Latest / The BioHub - by Avetix / Episode 203 - Tim Noyes - CEO of Newleos Therapeutics

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Episode 203 - Tim Noyes - CEO of Newleos Therapeutics · The BioHub - by Avetix

• 0:06
  Welcome back to the Biohub podcast by Avetix Now.
• 0:10
  Today, I'm joined by Tim Noise, CEO of Newlyos Therapeutics.
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  Tim brings more than 35 years of experience across the life
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  sciences industry, beginning his career at Merck before going on
• 0:21
  to lead and build companies across biotech and pharma.
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  At Newlyos, Tim is leading A-Team focused on developing the
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  next generation of treatments for anxiety and other
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  neuropsychiatric conditions, built around a pipeline licensed
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  from Roche and centred on highly differentiated GABA A receptor
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  modulators. Tim, it's a pleasure to have you
• 0:41
  with you today. Thanks, Ben.
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  Good morning. Thanks for having me.
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  Absolutely. Let's, let's kick things off
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  from the beginning, Tim. I mean, your career has spanned
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  more than 35 years in the industry.
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  It began at Merck. What first really drew you into
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  this sector and what's kept you so committed to it?
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  Yeah. Wow.
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  So big question there. So my first job out of college
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  was was nowhere near pharmaceuticals.
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  It was in the international division of a commercial bank
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  where I was actually a foreign exchange trader.
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  And you know, it was a fast-paced, exciting
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  environment. I was learning a lot, worked
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  with great people, but I quickly realized I was just looking for,
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  you know, a larger purpose. I wasn't sure what that was, but
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  betting on currencies everyday, I'm trying to make a lot of
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  money just wasn't going to be that purpose for me.
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  So I went back to Business School to reorient my career
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  and, and, and get exposure to a variety of industries.
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  There's no Internet back then, So doing job searches and career
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  changes was a little more involved than it is today.
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  But but you know, during Business School, I found the
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  pharma industry. I don't know how to say it any,
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  any differently than that. It was, it was, it is technology
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  based, you know, constant learning, complex business
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  challenges, really great people. It's hard to imagine, but back
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  then the pharma industry was, you know, every year voted
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  America's most admired industry. So different times.
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  But importantly, it really had a strong sense of mission, almost
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  appalling for people who were going into that field.
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  And that really drew me. And then I, I think what put me
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  over the top is I was doing some research on the industry,
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  looking at a company called Merck, which was, you know, one
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  of the top companies back then, I guess arguably still is.
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  And I was just really struck by a comment that the CEO had made
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  and that wasn't the CEO. Then the George Merck, who was
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  the namesake and had been the president for many years, was,
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  was famously quoted for saying, and I'll, and I'll miss the
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  quote here, but I'll try and get it right.
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  It was something like we try never to forget that medicine is
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  for people. It's not-for-profit.
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  The profits follow and if we've remembered that, they've never
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  failed to appear. And that just struck me.
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  And so I think my 35 career, 35 year career has really been
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  focused on companies that are trying to solve really hard
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  problems with great science and great people.
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  And that's still what motivates me and that's what drew me into
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  the industry. Yeah.
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  And your career has trended from bigger companies towards smaller
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  ones. What is it about the smaller
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  companies that that makes you feel as though it's the right
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  environment for you? You know, I think small
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  companies, and I wouldn't criticize larger companies have
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  been in both. But I think I mean, for me,
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  everybody knows the advantages of little companies.
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  They're flexible, they're fast, they're fun, get to do a lot of
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  things. But for me personally, and it
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  was a personal choice, I'm, I'm an introvert and I feel most
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  comfortable in small groups where I can connect individually
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  with people. And I know that and I've learned
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  that about myself. But I think beyond that, for me,
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  you know, for me to thrive, I need an environment in which,
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  you know, basically everyone is in the same boat, trying to
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  solve their piece of the same hard problem.
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  And people need to, you know, sort of trust everybody else in
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  the boat. You know, there's a strong sense
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  of individual and, and shared accountability, which to me is
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  really the definition, you know, of a team.
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  And, you know, we succeed or we don't succeed, but we do it
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  together. We do it as a team.
