Latest / The BioHub - by Avetix / Episode 167 - James Mackay - Co-Founder, President & CEO of Crystalys Therapeutics

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Episode 167 - James Mackay - Co-Founder, President & CEO of Crystalys Therapeutics · The BioHub - by Avetix

• 0:06
  So welcome back to an episode of the Bio Hub.
• 0:08
  Today we're delighted to welcome on James Mackay, who's the Co
• 0:11
  founder, president and CEO of Crystallis Therapeutics.
• 0:15
  James brings more than 40 years of experience in the
• 0:17
  Pharmaceutical industry with a track record that includes
• 0:20
  multiple drug approvals and leadership roles across across
• 0:24
  companies like AstraZeneca and our Day of Biosciences.
• 0:27
  And now he's leading Crystallis Therapeutics, which is a company
• 0:30
  that launched out of stealth with a remarkable 205,000,000
• 0:34
  series around, which was one of the largest early stage
• 0:38
  financings in recent years. Chris Dallas is focused on
• 0:41
  transforming the treatment of gout, advancing a late stage
• 0:44
  clinical clinically validated therapy called Dosen Urads into
• 0:49
  global phase three trials. So join us today as we'll
• 0:53
  discuss pulling off an incredible financing round in
• 0:56
  the current market where the gout treat lands treatment
• 0:59
  landscape is today and the role China are playing in innovation
• 1:03
  today as well. So James, thanks so much for
• 1:06
  coming on. How are you I'm.
• 1:08
  Good, Tom, Thank you very much for having me on the podcast.
• 1:11
  Look, it's a it's a pleasure. So let's just start off with a
• 1:15
  little bit about your story, your journey through through the
• 1:17
  field and how you got to where you are today.
• 1:19
  So you spent close to three decades working across both
• 1:22
  farmer, biotech, life sciences. Looking back to the beginning of
• 1:27
  your career, what originally drew you into the field, and how
• 1:30
  did your early experiences shape the way you think about drug
• 1:33
  development and innovation today?
• 1:36
  Yeah. So it was interesting, Tom,
• 1:38
  because initially I wasn't in the pharmaceutical development
• 1:42
  field at all. I started off my career in the
• 1:45
  industrial chemical agrochemical business and that, but that was
• 1:50
  part of the what was called then ICI Imperial Chemical
• 1:54
  Industries. That was the predecessor company
• 1:57
  to AstraZeneca. And it got to the, you know,
• 2:00
  after by 10 years in that side of the business, you know, just
• 2:04
  starting to look for something else and saw saw a job advert
• 2:08
  for what was called the clinical project leader in the
• 2:10
  pharmaceutical side of that business.
• 2:13
  And interestingly, I couldn't take off any of the job
• 2:17
  requirements because it was all very clinically focused.
• 2:20
  But looking at it, I thought, you know, this is a project
• 2:23
  management role and and that's, that's what I do.
• 2:27
  So I applied for the job and I became the first clinical
• 2:31
  project manager of the Dastra Zeneca ever hired that didn't
• 2:34
  have any clinical experience. And then that was the start of a
• 2:38
  a very long and successful career developing drugs.
• 2:42
  Amazing. And when you when you were
• 2:44
  originally launching or thinking about the idea of Chris Dallas,
• 2:49
  was there a specific gap in the market or unmet need that you
• 2:53
  felt strongly compelled to address?
• 2:55
  Like talk us through, like why did you and your Co founders go
• 2:58
  around setting the company up? Yeah, sure.
• 3:01
  So my final role at AstraZeneca was I led the business
• 3:05
  development team that acquired a company called Ardea Biosciences
• 3:09
  that was developing treatments for Gout.
• 3:11
  So that was my first introduction to to gout as a
• 3:14
  disease and the the lack of available therapies and I took
• 3:20
  over the CEO role of our day and we took a couple of year out one
• 3:24
  inhibitors through to approval in the US and Europe.
• 3:28
  But there were some challenges with those molecules.
• 3:31
  So when our one of our Co finders, Noble Ventures
• 3:35
  approached me, they were the lead investor in my previous
• 3:39
  biotech that I founded, Arista Therapeutics.
