NAUT - NASDAQ

Good day, and thank you for standing by. Welcome to the Nautilus Biotechnology Q4 2025 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Ji-Yon Yi, Investor Relations. Please go ahead.

Thank you. Earlier today, Nautilus released financial results for the quarter ended December 31, 2025. 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 [email protected]. Joining me today from Nautilus are 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 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 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 on February 26, 2026. With that, I'll turn the call over to Sujal.

Thanks, Ji-Yon, and thank you all for joining us today. Before turning to the quarter, I want to briefly remind everyone of what we're building and why we believe it matters. Nautilus was founded to address a long-standing challenge in life sciences, the lack of technologies capable of comprehensively measuring the proteome with the sensitivity, scale and reproducibility needed to fully understand biology and disease. Our proprietary Iterative Mapping methodology is designed to analyze single intact protein molecules at scale and generate highly reproducible digital protein counts. This methodology is delivered through the Nautilus platform, an integrated system of instrumentation, consumables and software, which can support both broad-scale proteome analysis and targeted proteoform characterization on a single platform. Over time, we believe this data foundation will unlock new biological insight, integrate more effectively with other omics modalities, support next-generation AI-driven discovery in human health and medicine and ultimately help accelerate the development of new therapeutics and diagnostics. With that context, Q4 marked a strong close to 2025 as we continue to make tangible progress towards commercialization, deepen external validation and build momentum with leading research institutions. A key highlight of that progress was our presence at the US Human Proteome Organization Conference, or US HUPO in St. Louis, Missouri this week, where we publicly unveiled the Nautilus Voyager instrument in dramatic fashion to a large audience of influential researchers and prospective future customers, providing the proteomics community with its first tangible view of the instrument we've been building. The response was highly positive and reinforced the strong interest we're seeing from researchers seeking a new class of protein measurement technology. Importantly, when designing Voyager, we were intentional about creating an instrument that looked and felt different, one that conveyed sophistication and innovation while still being approachable and easy to use. We wanted an instrument that reflected the ambition of what we're building while also fitting naturally into modern research environments. And the feedback we received confirmed that this balance resonated strongly with the community. Building on the capabilities of the Voyager instrument and supported by the encouraging tau data we've seen emerging from our early collaborators, we elected to launch our Early Access Program for Iterative Mapping in January earlier than previously communicated. This milestone represents a meaningful step in Nautilus' transition from development to active customer engagement, enabling partners to submit samples, receive data and provide feedback in a streamlined manner. Initial customer response has been encouraging. And while these early engagements are not intended to drive near-term revenue, they are designed to enable real biological discovery, support publications and grant applications and ensure our workflows and data outputs align closely with customers' needs, an approach consistent with how many transformative life sciences platforms has successfully entered the market. The Early Access Program will begin with our Tau proteoform assay and establish a foundation for future assay expansion covering additional proteoform targets and broad-scale applications. Importantly, we believe this early access launch also reflects a forthcoming diversity of assays for our platform beyond tau. For example, in late January, we announced a collaboration with Weill Cornell Medicine-Qatar and The Michael J. Fox Foundation focused on alpha-synuclein proteoforms in Parkinson's disease. This MJFF-funded project, $1.6 million in total with $1.2 million coming to Nautilus, combines Professor Hilal Lashuel's deep expertise in neurodegeneration with Nautilus' ability to measure proteins and their functional variants at the single molecule resolution. Understanding alpha-synuclein proteoforms is a priority for MJFF, and we believe this collaboration is a strong example of how Iterative Mapping can be extended to additional high-value proteoform targets and disease areas over time. On the technology front, we continue to make strong progress as we moved into the later stages of our broad-scale assay configuration change. This work is designed to better align with our expanding probe library and improve overall platform performance. We're now seeing the first data from the updated assay on new chips and early readouts are encouraging. Parag will walk through these technical details in more depth, and I'll return later to discuss how this progress informs our expectations for 2026. Taken together, these developments reflect steady progress towards commercialization grounded in real samples, real data, real customer engagement and increasing external validation. Throughout 2025, we remain disciplined in how we invested our resources, meaningfully reducing expenses while continuing to advance our most important technical and strategic priorities. I want to recognize our scientific and engineering teams for their continued focus and execution. With that, I'll turn the call over to Parag.

