Good day, and thank you for standing by. Welcome to the Nautilus Biotechnology Q4 and Full Year 2022 earnings conference call. [Operator Instructions] Please be advised that today's conference is being recorded. And it is now my pleasure to introduce your first speaker today, [Alex Conn], Investor Relations of Nautilus Biotechnology. Please go ahead.

Thank you. Earlier today, Nautilus released financial results for the quarter and full year ended December 31, 2022. If you haven't received this news release or if you'd like to be added to the company's distribution list, please send an e-mail to investorrelations@nautilus.bio. Joining me today from Nautilus are Sujal Patel, Co-Founder and CEO; and Anna Mowry, Chief Financial Officer. Nautilus Co-Founder and Chief Scientist, Parag Mallick, will be joining us for Q&A. Before we begin, I'd like to remind you that management will make statements during this call that are forward-looking within the meaning of the federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. Additional information regarding these risks and uncertainties appears in the section entitled Forward-Looking Statements in the press release of Nautilus issued today. Except as required by law, Nautilus disclaims any intention or obligation to update or revise any financial or pipeline projections or other forward-looking statements, whether because of new information, future events or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast, February 23, 2023. With that, I'll turn the call over to Sujal.

Thanks, Alex. Good morning, and thank you to everyone for joining us today. On this call, we'll share our results for the fourth quarter and full year 2022 and provide an update on a range of recent activities. The progress I'll be sharing with you today is due to the extraordinary work of our growing teams in the Bay Area and Seattle and now in San Diego, where we've opened an office in the University Town Center, one of the largest and most talent-rich biotechnology and pharmaceutical hubs in the country. The new office will initially have a focus on instrument engineering, reagent development, software engineering and bioformatics positions. Eventually, we anticipate some percentage of our commercial team being based there as well. This expansion of the Nautilus geographic footprint reflects our continued progress and focus on short-term development milestones and longer-term commercialization goals. Through these and other efforts, we remain ever motivated by our goal to revolutionize Proteomics in the name of improving the lives and health of millions of people around the world. Our entire team is motivated by this goal, fully aligned and committed to doing what it takes to make this goal a reality. When I reflect on 2022, I see it as a year of accomplishment and a foundational progress. Progress that will bear fruit as we move through 2023 and towards our plan to launch our proteome analysis platform, instruments and reagents in mid-2024. Here are a few examples. We made solid progress against our core scientific goals in 2022. Our major focus last year was on development activities such as increasing the scale and robustness of our consumables, both reagents and blood cells. This progress goes hand-in-hand with advancing the quality and customer readiness of our offering. Critical to those advances were our…

Thanks, Sujal. Total operating expenses for the fourth quarter of 2022 were $16.3 million, which was $500,000 less than the fourth quarter of last year. This result is a testament to our diligent focus on controlling our spend. This past year, we continued investing in the business, growing our headcount and making significant progress internally while decreasing our expenses overall. Research and development expenses in the fourth quarter of 2022 were $9.6 million compared to $9.9 million in the prior year. General and administrative expenses were $6.7 million in the fourth quarter of 2022 compared to $6.9 million in the prior year. Overall, net loss for the fourth quarter of 2022 was $13.4 million compared to $16.7 million in the fourth quarter of last year. Our bottom line was helped by our prudent cash investments in debt securities, resulting in net other income of $2.9 million versus $127,000 in the fourth quarter of last year. We continue to take full advantage of the opportunities created by having a strong cash balance and generating earnings from our investments is another source of funding we are maximizing. For fiscal year 2022, operating expenses were $63.6 million compared to $50.5 million in 2021. That increase of 26% was driven by growth in personnel costs, along with an increase in expenses tied to our first full year of operating as a public company. Net loss for the full year was $57.9 million compared to $50.3 million in fiscal year 2021, an increase of 15% year-over-year. Net net loss includes $5.7 million in net other income compared to $183,000 in fiscal year 2021. Finally, turning to our 2023 guidance. As we have consistently said, we expect to continue to grow our spend but in a conservative intentional manner. This year, we expect our overall operating expenses to grow by approximately 40% from 2022 levels. However, you can be sure that we will manage our growth in spending tightly to ensure we preserve our ability to invest in the commercial expansion leading up to our platform launch in mid-2024. Our time line for product launch are unchanged. As we've said previously, we anticipate meaningful early access engagement and associated revenues to begin at the start of 2024. Revenue tied to the platform launch is expected to begin in mid-2024. We ended the year with approximately $314 million in cash, cash equivalents and investments, which represents a trailing 12-month cash burn of approximately $48.5 million. While that cash burn will certainly increase going forward, we continue to anticipate our cash runway extending well into 2025. With that, I'll turn it back to Sujal.

