First in Human Episode #26 featuring Margo Georgiadis

For episode 26, we chat with Margo Georgiadis, CEO & Co-Founder of Montai  Health. Find out about Montai’s creative approach to tackling chronic disease by harnessing the power of nature to find safer, more effective treatment options. First In Human is a biotech-focused podcast that interviews industry leaders and investors to learn about their journey to in-human clinical trials. Presented by Vial, a tech-enabled CRO, hosted by Simon Burns, CEO & Co-Founder & guest host Co-Founder, Andrew Brackin. Episodes launch weekly on Tuesdays.

Andrew Brackin: [00:00:00] This is First in Human. My name’s Andrew Brackin, I’m the co-founder of Vial. Vial is a next-generation CRO, built for biotech offering faster and more efficient clinical trials. Today, we’re here with Margo Georgiadis, the CEO of Montai Health. Hi, Margo. Welcome to the podcast.

Margo Georgiadis: Hi, Andrew.

Andrew Brackin: Why don’t you tell us a little bit more about yourself and the company?

Margo Georgiadis: I’m excited to be here and tell you a little bit more about Montai. Our mission is to improve health outcomes for as many people as possible by transforming the paradigm to treat and preempt chronic disease. 

Andrew Brackin: That’s obviously an incredibly exciting mission. We would love to learn more about that approach you’re taking to tackle chronic disease.

Margo Georgiadis: It’s a huge societal problem. If you look up on any CDC website. Or wherever you look, the numbers are staggering. Two billion people around the world are suffering. It’s trillions in healthcare cost and an unsustainable burden on our society. The numbers are like, 6 in 10 Americans have one, and 4 in 10 have two or more. That gets even higher for our aging population that’s 65 years-old. The patient’s unmet needs are enormous in this area.

We’re pioneering to tackle this problem by unlocking the power of nature with digital technology so that we can rapidly and repeatedly create new therapies. We’re designing therapies specifically to address the unmet needs, which are therapies that are needed to slow or even halt the progression of these diseases, not just treat symptoms. We want to create therapies that are safe for long term use and early intervention. We want therapies that are consumer-friendly in their delivery, like a once-a-day pill or something they inhale. They have to be more affordable than a lot of treatments today, which are highly restricted by payers in terms of their access.

Coming into this industry as a technologist, I long believed that there’s creativity in constraint. We set this high bar for what we needed to do, and then we said, “What if we could take a completely different approach so that we could make this possible?” We did this by creating a uniquely human-centered approach. It’s grounded on a privileged molecular starting point which we call Anthromolecules: molecules that have co-evolved with humans for hundreds or even thousands of years.

We have this incredibly long history of safety and consumption that can come from sources like food, herbs, and supplements. It’s an incredible diverse chemical space that has gone largely untapped, and actually was looked at many years ago by the pharma industry, but it was only able to be discovered serendipitously. Technology is enabling us to transform our ability to access what the power is in this nature. We’re using digital tools to comprehensively map all the potent connections between these Anthromolecules and the biology that underlies chronic disease.

Together, these are the assets that let us rapidly and repeatedly develop these powerful pathway modulating medicines for chronic disease. We’re excited about its potential. On a basic human level, we’ve always known that food is medicine. We’ve just never understood it at the molecular level. Now, we can do that systematically. It’s like this amazing pile of keys of nature, and we can pull them out systematically with technology and find that optimal pathway lock for all those biological pathways we need to address for these diseases.

Andrew Brackin: It’s a very unique approach to medicine. But, at the same time, it makes total sense. And, you’re totally right, in many ways this seems obvious. 

Margo Georgiadis: It’s how medicine started, right?

Andrew Brackin: Right.

Margo Georgiadis: Antifungals, antibiotics.

We’re kind of back to the future. But, we’re doing it with technology.

Andrew Brackin: I’d love to learn more about what the technology means in this case? I know you come from a technology background. You’ve built numerous technology companies.

