Latest / The BioHub - by Avetix / Episode 132 - Fabian Gerlinghaus - Co-Founder & CEO of Cellares

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Episode 132 - Fabian Gerlinghaus - Co-Founder & CEO of Cellares · The BioHub - by Avetix

• 0:06
  On this episode of Dubai Hub Podcast, we're joined by Fabian
• 0:08
  Gillenhaus, CEO and Co founder of Solaris.
• 0:13
  So since founding in 2019, Solaris have raised over $600
• 0:16
  million to develop their fully automated cell therapy
• 0:20
  manufacturing platform. It's got the likes of Carl,
• 0:24
  Dune, Pioneer and Cell Therapy Space calling it a game changer.
• 0:28
  And it's backed by, yeah, big pharma partnerships with the
• 0:31
  likes of BMS. So yeah, really interested to get to know a
• 0:35
  little bit about the origin story.
• 0:37
  Fabian today. Been a crazy few years.
• 0:41
  Indeed, a husband. Callum, thank you for having me.
• 0:43
  I'm looking forward to the conversation.
• 0:45
  Very good, awesome. I mean, we always ask Fabian for
• 0:49
  for any guest who comes on. I think it's really helpful to
• 0:51
  get to know a little bit about your own personal back story.
• 0:55
  Obviously grew up in in Munich, right And were robotics to start
• 1:00
  with and then a transition to sunny California and and
• 1:04
  biotech, yeah. How did that transition come
• 1:08
  about? Yeah.
• 1:09
  Yeah, happy to I I'm an aerospace engineer by training.
• 1:14
  Born, raised, trained in in Germany at the Technical
• 1:18
  University of Munich and then came over to the Bay Area,
• 1:21
  California about 13 years ago now and made a switch into the
• 1:25
  life science tool space, became an inventor of quite a few
• 1:29
  different biotech tools. Just before starring Solaris, I
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  was the chief innovation officer at the Crispo cast 9 GM
• 1:35
  engineering company actually developing tools for monoclonal
• 1:39
  antibody manufacturing, biorectors, centrifuges.
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  And that's how I got exposure to inventing novel bioprocessing
• 1:47
  technologies and leading a department in in that space.
• 1:51
  And I'm also I was very fortunate to meet my Co founder
• 1:56
  there, Omar Curdy. Omar ran a $200 million business
• 2:00
  unit that's Hammer Fisher Scientific making certified
• 2:02
  medical devices. And then they've worked at
• 2:05
  Finesse. Finesse was selling 2000 liters
• 2:08
  single use biorectors to virtually every pharma company
• 2:11
  until Samer Fisher bought them. And then he and I met together
• 2:14
  met at Centigo and and what then happened next was I will say a
• 2:23
  really key inflection moment in, in in modern medicine 2017, the
• 2:30
  first Carty cell therapy was FDA approved.
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  That was Kymriah, which was invented by our advisor,
• 2:35
  professor Doctor Carl Jun out licensed and commercialized by
• 2:39
  Novartis. And it really marked the
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  beginning of the commercialization phase in cell
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  therapies. For prior to that cell therapies
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  were by and large in academic pursuit with 10 patients in the
• 2:55
  clinical trial here, 20 patients in the clinical trial there.
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  But nobody had the challenge of how do you scale this up to a
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  commercial scale numbers. So 10,000 patients a year,
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  20,000 patients a year, 100,000 patients per year per drug.
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  And at this point, we've got more than 1/2 a dozen drugs on
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  the market. Cell therapies have proven their
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  potential to actually cure very, very aggressive forms of blood
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  cancers. Where chemotherapies have
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  failed, they're now expanding to solid tumors, autoimmune
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  diseases, rare genetic diseases. So it's, it's really a
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  completely new class of medicines that's incredibly
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  powerful and and very, very different than small molecules
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  of biologics DD medicines that came before us and the other
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  cell had been manufacturing bottleneck.
