Latest / The BioHub - by Avetix / Episode 236 - Dan O’Connell - President & CEO of Acumen Pharmaceuticals

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Episode 236 - Dan O’Connell - President & CEO of Acumen Pharmaceuticals · The BioHub - by Avetix

• 0:06
  Welcome back to another episode of the Bio Hub and Avetix
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  podcast. Today I'm joined by Dan
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  O'Connell, CEO of Acumen Pharmaceuticals.
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  Dan has spent more than 20 years creating, investing in and
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  leading neuroscience companies. Since joining Acumen, he has
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  helped transform the business from a private early stage
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  biotech into a publicly traded clinical stage company,
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  developing a potential new treatment for early Alzheimer's
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  disease. In this conversation, we discuss
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  his move from VC into the CEO role, the origins of Acumen,
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  taking the company public with just nine people, balancing
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  financial discipline with clinical progress and the major
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  results expected later this year.
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  Pleasure to have you, Dan, How are you?
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  I'm terrific, Max, Thanks for having me.
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  No, it's seriously a pleasure. Like I was just saying before,
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  we jumped on a while in the making, so I really appreciate
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  you coming on. Yeah, no, thanks for thanks for
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  having me. So I, I want to start with your
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  career, you know, you, you spent your career creating, investing
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  in and leading neuroscience companies.
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  What what originally drew you into the field and how did that
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  journey eventually lead you to what is now, you know, acumen?
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  Sure. So, so Max, I think I was first
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  drawn to what I would characterize as the business of
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  neuroscience during my MBA graduate studies at the
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  University of Virginia. And it was through a combination
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  of personal experiences with neurodegenerative diseases such
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  as family members afflicted with disease as well as a cousin who
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  was a physician, inventor, entrepreneur that was also in
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  the field. So those are some of my personal
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  ties into the area. And then I think other factors,
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  including my own personal motivation, but also a small
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  group of venture capitalists and neuro researchers were
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  interested in establishing an investment vehicle to, to invest
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  in and, and support emerging neuroscience companies.
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  So that was in the early 2000s. And that, you know, really
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  culminated in the founding of Neuroventures, which was a
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  petite venture firm, which gave me broad exposure to a diverse
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  set of companies, to technologies and science, as
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  well as people, entrepreneurs and scientists and researchers
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  in that emerging ecosystem. And as it, as it turns out, the
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  2000s, there was the 1990s were the decade of the brain from a,
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  a research perspective sponsored by the NIH.
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  And I think there was a lot of enthusiasm and optimism of what
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  was possible from leveraging some of the the basic research
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  and translating it into new and better treatment options for
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  people living with CNS diseases. So and as it would turn out,
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  Acumen was one of those early neuro venture investors
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  investments, excuse me. And so my my involvement with
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  the company goes back to those earliest days, formative days of
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  the company. Yeah.
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  And that that's sort of why I want to go next as well, because
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  like, like you say, Acumen's scientific foundations go back
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  decades. Can you just take us through the
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  origin of the company and the belief that certain toxic forms
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  of amyloid beta play an important role in Alzheimer's
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  disease? Sure.
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  So, so Acumen sort of in the late 90s, early 2000s was
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  organized and founded by three researchers in the in the
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  neurosciences space, 2 researchers that at the time
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  were at Northwestern and one at the University of Southern
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  California. And these scientists were some
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  of the first researchers to sort of characterize and demonstrate
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  the specific toxic properties of soluble aggregates of the
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  amyloid beta peptide. And so they they characterized
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  or termed these toxic species amyloid derived diffusible
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  ligands or atolls. And in their research, they
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  demonstrated a high propensity to bind to neurons and cause
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  deleterious or toxic effects to circuits as well as as well as
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  neurons. That founding science from a
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  company's perspective served as some intellectual property.
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  And and that founding team generated some mirror mouse
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  antibodies that were sort of against this particular target.
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  All of that came together as some Seminole intellectual
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  property that became the cornerstone of the company and
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  really the call to action to make a seed investment on the
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  part of myself and partners at Neuroventures and ultimately
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  what led to a collaboration between Acumen and Merck in the
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  early days. I should also say that the the
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  original sort of founding science at at Acumen has further
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  been supported by a couple of decades of research at labs
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  throughout the world, both in industry and in academia that
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  continue to to provide support and evidence that these
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  oligomers broadly or a distinct and toxic, a distinctly toxic
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  species of, of a beta. And you know, the field has made
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  a lot of progress. And I think, you know, we at
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  Acumen are very much committed to providing the clip clinical
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  evidence that targeting these toxic species has preferential
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  treatment benefit in terms of both safety and efficacy.