• 3:42
  They approached me after we closed Arista Therapeutics and
• 3:45
  said, look, we're interested in working with you and the team
• 3:48
  again and, and we've become very interested in the gait space in
• 3:52
  the meantime. So you know, would you be
• 3:55
  prepared to create a company with us and then see if we can
• 3:59
  find something that's worthy of investment and development to to
• 4:03
  really reshape the the treatment of gait?
• 4:07
  And you know, they were obviously had worked with us
• 4:09
  before and then we're attracted to the fact that, you know, we
• 4:12
  had a lot of drug development experience.
• 4:14
  So we agreed to do that and we Co founded the company with
• 4:18
  Noble Ventures and a second venture capital firm Catalyst
• 4:22
  Specific that specializes in finding assets that are approved
• 4:26
  in Japan, but the rights are available in the US, Europe and
• 4:30
  and other areas around the world.
• 4:32
  And for me, you know, when we decided to do this and for my
• 4:35
  team as well, this really felt like unfinished business for us
• 4:39
  because, you know, we got so enmoused in understanding guide
• 4:43
  as a disease and the fact that there was a desperate need for
• 4:48
  additional treatments for these patients.
• 4:50
  And we felt that, you know, although we made some success at
• 4:53
  our day in getting a couple of molecules approved, that there
• 4:57
  was limited compared to what we ultimately thought we could do.
• 5:00
  So this was really unfinished business and you know, I'm so
• 5:04
  happy that we're back in this space and, you know, we have
• 5:08
  very good relationships with all the key opinion leaders from our
• 5:11
  time at our day. And when we came back in with
• 5:14
  the tenure add, it was it was really like being welcomed home
• 5:17
  to family by them. So it was it was really nice to
• 5:21
  step back into the space. So a little bit of a different
• 5:25
  right for right for creating a company, you know, with the
• 5:28
  investors coming to us initially rather than us pitching to the
• 5:31
  investors, but it's, it's worked out really well.
• 5:35
  Yeah. And you obviously pulled off a
• 5:37
  pretty incredible Series A around 205,000,000, which yeah,
• 5:42
  it's been pretty unheard, unheard of for the past few
• 5:44
  years with how biotech has been. You mentioned a little bit about
• 5:48
  the story and how the investment came, but what do you believe
• 5:52
  some of the key factors were in the investors wanting to go out
• 5:56
  and build this company in, in this space particularly it is
• 5:59
  quite a competitive and a high risk space as well.
• 6:02
  Just talk us through through that.
• 6:05
  Yeah, Tom, it probably was the worst period of time to try and
• 6:08
  raise money. We started raising the round in
• 6:12
  the end of January 2025. Things actually got worse after
• 6:17
  that, after President Trump's Liberation Day tariff
• 6:20
  announcement in April 25. But I think there are really two
• 6:25
  things that, you know, made us successful here. 1 was the
• 6:29
  molecule. So the molecule we'd identified
• 6:32
  was called the tin urad, developed in Japan by a small
• 6:37
  Japanese farmer called Fuji Yakin, and was actually approved
• 6:41
  in Japan in 2020. So it'd been on the market for
• 6:44
  over 5 years with over 2.2 million patients having received
• 6:48
  the drug in that time. So, you know, very well defined
• 6:52
  safety and efficacy profile and a very large safety database.
• 6:56
  So quite an unusual situation. It's also now approved in China
• 7:00
  as well and that's just being launched there.
• 7:03
  But you know, we had the opportunity to get our hands on
• 7:06
  a very de risked molecule and you know take that straight into
• 7:11
  face the trials in the US and Europe.
• 7:14
  And I think that de risking of the molecule combined with a
• 7:18
  team who'd previously in fact the only team that's ever been
• 7:22
  successful in getting approval for a year at one inhibitor,
• 7:25
  which is the mechanism of action of the tinurat is the is the
• 7:30
  team that basically forms the basis of Cristalis.
