Thank you for standing by, and welcome to the Nautilus Biotechnology Second Quarter 2023 Earnings Conference Call. [Operator Instructions] As a reminder, today's program is being recorded. And now I'd like to introduce your host for today's program, Carrie Mendivil Investor Relations. .

Sujal Patel, Co-Founder and CEO; Parag Mallick, Co-Founder and Chief Scientist and Anna Mowry, Chief Financial Officer. 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 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 product, 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, August 2, 2023. With that I'll turn the call over to Sujal. .

Thanks, Carrie. Good morning, and thank you to everyone for joining us today. On this call we'll share our financial results for the second quarter and provide an update on our recent activities.

But first, I want to take a moment to acknowledge the Nautilus teams in the Bay Area, Seattle and San Diego, who day in and day out exhibit the type of passion, ingenuity and commitment that will enable us to bring to market a platform that we believe will set the new gold standard for proteomic exploration.

A platform capable of unleashing the potential of the proteome to advance basic science research, to build new diagnostics and of course, to make a substantial impact on drug development.

As Parag will expand on in a few minutes, I'm excited by the progress we made in Q2, against some of our foundational, scientific and development goals and in the ways we continue to prepare the various elements of our platform for commercial launch.

For those paying close attention, you'll note that June 9th, represented the second anniversary of Nautilus entering the public markets on NASDAQ.

In those two years, we've evolved and matured as a business, buttressed our senior leadership teams, particularly in R&D and continue to operate in a highly efficient way intended to maximize our cash runway. More on that from Anna later on.

Through it all, we remain convinced that the world of biological research thirst for a platform that overcomes the inherent limitations of both traditional, protein analysis methods and of emerging affinity-based and peptide sequencing methods.

The market understands how important intact single molecule protein analysis and the Nautilus platform in particular will be to their explorations of the proteome and its role as a critical driver of innovative impactful biological research.

Many of the people in audiences we speak with maintain a heavy focus on the use of mass spectrometry for proteomics. The positive attention our platform and methods consistently received from them is a good sign for things to come with this critically important and influential buying audience.

We believe that the Nautilus platform is going to spur tremendous creativity and innovation in the broader proteomics community.

We took advantage of additional opportunities to share our story this quarter at events including the European Proteomics Association Conference, the Alzheimer's Association International Conference and we look forward to being a sponsor of the Human Proteome Organization International Congress in Busan, South Korea in mid-September.

At these and other events, we consistently hear from proteomics KOLs about the broad range of uses they see for our platform and the excitement that is building, as we gather feedback from them in the lead-up to our early access program. The EIP will launch in the months leading up to commercial availability.

And while never intended to be a significant revenue driver, it will serve as a high-value means, by which to generate data to support both internally and externally generated scientific papers, customer grant proposals and will get meaningful data into the hands of potential future customers.

We will keep you informed, as we get closer to launching the program. Meaningful progress has been made in development activities surrounding each of the core components of the platform. For updates on these and other things, let me now turn the call over to Parag..

Thanks Sujal. As Sujal mentioned in his opening remarks, we made solid progress across a number of important research and development fronts in Q2. I'm very proud of our team and the way they continue to positively and methodically address the inevitable scientific and engineering challenges associated with pioneering a platform as innovative as ours.

My thanks go out to each of them. As a company, bringing to market, a first-of-its-kind product capable of comprehensively quantifying the proteome, there are a wide range of platform elements that must integrate seamlessly.

These elements include nano fabricated chips for a single molecule protein deposition, nanoparticles for a fixing proteins to those chips, affinity reagents and their labels for probing a fixed protein, assay buffers and parameters and instrument capable of reliably and routinely performing a series of single molecule binding measurements and machine learning-based software for determining protein identities and quantities from those measurements.

In Q2, we made considerable progress in each of these areas, enabling us to successfully execute the largest scale and complexity experiments that we have pursued to date. Let me briefly discuss some of the key Q2 advances.

Critical to the creation of a high-quality hyper-dense, single molecule protein array is our ability to consistently fabricate the nano pattern chips that form the foundation of that hyper dense array. Considerable progress was made, qualifying our external patterning and assembly partners.