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  Yeah. We can kind of go on to your
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  science and a little bit more in a bit.
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  But I want to talk about, I mean you personally moved from a,
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  from a venture investing role into into the CEO role acumen.
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  What What were some of the biggest companies between what
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  was assessing a company from the outside and being responsible
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  for building, well, building the company?
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  Sure. It's it's such a different
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  mindset. I think, you know, I spent
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  about, I would say 10 years post MBA in more of an investing kind
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  of role. And there you're constantly
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  assessing, you know, the people, the science, the technology, the
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  plan and trying to manage risk and contribute to or otherwise
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  help direct, you know, the most successful return or outcome you
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  can. But at the end of the day, it's
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  a bit of a, a participation or passive experience.
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  What I've found in, in leadership roles, in operating
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  leadership roles such as at, at Acumen in the CEO role, it's a
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  much more applied existence and it's really, you know, you've
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  got skin in the game on a daily basis and you've got the lead
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  role to shape strategy, grow the organization and ultimately
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  direct the, the, the success of the company.
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  So it is a, it's a just a fundamentally different mindset,
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  I think one that that I've embraced and enjoyed.
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  And we've had a remarkable run, you know, as you described at
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  the front end going from a very small formative company with
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  just a handful of people really which started as consultants,
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  myself included, and transitioned into an emerging
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  clinical stage publicly traded biotech company with roughly 60
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  employees. And now doing really an upscale
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  phase two study for an asset we think could be a game changer in
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  the in the Alzheimer's space. Yeah, I mean, when you when you
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  word it like that, the journey actually sounds so, so exciting.
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  You know where you've come from. I mean, for example, right, you,
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  you guys went public with a team of of only 9.
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  Why? Why was becoming a public
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  company so important at that stage?
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  And what did it take to prepare such a small team for that
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  transition? Yeah.
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  So, so a couple of thoughts on that question.
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  Max, I think that if you if you take a step back, the field that
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  we're in is very, very capital intensive, right.
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  You know, conducting Alzheimer's clinical studies is a is a long
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  and expensive process. And what we've been fortunate at
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  acumen to garner, you know, strong capital base of
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  experienced institutional investors supportive of our
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  really long on our thesis for Sabernatug and targeting
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  oligomers. So I think and even, you know,
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  in my experience as a venture investor seeing things, this is
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  not an industry where you can, you know, underfund or sort of
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  save your way to a successful outcome.
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  You've got to really be able to do things with the right
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  expertise and and at scale. And so I think that the going
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  public in 2021, it was slightly opportunistic in that the
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  markets were permissive and allowed us to do so, but it
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  really did give us the capital base to go out and, you know,
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  grow the organization from nine people.
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  I think it in those, you know, for the phase one study, we were
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  about 40 people roughly through that phase of the company's
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  growth and, and conduct a a a very innovative phase one study
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  in Alzheimer's patients across a number of sites and which
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  yielded a a successful outcome that allowed us to again, as a
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  public company, you know, raise additional capital, which then
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  begot, you know, the resources necessary to conduct the ongoing
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  altitude AD study. So I think that, you know, being
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  a public company raises the visibility of the company.
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  I think it, you know, provides some, you know, sort of
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  credibility and stature, but ultimately it's, it's access to
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  capital that, you know, drives the innovation, particularly in
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  neuroscience where, you know, these can be expensive, you
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  know, clinical translation experiments to conduct.
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  Yeah. I think it says a lot about you
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  as a leader, but also acumen that you saw a window in the
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  market where you could go and take the company public even
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  though it was a risk so early on, but you saw an opportunity
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  to then you say you get the capital to to take the company
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  forward. Like, what was that like, you
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  know, as trying to make that decision quickly as a team to
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  capitalise on that? Yeah, we did.
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  And that's where having a really experienced board and strong
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  base of investor support was very helpful.
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  We had only just closed our crossover Series B round in late
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  2020, in November of 2020, where RA Capital LED a $75 million
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  Series B round, which really was the first formal capitalization
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  of the company, you know, as a private entity.
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  And it really what what came together in 21 was this robust
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  IPO window and a groundswell of enthusiasm in the investment
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  community for what would be possible at Alzheimer's and in
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  particular the the prospect of at the time Biogen getting
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  approval for their original anti a beta antibody aducanuma.
