
Ben One is you know, if youlook at the BLA designation the
biologic so there's a very youknow well-defined criteria for
what is considered a biologicand it has to have a certain
number of amino acids andinsulin basically falls under
those number of amino acids youknow to be considered a biologic
.
So that is why traditionally ithas to have a certain number of

(46:31):
amino acids and insulinbasically falls under those
number of amino acids to beconsidered a biologic.
So that is why traditionally ithas not been considered a
biologic.
But where we were able to arguewith the FDA was that the
amount and the concentrations ofinsulin that we are giving to
these patients are at asupraphysiological level, not at
a insulin replacement dosagethat we typically do for

(46:54):
diabetes and other conditions.
This is much, much, much, much,much higher concentrations and
therefore, given that form ofinsulin that is going into the
body, it should be considered asa biologic.
And we were able to convincethe FDA that that rationale
should hold true versuseverywhere else where insulin is
typically used.

(47:15):
And that is how we were able toconvince them about the
biologic license application orbiologic or the BLA designation.
The benefit of that is multiplefold, as you can imagine.
On the IP side of things I'llcome to the IP story in a second
.
You can imagine On the IP sideof things, I'll come to the IP
story in a second.

(47:35):
But you know, with glucose,potassium insulin, there's no
composition of matter IP that itcan put into place.
I mean, the USPTO or any otheryou know agency across the world
is not going to give you, youknow, for combining three
different things that arealready out there in the public
domain.
And so what the BLA does inlieu of a composition of their
IP is gives us 12 years ofexclusivity.
Here in the US, typically, ifyou look at any drug coming to

(47:59):
market, you know patent life isabout 20 years.
You know, on an average, anydrug takes anywhere 10 to 12
years to come to market andyou're left with, you know,
maybe eight, maybe 10 years ofpatent exclusivity in the
marketplace.
But with the regulatoryexclusivity that we have, we

(48:19):
already are from the onset.
As soon as the trial is done,the BLA designation kicks in and
we have 12 years of exclusivityfrom the time the trial is done
to make sure that we are ableto make this and keep this in
the marketplace under theimmediate umbrella.

Ben Comer (48:37):
Yeah, and intellectual property is it?
I'm glad we're coming to thatnext.
It's a key piece of anybiotech's valuation and
something that I'm sure isprobably the first question that
you get from potentialinvestors, which I would assume
are what's standing between youand the launch and completion of
the phase three trial.
So what you know, what else canyou say?
Is there anything else to sayabout?
You know your IP holdingsaround GIK?

(48:59):
You've just laid out, you know,through the BLA, that you, you
know you get some runway, goodexclusivity there.
Is there anything else that youwant to share just generally
about the IP holdings thatimmediately?
Is there anything else that youwant to share just generally
about the IP holdings thatimmediately?

Atul Deshpande, Ph.D. (49:13):
Yeah, absolutely Ben.
So one of the things that wehave done is kind of built a
moat around the INT358.
And part of the moat isobviously this you know, bla
designation.
It's a big one.
It's a big win from anintellectual property
perspective.
Traditionally, if you, you know, kind of look at intellectual
property, it unfortunately getsequated to patents.

(49:33):
But there's so many other waysof intellectual property or
protection, know-hows, andpatents are part of it,
trademarks are part of it.
The know-how around doing thisclinical trial is a big one.
As we discussed before, there'sa lot of tacit knowledge that

(49:53):
sits with the team to carry outthis last phase three clinical
trial.
One thing that I mentioned toforget in terms of the SPA
designation was also for thephase three, we actually don't
have to do two clinical trials.
We only have to do one 1600patient clinical trial, because
the phase two would beconsidered as the second pivotal
trial.

Ben Comer (50:13):
Oh, okay, so no confirmatory phase three
Excellent.

Atul Deshpande, Ph.D. (50:16):
Exactly, exactly, and so going back to
the moat around that, the BLA isobviously a big win.
But the other thing is also wehave a companion diagnostic that
I mentioned before, which wealready have a patent for.
It's called GIKTP, and again,that's a tool to identify, you
know, which patient is going tobenefit the most from
administration of GIK.

