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Dina Burkitbayeva, MBA. February 2024

May 14, 2024

Title: An overview of the current psychedelic business and investment landscape

ID
11671

Transcript

  • 00:03All right. So thank you, Chris.
  • 00:06As Chris mentioned, I wear,
  • 00:09I've been involved in the
  • 00:10psychedelic industry in a few ways.
  • 00:12So the 1st way I got
  • 00:14involved is as an investor,
  • 00:16first as an Angel investor.
  • 00:18So I was one of the first Angel investors
  • 00:21to start supporting the psychedelic space.
  • 00:24And you know this was sort of 20/16/2017.
  • 00:28And then as the industry grew,
  • 00:30I became a venture investor forming my
  • 00:33own venture fund called Simon Ventures.
  • 00:36It's actually one of a handful of venture
  • 00:40funds that we say mushroomed as as the
  • 00:44psychedelic boom started and started
  • 00:47investing in this very rapidly growing space.
  • 00:52And then in 2020,
  • 00:53I met Doctor John Crystal doing actually due
  • 00:56diligence on another psychedelics company.
  • 00:59And then obviously once I learned what
  • 01:02incredible work has been done at Yale,
  • 01:05I knew that I wanted to be
  • 01:06involved in a bigger way.
  • 01:07And so Simon incubated Freedom
  • 01:10Biosciences and I became acting CEO,
  • 01:13transitioning to be full time CEO and
  • 01:17eventually leaving as an active kind of
  • 01:20fully operating partner at Simon Ventures.
  • 01:22So there's there's one other way
  • 01:26that I'm involved in the psychedelic
  • 01:28space is is I'm doing a very part
  • 01:31time PhD at a California Institute
  • 01:34of Integral Studies which is a school
  • 01:38in in San Francisco which is very
  • 01:40different from I would say Yale.
  • 01:43And the focus there is really how
  • 01:46it it it's it's the first school
  • 01:49where they launched the Psychedelic
  • 01:51Research Center on Training Therapists.
  • 01:53So most of the therapists in the MAPS
  • 01:57trials for example are coming out
  • 01:59of CIS and it's it's it's a focus
  • 02:01more on the kind of the therapy
  • 02:03modalities and how to support patients.
  • 02:06So it was it was kind of important
  • 02:07for me not to just sort of stay
  • 02:09at high level on the investing and
  • 02:11the operating side,
  • 02:12but also sort of what's happening
  • 02:15in the room with with a patient and
  • 02:18how do patients get supported and
  • 02:21how do therapists get trained.
  • 02:24So kind of a Broadway that I've been
  • 02:27involved in in the psychedelic space.
  • 02:29It seems that probably the most
  • 02:33helpful topic to cover here is what's
  • 02:35happening on the investing side.
  • 02:40And I have a few slides prepared here,
  • 02:43but then would love to take your
  • 02:46questions and and answer those.
  • 02:48So some of the slides that I will be showing
  • 02:51are those prepared by Simon Adventures,
  • 02:54which is which is the fund that I Co founded.
  • 02:57Let's see if I can manage to share. While
  • 03:02you're pulling those up,
  • 03:03could you, for this group,
  • 03:04could you define the different?
  • 03:06You said you started out as an Angel vest,
  • 03:08Angel investor and then you
  • 03:09then started the venture front.
  • 03:10Could you define
  • 03:11those terms? Sure, absolutely.
  • 03:14So an Angel investor is someone
  • 03:17who's investing personally,
  • 03:18not kind of representing a group of
  • 03:24investors and not doing it professionally,
  • 03:26I would say, right.
  • 03:27So an Angel investor is someone who's
  • 03:29taking their own money and investing
  • 03:31versus a professional investor,
  • 03:33someone who would form a fund would
  • 03:36need to have certain qualification
  • 03:39certifications and then form a a
  • 03:42venture fund in this particular
  • 03:44instance and pull money from
  • 03:47various investors and then do due
  • 03:49diligence and invest into companies.
  • 03:52Thank
  • 03:52you. We're seeing your slides,
  • 03:54but we're seeing the presenter view.
  • 03:55You may want to swap displays.
  • 03:57How do I do that?
  • 03:59At the top there's well,
  • 04:02go go back to to sharing and there's
  • 04:06a swap displays button at the top.
  • 04:09Oh, there, there.
  • 04:10We're good. Perfect.
  • 04:12All right. So I think, you know it's it's no,
  • 04:21this is something that we usually cover
  • 04:24with with potential investors and I
  • 04:27don't think this is news to anyone.
  • 04:30But mental health is one of humanity's
  • 04:33biggest crises and I think COVID-19 has
  • 04:38a kind of contributed to to
  • 04:41the growth of this crisis but
  • 04:44also putting a spotlight on it.
  • 04:46So one thing that I think is usually
  • 04:50very interesting for investors to
  • 04:52know is that psychedelics, right,
  • 04:57are something that have been around
  • 05:01for millennia and these have been
  • 05:05indigenous practices that were practice
  • 05:08across across the world in different
  • 05:11pockets of the world and have been
  • 05:13big parts of different cultures.
  • 05:15So psilocybin and peyote in Mexico,
  • 05:19ayahuasca and Peru and and the Amazon
  • 05:23and Iboga in Gabon, Africa, right.
  • 05:26And so this is something that's
  • 05:28usually very interesting for people
  • 05:30who are not close to the medicine to
  • 05:33know because a lot of the knowledge
  • 05:35of psychedelics is more from,
  • 05:37you know starting the 40s and
  • 05:38the 50s in the Western world.
  • 05:43Again, I think this is a group
  • 05:45that a lot about this already.
  • 05:47So Chris, let me know if we're we
  • 05:50should kind of Fast forward from this.
  • 05:54You could be be efficient with this but
  • 05:56it's efficient. OK.
  • 05:59So there's you know the way kind
  • 06:02of the investing world looks
  • 06:04at it is there's three pockets
  • 06:07in within psychedelics, right.
  • 06:09There's the, there's the traditional
  • 06:11psychedelics which are the
  • 06:12five HT two based tryptamines.
  • 06:14There's the intactogens such as MDMA
  • 06:17and different derivatives of that.
  • 06:19And then there is kind
  • 06:21of ketamine S ketamine,
  • 06:22the NMDA receptor modulators and the
  • 06:26psychedelic assisted psychotherapies
  • 06:28based on these three kind of groups
  • 06:33of molecules are are similar and
  • 06:36different in in other ways as well.
  • 06:40So I think you know based on
  • 06:44what the slide suggesting,
  • 06:46there's different,
  • 06:48there's different assisted
  • 06:50psychotherapy modalities that go
  • 06:52with these different molecules
  • 06:55and MDMA is one that is due to
  • 07:00be approved just a few days ago.
  • 07:03It got a priority review from the FDA
  • 07:08and you know most likely there will
  • 07:11be approval by August of this year.
  • 07:14Ketamine and escetamine are
  • 07:15obviously already on the market.
  • 07:16Ketamine is being administered
  • 07:19off label for mood disorders.