• 7:33
  So I think the investors looked at both of those and thought,
• 7:36
  you know, this is a, this is a pretty de risked scenario that
• 7:40
  we're in here and and it's worthy of investment.
• 7:43
  Obviously the round needed to be large round because we were
• 7:46
  going straight into phase three trials.
• 7:49
  But yeah, we were pretty happy that we were able to achieve
• 7:53
  that in the particularly in the difficult circumstances at the
• 7:56
  time. Yeah, amazing.
• 7:59
  And just turning into switching over to the therapeutic area
• 8:04
  itself, gout and it's an area as you mentioned, you know this
• 8:08
  space, you've worked in it previously.
• 8:11
  If you just to look at the broader picture, how do you
• 8:13
  currently assess the gout treatment landscape and where do
• 8:17
  you see some of the most significant unmet medical needs
• 8:20
  that are out out there today that are in the space?
• 8:23
  Yeah. So gout is, you know, one of
• 8:25
  the, it's the most common form of inflammatory arthritis.
• 8:28
  And you know, there are over 13 million patients in the US
• 8:32
  suffer from gout. So it's a very significant
• 8:36
  disease burden. Those patients are normally
• 8:40
  treated by PCPS or GPS and the standard of care treatment is
• 8:46
  allopurinol, which is xanthine oxidase inhibitor that actually
• 8:50
  reduces the production of uric acid in the body and gout is
• 8:54
  caused by excess uric acid in the body.
• 8:57
  It's a pretty simple biology. The standard of care is
• 9:02
  allopurinol. It's a generic drug being used
• 9:05
  for over 60 years, is relatively effective in only 40 to 50% of
• 9:11
  patients. So there's a very large portion
• 9:14
  of those patients are uncontrolled.
• 9:16
  And if you have uncontrolled levels of uric acid, then you
• 9:19
  will continue to have what are called gout flares.
• 9:22
  There are sudden intense attacks of pain and inflammation that
• 9:26
  happened primarily in the joints, in the hands and feet,
• 9:29
  very debilitating, often requires emergency room
• 9:33
  treatment, often will result in time off work.
• 9:37
  And then as the disease progresses and the uric acid
• 9:40
  levels remain high, then patients will develop what are
• 9:43
  called TOFI, which are deposits of uric acid on the joints.
• 9:47
  And these are very disfiguring, debilitating and the current
• 9:52
  standard of care. You know, allopurinol, there's a
• 9:54
  second Zante in oxidase inhibitor called for boxestat.
• 9:59
  You know, they, as I said, can get about 50% of patients under
• 10:03
  control. There is a third line treatment.
• 10:06
  I'll come back to the second line space.
• 10:08
  There is a third line treatment called Crestexa, which is an IV
• 10:13
  infused uricase. It's very effective in reducing
• 10:17
  uric acid and resolving the clinical symptoms of gout, but
• 10:22
  it requires a multi hour infusion and it's also a very
• 10:26
  expensive drug. It costs between 350,000 and
• 10:29
  700,000 per treatment. So it's limited to about 6000
• 10:36
  patients a year. And in the second line space,
• 10:40
  which is where we're developing Detinurad, so where patients
• 10:44
  have failed the standard of care allopurinol, you know there's
• 10:48
  really nothing else approved in that space.
• 10:51
  There are some other drugs in development as you mentioned
• 10:54
  earlier, but we feel that there's a very significant
• 10:57
  opportunity in that second line space where patients have failed
• 11:01
  on the standard of care and really are in need of an
• 11:03
  additional treatment. And we estimate that our target
• 11:07
  population in that space is probably about 500 to 600,000
• 11:11
  patients, which is quite a significant portion of patients.
• 11:15
  And those are all treated by rheumatologists.
• 11:17
  They've already been referred on from their PCP or GP because
• 11:22
  they basically can't control them with the standard of care.
• 11:24
  So we think that we can make a big difference here to those
• 11:27
  patients and really bring something to the market that
• 11:30
  will fill that second line space.