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  And that's that's what Omar and I set out to solve when we
• 3:41
  started Solaris in 2019. Yeah.
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  When did you start noticing the bottleneck?
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  I guess after Kim Rao was launched, sort of, yeah.
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  2018-2019 you guys got together, started talking about it more
• 3:53
  and more and then the idea becomes Solaris or.
• 3:57
  Yeah, that's right. So Omar and I, we were attending
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  all the typical cell type of conferences and the picture that
• 4:04
  emerged was cell therapies represent world class science.
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  The scientific challenges have been solved and what was holding
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  back cell therapy now is really the lack of industrialization,
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  the lack of high throughput, fully automated cell therapy
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  manufacturing technologies. People were screaming from the
• 4:24
  rooftops, we've got cures for cancer and we just have no way
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  of manufacturing them at scale at a sustainable price.
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  Yeah, I mean, it's probably the biggest challenge in self
• 4:35
  opiate, right. I mean, obviously you've, you've
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  identified the problem that coming up with a solution to
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  it's a entirely different proposition, right.
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  I know you're both inventors as it were.
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  Walk us through the early days like what, what did the the
• 4:51
  platform look like at the beginning?
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  Because I'd imagine it's very different now to what you set
• 4:56
  out with. It's actually exactly what we
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  envisioned when we first set out our, our board members sometimes
• 5:04
  point this out and set up. And now we walk through your
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  facilities in the US, Europe, Japan and we see these cell
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  shuttles in the South use that you've built and they pretty
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  much look exactly like the early wireframes that you pitched us
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  on during your Series A. So I think you know, the, the
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  core when it comes to the technology, the core insight was
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  what's holding back self hyper manufacturing at scale at a
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  sustainable price. And it's really, but those are
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  the two key problems. You know, how do you scale this
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  up to meet the needs of all the patients that are eligible and
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  in need of car T cell therapies? How do you bring down the
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  manufacturing cost? How do you make self hyper
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  manufacturing much more reliable and, and then also how do you
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  streamline tech transfer to other to, to other markets like
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  Europe and Japan? I think those those were the key
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  problems and the key insight initially was, well, in order to
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  make cell therapy manufacturing scalable, we need to automate
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  the entire process from start to finish.
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  In order to make cell therapy manufacturing reliable and bring
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  down the process failure rates, which are sky high in the
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  industry today with millennial cell manufacturing, we need to
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  fully close the process. And that led us to build a
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  consumable cartridge that's about the size of a carry on
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  piece of luggage that is actually a whole laboratory in
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  the box. It contains all of the different
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  technologies required to run the entire self manufacturing
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  process from start to finish. So specifically there's a
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  centrifuge, an Excel sorter, electroprater, Birect or steroid
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  transit technology in there, all connected in one closed fully
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  automated tubing set. And that's how we're automating
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  entire process from start to finish.
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  And then we built a cell shell that's roughly the size of a big
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  conference room. And the cell shell actually can
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  receive 16 of those cartridges. And each cartridge is an
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  independent swim lane. You know, each cartridge can run
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  a different cell type of manufacturing process, different
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  drug product for a different pharma company, for a different
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  patient. And that throughput is
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  unprecedented. You know, so most of the most of
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  the technologies I used in manual cell phone manufacturing
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  today are bench top equipment that handle one of the
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  manufacturing steps for one patient at a time.
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  And what we're starting with the cell shuttle is we're, we're
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  automating all of the manufacturing steps for 16
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  patients at the same time. And then the cell shuttle can
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  produce up to 2800 patient doses per year.
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  So with, you know, the entire industry producing just over
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  30,000 patient doses last year. What that means is that you
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  know, with, with five to say 20 socials, depending on the
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  process length, the throughput is different somewhere between
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  5:00 to 20 socials. We could have manufactured every
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  single cell therapy dose with the, the entire industry
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  manufactured last year. So that's, that's really hard
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  throughput that solves your scalability issue.