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  You know, you embrace risk and there there just isn't time for
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  the distractions of, of you know who sits where and you know who
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  reports to whom and, and nobody's trying to take credit
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  for things. And so at the end of the day,
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  for me, I've seen first hand how that that that sense of shared
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  purpose really breeds a culture of transparency, transparency,
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  humility, and it creates a really strong culture, a fun
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  culture. And you know, I thrive in a
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  culture like that. So for me that works and that's
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  where I belong. Yeah.
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  I feel like a lot of people resonate with that as well
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  because one trend that we do typically see throughout the
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  entire industry is that as people grow and as people learn
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  the skills that that large farm are able to provide.
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  So, well, they do typically trend towards joining these
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  smaller companies working in these more sort of innovative
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  and fast-paced environments. Yeah, I mean, everybody has to
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  choose. I mean, I, I would also be very
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  quick to point out I couldn't do what I do today if I didn't
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  first work at Merck. I liken it to boot camp.
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  I mean, I, I talked to a lot of young people coming out of
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  school and they all want to, you know, especially now, like
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  entrepreneurship wasn't like that wasn't even a word.
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  You know, 10 people understood when I get out of college now,
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  every young person wants to do it.
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  And I say that's great if it's for you, but make sure you go to
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  boot camp first. Go somewhere where you're going
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  to learn from people, see what's done, choose a great company
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  with great people and learn before you go out on your own.
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  Now, some people want to start right off the bat.
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  That's great. But I couldn't do what I do now
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  if I didn't spend my time at Merck.
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  I I learned skills, techniques, styles, and I learned a lot
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  about myself. I grew up small companies can be
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  lonely places. Yeah, no, 100%.
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  I mean, let let's shift over to Nulios now.
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  I mean, you've built a pipeline around 4 distinct molecules that
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  you license from Roche. What made those assets the right
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  foundation to build around? Yeah.
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  So really good question, but you know, so first I should point
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  out, so I'm not a founder, I'm the founders of the company.
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  We're our current Chief Medical Officer, Federico Bolignani,
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  David Donabedian and Longwood and and Bill Martin.
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  So I'm not a founder, but but having been attracted to the
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  company really early on and having spent a lot of time with
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  the founders, I know that you know what, what drew them really
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  was what, what, what really starts every great company.
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  They were drawn to Roche's pioneering work and long
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  standing commitment to anxiety research.
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  I think as you know, Roche discovered the first
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  benzodiazepines back in the 1950s and benzos were really are
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  still transformative for people suffering from from anxiety.
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  And so Roche has really just been at the forefront of
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  neuropsychiatric disorders. And you know, I think that
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  legacy of innovation and excellence really matters a lot.
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  Second, you know, the opportunity to in license for
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  clinical stage molecules from the leader in the field, you
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  know, targeting very clear and and and undisputed, you know,
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  patient needs all with all with phase one data is just, you
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  know, an ideal place really to start a company.
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  So it's perfect. And you know, the evidence of
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  that is is based on all of that. The founders were able to, you
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  know, sort of craft a company mission to provide a new dawn
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  for patients suffering from a variety of mental health
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  conditions. And that mission, that purpose
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  and that, that, that, that excellence of science and
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  molecule allowed them to attract fantastic investors.
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  And so that's really the core of starting any company.
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  Great, great science, great opportunity to address patient
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  needs, bringing in great investors.
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  And from there they hired a core team that, you know, that's what
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  everybody's looking for. So I, I guess I'd say it's just
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  really the ideal place to start, start a a new company.
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  Yeah. And you, you touched on this
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  briefly about sort of Roche really helping to define the
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  anxiety treatment landscape with benzodiazepines, with Newlyos's
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  next generation GABA a approach. How do you think about
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  preserving the efficacy that sort of made that class
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  important whilst moving beyond the liabilities that have really
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  limited it today? Yeah.
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  So it's, it's a great question and it's an important one to
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  Nulios because you know the found, so our lead program is,
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  is what we call NTX 1955. And, and really the, the
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  foundation of that is that we know that benzodiazepines work,
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  as you point out. And so modulating the GABA A
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  receptor is a proven therapeutic approach to treating anxiety.