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  And so is that confluence of a board that was knowledgeable in
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  essentially launching public companies and an investor base
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  that was willing to support that effort and and really anchor the
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  IPO come the middle of 2021? I mean there were other factors
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  that that played in. I mean we as a as a factual
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  matter, we did go on clinical hold after we had filed our ID
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  in late 2020. And it was a little bit of a
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  technicality, but it kind of held us up a little bit in the
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  early part of 21. So I think it was April 9th of
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  2021, we came off clinical hold. We held our phase one
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  investigator meeting and we filed the confidentially the S
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  1. So it was like a triple-A a a
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  triple witching hour or day that will be kind of is, is sort of
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  in the history of acumens aggressive planning and, you
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  know, willingness to to execute. I love that, yeah.
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  What what was it like when you went on clinical hold then as a
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  leader in the company, you know sort of that?
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  Yeah. So we we had strong regulatory
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  leadership in the company. I mean part of that nine person
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  team that was in place when we went public were a small group
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  of former Eli Lilly professionals that had been in
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  various leadership roles or, or technical roles in Lilly within
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  their regulatory and clinical and operational elements.
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  And so I think there was a, a willingness to understand what
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  the issues were. These were non clinical issues.
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  So they're kind of technical in nature.
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  We had to do a couple of additional experiments and
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  generate some data. So it's a little anxious and at
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  at the time, but something that we were ultimately able to, to
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  navigate based on the, the expertise and the experience
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  around the table. And for me as a leader, it's
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  really leaning on that expertise and trusting, you know, sort of
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  the process, if you will. Yeah, 100%.
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  I mean because you, if you also take just a look generally at
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  the last five years in in biotech, it's it's been unusual
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  for sure. How have you handled the market
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  challenges since since you guys went public?
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  Sure. I mean, the market has been
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  volatile and you know, in the last five years up up until
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  about a year ago had been really in a, in a, you know, downward
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  trend, you know, from a macro perspective.
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  So the way we think about what I've tried to guide the team is
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  to stay focused on the goal, recognize that we've been
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  fortunate to have the resources to do the work and that we're
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  investing towards, you know, the evidence and the value
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  inflection that successful results will will yield.
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  I think there's a, you know, aside from the macro kind of
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  dynamic within biotech, which is kind of just generally, you
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  know, sort of been volatile over the last five years.
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  The Alzheimer's space in particular has its own dynamic.
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  And I would characterize, you know, investing in Alzheimer's
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  as a, as a, from an investment perspective, you often see, you
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  know, through through a series of cycles, you know, the space
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  is either overbought or oversold is the term I like to phrase.
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  So we have this, you know, sort of groundswell of optimism and
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  euphoria and that's probably overblown.
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  And then we have sort of this, you know, sort of downward trend
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  of pessimism and you know, nothing will work and we don't,
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  you know, these aren't real products and you know, and so
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  forth. And I think we're in the more
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  recent period here. We're starting to see some
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  maturation in the, in the commercial launch of the two
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  approved agents, a recognition that that amyloid targeting has
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  clinical validation and that you know, you know, I think there's
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  just a more rational approach in the marketplace today.
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  So I think it's been a challenge and you know the team I think
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  has stayed focused on the goal, but it is at times you feel a
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  bit discouraged that there is a greater appreciation for the
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  value intrinsic in the in the in the portfolio that we've created
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  a document. Yeah, I would agree with that.
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  It's, and we, we talked about this constant balancing act
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  that's needed to protect cash, you know, with the need to keep
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  important programs moving forward.
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  But but how? How do you decide where to save
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  and where the the company just can't afford to slow down?
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  So I think we have been very fiscally disciplined.
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  I think that my own experience is you just have to continue to
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  focus in on rationalizing a budget and and the intended, you
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  know outcome or purpose for a particular spend.
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  We've been really good about that.
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  I think we've as we've grown, we've even been able to deploy
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  that more broadly as an organization.
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  So we are constantly conscious of, you know, being efficient
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  with capital deployment and and capital allocation.
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  I do also think that there is a mindset whereby, you know, you
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  introduce risks to the extent that you don't adequately
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  support or or fund various activities and that's whether
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  that's people or, you know, parts of the program.
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  So I think we've been, you know, very rational about making sure
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  we get the numbers right and make sure that we are deploying
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  the resources that will, you know, optimize our probability
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  of success. I mean, I think that again there
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  are you know the biotech space, you know small emerging
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  companies are often times you know undercapitalized and
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  desperate for capital to do the right experiment.
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  You know, we and I think have been fortunate to have the
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  resources to as I'll just point to altitude ADI mean this is a
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  542 patient study whereby with an 18 month sort of placebo
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  control period. I mean, that's a major
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  undertaking for a small emerging company.