We additionally improved the stability of our in-house functionalization processes and transition those processes to our manufacturing scale facility in San Carlos, California.

When we conceived as a platform, we recognize the challenges associated, with creating a novel class of antibodies that were not typically built, because they were not protein specific. In Q2, we increased the development pace for our affinity reagent consumables.

This increase was a result of significant efforts to improve the yield and throughput of our affinity reagent pipeline. In addition, we have scaled our processes for labeling our affinity reagents and for quality assurance of labeled probes.

This increase in consumable scale and quality, has been critical in supporting our ability to consistently expand the number and breadth of the experiments we perform, getting us progressively closer to our launch targets of performing measurements with hundreds of probes, across 150 cycles.

Scaling our experimental capabilities is critical to demonstrating and validate the commercial viability of our PrISM methodology. In Q2, we performed a greater number of high probe and high cycle number experiments than in any previous quarter.

These large-scale experiments also incorporated advances in our formulations that delivered enhanced assay stability. These large-scale efforts are allowing us to improve the integration of our consumables assay instrument and software and increasingly complex model systems on the path to the proteome.

Initial studies were focused on validating targeted proteoform measurement studies with externally generated affinity reagents such as through the tau studies done in partnership with Genentech.

The next step is validating our internally generated affinity reagents through tests on individual short peptides that had been used in the creation of those affinity reagents.

At HUPO last year, we introduced data showing the application of our PrISM methodology to decode a model protein with an experiment incorporating two dozen probes across 70 cycles. In Q2, the use of a larger probe library, alongside a more robust assay enabled us to increase the set of model proteins that could be successfully decoded.

In the coming quarters, our planned efforts on model systems that include increased numbers of individual recombinant or purified proteins, mixes of multiple proteins across a range of concentrations, simple organisms such as viruses and ultimately wholesale lysates from well-studied cell lines.

We are excited about the upcoming efforts towards applying our assay to model systems that will increasingly resemble customer samples. Lastly, I'll note that Q2 also saw continued focus on advancing our commercial instruments.

The process of taking an instrument from concept to prototype to build to commercial use is complex and involves a number of important phases that are closely orchestrated collaborations between our engineering, software, assay development and product integration teams.

We continue to validate assay performance on our commercial instrument and to transition to a manufacturing posture. My enduring takeaway from Q2 will be the strong progress we made in advancing the robustness and scale of our work as we mature our assay towards achieving our launch targets. With that, I'll hand the call back to Sujal..

Thanks Parag. I am pleased with the scientific progress I saw in Q2 and continue to closely monitor our steady evolution from a company focused primarily on research to one focused on development and commercialization.

I also pay very close attention to the dynamics in the marketplace and the technical and product advancements happening in hours and adjacent spaces. And I'm really pleased to share that I believe that interest in proteomics has never been greater and continues to build momentum.

Despite what some have recently held up as improvements in the performance and specifications of traditional protein analysis methods, we are confident that Nautilus' core value proposition will deliver important and distinct advantages.

Specifically we believe that single molecule comprehensive quantification of intact proteins and proteoforms will establish a new gold standard for proteomic data.

In addition, our platform unlike any other on the market is designed to get better and better over time as additional data provides rich context to findings and additional identification data adds even greater precision to our machine learning algorithms.

And finally, our platform's ease of use was designed from its inception to far exceed that of traditional analysis methods. This innovation will open up proteomics to an entirely new universe of potential researchers.

These researchers who would love to incorporate proteomic data into their work but have been unable or unwilling to invest the time and resources required to have master traditional tools and methods.

Late last year, at a well-attended luncheon seminar during the Human Proteome Organization's Annual Meeting, Nautilus Scientific Advisory Board member, Dr. Ruedi Aebersold, shared that a frequent characteristic of new transformative platforms is that they often have an early phase during which platform performance can very rapidly improve.

This is in stark contrast to the comparatively slower pace of growth for more mature platforms. While this rapid iteration phase often leads to extremely valuable products and market-leading companies shipping that first product can be slower and more challenging than initially anticipated. Let me give you an example.