• 11:33
  Amazing. Sounds exciting and just maybe a
• 11:36
  little bit into the pipeline and I guess maybe a high level, but
• 11:39
  can you talk as a little bit about the lead program that that
• 11:43
  that you brought in a little bit into that the biology, maybe a
• 11:47
  little bit about what makes it different as well be interesting
• 11:51
  to hear. Yeah, no, happy to, happy to do
• 11:54
  that. So the TINURAD is A next
• 11:57
  generation URAT 1 inhibitor. So it's a mechanism of action
• 12:00
  that you know has been investigated before.
• 12:03
  As I said, when we were at ARDEA, we previously got
• 12:06
  approval for Lucinurad, which was a URAT 1 inhibitor as well.
• 12:10
  So we're very familiar with that mechanism of action.
• 12:15
  And as I said earlier, gout is caused by excess uric acid in
• 12:18
  the body and that can be the excess uric acid can result from
• 12:24
  either either or both the overproduction of uric acid,
• 12:28
  which is primarily related to diet, or the under excretion of
• 12:32
  uric acid. So the inability of the kidneys
• 12:34
  to excrete enough uric acid. And although many people believe
• 12:38
  that, you know, diet is a main cause of gout, that's actually
• 12:42
  not the case. You know, up to 90% of patients
• 12:46
  who develop gout actually develop it because they can't
• 12:49
  excrete enough uric acid. So their kidneys are basically
• 12:53
  not excreting enough uric acid in the urine and our molecule
• 12:57
  actually blocks the urat 1 transporter in the proximal
• 13:02
  tubule of the kidney and that blocks the reabsorption of uric
• 13:06
  acid into the body and results in new urinating or peeing out
• 13:10
  more uric acid. So our molecule, you know, is
• 13:14
  basically focused on the root cause of the disease.
• 13:18
  And you know, it's a very simple mechanism of action, isn't that?
• 13:22
  Basically it stops the reabsorption of the uric acid
• 13:24
  and allows more of it to be greeted from the body?
• 13:28
  And I never like to use the word competitors because I think
• 13:31
  ultimately what you're doing is for the patients.
• 13:32
  But if you look at like who are some of the companies that, and
• 13:36
  again, I don't want to use competitors, but who are the
• 13:37
  companies that are maybe doing similar sort of work to what you
• 13:40
  guys are doing? Or is this quite an uncharted
• 13:42
  field of of medicine with the approach that you take it?
• 13:46
  Yeah, yeah. No, absolutely.
• 13:47
  And there are really three main competitors that we have.
• 13:53
  The main 1 is a molecule called AR-882 from a company called
• 13:58
  Arthrosy Therapeutics. We know that team well.
• 14:01
  We worked with many of them at our day of Biosciences
• 14:05
  previously. They are they've completed
• 14:09
  enrollment in their phase three program.
• 14:11
  So they're actually ahead of us. That molecule is, is a good
• 14:16
  molecule. It's, it's got the ability to to
• 14:18
  reduce uric acid below the targets level.
• 14:22
  At this stage. It has an unproven safety
• 14:25
  profile, whereas we of course have a massive safety database
• 14:30
  that's been very stable over a period of time.
• 14:34
  But we would see that molecule as being the the main
• 14:37
  competitor. Arthrosy Therapeutics as a
• 14:39
  company was actually acquired last month by Sobe in a a pretty
• 14:45
  impressive deal as a 1.5 billion total acquisition with 950
• 14:50
  million cash paid upfront. So very happy for the Arthrosy
• 14:54
  team as a result of that. And I think, you know, my view
• 14:58
  is that although this is a competitive space, actually
• 15:02
  bringing multiple molecules to the market is a good thing for
• 15:07
  patients. And it actually increases the
• 15:10
  focus on the disease and, you know, gives physicians, you
• 15:15
  know, different basically tools in their toolkit to treat to
• 15:20
  treat the patients. The other two molecules that I
• 15:23
  would identify is there's a molecule from Atom Therapeutics
• 15:26
  ABP 671 and there's a molecule from Shanton Pharmaceuticals
• 15:31
  SH001. They are also you're at one
• 15:34
  inhibitors, same mechanism of action.