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  And then that's, I think maybe just finishing up the second
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  point on the second big problem is, of course manufacturing
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  costs and manufacturing costs today are incredibly high
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  because you've got teams of highly skilled scientists, very
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  highly qualified labor spending weeks in very expensive clean
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  rooms using a plethora of these benchtop instruments that I
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  mentioned. And I'm doing a lot of manual
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  labor meanwhile and our fully automated technologies to sell
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  for automated manufacturing, the sell key for automated quality
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  control together actually reduce the amount of labour that's
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  required by about 90%. So where our competitors on
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  doing manual self-employed manufacturing need to hire and
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  train thousands of employees, we need to hire and train hundreds,
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  roughly an order of magnitude less people.
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  That is both what unlocks the scale because there's actually
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  dearth of cell therapy talent. You can't even hire enough
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  people. And it also dramatically reduces
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  the, the cost. And at the same time, I the, you
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  know, the central is a big machine that's very compact.
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  It's, it's equivalent to about 100 of these bench top
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  instruments in one machine that put 100 bench top instruments on
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  100 benches with enough space for the human operators to walk
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  around and actually do their work.
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  You're going to take up 10 times more space than the social takes
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  up. So that's how we're shrinking
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  facility size by also an order of magnitude.
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  So where our competitors need to build 10 facilities to produce a
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  certain number of cell therapy doses, we need to build 1
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  facility of the same size. So 10 times less facilities
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  required, 10 times less people are required.
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  That makes the whole thing scalable.
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  That makes self help manufacturing I host efficient,
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  scalable, and then also closing the process.
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  Automating the process reduces process failure rates due to
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  operator error and contamination, which helps us
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  reduce process failure rates by about 75% compared with manual
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  self help manufacturing. Yeah, it's an interesting point
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  you mentioned as well. Like, yeah, it's not replacing
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  unskilled labour by any stretch, right?
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  Those those sites have been notoriously difficult to staff
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  over the years because of just how special that the rules are.
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  Yeah, we've seen that for sure. I mean, all of that is why
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  you've been allocated the advance AMT right from the FDA.
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  Talk us through how rare that is.
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  First of its kind, essentially. Yeah, yeah.
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  So we've, we've had a really good collaborative dialogue with
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  the FDA ever since we started Solaris.
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  The FDA actually very wise move of, of the regulators created
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  the pathway called the cat path Catt and it was a, a pathway for
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  developers of advanced manufacturing technologies to
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  have an early dialogue with the regulators and keep them
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  involved from from the very beginning, educate them, seek
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  their feedback, seek their input.
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  So that's what we've done with the regulators.
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  We've also, by the way, done that with our customers.
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  We've we've had a whole partnership program to actually
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  inform the user needs and requirements from gathered user
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  needs and requirements from not just one company, but a whole
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  number of companies. So collaboration has been the
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  name of the game from the beginning.
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  And then I at a later stage, we actually applied to the for the
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  advanced manufacturing technologies designation from
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  the FDA and Solaris was the first company to be granted an
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  advanced manufacturing, the advanced manufacturing
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  technologies designation AMT designation at all.
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  And to the state, we're the only company who's received the AMT
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  designation for a high throughput automated end to end
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  self hybrid manufacturing platform.
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  Yeah, it's super impressive. And you can sort of say why when
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  when you talk it through like you just have they've been cool.
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  I mean, talk us through where you're at now because you're
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  developing or you are now sorry manufacturing clinical grade GMB
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  material that's going to patients that.
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  Is the biggest. That is the biggest news.
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  That is the biggest news. We are incredibly excited and
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  incredibly proud to say that at this point we're actually
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  manufacturing cell therapies on the cell shuttle in our own
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  facilities, in Solaris facilities as a service for
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  paying customers in an FDA regulated environment.
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  And we're doing that for patient infusion, supporting the
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  clinical trials of our customers.