  • 07:22Esketamine was approved for two
  • 07:25indications in 2019 and then sort
  • 07:29of the next after MDMA in probably
  • 07:33around three years time would be
  • 07:37psilocybin assisted psychotherapy
  • 07:39that would be approved by the FDA
  • 07:42followed by various other programs and
  • 07:45there's there's quite a few of them.
  • 07:48Again,
  • 07:49I think this is something that
  • 07:50this group knows very well.
  • 07:52We don't have to cover this,
  • 07:58so important things here are for for
  • 08:02psychedelic assisted psychotherapy, set and
  • 08:05setting are very important, and usually
  • 08:11this is something that is offered in
  • 08:17A single room that's noise insulated.
  • 08:21There's one or two psychotherapists
  • 08:25or guides that are in the
  • 08:28room supporting the patient.
  • 08:32There's usually a blindfold and
  • 08:34music that's being played, but again,
  • 08:38it differs between the different modalities.
  • 08:41So this would be something that
  • 08:44would be offered with psilocybin
  • 08:46and MDMA and not something that's
  • 08:50usually required with ketamine,
  • 08:52Norse ketamine.
  • 08:55So I think just transitioning more over
  • 08:59to the topic of sort of how does the
  • 09:03investment world look at it, right.
  • 09:07So the there's no question about
  • 09:12whether this is a large market, right.
  • 09:15So as as we already said,
  • 09:18mental health is a huge problem right now.
  • 09:23And if we were to put dollar
  • 09:25amounts right on this,
  • 09:27if we had to put dollar amounts on this,
  • 09:29each one of these indications is,
  • 09:31is a really big potential opportunity
  • 09:35for investors, biotech companies
  • 09:38and pharma companies to address.
  • 09:42So you know,
  • 09:45psychedelics are being obviously
  • 09:48studied for various mood disorders,
  • 09:52but there's also interest and there
  • 09:57are studies that are going on for
  • 09:59neurodegenerative diseases, pain,
  • 10:00traumatic brain injury etcetera.
  • 10:04So these are just some of the indications
  • 10:08that psychedelics are being considered for.
  • 10:10And I think this the the number
  • 10:14of indications is due to grow in
  • 10:17terms of where investors have been
  • 10:20deploying capital and there's around
  • 10:23$2 billion plus that's been deployed
  • 10:26in psychedelics since I would say
  • 10:28around 2017 and $2 billion is,
  • 10:32is is obviously a lot of money,
  • 10:33but by pharma standards it's
  • 10:35it's really not a lot.
  • 10:37It's a it's kind of a nascent,
  • 10:40very niche industry so far.
  • 10:46So you know within psychedelics
  • 10:50where investors have been putting
  • 10:51in money is a few sectors.
  • 10:53Obviously drug discovery,
  • 10:55this is by far the largest
  • 10:59sector where psychedelics investments
  • 11:02have gone. You know you you,
  • 11:06you've probably seen this in the headlines.
  • 11:08There's some really big companies
  • 11:10that have raised hundreds of
  • 11:11millions of dollars. Some of these,
  • 11:15the largest ones have been Attire,
  • 11:17Life Sciences, Compass, Pathways,
  • 11:20Siben, Mind Med, etcetera.
  • 11:22It takes around you know 4 to 500 million
  • 11:27to bring a single drug to approval.
  • 11:31So if you look at you know sort of 2 billion
  • 11:36or so that's been invested in psychedelics,
  • 11:39it it's really not a lot, right.
  • 11:41If we kind of say 2 billion
  • 11:44has been invested,
  • 11:44takes about half a billion to bring a drug
  • 11:47to market that covers just about four drugs.
  • 11:51But obviously a lot of the capital
  • 11:54has gone towards other things
  • 11:56than just drug discovery.
  • 12:02Drug delivery is also something
  • 12:08is is where capital has gone into as
  • 12:13well as clinics retreats and telehealth.
  • 12:15What we mean by clinics,
  • 12:17retreats and telehealth here is
  • 12:19primarily has been ketamine clinics.
  • 12:21So the number of ketamine clinics
  • 12:23has grown 10X between 2015 and now.
  • 12:28So in 2015 there were 60 ketamine
  • 12:30clinics across the US and now
  • 12:33there's over 600 of them.
  • 12:35This was primarily driven by actually the
  • 12:40discovery that was made by John Crystal,
  • 12:42Rob Berman and their collaborators
  • 12:43in the late 90s,
  • 12:45the Berman 2000 paper that showed
  • 12:47that ketamine is an antidepressant
  • 12:50in humans and you know,
  • 12:53more and more clinics started
  • 12:56offering IVIM ketamine for depression.
  • 13:00And as Sprobato started moving
  • 13:03through the clinic and there was
  • 13:06more and more sort of clinical
  • 13:08evidence that ketamine is a
  • 13:13is is a potent and fast acting
  • 13:16antidepressant, individual doctors,
  • 13:18most of whom are anesthesiologists,
  • 13:21started forming their own
  • 13:23private ketamine clinics.
  • 13:25And that number has really, really
  • 13:27grown fast in the last 8-8 years or so.
  • 13:33Obviously retreats is another one.
  • 13:35There's many retreats,
  • 13:36most of which are outside of the US
  • 13:39because a lot of psychedelics are
  • 13:40still schedule one are not allowed.
  • 13:42But in places like Mexico, Costa Rica,
  • 13:46the Netherlands, Portugal,
  • 13:49I think there's been a few that
  • 13:52have been founded in Spain as well.
  • 13:55Telehealth is another one.
  • 13:57We've made a few investments
  • 14:00in the telehealth space,
  • 14:01but this is again primarily around
  • 14:06ketamine because that's the only
  • 14:10one that's that can be administered
  • 14:16via telehealth these days.
  • 14:18So there's companies and there's
  • 14:21many of these companies that are
  • 14:26providing ketamine via mail order.
  • 14:29So you can call in, have a, you know,
  • 14:34a few minutes conversation with
  • 14:36a doctor that will prescribe you
  • 14:39ketamine and then a compounding
  • 14:41pharmacy will ship that to you.
  • 14:44And we have not made actually any any
  • 14:48investments into companies like that.
  • 14:50We've only supported companies
  • 14:53that continue to ask for A to have
  • 14:57a relationship with a therapist.
  • 15:01There's also companies in
  • 15:03the software space that are
  • 15:08getting formed around the psychedelic space.
  • 15:12These are software companies
  • 15:13that are primarily supporting
  • 15:15the growing number of clinics.
  • 15:17So clinics need EHRSEMRS and other
  • 15:21types of support to to do booking,
  • 15:25scheduling, etcetera.
  • 15:27And there's a few companies that have
  • 15:29been formed and are doing quite well.
  • 15:31There's obviously education,
  • 15:32especially on the therapist front.