(50:37):
Now you know that is somethingthat we'll have to, you know,
kind of think about when webring this to market, because
what we want to do is give thebenefit to all of our patient
population.
You don't know which patient isgoing to convert at what point
in time into a full-blown heartattack, and so that is something
that we'll look into.
But a companion diagnostic isagain a beneficial way of
protecting your intellectualproperty portfolio.

(50:59):
The other things that we havealso done is around the process
of manufacturing and the wayit's packaged.
If you look at the way insulinis typically shipped, it's
shipped in glass vials or inglass syringes, and the reason
for that is insulin is a littlebit of a sticky substance.
If you put it in a PVC bag,it's going to stick to the walls

(51:20):
of the PVC bags and the ratiois going to change and you're
not going to see the benefit,and so we have worked already
with a couple of manufacturersthat can manufacture bags that
are inert to the insulinstickiness.
And those are some of theprovisional IPs that we have
already filed, and you know, aswe go through the process, the
next steps will be finding, youknow, conformatory patterns

(51:42):
around them.

Ben Comer (51:43):
Interesting.
It occurred to me that ifyou're using a kind of souped up
version of insulin, is thereany risk of hyperglycemia when
you administer that to patients,or is it too small of an amount
?

Atul Deshpande, Ph.D. (51:55):
Yeah, you know, the combination that
we're giving is such a balancedcombination that with all these
patients in our trial, but thenalso the other trials, we
haven't seen any side effectwhatsoever.
Hypo hyper glycemia you know ithas been given to diabetic
patients, you know kidneydisease patients.

(52:16):
We haven't seen any down, youknow, or side effects of this
extremely balanced combination,you have the glucose component.

Ben Comer (52:25):
that's balancing.

Atul Deshpande, Ph.D. (52:25):
Exactly, got it Exactly, exactly, and so
you know.
One final point on the IP thingas you said, you know that with
four major law firms here thatspecialize in IP and life

(52:56):
sciences and kind of scoredwhere the IP portfolio for
IMT358 might fall against someof the other blockbuster drugs
in the market and you know I wassurprised myself when we ran
that exercise the IP portfoliofor IMT 358 is pretty much neck
to neck with some of theblockbusters that are already
out there in the market.

(53:16):
So that gives me a lot ofconfidence that you know not
only that we have the BLA andeverything else, but this is a
product that can stand its ownand hold its own in the
marketplace without the risk ofgeneralization in at least the
first 12 years that we bring itto market risk of generalization
in at least the first 12 yearsthat we bring it to market?

Ben Comer (53:35):
Have you engaged payers about this product?
And granted, it's got tocomplete a phase three and be
approved ultimately by the FDAbefore it reaches the market.
But what kind of feedback?
If you've engaged with payers,have you heard from them about
this?

Atul Deshpande, Ph.D. (53:48):
That's an excellent question, ben,
because a lot of times, asfounders or as clinical
developers, we forget that theclinical benefit is only a part
of the story.
The other question that youneed to ask is who's going to
pay for it and how much, and sothat was one of the first things
that we did in June of 2021, isI have an excellent scientific

(54:12):
advisory board member, edPazella, who comes from United,
having worked several years atUnited, and brought that exact
same conversation to us.
What we did at that time wasactually have a peer ad board
where we had two national levelpeers and two regional pairs
come sit around the table withus and exchange what we have in

(54:35):
terms of IMD 358 and what theythink about the profile of the
drug and what they would bewilling to pay for the drug
eventually down the line, oncewe bring it to market.
The response was phenomenal.
Honestly, one of the thingsthat I have and I go back to
those notes all the time is oneof the pairs actually said it's
not a question of if this comesto market, it's a question of

(54:57):
when this comes to market, andthat was looking at the target
product profile for the drug andthe safety profile for the drug
and the data that we showedthem from the phase two clinical
trial.
Not just these three things thatI told you about mortality,
cardiac arrest and infarct sizebut also at the molecular level,
where the free floating fattyacids, which is one of the