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  That is a huge, huge value inflection point.
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  If you're thinking about it, you know, we started Solaris to
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  manufacture cell therapies for patient infusion on highly
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  automated, scalable, cost efficient technologies.
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  We built ourselves and after seven years, seven years of
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  company building technology, building facility building,
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  building quality management systems, I signing up the
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  customers doing preclinical proof of concept work with them,
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  ultimately generating strong comparability data between the
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  manual and the automated process.
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  Filing that comparability data. I with the regulator is gaining
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  regulatory approval. That was that was a big
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  milestone for us. In January, the FDA actually
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  cleared Caballita's Ind amendment and ultimately gave us
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  permission to proceed into clinical manufacturing,
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  manufacturing drug products for patients for Caballera, that's
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  it was a lot of work to get to the point where we're now at
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  manufacturing drugs for patient infusion on the cell shuttle in
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  our own facilities. Yeah, yeah, for sure.
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  And with the way you guys are set up with technology transfer
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  being a hell of a lot easier by this model as well, commercial
• 13:52
  grade production, that's next year, right?
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  Correct. We're we're planning for the
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  first commercial scale launch in 2027.
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  Awesome. I guess when, when you've
• 14:01
  successfully done that, if and when you successfully get that
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  going, I should say. I mean, I guess the question is
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  why, why would anyone go over a traditional route?
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  I mean, yeah, the the cost savings, the time efficiency,
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  Yeah, it seems like a a win, win, right.
• 14:20
  Yeah. I think that'll become
• 14:21
  increasingly rare. And I've always said that's a,
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  it's a winner takes all market. And I ultimately I think cell
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  therapy companies will long term either partner with Solaris or
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  or lose in the marketplace. We're offering the lowest cost
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  of manufacturing in the industry, which means
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  significant increases in gross margins for the pharma companies
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  that makes cell therapy manufacturing sustainable for
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  them. And also I think long term will
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  help reduce drug prices. And then scalability is a big
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  boon for patients. You know, the core problem that
• 14:54
  we started is a is a patient problem.
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  It's the lack of access to these life changing, often times life
• 15:01
  saving cell therapies. And you know, there are many
• 15:05
  publications on this that state that even today only about two
• 15:09
  out of 10 patients eligible patients actually receive a cell
• 15:13
  therapy because of the manufacturing bottleneck.
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  And we'll say also pharma companies by and large haven't
• 15:20
  really turned on the sales engine yet to aggressively push
• 15:24
  their products into the market because why would you do that if
• 15:27
  you know you're going to be supply constrained?
• 15:29
  So scalability is a big boon for patients.
• 15:32
  It actually democratizes cell therapies and, and makes it
• 15:37
  possible for all the patients who need cell therapies to gain
• 15:39
  access and then also unlocks a lot of business for the pharma
• 15:42
  companies. And then quality is a really
• 15:46
  important point. We're reducing process failure
• 15:48
  rates by about 75% versus manual cell type of manufacturing.
• 15:52
  And that directly impacts the reputation of our pharma and
• 15:57
  biotech clients in the marketplace, which directly
• 16:01
  impacts their market share. You know, if, if you've got 2
• 16:05
  competing cell therapies and one is delivered on time and on spec
• 16:10
  every single time and the other one is sometimes late, sometimes
• 16:15
  manufacturing process failed and didn't work at all.
• 16:18
  Well as an oncologist, if you have a choice between
• 16:21
  prescribing the one product or the other product, what are you
• 16:23
  going to do? You're going to prescribe the
• 16:25
  drug product that is delivered on time, on spec reliably every
• 16:30
  single time. And I think that is only
• 16:33
  achievable with automation because too many manual steps
• 16:37
  for 10s of thousands of patients per year.
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  Humans are just not good at repeating the same steps over
• 16:44
  and over again and never making a mistake.
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  Meanwhile it's fully automated process.