  • 15:35There's a lot of interest from
  • 15:38therapists who would like to work with
  • 15:42psychedelic assisted psychotherapy,
  • 15:44and there are a few companies
  • 15:47that are providing platforms for
  • 15:50existing licensed psychotherapy
  • 15:52psychotherapists to be trained with
  • 15:55ketamine and to start providing
  • 15:58ketamine assisted psychotherapy
  • 16:00as part of their practice today.
  • 16:03And obviously some media companies as well.
  • 16:07So this number is, is now more,
  • 16:11it's over 2 billion that have
  • 16:14been invested now through 2023.
  • 16:16And as you can see this is a number
  • 16:20that's you know that just exploded.
  • 16:23If we're looking at around
  • 16:2510 million in 2017,
  • 16:26this grew to you know 6700 million in 2021.
  • 16:35So the interest has been really tremendous.
  • 16:39So
  • 16:42you know I think what it is not really
  • 16:47a surprise to this group but a lot of
  • 16:50times when we speak at with investors
  • 16:54assignment people usually equate
  • 16:56or you know they find similarities
  • 17:00between psychedelics and cannabis.
  • 17:03And we have to make the point
  • 17:06that the psychedelic therapeutics
  • 17:08that we support through the fund
  • 17:12and there's a huge industry built
  • 17:15around are the are the teams that
  • 17:20are taking psychedelics through FDA
  • 17:23approval rather than having it be a
  • 17:26recreational for recreational use right.
  • 17:28And so this is
  • 17:35just sort of a graphic to show based
  • 17:38on where a a drug developer is,
  • 17:41what the probability of of
  • 17:44of their approval could be.
  • 17:46And this is obviously across
  • 17:48industries and in different companies,
  • 17:50but kind of gives you an understanding
  • 17:54a lot of the psychedelic,
  • 17:57the there's there's sort of three
  • 18:00waves of psychedelic drug development
  • 18:03companies that we've identified.
  • 18:06The first ones are obviously the
  • 18:09ones that came first and it's it's
  • 18:12companies such as Compass Pathways where
  • 18:15they take an existing compound that
  • 18:18they synthesize such as psilocybin.
  • 18:21There is there's some IP that
  • 18:23can be built around that,
  • 18:25but it's it's really around kind
  • 18:28of this existing first generation
  • 18:33psychedelic drug that they're developing
  • 18:36and trying to take through the FDA.
  • 18:39There was a second and there still is.
  • 18:43There still are companies that are
  • 18:45being built and programs that are
  • 18:47being developed in the second wave.
  • 18:49And the 2nd wave is basically derivatives
  • 18:52of these existing psychedelics.
  • 18:57And these most of the time are new
  • 18:59compound entities and they live in sort
  • 19:02of this drug discovery preclinical space.
  • 19:05A few of the companies,
  • 19:06oops apologize,
  • 19:10a few of these companies have now
  • 19:13are now in phase one.
  • 19:17But there were you know 10s of
  • 19:21thousands of molecules that were
  • 19:24derivatives of these existing
  • 19:26psychedelics created in in in the last,
  • 19:31I would say 6 or so years.
  • 19:33And just a few of these new compound
  • 19:36entities are now in phase one.
  • 19:37We're very excited to see sort of
  • 19:40where those go And there's the third
  • 19:46wave of psychedelics is and those
  • 19:50are non holosinogenic psychedelics.
  • 19:53Those could be combos or
  • 19:56new compound entities.
  • 19:57And there's a lot of interest
  • 20:00currently in the non holosinogenic
  • 20:02psychedelics that are hoping to take
  • 20:04advantage of the neurogenesis but
  • 20:06sort of engineer out the side effects.
  • 20:09And you know sitting where I sit
  • 20:12and having spoken to various
  • 20:15investors including those from sort
  • 20:17of you know strategic large pharma,
  • 20:20venture arms,
  • 20:21business development arms as well
  • 20:23as large biotech healthcare funds.
  • 20:25There is a lot of interest in non
  • 20:29hallucinogenic psychedelics because
  • 20:31that would comply more with the
  • 20:33the large pharma model of you know
  • 20:36people being able to take a drug,
  • 20:38a pill a day and and not sort
  • 20:44of have to incur the burdensome
  • 20:47administration and the cost of needing
  • 20:49to go into a clinic and doing kind
  • 20:52of the the the treatment session
  • 20:53with with the holosynogenic trip.
  • 21:00I think we've talked about this already.
  • 21:04These are just some of the
  • 21:07examples of the various clinics and
  • 21:11retreats that are that are that have
  • 21:15been formed in the space and these
  • 21:19companies are continuing to grow and
  • 21:22their numbers are increasing as well.
  • 21:25However, one thing that I will say
  • 21:29is that the funding sure let me
  • 21:35stop sharing the funding in the
  • 21:38psychedelic space has been very
  • 21:40challenging in the last two plus years.
  • 21:42I think this is in line
  • 21:44with what's happening,
  • 21:45you know across biotech,
  • 21:48the biotech winter that started probably
  • 21:52late fall of 2021 and is definitely
  • 21:58affected psychedelics therapeutics as well.
  • 22:00So those numbers of investment
  • 22:02that you've seen,
  • 22:03they kind of hit a peak in 2021 and
  • 22:06they've been on the decline in 22 and 23.
  • 22:13Yeah. I I'm wondering, I know
  • 22:16we're about halfway through now
  • 22:20if there's anything that's more
  • 22:24of interest that I can go into.
  • 22:28Maybe we can start out by a few
  • 22:30people have questions or reactions
  • 22:32to what you've shared up till now
  • 22:34about the overview you've given,
  • 22:35which was really helpful.
  • 22:36We can start there and then we can
  • 22:39open it up more broadly for anything
  • 22:41else folks want to talk about.
  • 22:45I mean I'll start with a question
  • 22:48just to get things going which is
  • 22:51the something that's kind of unique
  • 22:53about this space relative to other
  • 22:55drug developments is some this
  • 22:57development space is that some of
  • 22:59the early big players have been non
  • 23:02profits Usona and MAPS obviously are
  • 23:04what I'm thinking about and I wonder
  • 23:06if you can that which is weird right.
  • 23:08The idea of a non profit pharmaceutical
  • 23:10company or having a non profit bring
  • 23:12a drug try to bring a drug through to
  • 23:15approval And and I wonder if you can
  • 23:17speak to what that what that means what
  • 23:18it does to the space and then what
  • 23:20what challenges they've had because I
  • 23:21know that hasn't been smooth as they
  • 23:22try to scale up into phase three.
  • 23:25Sure absolutely.
  • 23:26So actually yes, absolutely.
  • 23:29So MAPS is you know is a is a non
  • 23:36profit that they then kind of
  • 23:39created APBC that did a lot of
  • 23:42the development for MDMA for PTSD
  • 23:46and now it's Lichas Therapeutics
  • 23:49that has been formed as a fully
  • 23:52for profit company right because
  • 23:54of the enormous capital demands
  • 23:59that this would take and they
  • 24:01recently closed $100 million round
  • 24:03that would focus on helping get
  • 24:05the NDA and then commercialize
  • 24:07the drug I mean Usona as well.