• 15:36
  They're they they're slightly behind us that they haven't
• 15:39
  started their phase three molecule, their phase three
• 15:42
  trials. But obviously we'll keep a close
• 15:44
  eye on those molecules as well. But this is a extremely large
• 15:47
  unmet medical need, extremely large market.
• 15:51
  So there's room for more than one new medicine here for sure.
• 15:55
  And just so you spent a big chunk of your career at
• 15:58
  AstraZeneca, I think it was around 27 years before taking
• 16:03
  biotech leadership roles. Just talk us through in the two
• 16:06
  different environments, like how do you compare the mindset, the
• 16:08
  pace, risk tolerance between the two?
• 16:12
  And what were some of the most significant adjustments you had
• 16:14
  to make personally and professionally when going from
• 16:17
  pharma to biotech? I know it's probably, yeah, a
• 16:21
  very different type of environment to be in.
• 16:24
  Yeah, I mean very different indeed, but both very
• 16:27
  fulfilling. So me and I spent nearly 30
• 16:30
  years at AstraZeneca across a whole range of roles both in the
• 16:35
  UK and the US and, and honestly, it was a fantastic training
• 16:41
  ground. I mean, AstraZeneca and the
• 16:43
  opportunities they gave me really equipped me to be able to
• 16:47
  do what I've been doing over the last 10 plus years in biotech.
• 16:52
  Biotech is obviously very different.
• 16:55
  You have to go out and raise the money yourself, you know, rather
• 16:58
  than, you know, getting the money from the the big company.
• 17:04
  And you know, once you've got that money, you know, you're
• 17:07
  clearly accountable for delivering on that, on that
• 17:10
  program. And I think the biggest
• 17:13
  difference for me is that obviously in something like
• 17:17
  AstraZeneca, you're operating within a big machine with, you
• 17:21
  know, hundreds and hundreds of people probably working on a
• 17:24
  project in biotech. You mean both biotechs I
• 17:28
  founded, the initial founding team was 4 people.
• 17:32
  And, you know, basically you have your hands on absolutely
• 17:36
  everything to do with that development.
• 17:39
  And every single action that you take is directly related to the
• 17:45
  development of the molecules. So obviously, you know, very
• 17:48
  strong focus on, you know, progressing the the drug
• 17:52
  development and you have to, you know, the biggest transition you
• 17:55
  asked about the transition is, you know, I LED multiple
• 17:58
  clinical teams in AstraZeneca and you know, they probably and
• 18:02
  you had in excess of 100 people in every team, sometimes even
• 18:07
  more than that as we got into late stage development.
• 18:11
  When you're in biotech, you don't have those people round
• 18:14
  about you. So you have to learn every
• 18:16
  single part of the the development program and have to
• 18:21
  basically identify experts that you can tap into to assist you
• 18:25
  where you you need that expertise.
• 18:28
  But you know, both environments are, are great.
• 18:32
  You know, I, AstraZeneca was in a fantastic experience, you
• 18:37
  know, gave me all the skills that I needed to do biotech.
• 18:40
  Biotech has been a lot of fun over the last 10 plus years.
• 18:44
  In my third biotech company now and you know, creating a company
• 18:51
  and then developing A molecule that can make a difference for
• 18:54
  patients is is the best thing ever.
• 18:57
  Just on that you've, you've already achieved a hell of a lot
• 18:59
  for your career already. Like what, what keeps you
• 19:02
  motivated? What you what continues to
• 19:04
  motivate you to stay deeply involved in the industry rather
• 19:08
  than stepping back into maybe a less demanding role, maybe an
• 19:11
  advisory role or board member role or whatever that might be.
• 19:14
  Like what, what keeps you going? What's what's keeping you here?
• 19:18
  Yeah, Tom, it, it's always comes back to the the patients and you
• 19:22
  know, particularly in the gout space, these patients have been
• 19:26
  so underserved for, you know, decades now.