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  Whatever comes up, you fix it once in hardware or software and
• 16:51
  then it never happens again. We just move sailing from there
• 16:55
  on out. So.
• 16:56
  I mean, I think what's crazy percentages in terms of FDA
• 16:59
  rejections for CMC related issues, right?
• 17:02
  The amount of CRLS out there in the past 18 months is, is pretty
• 17:06
  crazy. So cool.
• 17:08
  Talking of expansion news on Leiden, Netherlands and a new
• 17:13
  facility in Japan as well. What what made you up for those
• 17:16
  two locations? Yeah, we're, we're on a mission.
• 17:19
  We're on a mission to meet the total patient demand for cell
• 17:22
  therapies globally and we're doing that through rapidly
• 17:25
  expanding network of IDMO smart factories.
• 17:28
  And I think the the primary driver for this was our wasn't
• 17:33
  was an anchor partnership with Bristol-Myers Group.
• 17:36
  This is all public information we've got.
• 17:38
  We've got a $380 million partnership with Bristol-Myers
• 17:41
  Group for commercial skilled manufacturing in the US, Europe
• 17:44
  and Japan, $380 million in upfronts and milestones, not
• 17:49
  counting the actual business of actually manufacturing cell
• 17:53
  therapies is a commercial skip for on an ongoing basis, of
• 17:56
  course. And if you think about it from
• 17:59
  the pharma perspective, I, you know, for many cell therapies,
• 18:04
  manufacturing locally, and I don't mean bedside, bedside
• 18:07
  doesn't work, but manufacturing on the same continent is a
• 18:11
  practical reality. Just because shipping the
• 18:15
  starting material, the apheresis from the hospital and shipping
• 18:19
  back the final cell therapy for, for infusion.
• 18:22
  If you have to do that across the Atlantic for for Europe or
• 18:27
  across the Pacific for for Japan, that actually delays on I
• 18:33
  that, that, that delays I the time that is allowable based on
• 18:38
  the on the guidance from the regulators between collection
• 18:41
  for recess and started manufacturing beyond the time
• 18:44
  window that's been agreed upon with with the regulators.
• 18:46
  So we do need to manufacture locally.
• 18:49
  I will say an added benefit in this day and age with with all
• 18:52
  the tariffs globally is local manufacturing on on the same
• 18:58
  continent. It actually helps from a tariff
• 18:59
  perspective as well. And it also helps from business
• 19:03
  continuity perspective because you know, if in the case of a
• 19:07
  supply chain disruption, we don't have one facility, we've
• 19:10
  got a whole network of facilities globally.
• 19:12
  And while it's not ideal to ship drug products across the Pacific
• 19:16
  or the Atlantic, can we do that in an emergency?
• 19:19
  Of course. And from that perspective,
• 19:23
  building out these facilities is really crucial to the business
• 19:28
  continuity aspect of our service offering.
• 19:30
  But then ultimately comes back to what we talked about earlier,
• 19:33
  scale, the, the scale that we're building out here depends on
• 19:38
  the, on the length of the process, right?
• 19:40
  Cell therapy process, manufacturing process.
• 19:43
  He's varying length somewhere between 2 and 10 days.
• 19:46
  That's a big swing, right? If if you have a 2 day process,
• 19:48
  you can manufacture five times more cell therapies in the same
• 19:51
  time. We know that it would make him
• 19:52
  take you to manufacture A10 day process.
• 19:56
  So across the network of our facilities, we're building out
• 19:59
  capacity for somewhere between 40,000 and 200,000 patient doses
• 20:03
  across all the facilities in the US, Europe and Japan.
• 20:06
  Nice. Yeah, It's super exciting.
• 20:08
  I mean, funding that expansion, something that needs to be
• 20:13
  talked about as well. Obviously super impressive to
• 20:15
  see. Yeah.
• 20:16
  We're, we're actually, Yeah, yeah.