  • 24:11And actually one thing to note is
  • 24:14that COMPASS Pathways actually formed
  • 24:16as a non profit as well in 2017 and
  • 24:19then it was and then it was converted
  • 24:22to for profit in a year or so.
  • 24:24And I think it it,
  • 24:26it makes sense because while Rig Doblin
  • 24:30and MAPS were able to do it but it
  • 24:33took them more than 30 years to get here.
  • 24:36MDMA started being developed in the late 80s,
  • 24:39right.
  • 24:39And what they've done is,
  • 24:41is just tremendous and incredible and
  • 24:44they've pioneered the space in many ways.
  • 24:46But it's it's just incredibly
  • 24:48difficult to raise hundreds of millions
  • 24:51of dollars like I said that that
  • 24:54that are required for development.
  • 24:56So ultimately I think if we wanted
  • 24:59to if if you want to move fast which
  • 25:03many drug development companies do,
  • 25:08you need to be a for profit company.
  • 25:10So you can be raising these amounts
  • 25:12of capital. The reason why you want,
  • 25:14the primary reason why you want to be
  • 25:16moving fast is obviously to get the
  • 25:19drug to patients as soon as possible.
  • 25:21And being a schedule one drug,
  • 25:22it's hard for patients to get access
  • 25:25to it in a kind of legal Safeway.
  • 25:28But the other reason is patent life, right?
  • 25:31Patent life is so important,
  • 25:33but patents are only granted for 20 years.
  • 25:36And usually because it takes companies
  • 25:38about 10 to 12 years to get to approval,
  • 25:41You have, you know,
  • 25:43at best companies are left with 810
  • 25:46years of patent life during which
  • 25:48they're able to recoup the investment
  • 25:51that they've made for development.
  • 25:53And so, you know,
  • 25:55every few months means hundreds of
  • 25:57millions of dollars potentially if you're
  • 26:00a very successful drug and patent life.
  • 26:03So you know,
  • 26:04companies want to move as fast as possible.
  • 26:06They're trying to get to market
  • 26:10as as as soon as they can.
  • 26:12So I guess the answer to my answer to
  • 26:17this question is that it's it's just been
  • 26:20incredible what MAPS has been able to do.
  • 26:23But I think it's it's almost impossible to
  • 26:29think to to be able to do this in in now.
  • 26:35And one of the reasons and this is
  • 26:38something that we've seen in the
  • 26:40last two to three years as a drug
  • 26:43development company at Freedom is
  • 26:46that because so much capital has been
  • 26:49raised between 2020 and 2022 by drug
  • 26:52development companies because you know
  • 26:54there's been so much capital being
  • 26:58invested in biotech during those years,
  • 27:01the cost of development has
  • 27:04gone up significantly.
  • 27:05So if you, you know,
  • 27:07I don't have the exact numbers,
  • 27:08but I would say that CRO costs
  • 27:13and other vendors in the drug
  • 27:16development space have significantly
  • 27:17increased their prices just because
  • 27:19there was inflation of course.
  • 27:21But also there was a lot more
  • 27:24biotech funding which has kind of
  • 27:28you know disturbed the demand supply
  • 27:33with CR OS which made it even more
  • 27:37expensive to to bring drugs to market.
  • 27:39I think it's coming down now as the
  • 27:42funding hasn't been as as available,
  • 27:45but that's definitely something that's
  • 27:47that's been a problem for smaller
  • 27:49biotechs in the last few years.
  • 27:56Chris I don't know if that did
  • 27:57that answer your question.
  • 27:59Yeah it did it did and it's it it
  • 28:00is interesting to see how you know
  • 28:02they did both both maps and then
  • 28:03more recently Usona you know did
  • 28:05did did so well on the nonprofit
  • 28:07model and then kind of hit a wall
  • 28:09when they when the the capital needs
  • 28:11became greater as you as you planned.
  • 28:14Yeah.
  • 28:17Shouldn't you, you mentioned that
  • 28:19non hallucinogenic psychedelics
  • 28:21is an area where
  • 28:22people you know investors are interested
  • 28:24or or you know optimistic about
  • 28:27potential treatments. Are there other
  • 28:29areas that have come up with
  • 28:31in your interactions with
  • 28:32investors either as far as the
  • 28:34clinical population or the mechanism that
  • 28:36people have you know people have been more
  • 28:39excited about of of late.
  • 28:42Yeah you know it's interesting it's it's
  • 28:46sort of like ebbs and flows and I would
  • 28:49say like as probably in many industries
  • 28:54like venture tends to be kind of fatty
  • 28:59where you know something is is is
  • 29:01really attractive and everyone kind of
  • 29:03like runs to that And you know then if
  • 29:06there was if there was sort of some
  • 29:09disappointment there then everyone
  • 29:11turns away and goes somewhere else.
  • 29:13But there's there's been a few of these
  • 29:16waves in psychedelics you know the the
  • 29:20two latest ones that I that come to mind
  • 29:23is the non hallucinogenic psychedelics.
  • 29:25There's there's was a lot of excitement
  • 29:28there still continues to be and sort
  • 29:30of right now I think everyone's
  • 29:32just sort of sitting and waiting
  • 29:33to see what actually shakes out.
  • 29:35I think there's the constant
  • 29:37question that I get is basically,
  • 29:40do you need the holosinogenic effect,
  • 29:42right, for psychedelics to be effective?
  • 29:44Like can you have a non holosinogenic
  • 29:46psychedelic and it will still give
  • 29:48you the antidepressant effect.
  • 29:50And I think certain groups say yes,
  • 29:52other groups say no,
  • 29:53and it's just sort of a waiting
  • 29:56game to see how how this shakes out.
  • 29:59The second one that got a lot of excitement,
  • 30:04but I think the investment
  • 30:06community's feeling less
  • 30:10certainty about now is the
  • 30:13five MEODMT drug, right.
  • 30:15So I mean I think the excitement
  • 30:19started in mid 2021 when a
  • 30:23company called GH Research,
  • 30:26which is an Ireland based company
  • 30:29seemingly came out of nowhere
  • 30:31and had kind of an explosive
  • 30:36debut on the IPO markets.
  • 30:39They raised the substantial Series
  • 30:42B and then they went public a few
  • 30:46months later at a billion dollar
  • 30:49valuation and all they had was
  • 30:52an inhalable 5 MEODMT phase one
  • 30:58study with eight patients, right.
  • 31:02And so I mean, I think part of it
  • 31:06speaks to kind of the fluffiness
  • 31:09of of the public markets in 2021,
  • 31:14but also to the excitement around
  • 31:16psychedelics and five MEODMT in particular.
  • 31:18The reason I think 5 people and
  • 31:20investors were especially excited about
  • 31:225 MEODMT is because yes the data was
  • 31:25interesting for those eight patients,
  • 31:28but also it was a short acting drug, right.
  • 31:32So you know people sort of said listen,
  • 31:35if this can have comparable effects
  • 31:37to psilocybin which is 6 potentially
  • 31:408 hours and you need 2 therapists.