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  And yet we've had the resources and we've executed on that
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  program. Another example of kind of
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  innovative and efficient use of capital.
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  You know, we have a, a second program or enhanced brain
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  delivery program as part of the program.
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  And there we, we did several things.
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  I mean, firstly, we have a small team do an assessment of, you
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  know, what strategy would make sense for acumen to get into
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  this exciting receptor mediated space.
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  You know what, what receptor targeting mechanism, you know,
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  would we prioritize? How would we pursue it from a,
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  a, a development perspective, knowing that we are a, a company
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  that doesn't have in, in house R&D or, or discovery
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  capabilities. And you know with EBD, we first
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  prioritized Transferrin as the the right most clinically
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  validated receptor mechanism to deliver large payloads or
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  cargoes to the brain. And we entered into a, a, a, a
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  partnership with an established company called JCR Pharma.
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  And therefore what I would characterize as not a lot of
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  money. We got a tremendous amount of
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  diverse candidate profiles in collaboration with JCR.
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  And then those, those candidate profiles for a couple $1,000,000
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  yielded data that was allowed us to go back to the capital
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  markets and do a pipe financing led by RA Capital and get the
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  further funding to advance those candidates towards Ind enabling
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  work. So again, we you know that that
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  financing was in the first quarter of this year and you
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  know at the moment didn't call for a large capital raise ahead
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  of the phase two data readout, but we didn't want to slow down
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  the innovation that was occurring within the pipeline,
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  you know, on the on the EPD program.
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  So I think those are pretty good examples of just being on the
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  one hand willing to invest resources at scale for the right
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  purpose and then also being very capital efficient in pursuing
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  other early stage innovations that could be, you know, again,
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  kind of transformative for the field as they progress.
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  Yeah, yeah, it it must be hard that balancing out for sure.
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  I mean, even if you understand that you need to go full steam
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  ahead of a project, it's like, do you need that hire?
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  Do you need that piece of equipment or can we rent that or
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  what? Like all these little pieces
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  that that just start to add up. And you know what, like it's,
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  it's a part that companies went wrong with in 20/20/21.
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  So they would have jumped on that bandwagon that you guys did
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  in terms of fundraising, either going public or another raise,
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  but then just just weren't as cash frugal as as you were.
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  So that you were in a position now where as they are
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  unfortunately not no longer around.
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  Well, I think, I think Max, you know, the vision for Acumen sort
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  of in, in its growth cycle has been as an innovator in drug
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  development in, in Alzheimer's. And so I think there's been a, a
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  real focus on really only identifying the, the people and
• 20:13
  resources needed to, to do that translational work.
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  So, you know, we have, we're not in the discovery game.
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  You know, we, we just, we're not sort of, you know, at scale
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  investing in a broad set of, you know, target discovery and
• 20:27
  validation. But rather, you know, we have
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  the benefit of advancing an asset to Bermuda, which I
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  mentioned, you know, had really originated out of a
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  collaboration between Acumen and Merck.
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  So all of that sort of discovery, you know, the capital
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  investment principally was undertaken through that
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  collaboration. And and then we, you know, stage
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  gated the investments to get to Ind to get through a phase one.
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  And now, you know, we'll read out the Phase 2 later this year,
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  which will be another, you know, presumably another capital
• 20:57
  raising event on on a successful outcome.
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  Yeah. Well, that that moves on nicely
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  to what my next question. You just touched on it
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  obviously, but you've got these major clinical results expect
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  later this year. Just just just talk us through
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  what they are and what they could mean.
• 21:16
  Sure. So, so Sabernatog is our
• 21:19
  oligomer anti oligomer selective antibody that is in in a sizable
• 21:25
  global phase two study. And this is you know, a study
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  that's being conducted as a registration quality study that
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  has two active doses of of Sabernatog as compared with
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  placebo for an 18 month period. So we're we have enrolled
• 21:41
  patients that are early Alzheimer's patients.
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  So these are people that have a cognitive deficit and confirmed
• 21:47
  amyloid pathology and they go either on, you know, one of the
• 21:51
  two doses of Sabernatog or the placebo.
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  And the study is really designed to demonstrate that Sabernatog
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  given its mechanism, you know, has the potential to enhance or
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  improve upon the safety efficacy profile or what we call the the
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  benefit to risk profile of the existing anti amyloid agents.
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  And it's really, you know, central to that, that belief is
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  the toxic properties of these oligomers that that they
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  actually, you know, are early instigators of, of the disease
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  and they are persistent perpetrators in advancing the
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  diragenerative process in patients.