Solexa, the company that invented Illumina's next-generation sequencing technology spent eight years working on their first product the Genome Analyzer or GA. The GA had a lot of flaws.

It was incomplete, but it's fundamentally transformative nature paved the way for the GA IIx, the HiSeq 2500, the HiSeq X Ten and the MiSeq, all of which shipped within eight years of the first GA.

It took eight years to ship the first product but the next eight years were marked by incredibly rapid iteration and dramatic reductions in the cost of sequencing. We anticipate that our journey at Nautilus will be very similar to this path, much like Dr. Aebersold discussed at HUPO last year.

As we at Nautilus waived the work in front of us to get our first product out the door and balance that with our time-to-market goal.

It became clear that we needed to evaluate what part of our product specification needed to be in our first product and what could wait for version 1.5 or version 2 follow-ons? We spent a lot of time this year and particularly in Q2, listening to our customers and trying to refine towards a minimum product launch specification.

There are some characteristics like sensitivity and ease of use that are totally nonnegotiable. On the other hand, we've heard much more flexibility from the market around characteristics such as minimum amount of sample input and number of proteins quantified.

While I use the word minimum product launch specification, you should still interpret that to mean game changing. Just like the Solexa, Illumina Genome Analyzer launch in 2006, we expect our version one product will be transformative to our market and we will rapidly iterate reaching the full specifications we previously disclosed and beyond.

It should be noted that we expect enhancements to the V1 system enhancements that get us to the previously disclosed specification levels will only require updated consumable kits not a new instrument.

With the refined focus of our V1 launch specifications, we've updated our development plans and continue to target roughly the middle of 2024 for the launch of our platform. We look forward to updating you on firm law specifications and timing when we're closer to launch in 2024.

Let me now hand the call over to Anna for a look at our Q2 2023 financials.

Anna?.

Thanks Sujal. Total operating expenses for the second quarter of 2023 were $19.0 million, up $3.5 million compared to the second quarter of 2022 and up $0.9 million above last quarter.

This modest increase in operating expenses year-over-year was primarily driven by growth in personnel costs and laboratory expenses as we continue to invest in the development of our platform. Research and development expenses in the second quarter of 2023 were $11.9 million compared to $8.9 million in the prior year period.

General and administrative expenses were $7.1 million in the second quarter of 2023 compared to $6.6 million in the prior year period. Overall, net loss for the second quarter of 2023 was $15.8 million compared to $14.7 million in the prior year period. Turning to our balance sheet.

We ended the quarter with approximately $287 million in cash, cash equivalents, and investments. This compares to $302 million at the end of last quarter and reflects a cash burn of approximately $27 million since the beginning of the year.

We view our balance sheet as a critical competitive advantage and are continuing to be extremely diligent in managing our spend. At our 2022 year-end call in February, we stated that we expect our overall operating expenses to be up approximately 40% from 2022 levels ahead of a more meaningful ramp in 2024 along with our commercial launch.

Given our overall operating expenses from the first half of 2023, along with our expected spend for the remainder of the year, we now expect 2023 operating expenses to be up approximately 30% compared to 2022.

We continue to run a very lean business and our tight management of expenses means that we have a strong balance sheet to draw from in the coming years. We now expect our cash runway to extend through 2025 and into 2026.

It's important to note that our timeline for cash runway includes continuing our investment in development, includes the initial build-out of our commercial organization ahead of launch, and contemplates a range of 2024 product launch date scenarios.

With our robust balance sheet and no debt we have the flexibility to ensure we are in the best possible position for commercial launch. As Sujal mentioned earlier, the primary goal of our early access program is to generate data and customer interest ahead of our commercial launch.

While we do intend to charge for this service, it's likely that we will offer incentives and other perks that will serve to make it easier for early adopters to try our platform and ultimately, to buy a system. Once we transition out of early access, these incentive programs will expire.

However, revenue from those initial early access engagements is likely to be nominal. Finally, while we are targeting the launch of our platform in mid-2024, it's reasonable to expect that instrument shipments will begin in the second half of 2024 and pick up more meaningfully in 2025.

Once we begin placing instruments, we anticipate our revenue will grow quickly from the combination of new instrument sales and the region consumables, driven by our growing instrument installed base.