  • 31:43Maybe you can get a similar effect
  • 31:45with a 2030 minute treatment where you
  • 31:47know you would have someone in the
  • 31:50room but it's not like you know the,
  • 31:53you know, the patient would really
  • 31:55be able to have a cohesive therapy
  • 31:58session because clearly you know it's a,
  • 32:01it's a, it's a very intense experience
  • 32:03with five MEODMT.
  • 32:05And so there was, there was,
  • 32:08there was and continues to be excitement
  • 32:11around 5 MEODMT and see sort of can
  • 32:14this be an effective treatment.
  • 32:16And I think the question around
  • 32:215 MEODMT now is well,
  • 32:23is the experience too intense
  • 32:25for the patient
  • 32:28and you know what sort of what
  • 32:32the corresponding AES be and can
  • 32:35this really come come to market
  • 32:38and be an effective treatment.
  • 32:39Unfortunately since then GH
  • 32:41research has been on clinical hold
  • 32:45and you know we'll we'll sort of just
  • 32:49have to wait and see whether whether
  • 32:51this program is going to move forward.
  • 32:53There are, there are other programs.
  • 32:56There are other other psychedelic
  • 32:58biotech companies that are continuing
  • 33:01to develop 5 MEODMT Beckley Sci Tech,
  • 33:03which is one of the investments out
  • 33:05of Cym Adventures that is beginning
  • 33:10phase two with five MEODMT and
  • 33:13has recently received a 50 million
  • 33:16investment from a Thai Life Sciences,
  • 33:19which is another investment
  • 33:21from Cym Adventures.
  • 33:22So yeah, those are sort of the two
  • 33:27interests from psychedelics
  • 33:29investors at the moment.
  • 33:32I would say that the biotech and I'm,
  • 33:37I mean sort of the larger biotech funds
  • 33:40have been looking at psychedelics for,
  • 33:44for a few years now.
  • 33:47Some of these large funds have
  • 33:50already started deploying capital.
  • 33:52Some of the bigger names
  • 33:53such as you know RA Capital,
  • 33:56Boston based I think 4 billion
  • 33:59plus under management fund has
  • 34:01made a few investments right.
  • 34:03They've invested in Daleks
  • 34:05Therapeutics which is the non
  • 34:08hallucinogenic NCE Portfolio Co
  • 34:12founded by David Olson from UC Davis.
  • 34:16They also invested in GH Research
  • 34:18which is the company that had the phase
  • 34:21one data with five MEODMT and they
  • 34:24even at some point incubated company
  • 34:27inside RA Capital called Lusaris.
  • 34:30I don't think they could make the PK work.
  • 34:33In the end the company was disassembled
  • 34:35but that is all to say that there are
  • 34:38large biotech funds that are investing
  • 34:41in in psychedelic therapeutics
  • 34:44and doing so pretty actively.
  • 34:47If you're interested in sort of what
  • 34:50the that larger list of investors is,
  • 34:52I would suggest going and looking up
  • 34:54who invested in Compass pathways latest
  • 34:56round which happened just a few months ago.
  • 35:00I think they raised about 200
  • 35:02million and that has a pretty
  • 35:04impressive list of investors.
  • 35:06So it's definitely not so fringe anymore.
  • 35:19Any other questions,
  • 35:22meaning you made reference
  • 35:23to the biotech winter of 2021,
  • 35:26which sounded chilly,
  • 35:29but and it you implied
  • 35:30it was sort of a broader,
  • 35:31not a psychedelic specific thing,
  • 35:33but a broader fluctuation and
  • 35:35enthusiasm in the space.
  • 35:36What is, can you tell us just
  • 35:38a little bit about that without
  • 35:39progressing too much? Sure.
  • 35:42I mean I think in 2022,
  • 35:45which was really kind of the coldest
  • 35:47of the winter of the biotech winter,
  • 35:50the biotech index, right,
  • 35:52which was kind of they take 100
  • 35:56or so biotech companies that are
  • 36:00public and create an index of that.
  • 36:02I think at some point that index was down 70,
  • 36:05potentially 80%,
  • 36:06meaning that you know the public
  • 36:10companies were trading significantly
  • 36:12lower than they were in 2020 and 2021.
  • 36:17I mean there are obviously some individual
  • 36:20reasons like individual to company.
  • 36:21Certain companies weren't reading
  • 36:23out very strong data or some
  • 36:26other individual company news.
  • 36:29But I think the overall
  • 36:31trends were the following.
  • 36:32The first thing is there was
  • 36:34a huge overcorrection, right?
  • 36:36In 2020 and 20, 21,
  • 36:39there was so much capital in the
  • 36:44markets because there was so much new
  • 36:48money being printed that that flooded
  • 36:50the market with all this new capital.
  • 36:53You know,
  • 36:54funds were able to raise and then
  • 36:56they were actively deploying.
  • 36:59And when there's a lot of
  • 37:01new money that's available,
  • 37:02the companies tend to balloon in value,
  • 37:06right.
  • 37:06And so many companies were going public,
  • 37:08they were going public at valuations
  • 37:12that were likely higher than what
  • 37:15the market sustainably could,
  • 37:17could, could, could have them at.
  • 37:21And so there was an overcorrection.
  • 37:23And you know,
  • 37:23even when all of this was happening,
  • 37:25investors continued saying you know
  • 37:27these valuations are too high,
  • 37:28the market's too hot,
  • 37:30but people continue to invest and and
  • 37:34basically further heating up the market.
  • 37:37And So what happened in late
  • 37:382021 is that eventually the the,
  • 37:42the valuation started coming down
  • 37:45and and that overcorrection was
  • 37:47quite fast and it it was very
  • 37:50painful for many public companies.
  • 37:52It took about six months or so.
  • 37:55There's usually a lag,
  • 37:57right,
  • 37:57between what's happening in the public
  • 37:59markets to how that affects and
  • 38:03reflects on the private company's valuations.
  • 38:09And you know,
  • 38:11the public markets in 2020 and 21 were hot.
  • 38:15They were,
  • 38:15you know,
  • 38:16trading at high valuations And
  • 38:17then private companies that were
  • 38:19raising capital that were saying,
  • 38:20hey, you know,
  • 38:21if similar company just went public,
  • 38:24this devaluation let's say is a
  • 38:26billion dollars. I am similar.
  • 38:28I'm going to raise money private
  • 38:31capital at a similar evaluation.
  • 38:34And they were sort of being able
  • 38:37to benchmark against the private,
  • 38:39the public market valuations.
  • 38:41And so when the public markets went
  • 38:44down about six months or so later,
  • 38:47the private valuation started
  • 38:49coming down significantly as well.
  • 38:52I think the the private valuations
  • 38:54went down even further because
  • 38:57investors started favouring buying the
  • 39:00cheaper stock which was fully liquid,
  • 39:03right.
  • 39:03If you're an investor and you have a
  • 39:05dollar and you can buy a dollar that
  • 39:07you can invest in the public markets,
  • 39:08that's fully liquid,
  • 39:09right.