Thanks, Anna. Anna's report clearly demonstrates our unwavering commitment to responsible financial forward ship of this business and using our resources prudently and to our advantage during these challenging times. We're excited about what lies ahead for Nautilus and the difference our platform can make in biological science. Our mission to positively impact the health and lives of people around the world remains our guiding light and the standard to which we hold ourselves. I'm grateful to our team, our investors, our strategic partners and our research collaborators for joining us on this journey to revolutionize proteomics and empower the scientific community in ways never before thought possible. We made good progress in 2022 and look forward to building on those successes as we move through 2023 on our way to a commercial launch and beyond. With that, I'll turn the call back to the operator.

[Operator Instructions] Our first question comes from the line of Max Masucci with Cowen and Company.

First one, you exited the year with over $300 million in cash, low cash burn. So with the valuation re-rating in the public and private area to a degree, and with a few small M&A deals recently in the specialty tools space, has your appetite for M&A changed at all recently? And if the answer is yes, what types of assets could potentially advance your development in commercial time lines?

Max, it's Sujal, let me take your question here. And so you're absolutely right that the M&A environment generally in the Dx and tool space and the wider biotech space has picked up. We fundamentally believe that the product that we are building has a value proposition that is spot on for the customer base, and we have a very wide competitive moat relative to all existing traditional approaches and emerging or purchasing in proteomics. And so with that -- while I would never say never with that, we really don't see any near-term M&A or even smaller strategic types of assets that we would go after. We're really focused on leveraging our balance sheet to go and complete the development of our platform, to build our commercial organization and that on. We're always open to synergistic technologies out there, but I don't really see anything on the horizon or anticipate that will get use of cash.

Great. Makes sense. And then just in this market environment, we have increased scrutiny on near-term catalysts and milestones that can be used to track progress. So I guess, bigger picture question, what would you consider the biggest advancement for the company during Q4 or maybe even in the second half of the year? And what should we be keeping on our radar for catalysts and updates in the first half of '23?

Yes, Max, this is Sujal. Let me take the first part of that, and I'm going to kick that to along to Parag just give you a little bit of detail on your question around the biggest highlight from the quarter. As you look at Nautilus' scientific conference schedule for 2022. One of the things that you would observe is that at each scientific conference, we had either a manuscript that we talked about archive or a poster presentation or a talk that we gave. And as we went through the year, we slowly introduced to the scientific community more and more data about our platform and more and more sophisticated experiments. And as I mentioned in our prepared remarks, that culminated in a really interesting experiment in Q4 that I would consider the greatest highlight and we demonstrated that as a poster and a talk at U.S. -- sorry, excuse me, at the World HUPO Congress in December. Why don't I hesitant to, just to address just really briefly what that-- what that poster was about and talk to you a little bit about that.

Yes. That would be -- sorry, go ahead. Go ahead.