(55:19):
critical components whichincreases in heart attacks, is
reduced significantly very earlyon as you start the treatment.
So it's not only affecting thesigns, but also not only
affecting the symptoms, but alsothe signs, the underlying, you
know molecular pathways ofinfarct size and heart damage.
So, going through thatconversation, it was a very
interesting conversation as wewent to the next part, because

(55:41):
the question was okay I likeyour answer of, when it comes to
market, how much are youwilling to pay for it, and so
one of the things that we didwas working with Peter Newman at
Tufts Medical, who was one ofthe leading, you know, cost
effectiveness economists andthing, and Josh Cohen and his
team.
We had looked at what benefitwould this drug bring to
patients.

(56:01):
Imagine leaving the hospitalwith a 30% infarct size or a 20%
infarct size not getting IMT358, versus leaving the hospital
with a-person infarct size,because you got IMT-358 on time
and were able to stop thatinfarct right in its path.
And so when we look at, you know, potentially the less number of
days in the ICU or the hospitaloverall, less number of

(56:23):
readmissions, less, you know,rehabilitation, a better quality
of life, so on and so forth,you would have a significant
amount of cost offset that youwould get from giving the
patients IMT-358.
And so we showed them thenumbers.
You know runs into tens ofthousands of dollars with just
one single administration ofIMT-358.
And they were, you know,convinced that.

(56:43):
You know whatever you knowprice you come back to you know
it should be supported, you know, in line with some of the other
drugs that are out there in themarket.
We also did a QALY analysis.
So at 150,000 QALY, typicallywhat we look at is what would be
the price at which the drugwould provide value, and 150,000

(57:04):
QALY, the price could bepotentially a $24,000 drug.
But, that is not where we aregoing to position it.
We are very sensitive to marketaccess because our mission is
to get this to patients, it'snot to profit crazy off of
pricing it way higher than itcould, and so our position there

(57:25):
is we want to bring this as adrug that is given to any
symptomatic ACS patients asquickly as possible, and
therefore it has to beaccessible and affordable at
that point of care.

Ben Comer (57:37):
Excellent.
So what are your next steps?
Are you in full fundraisingmode at this point?
Atul, you know what I guessbest case scenario.
What would you?
When would you like to see thephase three, you know, started
and even you know those firstreadouts being announced or
publicized?

Atul Deshpande, Ph.D. (57:53):
Yeah.
So, yes, right now we are in afull fundraising mode.
It's a $50 million fundraise.
Most of it is going towards theclinical trial and the
manufacturing piece of it.
So we have our CROs lined up todo that.
We have our manufacturer linedup to manufacture and bring the
product to market.
We have our shippers lined upto do so.

(58:15):
So the idea is to hopefullyclose the round before the end
of the year and get the trialpreparation started in Q1 of
next year.
We anticipate taking about ayear to enroll the first 900
patients.
So we are looking at mid-2027to come out with the first set
of data from the interimreadouts and then, depending on

(58:37):
what the data looks like, wemight be in the market by the
end of 2027 or potentially sixmonths after, if you have to
continue carrying out theremaining 700 patients through
the clinical trial.
One of the things, then, is whenyou know, when we think about
the way IMD-T5-8 works, themechanism of action it's not

(58:57):
only limited to heart attacks orACS the way we are looking at
it is the underlying red threadaround this is ischemic injury,
and ischemic injury can happenin a lot of different
circumstances.
It could happen in traumaSomeone falls down from a ladder
or gets into a car accident,still the standard of care is

(59:19):
aspirin and saline If someone isundergoing high-risk surgeries.
These patients, because of thecomorbidities and everything
that they come in with livertransplant, kidney transplants,
you know, joint replacements,they may have cardiovascular
complications, and so you know agood number of patients with
all these comorbidities may beat the highest patients that

(59:41):
will benefit from havingsomething like this during and
after surgery given to protectthe heart.
And then eventually, you knowthere are other kinds of
ischemia, for example stroke,where a combination like this
may also be beneficial.
So we're kind of building aportfolio in a product approach
to make sure that we are able toaddress those you know ischemic

(01:00:02):
emergency, and just define anew global standard for those
ischemic emergency rather thanjust you know, the standard of
care which hasn't changed fordecades in the form of aspirin
and saline.