Margo Georgiadis: We’re organizing the world’s information of Anthromolecules. We’re building deep knowledge graphs of every single one of these so that we understand all the properties that go into making a pharmaceutical product. So we understand them very deeply and comprehensively. Some of that, we can pull out from literature or other things. But a lot of it, we actually have to develop or impute. So it’s a very complex NLP and modeling task. We use chemical ML and other AI and ML techniques to do all this bio-activity mapping so that we understand these connections.

What’s unique is we’re biology agnostic. What we’re able to do is pull. Biology pulls the chemistry that it needs. Which is the opposite with a lot of the things we identify the biology, and then we try to create the molecule that we test over and over to see if it works. In this case, we actually try to pull the optimal chemistry. We have to build that knowledge on both sides and then use ANML to make that efficient.

Andrew Brackin: Absolutely. You started focusing on autoimmune diseases. How do you plan to tackle these diseases? How are you thinking about other inflammatory diseases to go after in the future?

Margo Georgiadis: We started with autoimmune and inflammatory diseases because of the enormous unmet patient need. But our long-term goal is to develop these human-centered solutions for all of the people that live with chronic disease. There’s a lot of categories of those, and they strongly overlap with a lot of the inflammation backbone. 

These patients have lots of unmet needs [00:05:00] that I summarized before. They usually only have access, if you want to modulate the disease, they’re usually put on biologics. These are therapies that are not safe for long-term use or early intervention due to safety and tolerability issues. Many [patients] are immunosuppressive. Or, have other difficult side effects. There are some early small molecule therapies. But, a lot of them have black box warnings, in many cases. So these things become challenging to be used broadly.

There are also large non-responder rates. At least 30 to 40% is common for a lot of the mainline therapies. Consumer delivery is generally an injection versus oral, which is much less friendly for both the consumer and the provider. The insurance coverage is quite limited. The people who actually get access to these, you have to be quite severe, quite late stage in the disease before they decide that the risk benefit ratio works.

We want to flip that upside down so that we can actually try to intervene as early as possible in the course of these diseases. We have the chance to slow or even halt progression. This is the biggest single problem in something like autoimmune disease. I think about my own three kids. One of our sons has had several long standing autoimmune diseases. He started as young as one and two years old. These diseases just go on. The way you have access to medication, you’ll be on a medication, but you can only use it for a short period of time. Then you have to come off because of the side effects. 

So you just go through this constant cycle of flares. It just keeps getting worse. The son’s now in his twenties. He’s been suffering for all of these years. There needs to be a better way that we find to treat these. Especially, when you think about the fact that many people have more than one. These things are connected in terms of triads and other things. We need to think also about how to, more comprehensively, treat these triads. 

Andrew Brackin: That makes a lot of sense. Given all the work we’ve done in dermatology, you’re singing to the choir here, because these are exactly the challenges that patients have, especially those with mild to moderate symptoms. A lot of the current options don’t make sense for those patients. In many countries those options aren’t available. I think about the UK, where I’m from, and a lot of the options that are given to dermatology patients in the US and not available in the UK today.

Margo Georgiadis: That’s exactly right. Either because of the warnings, or because of the cost. This is something we need to find a way to work around. Which is why starting with something like Anthromolecules, which is fundamentally known and has a very strong safety profile, can enable us to flip this paradigm and think differently. That, plus, the technology and connecting it fundamentally to the bioactive, most important pathways that underlie these diseases. That’s the focus, for the therapies that we’re developing. A powerful pipeline in a target therapies that comprehensively enable us to get after all the things that are dysregulated in our system.

Andrew Brackin: Where are you focusing, right now? I know the company only launched a few months ago, or if I’m correct, but…

Margo Georgiadis: We launched publicly a couple of months ago, [laughs]. But, we’ve been building our capabilities for a couple of years. We’re rapidly advancing a pipeline of therapies. Through a combination of our own pipeline and partnerships, we’ll be developing solutions for the broadest range of chronic diseases possible over time.

Are there any specific indications that you can share you are working on?