  • 39:10You could go and sell it tomorrow
  • 39:12versus tying up that same dollar in
  • 39:14a private company which may never
  • 39:17go public right and may go down,
  • 39:21may may go down under
  • 39:23or it would be tied up for 10 years.
  • 39:26Even if the company were to
  • 39:28be eventually successful,
  • 39:29the investors are starting really
  • 39:32favouring buying the public
  • 39:34stock over the private stock.
  • 39:35And so this is what sort of
  • 39:39further made funding difficult
  • 39:42for private companies as well.
  • 39:47We're seeing a light at the
  • 39:48end of the tunnel after these
  • 39:50sort of two almost 2 1/2 years.
  • 39:52I think there's there's a few
  • 39:55things that happened in the last two
  • 39:58months that are very encouraging.
  • 40:00There were a few really large
  • 40:03acquisitions in the neuro psych space.
  • 40:05So ABB Vie bought Cerebell for 8.7
  • 40:10billion in December and then BMS
  • 40:14acquired Corona for 14 billion, right?
  • 40:18And so?
  • 40:19These are really large acquisitions
  • 40:21in the neurosite space and that's
  • 40:23been just encouraging to see
  • 40:26that M&A activity is picking up.
  • 40:29Another thing that happened is
  • 40:32that you know can be considered
  • 40:34this opening of the IPO markets.
  • 40:36If if you look at the last sort
  • 40:38of 18 to 24 months,
  • 40:39almost no companies have been
  • 40:41going public just because there's,
  • 40:43you know, even if they do go public,
  • 40:45there's probably not going to
  • 40:46be many investors who are buying
  • 40:48the stock or trading the stock.
  • 40:50So,
  • 40:50but just two weeks ago one of my
  • 40:54investments from Cy Med Alta Neuroscience,
  • 40:57which is a Stanford neuroscience
  • 41:00company went public and you know
  • 41:02has done decently well and there
  • 41:03have been a few other IPOs that
  • 41:05are outside of the neuroscience
  • 41:07space but in biotech.
  • 41:08So we're seeing these as very positive
  • 41:11signals that the markets are opening
  • 41:14up and probably more investment
  • 41:16is going to be going into this.
  • 41:19However,
  • 41:19you know both kind of CE OS and teams
  • 41:23of biotechs as well as investors
  • 41:25are not expecting anything as sort
  • 41:29of active and hot as it was in
  • 41:322020 and 21 in the near future.
  • 41:37Thanks.
  • 41:40I have a quick question.
  • 41:41Yep. Thank you so much.
  • 41:42Dina, some say that the current
  • 41:44model of psychedelic assistant
  • 41:46therapy are too complex and costly
  • 41:48and need a lot of infrastructure.
  • 41:50And so that even if they are to be approved,
  • 41:55it would be really hard to implement
  • 41:59them widely and make them accessible.
  • 42:02What's your opinion on that?
  • 42:04You know, as an investor,
  • 42:05can we make them accessible,
  • 42:07easily accessible to everyone?
  • 42:09Yeah, That's a great question.
  • 42:11Thank you so much.
  • 42:12I think it really depends on the
  • 42:15modality in the protocol, right.
  • 42:17So I think the most burdensome
  • 42:21protocols are that of MDMA and
  • 42:24psilocybin assisted psychotherapy.
  • 42:25The reason why I say that it's,
  • 42:27you know, 6 to 8 hours.
  • 42:29You need a single room and you need,
  • 42:33you may need up to two therapists,
  • 42:35right, Or like a therapist and a
  • 42:37guide for the whole day in addition
  • 42:40to also therapy sessions in
  • 42:44between the administration, right.
  • 42:46So that's kind of the most burdensome
  • 42:49protocol that I I think will exist.
  • 42:53However, at the same time you look
  • 42:56at sort of what are the options
  • 42:58like what do people with treatment
  • 43:01resistant depression or untreatable
  • 43:03PTSD have available to them?
  • 43:06If you look at PTSD,
  • 43:07there's no approved treatment
  • 43:08as far as I understand, right.
  • 43:10MDMA would be the first FDA
  • 43:13approved treatment for PTSD.
  • 43:14It's not like there's some other
  • 43:16easy way to treat this and then
  • 43:18all of a sudden this is you know,
  • 43:21the only other available treatment.
  • 43:23So and for treatment resistant depression,
  • 43:26if you know we're already talking about
  • 43:29patients who are you know their other,
  • 43:32their other options are ketamine S,
  • 43:37ketamine, TMSECT,
  • 43:39all of which are pretty burdensome, right.
  • 43:41So this is a patient population that
  • 43:43has failed other treatments and is
  • 43:46probably in in need of some pretty,
  • 43:49you know, big interventions.
  • 43:51So it might push
  • 43:53back to that as they're all reimbursable.
  • 43:55Sorry, I said, my push back to that
  • 43:57is all of those are reimbursed.
  • 44:00I think it's the reimbursement model.
  • 44:02The reimbursement model
  • 44:03is what determines whether a patient
  • 44:05can get care, not access well,
  • 44:06not physical accessibility
  • 44:09because once it's paid for,
  • 44:11it'll be paid for.
  • 44:12My push back to that is TMSECTS,
  • 44:15ketamine and ketamine.
  • 44:16You'll get some
  • 44:18version of reimbursement.
  • 44:18So it's a piggyback off of that.
  • 44:21My question is, is there
  • 44:23scope for these for is, is,
  • 44:25is the reimbursement model
  • 44:27being investigated, I guess in
  • 44:29tandem with the investments?
  • 44:33Sure. So I I think what you're
  • 44:36saying is if psilocybin MDMA
  • 44:40get insurance reimbursement
  • 44:43then you know that determines
  • 44:45accessibility to patients, correct.
  • 44:47It doesn't matter how burdensome,
  • 44:49the like the REMS and Sprovata
  • 44:50is the most burdensome
  • 44:51ever, but we get it done
  • 44:53because you get it paid for.
  • 44:55So even if you have the two therapists,
  • 44:57if it's reimbursed, then you can
  • 44:59give it to a patient. So I think,
  • 45:01yeah, I think I'll agree with you that
  • 45:03if the reimbursement makes it easier,
  • 45:04right, at least financially.
  • 45:06But actually one of the biggest
  • 45:08bottlenecks that I see for
  • 45:10psilocybin and MDMA is actually
  • 45:12the availability of therapists.
  • 45:14There's not going to be enough
  • 45:16therapists if if the FDA requires
  • 45:19A licensed therapist or two,
  • 45:21no matter how much pair reimbursement is,
  • 45:24there's just not going to be
  • 45:26enough therapist to do the work.
  • 45:28So I think there's there's
  • 45:29a few things at play.
  • 45:30I have completely agree with you that
  • 45:32reimbursement will help accessibility,
  • 45:34but it's not.
  • 45:35It's not the only thing that stands between
  • 45:39like being able to have it and not.
  • 45:42I think what the other point that
  • 45:43I was trying to make is sort of
  • 45:45like MDMA and psilocybin's probably
  • 45:47the most burdensome protocols.