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  That's, that's beyond dispute. Benzos are in the market, You
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  take a benzo, you know you've had a benzo and if you have
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  anxiety, they work. Unfortunately, the problem is.
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  And so we do want to preserve that efficacy and by modulating
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  GABA A, we would expect to maintain that efficacy because
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  that's the underlying proven mechanism.
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  What we're changing and the problem we're trying to solve
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  with benzos that are that are very well known is that benzos
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  lack selectivity. So we activate circuits
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  throughout the brain which lead to side effects that really
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  limit their use, side effects like very bad sedation or
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  cognitive impairment. And so with these side effects,
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  benzos can only be used short term.
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  Anxiety is a chronic disease that people will suffer from
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  their entire life, but benzos will only be used for maybe a
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  week, possibly two weeks because you're too tired, you're too
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  sedated and you have difficulty learning, you have difficulty
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  remembering. And so for somebody to have a
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  productive, these are young people, you know, productive,
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  you know, school, experience, job, relationships, benzos are
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  really limited. So unlike benzos, NTX 1955 is as
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  you point out is selective for the the GABA gamma 1 receptor,
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  which is really only expressed in the brain area called the
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  amygdala that acts really as sort of the brain's threat
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  detection center and drives threat response.
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  So by specifically targeting the amygdala, we hope to focus on
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  the brain region that will treat anxiety, maintain the efficacy
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  as you point out, but solve this problem of, of, of, of
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  liabilities, which is really a problem of selectivity.
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  So that's the, that's the hypothesis.
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  Of course, you know, we still need to prove this.
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  So that's the hypothesis. Phase 2 will hopefully prove
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  whether we've we've we've solved the maintaining the efficacy
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  while solving the tolerability problem.
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  Yeah. And something you touched on
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  there was was was young people specifically, I mean, NTX 1955
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  is in general generalized anxiety disorder, NTX 1472 is in
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  social anxiety disorder, both of which are conditions that often
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  emerge early in life. What?
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  Why does that really matter when you think about sort of the need
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  for better treatment options? Yeah.
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  So, you know, it's a really good question because, you know, at
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  the end of the day, if, if we're right about either one of these
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  molecules, it's it, there's an overused phrase in the industry,
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  but but I'll use it anyway. Both of these molecules have the
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  opportunity to be completely transformational and life
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  changing. As you say.
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  We, we, we don't talk as much about social anxiety, but 1472
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  is treating a condition, you know, that is, that is
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  absolutely, you know, crippling for these patients.
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  And so as you point out, both GAD and SAD, you know, really
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  emerge in adolescence. So teens, 20s very early on.
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  These aren't late in late in life diseases.
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  And so, you know, if not treated well, anxiety isn't just called
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  suffering, you know, like right now.
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  It really shapes the entire trajectory and course of life
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  for these patients over the rest of their life.
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  So education is effective, relationships are effective,
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  career, your very identity is affected.
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  So this is a really cruel lifelong disease.
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  And, and, and people, you know, it's interesting depending on
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  GAD and SAD and they're different, but people often
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  describe watching everyone else enjoy life while life just
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  passes them by. It's it, it, it's awful.
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  So you, you're almost trapped in this condition for decades, you
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  know, wondering why you can't enjoy life for a variety of
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  reasons. And unfortunately, millions of
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  patients, millions of people get treatments that we have and
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  they're entirely ineffective. And so, as I said, it's it, it's
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  really a cruel disease. I mean, where sort of within
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  your company sort of structure does that have the most impact?
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  Is it in the way that you design your clinical studies?
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  Would it be and how you would eventually roll these out from a
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  commercial standpoint? Where does sort of the age
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  factor and the way that it impacts them from a social
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  standpoint impact the way that you guys are doing your work?
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  So it's a good question, you know, so one of the one of the
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  ways we, so I would say from top to bottom, you know, so we start
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  and you know, we, we will frequently have, and it's hard
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  to do in this space, as you can imagine, but it's something I've
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  always done in my career. And we do here.
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  We invite people with general anxiety or social anxiety to
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  come and talk to our company. We're only 20 people.
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  So we start then by by making sure everybody in the company
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  has a very clear face to what this condition is.
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  So they understand it better because if you don't it, it,
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  it's easy to project what you think it's not that bad or this
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  is the problem or this is what they're suffering from.