• 19:31
  And that was so clear to me when we started to work in this space
• 19:34
  at our day of Biosciences. And you know, we did a lot to
• 19:37
  address that. In fact, when we closed our day
• 19:40
  of Biosciences down, one of the scouts, you know, key opinion
• 19:44
  leaders, in fact, you know, people used to call him the
• 19:47
  godfather of gout because he'd been, you know, involved for so
• 19:50
  long. He actually wrote me a lovely
• 19:53
  letter and, and thanked me and said that, you know, are they a
• 19:56
  Biosciences had done more for gout patients than any other
• 19:59
  company in his five or six decades of working in the, the
• 20:03
  gout space. And that that's what really
• 20:06
  makes the difference, right, When you can actually do
• 20:10
  something for patients and I remember it are there.
• 20:13
  They are they organization, most of those people had never ever
• 20:16
  taken a drug through to approval before.
• 20:18
  I'd been very lucky then my AstraZeneca career to take 6
• 20:22
  drugs through to approval. And I remember telling they are
• 20:25
  they a team that you know to be one of the proudest moments of
• 20:28
  your life when we could get this drug approved.
• 20:31
  And the, the the proudest moment will be when you walk into the
• 20:34
  pharmacy. You know, I'm here and Walgreens
• 20:37
  or CVS and you know you're going up to collect the prescription
• 20:41
  and you can see you the drug that you were responsible for
• 20:44
  developing sitting on the shelf. And I had a very interesting
• 20:48
  experience after we got approval for Lissingerad Roberts code.
• 20:50
  His trade name was Zerambic. I actually went in to pick up a
• 20:53
  script from my wife at CVS and the gentleman in front of me was
• 20:57
  picking up his first Cerambic script and I really wanted to
• 21:01
  tap him on the shoulder and say, you know, I led the team that
• 21:05
  developed that drug. But of course that would have
• 21:06
  been inappropriate because I really shouldn't have had the
• 21:09
  conversation between him and the pharmacist.
• 21:11
  But honestly, it's about, it's about taking drugs to patients
• 21:15
  and the, the massive difference that you can make to millions
• 21:19
  and millions of patients. And and as I said in
• 21:22
  particularly in the case of Crystallis Therapeutics for
• 21:24
  myself and my XR, their team members, this was really
• 21:29
  unfinished business and that we felt there was more to be done
• 21:31
  there, which is why we step back into this space.
• 21:35
  Yeah, amazing. And as you look ahead, what does
• 21:38
  success look like for for Chris Dallas, not just in terms of a
• 21:43
  fundraising or operational milestones, but in terms of real
• 21:47
  world patient impact? Yeah.
• 21:49
  So we're we're developing the tenure ad as you know second
• 21:53
  line specialty care treatment with a rheumatologist as the as
• 21:58
  the prescriber. So it's focused more on the
• 22:00
  moderate to severe gouts of the patients that have got, you
• 22:04
  know, the more severe symptoms they're having multiple flares
• 22:06
  per year. They're developing these TOFI
• 22:09
  which are the uric acid deposits on the the joints.
• 22:13
  And we feel that, you know, not only by not only reducing uric
• 22:18
  acid levels, we can actually impact those clinical symptoms
• 22:22
  that are most important for the patients and the and the
• 22:26
  physicians. And we feel that, you know, we
• 22:28
  can make a real difference to these patients.
• 22:31
  Quality of life. Focus right now is on execution
• 22:34
  of the phase three trials. They're up and running.
• 22:37
  We expect to complete recruitment in the the
• 22:40
  second-half of this year. And you know, we'll keep on
• 22:44
  focusing on on delivery of that and keep on focusing on ensuring
• 22:49
  that people, you know, have a better understanding of gout so
• 22:53
  that we're well positioned to really change the treatment
• 22:56
  paradigm once the molecule gets approved.
• 22:59
  Yeah, for sure. And I think a separate topic
• 23:02
  that's that's on everyone's lips and has been for a little bit of
• 23:06
  time now is, is China and the inning that's coming out of that
• 23:10
  on this, on this perspective. But do you see it primarily as a
• 23:13
  competitive force or a collaborative collaborative
• 23:17
  opportunity or both? And how should sort of Western
• 23:20
  biotech companies adapt their approach in response to to all
• 23:24
  of the innovation that is coming out from China?