  • 45:49And then it kind of I think where
  • 45:52the industry in in terms of biotech,
  • 45:54right,
  • 45:55drug developers as well as investors
  • 45:57in the psychedelic space are
  • 45:59they understand that the easier
  • 46:01we make the protocol,
  • 46:03the less burdensome the protocol,
  • 46:05the more likely it is to to be adopted,
  • 46:11right.
  • 46:11And so there's there are many programs
  • 46:15now that are trying to shorten the,
  • 46:19the trips,
  • 46:20right.
  • 46:21So there are now multiple programs in
  • 46:24phase one that are that have a derivative
  • 46:27of psilocybin that is only 2-3 hours,
  • 46:30right.
  • 46:31So can you have a comparable
  • 46:34experience and effect?
  • 46:35But then instead of needing only
  • 46:37being able to do one session a
  • 46:40week with these two therapists,
  • 46:42you could do 2 sessions.
  • 46:44So you could be treating twice
  • 46:46as many patients.
  • 46:47The non hallucinogenic psychedelics, right?
  • 46:49Can you entirely get rid of the R.E.M.
  • 46:52so people can, you know,
  • 46:54just just take a pill and it will work?
  • 46:57Yeah.
  • 46:58I mean,
  • 46:58here's this is something that I've
  • 47:01personally thought a lot about as
  • 47:03an investor and ultimately what led
  • 47:05me to want to start Freedom Bio,
  • 47:07right.
  • 47:07I I do believe that other other
  • 47:13molecules like psilocybin can can
  • 47:16be therapeutically efficacious.
  • 47:18But I always had a concern about
  • 47:21can they ultimately be accessible
  • 47:23to a large patient population,
  • 47:25right, If they're approved,
  • 47:27even if they get insurance,
  • 47:29reimbursement is still so burdensome
  • 47:33and expensive that they might not have,
  • 47:35you know,
  • 47:36the number of therapists or the
  • 47:38infrastructure like clinics to do it.
  • 47:40So that's why we focused on ketamine,
  • 47:44right, and what we do at Freedom Buy.
  • 47:45And this is based on Chatty
  • 47:48Abdullah's study from I think
  • 47:50it was 2019 and the paper that
  • 47:53was published in 2020 is that
  • 47:55the combination of ketamine and
  • 47:57rapamycin extends the efficacy of
  • 47:59ketamine to potentially 2 to 3 weeks.
  • 48:01So for a patient rather than
  • 48:02needing to come in twice a
  • 48:04week for ketamine as ketamine,
  • 48:06they could potentially only come come
  • 48:07in every two to three weeks, right.
  • 48:10And the model there is, is a lot more,
  • 48:14it allows for a much higher throughput,
  • 48:17right, of patients.
  • 48:18You have one large room,
  • 48:20You have, you know, I don't know,
  • 48:245-6 patients in one room.
  • 48:26You have one medical provider who can,
  • 48:30who can kind of monitor everyone.
  • 48:32And then if you wanted to be
  • 48:34really efficient about it,
  • 48:35potentially you could have what,
  • 48:363-4 cohorts a day.
  • 48:39So I think there's different
  • 48:42models that that could work.
  • 48:47The other thing that I think I remind
  • 48:50investors is spravato is it hit a
  • 48:53billion dollars in ARR and is expected
  • 48:55to be a blockbuster this year, right.
  • 48:58So they would make a billion dollars in
  • 49:01revenue to hit a billion dollars in revenue,
  • 49:03the only need to treat 50,000 patients,
  • 49:0850,000 patients is point O 5% of the entire
  • 49:13treatment resistant depressed populations,
  • 49:15point O 5%.
  • 49:16So when investors come to me and they
  • 49:18say can you compete with Sprovato,
  • 49:21like how are you.
  • 49:22I was like I don't need
  • 49:24to compete with Sprovato.
  • 49:25Psilocybin is not going to
  • 49:27need to compete with Sprovato.
  • 49:29The mark,
  • 49:30the the problem is so big,
  • 49:32there's so many patients that
  • 49:34don't have treatment that like we
  • 49:36can have another thousand similar
  • 49:39treatments approved and everyone
  • 49:41can be a billion dollar drug.
  • 49:43And so I just,
  • 49:44I really love what you know,
  • 49:46Yale's been doing and Yale's been
  • 49:48working on because this problem
  • 49:50is just so big and we really need
  • 49:54treatments at work and they can,
  • 49:56like I said,
  • 49:57I believe we can have another
  • 49:58thousand treatments and they
  • 49:59can all be successful.
  • 50:04Dina, it's it's Jerry.
  • 50:05How how are you?
  • 50:06Hi, Jerry, I, I do just want to
  • 50:09go back a little bit with the,
  • 50:11the idea of access though.
  • 50:13And it seems like you're sort of
  • 50:16diminishing the need for reimbursement
  • 50:20which for 95% of people is so critical.
  • 50:26Patients just can't get these
  • 50:29treatments without coverage.
  • 50:33And and I don't know how much that's been
  • 50:37thought of in the process in terms of
  • 50:41thinking about the actual implementation.
  • 50:44I mean it's one thing if a drug works
  • 50:45and you know there are perfect examples
  • 50:47where there are gene therapies that
  • 50:48work 100% but nobody can afford them,
  • 50:50so nobody gets them.
  • 50:52And you know example here is how
  • 50:56how much has the implementation,
  • 50:58the cost of implementation been
  • 51:00built into the the models,
  • 51:03the business models because I I
  • 51:05don't know if we can absorb another
  • 51:08thousand of these treatments.
  • 51:09The the insurers are panicking
  • 51:12even with something like bravado
  • 51:14how expensive this could be if
  • 51:16you open the lid on it you know
  • 51:18it'll it'll break the insurance
  • 51:19companies they they can't afford
  • 51:21to cover all of this is the is the
  • 51:24implementation cost being considered
  • 51:28And by implementation costs do you
  • 51:29mean the fact that like you need to
  • 51:32reimburse nurses time and then therapist
  • 51:34time and then build new infrastructure
  • 51:36like individual rooms. Exactly
  • 51:38that was. I mean the the there was
  • 51:40a lot of reasons why the delay in in
  • 51:44Spervato's uptake I think came yeah
  • 51:47that took almost four years to get
  • 51:49to the point where it was gonna be a
  • 51:52blockbuster almost and partly 'cause
  • 51:53it launched into an infrastructure
  • 51:55that just wasn't prepared. They didn't.
  • 51:58The Jansen just didn't understand that,
  • 52:01yeah, the drug was covered,
  • 52:02but the delivery,
  • 52:03if it wasn't so nobody could
  • 52:06figure out how to actually provide
  • 52:08the treatment and get real.
  • 52:10So how how much effort is going into
  • 52:12thinking about the delivery part
  • 52:14because that's the real expense.
  • 52:16I mean for ketamine,
  • 52:17if you do it in a place like
  • 52:19the Ellen even hospital,
  • 52:20it's almost $1000 per treatment.