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  And often you don't understand what, what, what the real issue
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  is and what patients are hoping for until you talk to them.
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  So that's the starting point. We just had someone in here a,
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  a, a month ago to talk to us and it's, you know, it's from a
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  business standpoint, it's essential.
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  So we start there. So it leads to how we approach
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  our job, how we're motivated, how we design A clinical trial.
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  Do we include patients with adolescents or, you know,
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  adolescent age? So for us, that could go down to
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  a 15 year old. Once you start doing that, you
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  know, a lot of the risk averse nature of clinical trials is
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  just take a rifle shot and get the drug on the market and then
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  you'll figure out exactly who needs the drug the most.
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  We have tried to focus on the opposite.
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  So if a 15 or 16 year old is really who needs it the most and
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  that's where we should start. We also try and understand and
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  and promote a discussion that says, is it possible that the
• 15:19
  drug may be most effective if you treat an adolescent who
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  still has a developing brain? So I think obviously people know
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  adolescents still have a brain that is that is developing and
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  maturing and that really probably goes into your mid 20s.
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  And so the other thing we think a lot about is where would the
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  drug have its greatest effects? We try and think through what is
• 15:41
  the patient need, where would the drug be most effective?
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  How do we instill that in our people and how do we design A
• 15:48
  clinical trial, embrace that? And then lastly, you know, how
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  do we make sure that that everybody who should get the
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  drug does get the drug? That's a much bigger topic.
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  But but but I don't know if that answers your question directly.
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  Yeah, 100%. I mean, let's, let's delve into
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  patient access a little bit deeper.
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  It it's often framed as a commercial issue, but within
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  neuropsychiatry, it can really shape whether innovation truly
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  reaches the people that it's intended to help.
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  I mean, how, how do you think about this, the stage that
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  you're currently in where you're in clinical stages and aren't
• 16:24
  yet at that commercial point? Yeah.
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  So I mean, I, I would say that, you know, apart from whether or
• 16:31
  not our drug works, you know, in parallel, our biggest risk is
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  worrying about and trying to think about how patients will be
• 16:38
  able to pay for our drug. And this is not an insurance
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  question. This is out of pocket.
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  And so I think, you know, you and your your listeners are well
• 16:46
  aware everybody's got insurance, but every understands that out
• 16:48
  of pockets can be really punishing.
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  And so, you know, the insurance companies and the PBMS have
• 16:54
  really done, you know, to their credit, a wonderful job of
• 16:58
  shifting cost to the patient. Unfortunately, I think it's been
• 17:01
  very harmful for patients. And so I don't say that with
• 17:04
  admiration in any way. And so this is a hard 1.
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  I don't pretend to have answers. You know, we, we think about it,
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  we talk about it. One of the things I did at my
• 17:15
  previous company, we went and started talking to payers a
• 17:18
  couple of years before we had a drug in the market to try to
• 17:21
  educate them and help them understand because one of the
• 17:24
  things that happens and it and it will almost certainly happen
• 17:27
  to us if we get a drug approved. They get you in tiers of
• 17:30
  formularies. And so the higher up, the first
• 17:33
  tier might be a generic, second tier might be a preferred, the
• 17:36
  third one might be a newly launched drug.
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  And each tier your patients, our patients are paying more and
• 17:41
  more of a co-pay out of their own pocket.
• 17:44
  And the difference can be tremendous.
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  And so we know, for example, for us, it's a waste of time for a
• 17:50
  patient to have to take a generic SSRI for a year to prove
• 17:55
  that it doesn't work if they've already been on that all the
• 17:58
  while a patient's disease is being unchecked.
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  So one of the things we do is we go to payers a couple of years
• 18:05
  before we launch and start talking to them about what day
• 18:08
  do they need, what evidence do they need?
• 18:11
  How can we work with them to keep our drug in a position
• 18:15
  where they get a good outcome for their patient and our
• 18:18
  patient isn't unnecessarily punished in their out of pocket
• 18:21
  pay. Another thing that we do is we
• 18:25
  will look at developing very early on how we can develop
• 18:29
  programs that will offset out of pocket payment for patients.