So we haven’t announced that yet. [laughs] but we will over the coming months as we rapidly move to the clinic. It’s an exciting time to be part of this innovation in biotechnology.

Andrew Brackin: I’d love to understand how you expect to navigate the approval process and regulatory process for these treatments. What are the challenges you’re anticipating? How are you thinking about that given that is a slightly different approach to developing medicine? 

Margo Georgiadis: It is a different approach analytically, in terms of coming up with these therapeutics the industry has followed historically. However, the regulatory path will be the same as any other therapeutics company. We do see some important opportunities given our privileged starting point. Given that Anthromolecules will be able to demonstrate a lot of understanding of human consumption and safety. We believe that particularly for our first therapies,we’ll, to the letter, go through many of the same steps that everyone else does.

We will certainly, of course, see benefits in things like the clinical trials design because by already understanding some of the dosing and other things, it will make it more efficient for us in the design of our clinical arms. We do see benefits and how we approach this over time. 

Andrew Brackin: I’d love to understand how you’re thinking about engaging with the healthcare community. Obviously, there are both providers and patient advocacy groups. I imagine you’re thinking a lot about how to educate them. There’s obviously a lot of benefits to your approach, and I think the education is going to be critical to success of these medicines.

Margo Georgiadis: If you were to ask the average consumer walking on the street, “Would you rather have a therapy that’s safe for long-term use based upon nature, and something you can actually understand? At the same time, people just want the therapies to work. If you’re a clinician– think about dermatologists– that are, on average, seeing 50, 60 patients a day. Things are fast paced right through that office.

The clinician needs to have the confidence to know that therapy is actually going to work, “How do I fit it into this enormous arsenal of things that people are throwing at me from the pharmaceutical industry.” So, as you said, their [00:10:00] feedback is essential to understanding the true experience in that clinician’s office. How you can make their lives simpler, easier, and beneficial, as well as the experience of the patient.

We spent a lot of time talking to both sides as we defined our target product profiles for everything in our pipeline. We found it important. You can look at the industry data. At the end of the day, getting underneath the day-to-day lives of clinicians and patients ensures that the way you think about your solutions that you’re addressing meaningful, unmet needs to improve both the patient experience and health outcomes. 

There’s a lot of nuances that you have to consider in terms of the design of the therapy, how fast acting it is, how safe it is. Adherence. All kinds of things become essential in that target product profile.

Andrew Brackin: Given that you’re driving down the cost of these drugs, it’s incredibly exciting to think about the global implications. So many of the new drugs being approved in the US will never reach patients around the globe. That’s pretty exciting about what you’re doing and the approach you’re taking with Montai. 

Margo Georgiadis: We certainly hope to both be able to, rapidly and repeatedly, create these new small molecule therapies, which of course have enormous advantages in terms of manufacturability and cost. As we think about all the ways in which we’ll build knowledge, we hope to take our technology to as many areas as possible. 

We do believe there’s an opportunity to hit real breakthrough points. One of the challenges that the industry faces. When we look at the data is enormous costs from failure rates in clinical trials. By starting with molecules that we fundamentally understand are safe, and then creating this systematic understanding of how to connect them to our biology, we believe we can enormously reduce cost in the ecosystem by reducing that failure rate, as well as, the form factors that we’re focused on.

Andrew Brackin: Definitely. You’ve had an incredibly impressive career prior to joining Montai. You were the CEO of, and the president of Google Americas. How have these experiences influenced your strategy in scaling companies and billing companies? I know that Montai is the first biotech company you’ve worked on as far as I’m aware, but I’d love to understand your approach for building companies.

Margo Georgiadis: I am definitely not the shortlist biotech CEO that most people would expect. At the same time, as we try to innovate categories with technology, a lot of the fundamentals of how we think about connecting the deep understanding of biology and computation are very similar to a lot of the problems that we solved at Google, or Ancestry in building scalable technology platforms. I feel privileged to get to work with many of the best biologists in the world through an organization like Flagship Pioneering. That gave me the confidence that together we could reimagine how to build a next generation biotech company.