I think -- so I'd like to just start out. 2022 was a tremendous year for our organization. We really built out the development side of our organization and brought the scientific community on our journey of -- with a series of milestones, as Sujal mentioned, presented at different conferences. And the largest milestone for me that we presented was really the scaling of our processes, demonstrating that we can comfortably run 70, 80 cycles and do that on a routine basis with dozens of multi-affinity probes that were developed by our in-house pipelines. And that really demonstrated the complete end-to-end sample prep all the way through instrument analysis through data analysis, aspects of our platform. And to accomplish this, we had to improve the scale of our reagents. We had to improve the quality of all of our consumables. We also had to improve our instrument to be able to support runs on that scale. And so over the coming year, we expect that scale to continue the improvement in quality of reagents and maturing towards our commercial launch. Sujal?

Thanks, Parag. Max, just to answer the last part of your question of what to expect in 2023. Nautilus has had in 2022 and will continue to have in '23, a strategy of bringing the scientific community and our potential partners, collaborators and customers along on the journey as we complete the development of our platform. And so as we move through conferences on the scientific side through 2023, starting with the U.S. HUPO conference in early March, you should expect us to continue to add talks and continue to have poster presentations and manuscripts that continue to show our progress on the scientific front. And I think that, that progress will indicate our progression towards that goal of a mix 2024 launch of our instruments and reagents and our system.

Yes. And of course, congrats on the poster at HUPO and the 70 cycle run on a platform. I would be curious to hear any feedback you received the Annual Congress? I guess, generally, throughout 2022, as you rolled out new manuscripts and posters, how the feedback has sort of evolved among the scientific community?

Yes, that's a great question. We've seen really just tremendous enthusiasm for the platform. It has been at HUPO, we met with a very large number of key opinion leaders, talked about their anticipated needs, their excitement about the platform, the sensitivity, the scale. And it's -- I think that was underneath well in the first access challenge that we saw just incredibly creative applications from around the world. And so I think what we're seeing overall is -- and one of the other points I'll just mention about HUPO at our seminar really great questions, strong engagement, standing room only. In fact, lots of people sitting around the walls. And it was just fantastic to be able to share our journey with the scientific community and to have that kind of feedback.

[Operator Instructions] our next question comes from Matt Sykes with Goldman Sachs.

Maybe I just want to start on that last question and be a little bit more specific on some of that feedback. Sujal, you mentioned you spoke to a lot of mass spec users. And I'm just curious, as you spoke to them and gathered feedback, what are some of the things that they're excited about on Nautilus relative to what they're doing on mass spec? Is it throughput? Is it depth of analysis? What types of specific feedback you're getting from them that can kind of give you comfort that there is a competitive advantage relative to the mass spec being work done in proteomics that's going on today?

Matt, this is Sujal. The comments you heard earlier were from the Parag, but why don't I start here? And then I'm going to pass it to Parag to give you some more specific feedback from what he heard in December. From a broad perspective, the way that we ensure that our product is going to hit the market correctly is by a a constant and wide range of activities that engage with our potential customers. And that is one-on-one conversations, voice of the customer studies, it is pricing studies, it's engagement at scientific conferences, it's engagement with inbound activity and is -- as well really spending time and understanding what are the applications scientists are interested in and then how does our technology apply. The first access challenge, of course, underscores that as well because that was an opportunity for them to tell us how our platform would apply to their research. What we hear time and time again is that traditional methods, meaning generally mass spectrometry and then emerging affinity-based and peptide sequencing method. Really, the challenge with us is a challenge in terms of sensitivity, scale and reproducibility. And so to give you an example, on sensitivity front being able to analyze intact protein molecules without having to digest them into peptides gives you 2 log sensitivity advantage right off of the top and is critical for this next phase of proteomic that's coming over the course of the next 5 to 10 years. Scale is another one of those things that's been quite a very important to these customers. Our platform is being designed with a chip that can mobilize up to 10 billion proteome molecule. That leads to the ability to quantify across an extremely wide dynamic range, which is critical when you're in a wide range of applications. For example, in pharmaceutical development, where you are looking at a medical plate that has samples, which are lysates, those might be 100 to 1,000 cells, which is the typical in each of those wells. You need a chip that's 10 billion protein molecules large in order to be able to analyze those with the greatest step. And there are no platforms that are within many orders of magnitude that are existing today or conceived. And so it's those aspects that researchers have really been -- really been captivated by. And in the conversations that I've had, customers readily are able to see how our specifications and what we're building would be impactful and differentiated for their biological research. Parag, why don't you want to add some specific commentary in December from the HUPO event?