From a planning perspective and taking into account my earlier comments on revenue from our early access program, we expect revenue in 2024 to be modest and opportunistic. As you have consistently heard from our team, our priority is to deliver a best-in-class platform that will enable our customers to achieve new levels of proteomic insight.

Looking ahead, we are confident in our strong position that is allowing us to focus on our scientific progress and to deliver the type of platform that will change the trajectory of proteomics. With that, I will turn it back to Sujal. .

Thanks, Anna. Based on what we shared with you today, we are excited about what lies ahead for Nautilus and the difference we plan to make in biological science. Our mission to positively impact health and lives of people around the world remains our guiding light and reflects the passion for innovation, exhibited by every member of our team.

I'm grateful to our investors, our strategic partners, our research collaborators and our team for joining us on this journey to transform proteomics and empower the scientific community in ways never before thought possible.

We continue to make good progress and look forward to updating, you all along the way, as we continue towards commercialization of our platform next year and beyond. With that, I'll turn the call back to the operator.

Operator?.

Certainly [Operator Instructions] One moment for our first question. And our first question comes from the line of Tejas Savant from Morgan Stanley. Your question, please..

Hi, this is Yuko on for Tejas. I was wondering, if you could elaborate on the current thinking on the initial specs of that V1 product.

And what could you -- what could be pushed out for a later update?.

Good morning, Yuko. This is Sujal. Maybe I'll take a stab at this and see if Parag has anything to add. In terms of some areas where we think that our capabilities that we've talked about before are nonnegotiable. Things like single-molecule sensitivity, things like ease of use, exceptionally high dynamic range is important as well.

And I think, what we've heard from the marketplace in talking to a lot of our customers in the first half of the year here, is that there's more flexibility on the initial specifications around things like the number of proteins that can be quantified, or the sample input.

And so those are some of the areas that would -- that will be the first areas that we will likely make a few compromises. But as I mentioned in prepared remarks, we still expect that end result here is a game-changing product.

And we expect that, consumable revisions only will be required to take us all the way through all the specifications that we've disclosed and talked about in the past. .

Great. That was super helpful. And then, with the recent launches from mass spec vendors at ASMS bringing instruments, with greater sensitivity and deeper coverage to the market.

How do you feel about the competitive positioning of your proteomics engagement? And then, with the new instruments improving on throughput as well, could you give us a color on how your instrument expects the V1 may compare?.

Yes. Why don't I take this first. This is Sujal again, and then I'm going to probably kick it over to Parag to see if he has any other comments, since he is a mass spec key opinion leader. We have obviously, have been watching the announcements from the mass spec community very, very closely particularly year.

And your first question was sort of, how I react to it. I'm incredibly excited when I see those heads of announcements. And I've said it, for a few reasons. One is that, we continue to see as we expected over the last five-plus years, just modest incremental improvements to the capabilities of the mass specs.

And many of these companies are very successful and they're very good at taking their strongest suits and figuring out how to talk about them in a really compelling way.

But when you dig underneath, the fundamental limitations with sensitivity and dynamic range the fundamental limitations, with quantification of proteins all those limits are still there.

And one of the things that gives me really, a lot of excitement is that one of the vendors, which I won't mention push, the price point of the mass spec that they released up close to $2 million, which to mean is an incredible indication of the power that the customer sees in these solutions and the opportunity that Nautilus has.

Even the on specifications that, I discussed earlier with respect to dynamic range sensitivity the coverage of proteins that could be quantified the ease of use we will exceed the capabilities of all of the traditional proteomics analysis solution the affinity-based arrays and we expect to exceed the solutions of all of the emerging peptide sequencing companies as well.

Parag, do you have anything to add there?.

I think that was a fantastic answer. The only other point that, I'll add is our general philosophy on the proteomics space has been that depending upon the question that you are interested in asking there are different tools that may be best suited for asking and answering that question.

And the new offerings, the expanded offerings from the different vendors we're really excited to see the progress in the field. We're really excited that that's driving the conversation more and more towards the importance of proteomics in the biological community. But we also still see tremendous differentiation.