At Ancestry and Google, the commonality was using technology in new ways to enable us to solve important problems at scale. It’s not that complicated, right? At Google, we wanted to organize the world’s information, to level the playing field in content creation, and to enable everyone to be able to have a computer in their pocket and have everything that they needed at their fingertips and get technology out of the way, and them to go on with their lives.

At Ancestry, we were trying to enable everyone to find their family story. We had to find creative ways to organize the world’s information of all of those records all over the world. Then, to enable people to easily find their way through all that through either DNA testing or direct interrogation into the massive tomes of clinical records that we had. By doing that, you start with how can you fundamentally design a hard problem? You have to reimagine the way things are to get to that future. What can make that much more magical product and experience that can have a transformational benefit? How do you make sure you create a scalable platform? 

That requires thinking deeply about what are the fundamental assets you’re building that can keep scaling and get smarter and more efficient over time at solving that problem? If you think about it at Ancestry, you can have a bunch of people start entering who are genealogy experts family trees, but the average person who comes in has no idea [laughs] how to look at a record from three or four centuries ago.

It may not even be in their own language. It might have information laid out in a way that they wouldn’t even understand. You use technology to make it easy for people to connect the dots and to navigate. At Montai, that’s true as well. The problem we’re trying to solve is just different. The foundations of medicine, as we talked about before, came from discovering things in nature. Many of those discoveries were serendipitous, like asking your grandmother about your family story, but not necessarily knowing if what she told you was actually right or could you validate it. You had to go and systematically see if it was true.

We’re now able to use technology to build the world’s largest understanding of human-centric chemistry. And, to connect it to our biological pathways, comprehensively, as we could never have done this [00:15:00] before. The digitization of chemistry and biology, and powerful AI and ML tools are enabling us to make this happen at scale.

Even more exciting for me as a technologist, as we do this, is how we can keep scaling this over time so we can go further and faster. If you think about it, a hundred thousand Anthromolecules are known today, but there are millions more to discover. Our Anthromolecule solutions can only continue to grow as our capabilities build. 

We can build solutions that can grow across different types of diseases. We can work across different kinds of stages as our bioactivity atlases expand. Our models can advance from just offering a single pathway solution. We can look at synergistic pathway solutions. We can even go to preemptive solutions with the development of new biomarkers. 

We can keep scaling our capabilities over time so that we can go further, even faster. If you think about the foundation, it’s just an understanding of Anthromolecules. A hundred thousand of those are known today, but there are millions more that we can discover. We can also grow our Anthromolecules solutions in lots of different ways. We can grow our bioactivity atlas across stages of a disease. This will all happen as our models advance and enable us to move from a single pathway solution to a synergistic pathway solution.

Maybe we need to go after two pathways to get the outcome we want from a health perspective on a disease. Our ultimate goal is to go to preemptive solutions, but, to do that we need to develop new biomarkers so that we can create those moments in which we would intervene based on very specific, measurable biology. 

We also believe personalized solutions are incredibly important because we have an aging population where 60% have multiple chronic diseases. We have to find a way to keep growing our capabilities to solve these new problems. We believe our fundamentals enable us to keep growing and learning over time.

So that concept of what we learned at places like Google and Ancestry, how do you create scalable assets and computational capabilities that keep opening up more and more ways to reimagine development? Right now, for us, it’s taking small molecule development from cost ineffective in four to seven years, we can now make it predictable in two years or less. For us, that’s where we’re starting. But there’s just limitless opportunity ahead.

Andrew Brackin: Three years or less is exciting goal and forward to seeing your progression toward that.

Margo Georgiadis: We’re excited to do it.

Andrew Brackin: Margot, thanks so much for the time today. It’s incredibly exciting the work that you’re doing at Montai. Everyone will look forward to following your progress and announcements regarding the indications that you’re going after, and some of the initial medicines you developed. I appreciate learning more about Montai.

Margo Georgiadis: Thanks, Andrew.

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