• 23:26
  Yeah, I, I think it's both Tom. Clearly you know, the, the
• 23:32
  Chinese companies have the ability to move extremely fast
• 23:36
  and that's something that you know we need to pay attention to
• 23:40
  and learn from. I think there's great
• 23:43
  opportunity for collaboration as well because although there's
• 23:46
  Chinese companies in general very successful from a discovery
• 23:50
  perspective and early clinical perspective, there are few of
• 23:53
  them that have late stage drug development experience.
• 23:56
  So I think there's the opportunity to partner and we
• 23:59
  obviously partnered with a Japanese company and took the
• 24:02
  molecule into the US and that's been a very successful
• 24:06
  collaboration. So I'm sure there's going to be
• 24:08
  opportunity and you know, many pharma have stepped in and and
• 24:12
  acquired Chinese based assets. So I think there's opportunity
• 24:17
  there. There's also the the reverse
• 24:19
  opportunity as well whereby you know, companies like ourselves
• 24:24
  could, could out license a, you know, a molecule to China.
• 24:27
  In our case the the Chinese rights for our molecule were
• 24:30
  already licensed to ASI. So that's not something we're
• 24:33
  specifically doing, but more generically, you know, biotechs
• 24:37
  have that kind of two way opportunity to collaborate with
• 24:40
  the with the Chinese company. So I see it as both competition,
• 24:44
  which is good because that makes everyone better and then the
• 24:48
  opportunity for collaboration is clearly there as well.
• 24:51
  Amazing. And just another question, just
• 24:54
  in terms of some of the culture that you're trying to build at
• 24:57
  at Chris Dallas, it sounds like you've maybe worked with some of
• 24:59
  the team previously, but like just talk us through the culture
• 25:02
  that you're trying to build at the company.
• 25:06
  Yeah, I know it's probably a smaller team as well.
• 25:08
  So talk through the importance of culture and early stage
• 25:10
  biotech And yeah, what you trying to build at Crystallis?
• 25:15
  Yeah, so we still have a relatively small team here.
• 25:17
  There's thirteen of us, you know, and we're we're conducting
• 25:21
  multiple clinical trials. So, you know, we need to be very
• 25:25
  efficient and effective. I think at this stage in my
• 25:29
  career, it's all about working with people that I want to work
• 25:31
  with. And you know, we, we have a
• 25:35
  culture within Crystallis Therapeutics where, you know,
• 25:38
  everyone is, everyone is focused on development of the drug.
• 25:43
  And you know, we work very flexibly together.
• 25:45
  So although every individual has a specific role, I don't think
• 25:50
  anybody looks at their job description after day one.
• 25:54
  They basically people do whatever needs to be done in
• 25:56
  order to to make this successful.
• 26:00
  And for me, one of the most important things, one of the
• 26:02
  most important culture in in in a company is creating a really
• 26:07
  open environment of trust. One of the biggest issues that
• 26:10
  you have in drug development is if something's going wrong and
• 26:13
  it's not made visible, then ultimately the impact of that is
• 26:19
  going to be so much larger than if, you know, people are working
• 26:22
  in an environment where they're not found about, you know,
• 26:25
  flagging that there's an issue. And, you know, we have an
• 26:29
  environment here where, you know, if there's a an issue
• 26:32
  that's developing, which is common in drug development,
• 26:35
  then, you know, people get it on the table as early as possible.
• 26:39
  And then we work as a team to, you know, develop a solution to
• 26:43
  that and then minimize the impact.
• 26:46
  I think the second thing from my perspective is, you know, is, is
• 26:50
  your team and, you know, really caring about your team.
• 26:54
  And I, I, I mean, not only the individuals that work in the
• 26:57
  company, but everybody has a life outside work.
• 27:01
  And I'm a great believer that you need to give people the
• 27:04
  flexibility that they need to, you know, manage their lives,
• 27:08
  whatever that is. And as a result of that, people
• 27:13
  will give you that flexibility back.