Thanks, Sujal. I think one of the key aspects as we look at this field in this space, is that we find that even current mass spec users recognize the need for complementary tools so that they're really asking the right question using the right tool. And they recognize the key aspects of our platform, comprehensive analysis, sensitivity, dynamic range, reproducibility, run time and ease of use are really important factors when they're thinking about their study design. One of the aspects that we've done as well is really a series of deep interviews in 2022 with 40 or more key opinion leaders, most of whom are mas spec users. And those design criteria for the platform, the ability to get to a single molecule incredibly sensitively, the ability to look at proteoforms because you are not digesting the proteins and are able to look potentially at multiple modifications on the same protein molecule. Those are capabilities that they're excited about unlocking novel biology.

Great. And then, Anna, just on OpEx, you mentioned the 40% growth in '23. Two things. One, should we think about the R&D versus G&A splits as being kind of similar to what you did in '21 and '22 was sort of that 60-40-ish split between R&D and G&A? And then secondly, how should we think about the San Diego facility costs coming through assuming that's a lease, just either as a percentage of or just maybe kind of characterize as those costs come through in '23, what that might represent of that growth in OpEx?

Matt, I can definitely speak to that. As you suggest, as you mentioned, the majority of our spending is still definitely going to R&D in 2022. That was at approximately 60%. And given that we're still very much focused on development, I would expect that to continue for most of 2023. And then dollars would shift more towards SG&A as we come closer to that commercial launch. We are very excited about our San Diego facility. It's a fairly small facility, so I don't think it will contribute any meaningful expenses those OpEx numbers. And I think overall, our facilities -- we've done a really fantastic job of linking on new facilities without a significant amount of cash outlay for adding significant structural spend to our ending forecast.

[Operator Instructions] Our next question comes from Brandon Couillard with Jefferies.

Sujal, on the TGI partnership, I'm curious why they were the next logical collaboration partner? Why focus on such a rare disease like DIPG and how many additional partners would you like to add in '23 on top of the card 5?

Yes. So let me take a couple of aspects of your question, and then I'll pass it to Parag to talk specifically about DIPG and why this was an interesting application. When you look at our existing set of collaboration, Genentech, Amgen, MD Anderson and now TGen. What we've tried to do is we've tried to focus on proteoform use cases that are within the capabilities of the platform today so that we can do analysis and delivery to the customer biological insights that they can't get from somewhere else. And the additional criteria is that we want all of these early collaborators to continue with us on this journey as we move towards platform launch and be great potential early access partners, data sites and then ultimately customers. And so that's kind of the initial criteria for us. The other thing that's important to us is to have researchers who are focused on really important research who are known well and are willing to publish with us so that we can start building this body of evidence around our platform and start showing the scientific community data coming off of our system. And so with PGM, it was able to hit all of those marks. Now that being said, as we start to move deeper into 2023, our intention will switch a bit not to these proteoform partnerships, but really switch to our early access program, which is a more formal program where the customer may take 24 or 48 samples, run them on our platform once we are capable of broad scale proteomic analysis. And then we would return the data to them. We might have a small fee for that engagement. And really, those early access partnerships are about data generation and showing the scientific community what we can do. But equally, they are important for pipeline generation and starting to drive towards preorders of the instrumentation. Parag, do you want to talk about the particular application for TG and why it's interesting in our portfolio of applications?