  • 52:23Just in terms of the hospital charges,
  • 52:26the and and the professional fees.
  • 52:30Is that being considered,
  • 52:31you know, I, I well,
  • 52:33I I mean I know I'm in the
  • 52:34space but how much is that being
  • 52:35considered in the development plan?
  • 52:38Yeah,
  • 52:41it's it's hard to say because
  • 52:46payers aren't not really entering,
  • 52:48they're not really participating
  • 52:49in these conversations right now.
  • 52:51I'm sure they're, you know,
  • 52:52they're having isolated conversations,
  • 52:54especially now that you know a lot
  • 52:56of them covers spirivato and it's
  • 52:58interesting to hear your perspective
  • 53:00that you're saying they're already
  • 53:01panicking about how expensive it is.
  • 53:03It is very expensive.
  • 53:05It's 20 to $50,000 per year
  • 53:09for Spirivato patients.
  • 53:11And you know obviously there
  • 53:13are hurdles to jump through for
  • 53:16patients to qualify for Spirivato.
  • 53:18My guess is that if they're covering it,
  • 53:21that means that the alternative right is,
  • 53:25is, is more expensive,
  • 53:27right having this patient have a
  • 53:29lot of comorbidities and needing
  • 53:31hospitalizations and whatever
  • 53:32else comes with the treatment
  • 53:35resistant depressed patient.
  • 53:36And I think you know,
  • 53:38it's it's hard to know what those
  • 53:41economics look like because I
  • 53:42think only payers have them.
  • 53:45The way the biotech companies think about it,
  • 53:50at least from the ones that I've
  • 53:53spoken with is that these patients
  • 53:55that are not being treated are
  • 53:58very expensive to the healthcare
  • 54:00system and to payers.
  • 54:01And so payers believe that
  • 54:04this patient would eventually,
  • 54:07you know,
  • 54:07be cheaper and it's horrible to sound,
  • 54:09but that's how they think about patients,
  • 54:11right.
  • 54:12If they're being treated with Spirivato
  • 54:14and it's kind of unpredictable 20,
  • 54:17$1000 a year expense and but they're
  • 54:19not paying for all the other issues
  • 54:22that are aggravating that that
  • 54:24that's probably that something that
  • 54:27financially makes sense to the payer.
  • 54:32You know, I think if you look at sort
  • 54:34of what's available in fourth line,
  • 54:37right, 'cause this, these are the
  • 54:39patients that we're talking about
  • 54:41that have failed at least two to
  • 54:44three antidepressants right now,
  • 54:45what's available to them is ketamine
  • 54:47S ketamine, which you know,
  • 54:48we've said is very expensive.
  • 54:50Then there's TMS, right,
  • 54:52which is also in the sort of I think
  • 54:5420 to 30,000 range, and then ECT,
  • 55:00which has pretty severe side effects.
  • 55:03So we're talking about a patient
  • 55:05population that's that doesn't
  • 55:06have a lot of options right now
  • 55:07and is very expensive
  • 55:12Then I completely agree.
  • 55:13I mean, the pharmaco economics is
  • 55:15gonna drive this to a large extent.
  • 55:17So are people using like the
  • 55:19NICE model and stuff like that?
  • 55:20Because you know,
  • 55:22this is gonna have a big thing like
  • 55:23the National Institute of Health
  • 55:25and Clinical Excellence model.
  • 55:26I mean, this is what's gonna determine
  • 55:30whether third party payers
  • 55:31actually want to pay for it or not.
  • 55:33So people are thinking about that
  • 55:34'cause it's one thing it doesn't work,
  • 55:36but the other, is it affordable.
  • 55:38And it sounds like there
  • 55:41there is some thought to this,
  • 55:43but it sounds like maybe not enough
  • 55:46attention being paid to the payers
  • 55:49cause healthcare, especially U.S.
  • 55:51healthcare, is so unique where
  • 55:53the patient doesn't pay for it.
  • 55:55Ultimately at some level they do,
  • 55:56but the person who's paying for it is
  • 55:58a third party payer in the most case.
  • 56:00And it, it may be the best thing
  • 56:02in the world for the patient,
  • 56:04but they're not the one who's
  • 56:07paying the bill.
  • 56:08So I it sounds like there's some work
  • 56:10but maybe not as much as we'd all
  • 56:13like to see communication with the
  • 56:14actual payers asking what they would pay for.
  • 56:20Yes, I think I think that's that's
  • 56:22really the case and they're not really
  • 56:24going to have a communication with
  • 56:26you until you're an approved drug
  • 56:28and they see your phase three data
  • 56:32and they see a long term data and
  • 56:35then they can sort of make you know
  • 56:38make some conclusions off of that.
  • 56:41You know I I know the biotech
  • 56:43companies are trying to have
  • 56:44those conversations but they're
  • 56:46not really being you know met but
  • 56:49but NICE has its, I mean for example NICE
  • 56:52has its outline pretty clearly published.
  • 56:55So you can you can get a sense of what
  • 56:57how they're going to value these are
  • 56:59are the investors looking at these and
  • 57:02considering that as part of their thing,
  • 57:04you know is it meeting the nice
  • 57:06criteria for for approval And
  • 57:10yeah
  • 57:12I I don't know the exact
  • 57:14answer to to that question.
  • 57:16I know that maps when they were
  • 57:20as they've been thinking about
  • 57:22how to price the drug versus how
  • 57:25to price the the psychotherapy.
  • 57:27They've definitely done a lot of
  • 57:29modeling on this end and they sort
  • 57:32of landed on a range of what the
  • 57:35medicine and the psychotherapy could
  • 57:37could could be, could be right.
  • 57:42But what I think their next step
  • 57:44would be is to get approval at some at
  • 57:46some point later this year and then
  • 57:49start working with payers and they
  • 57:51they won't know for at least I think
  • 57:53another year and a half to two years
  • 57:55whether it will be covered or not.
  • 57:57That's how it usually takes.
  • 57:59I think the advantage of well pursuing
  • 58:01the time. So that's maybe
  • 58:03final comment or wrap up.
  • 58:08As you say, there is a quick advantage
  • 58:10that Sparvato has sort of blazed
  • 58:12the trail here so that they that
  • 58:14there's some groundwork to it. Yeah,
  • 58:17yeah, absolutely agree.
  • 58:20All right. I mean, clearly,
  • 58:21Dina, there's a lot of interest.
  • 58:22We're very appreciative of you being
  • 58:24here and this conversation could go on,
  • 58:26but I do know the time.
  • 58:27It's the end of the day on Friday out here,
  • 58:28so I want to be respectful of
  • 58:30people's evenings and of your time.
  • 58:32Dina, thank you again for being here.
  • 58:33You really bring such a rich perspective
  • 58:35to this field and we appreciate this,
  • 58:37this conversation.
  • 58:38Thank you so much. Thanks for having me.
  • 58:40This was great. Feel free to reach
  • 58:42out with more questions. OK, Bye.
  • 58:44Bye. Have a good day. Thank you.
  • 58:46Take care, everyone. Bye. Bye.