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  Now you really can't do this for Medicare.
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  Thankfully our patient population is really not a
• 18:39
  Medicare population, but private payers will allow this.
• 18:42
  So we look at what's the impact of providing co-pay coupons.
• 18:46
  So any patient who says, hey it cost me, I'll make this up $200
• 18:51
  a month in co-pays, but we can cover the cost of that through a
• 18:54
  coupon. Again, you can't do that with
• 18:56
  government, with government payers like Medicare, but you
• 18:59
  can in the private. So my point is you have to plan
• 19:01
  really early on well before the drug is on the market because
• 19:05
  all of these programs and initiatives take time.
• 19:08
  If you want to launch with the ability to say any patient who
• 19:14
  gets prescribed our drug will get it, if the hurdle is their
• 19:19
  out of pocket concern, we will solve that problem.
• 19:23
  So I'm describing it as if we have solutions, we have things
• 19:27
  that will help. Nobody has a solution.
• 19:29
  You know, I stay close to the No Patient Left Behind initiative
• 19:33
  that has come out of RA capital, which is amazing.
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  But it's really, you know, the, the, the focus of that No
• 19:39
  Patient Left Behind that that is our philosophy.
• 19:42
  Yeah. And I think that that's, it's
• 19:44
  certainly the right approach to take you.
• 19:48
  You mentioned earlier that you're you're currently a twenty
• 19:50
  person organization and that sort of size culture becomes
• 19:54
  very real. You know, every hire, every
• 19:57
  decision carries more weight. An organization of this size is
• 20:03
  built to a place where people feel appreciated, they feel
• 20:07
  valued, and then they're able to do their best work as well.
• 20:12
  Yeah. So, you know, again a big topic.
• 20:16
  So in reverse, we, we hire for fit and we talk about that all
• 20:21
  the time. There's lots of people who can
• 20:22
  do a job and often in young companies there is this need for
• 20:27
  speed and, and we feel that. And so you're willing to hire
• 20:31
  people sometimes because they can get the job done and get it
• 20:33
  done quickly. We explicitly will not do that.
• 20:36
  So we make sure everybody we hire can do the job, of course,
• 20:40
  but they're going to be, you know, a good fit.
• 20:44
  So that's important. So what is the culture that
• 20:46
  that? That's a harder question.
• 20:47
  But in my experience, people, maybe it's a simple answer.
• 20:51
  People feel valued when they actually are valued.
• 20:54
  I mean, this isn't something you can put on a wall.
• 20:56
  I'm sure Enron had the same values on the wall of honesty
• 20:59
  and integrity. And well, I don't know how old
• 21:01
  your listeners are. Maybe some don't remember Enron,
• 21:03
  but you know, it, it, it if you don't hire people who value
• 21:07
  others and value their input, then then you can't, you know,
• 21:10
  demand it by by by determining it to be one of your core
• 21:13
  values. But I think by hiring people
• 21:16
  like that, it extends really not just to the people you hire, but
• 21:21
  but but, but but to your partners, your, your clinical
• 21:24
  trial sites, your CR OS, and then it has to be model.
• 21:27
  I personally visit every single clinical trial site that does
• 21:31
  research for us. At my previous company, that was
• 21:34
  more than 100 sites. At this one, I've already
• 21:36
  visited, I think 18 out of the 19 sites we're doing research
• 21:40
  at. Why?
• 21:42
  Because it's important to go out there and say, and they say,
• 21:45
  I've never talked to ACEO, why are you here?
• 21:47
  And I say it's important for you to know we're the face of this
• 21:50
  trial. I want to thank you for working
• 21:52
  with us. They're your patients.
• 21:53
  This matters to us. And so I guess it's a long
• 21:57
  answer to saying it has to start with people who actually do
• 22:02
  value other people and value their input.
• 22:06
  And then second, you've got to, you know, sort of create and and
• 22:09
  communicate a mission, a purpose that that that draws people in.
• 22:13
  And, and that shouldn't be hard in biotech, but it's something
• 22:16
  that ultimately is super important that Nulios, as we've
• 22:19
  talked about, as you know, that centers on, you know, creating
• 22:23
  new treatments for people with anxiety and substance use
• 22:25
  disorder. And, and, and that mission is
• 22:29
  really ultimately what self motivates people.