• 20:19
  How was that? I, I will call out that this
• 20:25
  global expansion we're very, I think we've been very smart in
• 20:30
  terms of how we structured that financially.
• 20:32
  First and foremost, we're not buying these facilities, we're
• 20:36
  leasing them for 10 to 15 years. So we're, we're effectively only
• 20:39
  paying rent. And then we negotiated very,
• 20:44
  very strong tent improvement packages with the various
• 20:47
  landlords and for the various facilities.
• 20:50
  So the the shell of the building we never pay for the internal
• 20:56
  build out is largely financed by by the landlords themselves.
• 21:01
  We committed to very long term leases, 10 to 15 years and it
• 21:04
  just makes financial sense. But landlords to put a lot of
• 21:08
  money towards building out the facility and then putting the
• 21:12
  actual equipment in there is largely financed by our clients.
• 21:17
  So I, I think in, in this way, we're able to structure the
• 21:22
  financials of our global expansion or in such a way that
• 21:26
  we're actually using very, very little equity dollars to expand
• 21:32
  globally and and build out the the global infrastructure that's
• 21:34
  required for commercial skill manufacturing and meeting the
• 21:38
  entire patient demand globally. And yeah, I think you wanted to
• 21:44
  touch on Series D. Yeah, yeah, sure.
• 21:47
  Just how you found it. I mean, that's obviously a super
• 21:50
  impressive raise, but yeah. I, I will say, you know, capital
• 21:57
  markets were easier in 2022 or you know, 2021 even 2019.
• 22:05
  So this was not the easiest market and at the same time the
• 22:10
  best companies always get funded.
• 22:12
  And so you know, in in January, late January, we're very proud
• 22:16
  to announce that we raised a 200 two $157 million serious deal
• 22:20
  led by BlackRock and Eclipse to industrialize global sell time
• 22:24
  manufacturing with breakthrough automation.
• 22:25
  And Eclipse, of course, is has been backing Solaris for many,
• 22:32
  many rounds since the inception of the company.
• 22:34
  But BlackRock is a new investor that's newly backed the company
• 22:39
  in this financing. Then we also attracted a number
• 22:43
  of additional very high profile growth class Wall Street firms
• 22:48
  such as T Rowe Price, but but also Billy Gifford, Gates,
• 22:55
  Frontier on high, Harvard Management to Kane, Intuitive
• 23:00
  Ventures, EBI Mitsui. There's there's a long list of
• 23:05
  of new backers who newly newly joined the cap table in in this
• 23:09
  financing. Yeah, super impressive.
• 23:12
  And yeah, it's exciting to see where you guys are going to take
• 23:15
  things in the next couple of years.
• 23:16
  Is there? I know you've been fairly vocal
• 23:19
  about it elsewhere. Is plan to go public in the
• 23:21
  next? Couple of years.
• 23:23
  Or. Yeah, that's timeline.
• 23:25
  Yeah, that's right. So the plan with this financing
• 23:28
  is ultimately to finance the company all the way through the
• 23:33
  first, well, of course, clinical scale manufacturing.
• 23:37
  That's what we're doing right now for multiple customers in
• 23:41
  2026 and then the first commercial launch on a cell
• 23:45
  therapy on our platform in our own facilities in 2027.
• 23:50
  And yes, as you mentioned that we're planning for an IPO
• 23:54
  shortly thereafter. Yeah, nice.
• 23:57
  Our can't wait to try the progress.
• 23:58
  And yeah, thanks for coming on. Really appreciate it.
• 24:01
  Great to get the insight into such a, yeah, groundbreaking
• 24:05
  option. Like you say, cell therapies
• 24:07
  prove that it can work. It's just about the scale.
• 24:10
  So. Yeah, look.
• 24:11
  Forward to see Keeping in touch. Awesome.
• 24:14
  Thank you so much for your time today and thanks for having me.
• 24:17
  Yeah, pleasure.