Absolutely. Thank you, Sujal. So I think DIPG is despite being a relatively rare cancer is a model for many other types of cancers. Additionally, the particular protein target that we're studying in that collaboration. Our goal is to measure mutations and post-translational modifications, proteoforms, on individual histone molecules. And that ability will provide really critical new insights into how histone modification and variation thereof drives the biology of this disease, but also will provide a window into epigenetic modification in general. And that's a tremendous area of scientific interest. It's incredibly exciting. TGen is a fantastic partner to work with on these studies. So we're really excited to dive in with them.

That's helpful. Sujal, any updated thoughts on the supply chain? And as you look out over the next kind of 12, 18 months, any pain points you anticipate that you start moving towards commercial launch?

Yes, Brandon, that's -- it's a great question. And we certainly are continuing to see supply chain pressures out there. And most of that pressure is with respect to lead times for various things. It could be simple things for -- simple things like tubes and pipes tips, and can be -- it can be more complex pieces of implementation as well. The third area for us is that there certainly are some slow parts of the supply chain with respect to some of the parts of our instrument as well. And so -- what I would tell you though is yes, there's some pressure, but we are managing it well. We have a team on the supply chain plan has led by our SVP of Operations and Supply Chain. Mary Godwin has been doing this for 4 decades, and we've been doing a good job on our instrument side and making sure that we have pipeline for all of the instrument builds that we're planning, and we're planning our supply chain appropriately given the extensive lead times for a few components.

Got it. Last question, maybe better for Anna. The CapEx outlook made another $30 million in incremental spend, let me mostly weighted to the back half and I think you've been pretty cautious about building the commercial team up too soon. Will that begin to take shape in the back half? And I guess, generally, where will that incremental $30 million be concentrated?

I can speak to the first part, and then, Sujal, maybe you want to tag on to that. But last year was a bit of an interesting year. We saw a dip in expenses as we consolidated our costs, and then we picked up in the second half. I would expect going forward that we would see more consistent growth over the course of the year, certainly with the highest spending being towards the end of the year. And that's really still very much focused on development. We're still continuing to invest there. We're preparing for scale up, quality, manufacturing. So those are some of the areas where we'll continue to put both hires and dollars as we scale our experimental capacity. And then certainly, towards the tail end of the year, we would begin hiring for the commercial launch that we expect in the first half and in the middle of 2024.

Yes. So let me take the second half and take your question here. Brandon, let me take the second half of your question here, then you can dive in and more. So one of the things you asked was really when to expect the commercial build-out. And I think that I will add a little bit of nuance here. There were some questions earlier about the macro environment and how we're reacting to it. And one of the things that we will do here our commercial launch in mid-2024 is built out a commercial team. But there are 2 things that you should relax there. Number one is that the team itself, we believe, will be a very efficient team, and it's not going to be a team that's going to be huge. And the primary reason there is that we have an instrument deal price, an initial deal price, that's roughly $1 million. And so the transactional mode of being able to generate significant bookings from a particular sales rep out there is actually really good. And that leads itself to sales efficiency and helps us with the cost structure of our commercial organization. The other thing to think about is that when capital is readily available in the wider market, you would build your commercial team and start your oppormal activities earlier in the cycle. And when things are tight like the environment is today, you'll build the commercial team much closer to the launch. And so I'm not going to commit to exactly what the timing is of that commercial team build out. But what I will tell you is that we will compress that down pretty tight in front of that commercial launch. And that while that might affect our revenue ramp rate right after the commercial launch. It's our job as a management team to try to mitigate that. But we think that that's probably the most prudent thing to do because the last thing we want to do is overbuild the commercial organization and then have some sort of timing difficulty that leads to an additional pressure on our OpEx.

Okay. Our last question comes from Tejas Savant with Morgan Stanley.