• 22:32
  That's what motivates people. That's what is going to create a
• 22:36
  culture. And so if you hire those kind of
• 22:38
  people with fit and give them a chance to do something that
• 22:42
  matters in respect to our small company analogy, the rest takes
• 22:46
  care of itself. You end up with, you know, a
• 22:48
  culture that you can't dictate. If you hire the right people,
• 22:52
  you will end up with that culture that you were looking
• 22:54
  for. And then the rest just takes off
• 22:57
  and sort of hopefully the magic starts it.
• 23:01
  Sounds as though New Lewis is certainly a great place to work
• 23:04
  then. I hope so.
• 23:06
  That's that, that. That's our goal.
• 23:09
  I mean, just to sort of wrap things up here, you know, our
• 23:12
  typical final question. If you could have dinner with
• 23:15
  any scientist or innovator, past or present, who would it be and
• 23:19
  why? Yeah.
• 23:22
  So I think about that a lot and I think about leadership given
• 23:26
  my role, sort of what what can I do?
• 23:28
  I don't invent drugs, I don't make the drugs, but I'm the
• 23:32
  leader of the company as the CEO.
• 23:34
  That's my job. Doesn't make me smarter or
• 23:36
  better, as I say to everyone we hire, just means that's my role
• 23:39
  and I have to be a good CEO just like they have to do their job.
• 23:43
  Unfortunately, I don't get a lot of, you know, feedback like they
• 23:46
  do. So, you know, I, I, I, I'm
• 23:49
  inspired by what I consider to be great leaders, people I'd
• 23:52
  love to have dinner with who sort of modelled and
• 23:55
  demonstrated sort of, you know, honesty, humility, perseverance,
• 23:59
  that, that, that, that I try to model people who never lost
• 24:03
  sight and this is really hard, never lost sight of the big
• 24:06
  picture while they were dealing with the daily urgent and
• 24:10
  important. And so I guess a few examples
• 24:12
  I'd give or Abigail Adams, I would love to have dinner with
• 24:17
  and understand her life and how she was often referred to as
• 24:21
  Missus president and, and, and is a great case study for
• 24:24
  anybody who hasn't done a case study on Abigail Adams.
• 24:27
  But but but just a visionary and a patriot and somebody who never
• 24:31
  lost sight of the importance of the country and didn't care
• 24:35
  about politics and didn't let her husband care about politics.
• 24:38
  Her husband, her husband, of course, was the president, but,
• 24:41
  but that goes without saying. Abraham Lincoln the same.
• 24:45
  And I guess maybe a business leader more current for some of
• 24:48
  your listeners would be Ewing, Marion Kaufman.
• 24:53
  So the founder of Marion Labs and the Kauffman Foundation,
• 24:56
  somebody who understood the purpose of business was give
• 25:01
  people a chance to thrive and build and grow.
• 25:05
  But it was always a vehicle for him of upward mobility and a
• 25:10
  chance for people to grow and improve their lives.
• 25:13
  And, you know, we founded one of the great, one of the great
• 25:16
  foundations still today that, that, that embraces education
• 25:20
  and entrepreneurship, not for entrepreneurship, but as a means
• 25:25
  for, for giving everybody a chance and growing their lives,
• 25:29
  expanding their lives and, and, and upward mobility.
• 25:32
  And all of those people really, you know, never did anything
• 25:36
  that made the people around them feel smaller.
• 25:39
  Quite the opposite. Their goal was to make people
• 25:41
  around them bigger. And so, you know, I, I would
• 25:44
  hope to do that. I'd love to learn how they did
• 25:46
  it. So long answer, sorry.
• 25:50
  Absolutely no, those are those are some great answers.
• 25:54
  But look, it's been an been an absolute pleasure having you
• 25:56
  having you here with me today. Tim really enjoyed our
• 25:57
  conversation. As did I, Ben.
• 26:00
  Thank you. And thank you to everyone for
• 26:03
  tuning in and I hope you enjoyed this episode and make sure to
• 26:06
  drop a like and subscribe for any future episodes coming out.
• 26:09
  That's all for now. Goodbye.
• 26:11
  Bye now.