Ben Comer (01:00:13):
So you will pursue those additional indications you
know following, you know, asuccessful phase three and
market launch in the initialindication.
Is that your plan?

Atul Deshpande, Ph.D. (01:00:23):
That is absolutely our plan.
Acs is our first indication butwe already have, you know,
plans lined up, clinical trialsthought about for the additional
indications.
And not just that, there'sactually a list of 15 other
indications that we havereviewed, looked at the
scientific data, looked at theunderlying mechanisms, including

(01:00:44):
, you know, one, expanding intooncology, where patients could
benefit from it.
And you know, as I startedreaching out to cardiologists
across the world, all the wayfrom Alaska to Australia,
cardiologists have been comingto me and asking hey, have you
thought about this indication?
I mean, you know there was anevent history around oncology

(01:01:05):
and cardiovascular in my ownfamily, but this cardiovascular
oncology connection was alsoproposed by another leading
cardiologist here in the US whoactually said you know, if you
want, I can run this trial foryou.

Ben Comer (01:01:21):
Wow, interesting.
Well, that leads me to ask youknow you mentioned you have your
CDMOs in place, yourmanufacturing in place.
Do you anticipate needing acommercial partner to launch
this after it makes it acrossthe finish line and is approved
by FDA?

Atul Deshpande, Ph.D. (01:01:38):
We would absolutely love to have someone
who has the right channelsestablished into the place where
we are going to position this,which is the emergency rooms.
So if there are companies,strategics, that are interested
in partnering with us in, incommercializing this, we are
more than open to thatconversation.
But we are not limited by thatconversation.

(01:01:59):
And that again, you know, takesme back to my depiction,
experience of launchingdepiction and having the
knowledge base and the know-howof of how to bring a successful
blockbuster drug to market.
And so you know we would loveto partner with the right
partners to bring this to marketand to patients as quickly as
possible.
But we are not limited by that,given the experience that sits

(01:02:20):
within the organization to do itourselves as well.

Ben Comer (01:02:22):
And so you would look at global markets as well, and
you're willing to become asexhausted as you were after
Duplexant with this product.

Atul Deshpande, Ph.D (01:02:31):
Absolutely .
You know, honestly, I would loveto do that because you know,
every single time that we hearstories about patient success,
about how to benefit from, youknow, any of the drugs that we
come to market, that you know it.
It it channelizes you, itenergizes you, it, you know it
allows you to focus and you knowit gives you the purpose, why
you're doing, you know whatyou're doing, and so the idea

(01:02:53):
here is, even with the phasethree clinical trials right now,
as we speak, ben, we areexploring potentially having
sites in Europe, we areexploring potentially having
sites in Australia.
You know we have had aconversation with a couple of,
you know, agencies in the MiddleEast in terms of, you know,
potentially bringing disruptivemarket there, and so we're not
just thinking US, we're thinkingway beyond US because the

(01:03:17):
benefit that this combinationcan bring to patients is, I
think, you know, justunbelievable and there's no
reason why we should limit it toany specific market.
Or, like I said, there's noreason why we should not look
beyond the initial indication ofcardiac arrest.
But, you know, think aboutwhere this combination can be
cardioprotective, where thiscombination can be

(01:03:38):
neuroprotective and therefore,you know, give the maximum
benefit to all the patients.

Ben Comer (01:03:43):
Atul, thank you so much for coming on the show and
sharing your journey, as well aswhat immediate therapeutics is
up to.
I really appreciate it.

Atul Deshpande, Ph.D. (01:03:53):
Thank you for taking the time and really
thank you so much for allowingme to share what we are so
passionate about.

Ben Comer (01:03:59):
We've been speaking with Atul Deshpande, phd, ceo at
immediate therapeutics.
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.

(01:04:20):
We'll see you next week andthanks, as always, for listening
.