• 27:15
  And I think if you create a culture like that, then you
• 27:18
  actually never need to tell anybody that something needs to
• 27:21
  be done because they already know it needs to be done.
• 27:24
  And they know that you gave them the flexibility when they needed
• 27:28
  it. And they'll step up and do
• 27:30
  whatever's needed to, to develop the the drug.
• 27:34
  So I think that's a very positive culture to create
• 27:38
  within a company and that's what we're doing at Crystallis
• 27:40
  Therapeutics. Amazing.
• 27:42
  And just to finish this off, as Crystallis moves into its next
• 27:46
  phase of growth, what should people be watching closely over
• 27:49
  the next 12 to 24 months? You've obviously had a
• 27:53
  significant financing round. My guess is, is that it's now
• 27:56
  execution. But I'd, I'd love to hear like,
• 27:58
  yeah, what are you guys next looking forward to over the next
• 28:01
  year or two? Yeah.
• 28:02
  So Tom, yeah. So absolutely, you know, first,
• 28:05
  second and third priorities are execution of the the phase three
• 28:09
  program. And you know, so people should
• 28:13
  you know, watch out for announcements about us
• 28:15
  completing recruitment into the trials.
• 28:18
  And then you know, subsequently we'll see data, the data will
• 28:22
  take a little bit longer than the normal because we we decided
• 28:26
  to run our trials. Normally go trials are run for
• 28:29
  12 month period. But based on our experience of
• 28:33
  working at our day previously on the senior ad, we were aware
• 28:37
  that if you really want to impact the clinical symptoms of
• 28:40
  the disease then you need to treat longer than 12 months.
• 28:43
  So we're actually treating for 15 months and 18 months
• 28:46
  respectively in our two trials. So they'll be a little while
• 28:49
  before we see the data, but a lot of work to be done before
• 28:53
  that. From a financing perspective, we
• 28:56
  don't need to raise any additional money to to get to
• 28:59
  our phase three read out. But as you're probably aware and
• 29:03
  your, your listeners will be aware, the financial market is
• 29:07
  much more positive now than it's been for many years.
• 29:10
  So we will of course remain opportunistic.
• 29:13
  And if there, if it makes sense to raise an additional round of
• 29:17
  capital or indeed take the company public, then we'll be
• 29:20
  ready to to do that. So multiple, you know, things
• 29:24
  running in parallel here. And it's always my belief in the
• 29:27
  biotech that the best thing you can do is have optionality.
• 29:31
  And you know, we'll be working to make sure that we continue to
• 29:33
  have optionality as we run through to generation of the
• 29:37
  data and you know, ultimately, you know, submission and
• 29:40
  approval of the drug focus. Beyond that, of course, you
• 29:44
  know, we'll start soon to think about commercialization.
• 29:48
  As I indicated to begin with, we're positioning this as a
• 29:51
  specialty care treatment with the rheumatologist as they as
• 29:54
  the prescriber. That means it's perfectly
• 29:57
  feasible for a small biotech to raise the to, to launch this
• 30:02
  drug. And you know, we'll start, we're
• 30:05
  just starting the commercialization planning and
• 30:08
  we recently announced that Tim Wahlberg, who was the CEO of
• 30:11
  Horizon Pharmaceuticals has joined our board.
• 30:15
  And Tim was responsible for the fantastic success of Crestexa,
• 30:22
  which was also a specialty care treatment with the
• 30:24
  rheumatologist as the prescriber.
• 30:27
  So Tim will be a tremendous help to us as we start that
• 30:30
  commercialization journey and really look forward to working
• 30:33
  with him as we as we do that. Yeah, amazing.
• 30:37
  Well, look, James, thanks so much for coming on and helping
• 30:39
  us out with this. It sounds like the progress that
• 30:41
  you guys have made already and the next upcoming milestones is
• 30:44
  definitely something to keep an eye out for.
• 30:46
  So thanks again for helping us out with this.
• 30:49
  It was a it was a pleasure to to to chat and and hear your
• 30:52
  thoughts on all of. Those Yeah, No, Tom, thanks for
• 30:55
  having me on the podcast. I really enjoyed it.