The single molecule nature of what we're offering is very unique. The way that, we identify proteins such that every protein is identified from 10, 20 distinct measurements, provides incredibly high confidence in identifications that are made quantifications that are made.

So there are a number -- and then really this -- one of the critical differentiators of our instrument is that you walk up you drop a flow cell on a new presto.

So that ease of use starting all the way back at the sample handling process through instrument execution and data interpretation analysis are really important differentiators to our platform. .

Great. Thank you very much..

Thank you. One moment for our next question. And our next question comes from the line of Dave Delahunt from Goldman Sachs. .

Hey, guys. I appreciate the update. You mentioned the platform is demonstrating routine assays with higher numbers of probes and cycles. I think you said before that the number of probes is directionally helpful but it's not linearly correlated.

So any other qualitative or quantitative detail you could share with us on the progress there?.

Parag, you do want to kick off here – sure, go ahead and then I'll jump in after..

Yeah, absolutely. So I think we really brought to light a few very specific areas of advancement this quarter. So one of which I'll point out is really around the reagent scale and quality. As you know, the system uses a very large number of reagents.

And so being able to build them effectively being able to build a large number of them being able to qualify them were really important advances. One of the other key areas that you highlighted was on just the scale of experiments.

Sujal in his remarks called back to the initial efforts with Celexa and there were points in that development process and this is very normal in any multi-cycle measurement where they were operating in the handful of cycles. And then they were working in the teens of cycles and they were working up to about 100 cycles.

And so we're seeing similar progressions in our hands, where we're identifying sources of instability or variability and pushing that number up and up and up. I think at HUPO last year, we've talked about experiments that were 80 cycles.

And so I think what you're seeing is you're seeing us finding out all of the aspects of our platform that are critical for stability and optimizing each of the different steps and formulations and pieces of the process to enable that scale..

Great. And with the flexibility you mentioned that potential users have on sample input and number of proteins.

Any additional color there to help us think about that?.

Yeah, Dave, this is Sujal. I don't think I've got anything more there to add this minute. I mean, we still have time to finalize those specifications. And I think that once we have kind of wrapped up specifications pricing firm time line all those sort of things, I think we'll do a larger update for the street.

But at this point, I think all the comments I mentioned earlier in prepared remarks and then in terms of -- the answer to you gas questions I think are all the detail I've got right now..

Got it. All right. Congrats on the progress. Thanks..

Thank you. And our next question comes from the line of Dan Brennan from Cowen. Your question please..

Great. Thank you. Thanks for taking the question. I joined a little late.

But maybe just the first question would be just broadly when will investors be able to get the first kind of thorough would you say on the product as it gets more fully in the customers' hands with the early beta? Just kind of wondering if you can just and if you spoke to this a little bit during the prepared remarks I apologize, but just kind of getting a sense of when we'll be able to do some checks and kind of see some early publications as a new product?.

Yeah. That's a great question, Dan. Let me kind of walk through that. And maybe just kind of just to set, just a little bit of context that will help understand my answer.

One of the things that is very important about our platform is a unique characteristic that enables us to take at a single molecule level, one protein molecule and probe it over and over and over again getting more and more and more information about it.

And after we probe that molecule with about 300 different probes roughly as we've disclosed in the past, we can with a very high degree of certainty identify what that molecule is for the vast majority the 90% and 95% of the proteome identify what the molecule is.

And then we can keep probing that molecule to understand the heterogeneity of the proteoform landscape, to understand what ice from it is, to understand all sorts of different characteristics and that's incredibly unique.

As we go and continue to integrate probes, we continue to increase the number of cycles that our instrument and assay perform, as we continue to optimize those conditions more and more things can be identified.

And as Parag mentioned in his prepared remarks, over the course of the last six months we've been moving through various model systems from peptide to logger peptides to proteins.

And as we start getting up to a reasonable number of proteins call it a couple of thousand, we will start putting that technology into the hands of some KOLs and some labs that could help us to validate those assumptions.

And that would be the first point at which the investment community and the analysts could go and make those checks and see what the potential of our technology is. And we've told that to investors as well as like that's the key milestone to look for, because at that point everything has come together.