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  So we're we're hopeful that that both the safety and efficacy of
• 22:35
  severity will provide the clinical validation of that
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  hypothesis and really usher in a different discussion around
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  amyloid targeting approaches and which targets are preferentially
• 22:47
  beneficial for for patients. And we think that's going to be
• 22:51
  an exciting moment for us at Acumen, but even, you know, more
• 22:54
  broadly within the field. Yeah.
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  I think something that that you obviously want to touch on as
• 23:00
  well is how do the patients and families affected by Alzheimer's
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  keep keep the team focused for all of these challenges?
• 23:08
  Well, well, I, I think that, you know, we are, are grateful for
• 23:11
  all of the participants in the altitude study as well as in the
• 23:15
  our phase one study, the intercept study.
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  I mean, it is, you know, people's willingness to enter
• 23:19
  into research studies, particularly given that there
• 23:22
  are approved agents is a real indicator on the one hand of,
• 23:27
  you know, people seeking something better or different.
• 23:30
  And on the other hand, you know, the evidence so far of the
• 23:33
  promise of Sabernitaug, the study conduct has been
• 23:36
  phenomenal. I mean we've, we've, you know,
• 23:39
  the, the retention in the studies exceeded our
• 23:41
  expectations. We have an open label extension
• 23:45
  whereby everybody has the opportunity to roll into, you
• 23:48
  know, basically be guaranteed to go on drug.
• 23:50
  And we've had a very high rate of rollover of eligible patients
• 23:54
  into that open label piece. I think as a, you know, so all
• 23:58
  of those metrics like the study execution metrics, the study
• 24:01
  conduct metrics are really in our favor and, and encouraging.
• 24:04
  And I think that's where, you know, the motivation, the team
• 24:08
  at Acumen is united in purpose. I mean, I think people are very
• 24:11
  focused and appreciative of what the goal and objective is for
• 24:15
  the company and for our programs and pipeline.
• 24:18
  And so I think the, the, I'm super proud of the, the team
• 24:22
  that we put together and the level of commitment and
• 24:25
  dedication that our people have put towards towards Acumen and
• 24:28
  the people we're intended to serve.
• 24:29
  So I think all of this comes together.
• 24:32
  You know, if I think it's when we were, you know, I guess we we
• 24:36
  can't reflect that you asked about the markets and the and so
• 24:38
  forth. I mean, you know, we're running
• 24:41
  a 542 patients study with an 18 month outcome.
• 24:44
  So you know, you're talking about what what can be
• 24:47
  characterized as a data, a catalyst desert in public market
• 24:52
  terms. But we're now, you know, in the,
• 24:55
  the, the end line here is on the horizon.
• 24:57
  It's very in the fourth quarter of this year.
• 25:00
  And so the team, you know, the execution risk is been generally
• 25:04
  dispatched. We clearly need to deliver the
• 25:07
  results. Team is super focused on that,
• 25:10
  you know that deliverable and hopeful about the results.
• 25:14
  I mean, I think that's, you know, that's everybody's
• 25:16
  motivation. Absolutely.
• 25:18
  Yeah, to right. That's a great place to leave it
• 25:21
  as well. Other than what is my final
• 25:24
  question that goes to every single guest.
• 25:28
  If you could have dinner with any scientist or innovate, past
• 25:31
  or present, Dan who? Who would it be and why?
• 25:34
  So, so Max, just reflecting on the conversation we've, we've
• 25:38
  had in the history of this whole space, I think I would be
• 25:41
  interested in sitting down with Professor Alzheimer to get his
• 25:45
  perspective on where things started and where they are and
• 25:50
  whether we're on the right track and what else we might be able
• 25:53
  to do in the interest of improving patient lives.
• 25:57
  I think that would be a really fascinating conversation given
• 26:01
  his early contributions to the identification of, of amylic
• 26:05
  pathology, as well as as Tao Tangles and all the debates
• 26:09
  that, you know, sort of have been played out over decades
• 26:13
  now. But it would be interesting to
• 26:15
  see his his assessment of the state of play and and any
• 26:19
  recommendations he might offer again to to advance the field.
• 26:24
  I love that and I, I don't need to ask why.
• 26:27
  That was the answer for sure. Look, thank you so much for
• 26:32
  coming on, Dan. It's been an absolute pleasure.
• 26:36
  Max, thanks for having me, enjoy the conversation and hope you
• 26:40
  have a great day. Yeah, and everyone please like
• 26:43
  and subscribe to the Bio Hub and thank you so much again, Dan.