Tejas. I guess the first one for me would be for Sujal. Thank you for the color on the access challenge. But I was thinking aside from the access challenge and your conference presentation and data releases, how else are you keeping customers engaged ahead of your mid-'24 launch?

Yes. So that's a really great question. So I think that there are a lot of different ways that we are keeping the scientific community, meaning the researchers and our potential collaborators and customers engaged. So first and foremost, we've had a large number of conversations, hundreds of conversations over the course of the company's 6-year life with with potential customers and partners. And the response has been incredible. We continue to engage with those customers, giving them regular updates. We engage with them on surveys and formal voice customer types of interviews. We meet with them at our various conferences and spend time keeping them up to date. So that's number one. Number two, that one of the things that's really been great here at Nautilus is that there is quite a bit of inbound activity from potential partners and customers because of the excitement around our platform and the capabilities that we we've begun to show at scientific conferences. And so we have a steady stream of conversations with customers, getting them up to speed and doing presentations because of that inbound types of activity. One of the other things as well, that we did in 2022, is that we engaged with about 40 KOLs, most of whom are mass spec users, and we did deep interviews with them, engaging them on where their pain points are what they're looking for out of a proteomic solution that really tries to make a significant impact on their biological research. And through those engagements, we've had a continued meaningful dialogue. So all of those things together, the first access challenge, the data release of conferences, we have a very, very good interface with our potential customers and collaborators and partners.

Got it. That's helpful. And then Sujal, I'm just wondering, if you look over the past year and all the changes in the proteomic landscape, has your views on the competitive changed at all over the past few months? And are you anticipating any dynamic changes ahead of your mid-'24 launch?

That's a great question. What I'm seeing over 2022 and the first couple of months here of 2023 continues to reinforce for me that we are building a highly differentiated product with a wide competitive moat. What I've seen from the traditional method competitors that seen continued evolutionary improvements to their platforms, but nothing that really is fundamentally game changing. And from the emerging competitive landscape, there are a few names that are performing quite well on the targeted side of proteomics, which is different and highly complementary to what we're doing. But on the discovery side, where there are some companies looking to improve sample preparation, some that are focused on pest type sequencing methods. When we look at the capabilities of those platforms and how they've evolved over the course of the last 12 to 14 months if I include the first couple of months of 2023, I'm not seeing any major capability improvements or anything on the horizon that would--that would close the gap with the capabilities of our platform that we're building.

Great. And one final one for me. I guess it's a little bit looking out into the longer term, but the clinical market is a huge opportunity for you guys. And with the clinical market today, relying primarily on single biomarker assays. What do you think it will take to drive that market to using a broader set of proteins in the clinic? And I know you guys highlighted sensitivity, scale and producibility of onetimes and ease of use as key characteristics. But what do you think are some of the key features that this specific market would be looking for?

Yes. I think that's a great question. I think when we look at the clinical market, we've seen a similar trend in transition from single marker-based studies to panels, occur in genomics. And it started with providing the research data across a wide spectrum of initial mutations in genomics so that people were able to take a more comprehensive look in a retrospective manner. From the comprehensive look, it just made sense to start using panels. There was a point that measuring those panels by orthogonal means, was inefficient. And it was easier. It was faster. It was to simply use the discovery platform as a clinical platform. And so we anticipate a similar transition will occur in proteomics. Initially, people will use the discovery platforms, look at a wide variety of markers, understand the synergies between them, understand the predictive power that comes from being able to look at many biochemical axes at the same time as well as diving into proteoforms and really looking at that molecular heterogeneity as a marker. As those panels get larger and larger and it becomes challenging, to convert them into traditional assays, Eliza's others, it will spur a natural transition towards using our discovery platform as a clinical platform. And we are excited about that opportunity going forward. We're preparing for that opportunity going forward. And I think it's a really natural evolution of the field.

Okay. Thank you, guys, for the time today.

Okay. Thank you, everyone, for your participation in this conference. This does conclude the program, and you may now disconnect.