And from there it's more probes more cycles and just getting over that last hump to go and rapidly climb from 2,000 to 5,000, 7,000, 10,000 and beyond. And that rapid climb is based on the fact that the combination of all of these probing of each molecule is a computational data science task.

And so the first 50, 70, 500 probes virtually give us nothing on a complex human sample but the next 100 from there give us a tremendous amount of data in the last 100 finished off. And so once we get to that milestone, you'll have some data some things that you can go and talk to KOLs about.

But in addition to that, we'll have a much firmer sense on specifications first release timing and our cost and all those sorts of things..

Correct. And that would be middle of 2024 -- first half 2024 like it's 2024, I'm just wondering. .

Yes. So if you -- so prepared remarks -- in prepared remarks and you were didn't -- you weren't able to attend all of it. But in prepared remarks what we said was that we have gone out to the marketplace over the course of the first half of the year.

We talked to a lot of our customers and we refined sort of a minimum set of product specifications that we believe are still game-changing. And with that set of product specifications in hand, we are still targeting the middle of 2024 for a launch. And when we talk about that launch that launch is instrument consumables software.

That is the actual instrument ready to go. And it's our intention sometime before that to have this 2,000 protein mark to be able to put that in some customers' hands.

And as that climbs up a little bit to 3,000, 4,000, 5,000 really start our early access period as well where customers can go and really look at the data coming off of our platform and we can use that to drive primarily publications and market evidence for future customers, but in addition to begin to get customers thinking about pre-orders. .

Got it.

And in terms of like a scientific meeting next year with these early publications come out just on a as done basis, or like what would be the scientific meeting we would look for that you think the first wave of these would be presented at?.

Yes. I mean between U.S. HUPO, the Human Proteome Organization Show, the World Congress that they do there's two shows. And then there's a whole host of others between HVT [ph] and ASMS and AIC, which we attended recently.

And so at each of those conferences, we take the opportunity to either take one element of our product and explain it in depth to the scientific community or to show our advances.

And so I don't know if I've got an exact show lined up for you, but those are the primary vehicles that we use to deliver updates out to the scientific community and by proxy..

And maybe a final one.

Could you speak to just kind of customer interest broadly? Obviously, the leading edge customers are super excited to the extent the product can meet kind of the targets that you're kind of discussing qualitatively and quantitatively but just any color about what an early funnel looks like obviously you have to deliver on the product but just any thoughts there would be helpful.

Thank you..

Yes. Maybe I'll chime in here and then Parag spends a ton of time talking to the customers in proteome's community. I'll let him chime in as well. What I'm hearing from the marketplace is a tremendous amount of excitement around our platform. We've disclosed our method. We've disclosed early data.

At HUPO last year, we showed the first really significant multi-cycle data. And we continue to roll out data that is quite exciting to the KOLs and the customers that I talk to. And this fundamental nature of being able to in a nondestructive way take a molecule and probe it over and over and over again in order to get more and more information.

The scientific community sees that idea and the implementation of it that we are pursuing as a really significant advance over what's available today, which either has to chop proteins into peptides for analysis where you lose a huge chunk of the context in the data or the emerging peptide sequencing methods all of which are destructive to the protein and incredibly insensitive and the affinity-based solutions that are out there, which you have to build a specific antibody that answers one specific question.

All of those approaches are fundamentally limited. And I'm hearing from customers a huge amount of excitement around our approach and they're tracking us pretty closely.

Parag, do you want to chime in and add anything there from what you've heard from the market recently?.

Yeah. Absolutely.

I think certainly one of the things that's really fun is chatting with customers and hearing the incredibly wide range of applications that they see for the platform both in ways that are complementary to studies that they have ongoing in mass spectrometry as well as in areas like single molecule intact proteoform analysis that simply can't be done any other way.

And so every time we go out and talk to customers we come back with new exciting applications of the technology. And so, I'd say all of those conversations are illuminating and are helping us understand that frankly there's so much more that can be done with our platform than we had even envisioned at the outset. .

Terrific, guys. Thank you very much..

Thank you..

This does conclude the question-and-answer session as well as today's program. Thank you, ladies and gentlemen for your participation you may now disconnect. Good day..