Thanks, Sujal. I'll now provide an update on our technology and product progress, including what we're learning from our development work and the external validation we're seeing through collaborations. Overall, Q4 was a strong quarter of execution for our product and scientific teams. We continue to see growing validation of the Nautilus platform through both internal development and external partnerships. Importantly, we are increasingly moving beyond demonstrating that the technology works and towards applying it to obtain remarkable biological insights, not possible with existing proteomics approaches. This shift from capability to meaningful application is an important marker of platform maturity and a central focus for the team. Collaborations continue to play a critical role in validating the platform and demonstrating real-world relevance. During the quarter, we completed work with the Buck Institute for Research on Aging, culminating in the presentation of novel tau biology at World HUPO and most recently at US HUPO, and we are now supporting our partners as they prepare their findings for publication. In parallel, through our collaboration with the Allen Institute for Brain Science, we analyzed human brain samples spanning multiple brain regions, genetic backgrounds and disease severities. We believe this work represents the most comprehensive and quantitative Tau proteoforms landscape study to date. Notably, we are observing clear differences in Tau proteoforms patterns across disease severity and brain regions, signals that are not detectable using conventional proteomics approaches and that may help explain variability in disease progression and clinical outcomes. We also anticipate that such insights may be essential for developing the next generation of therapies for neurodegenerative diseases. Stepping back, what stands out is that the data emerging from these collaborations is not only technically robust, but biologically compelling. With each additional study, we gained confidence that Iterative Mapping is enabling access to important biology that has remained out of reach for existing technologies. We believe this new class of proteoform level data has the potential to drive real-world impact by deepening our understanding of disease mechanisms, revealing new therapeutic targets and enabling the development of more precise biomarkers for diagnosis, patient stratification and treatment monitoring. Ultimately, our goal is to demonstrate to the broader scientific community that this represents a transformative foundation of information, one that can help accelerate drug discovery workflows and improve the probability of success in developing new therapeutics. From a platform development perspective, we made meaningful progress across both our broadscale assay and our proteoform assay portfolio, while also gaining greater clarity on the remaining work required to reach our next milestones. Starting with the broadscale assay, we continued advancing our assay, including advancing the assay configuration change we have discussed previously and are now routinely employing our new configuration. During the quarter, we achieved several encouraging milestones, including performing our largest scale experiments to date, which demonstrated Iterative Mapping-based decoding of proteins from increasingly complex mixtures, including cell lysates. In addition, we made good progress on hardening the fabrication process for our new flow cell configuration, and showing assay performance characteristics such as increased on-target binding that give us indications our new assay configuration will enable an expanded affinity reagent library. The work completed in Q4 helped validate key elements of the new configuration and clarify the primary levers needed to drive further performance improvements as we scale towards complex biological samples. Progress on Proteoform assays remains strong. The Tau Proteoform assay continues to track as our first early access offering, and we remain on schedule to begin processing samples through the Early Access Program by the end of Q1. Verification and validation activities are largely complete, and the assay is meeting our requirements for accuracy, dynamic range, reproducibility and stability, marking an important step as we transition tau from development into a high-quality commercial-ready product. In parallel, we formally initiated our proteoform expansion pipeline. As Sujal mentioned, we launched an 18-month collaboration funded by The Michael J. Fox Foundation to develop an alpha-synuclein proteoform quantification assay, extending the platform into Parkinson's disease. This program includes development of a pilot assay focused on key post-translational modifications, optimization of enrichment and sample preparation workflows and application of the technology to human brain and biofluid samples. We view this collaboration as an important opportunity to further demonstrate the breadth of Iterative Mapping beyond tau and to expand our proteoform capabilities into additional high-value disease targets. While much of our current momentum is in neurodegeneration, it's important to emphasize that Iterative Mapping is not limited to neuroscience. We see meaningful long-term potential across oncology, immunology, cardiology and beyond. We are currently evaluating multiple oncology-focused candidate proteins with the goal of having an oncology-focused proteoform assay enter early access in the second half of 2026. We believe oncology represents a compelling next market opportunity, providing access to a broader customer base while also aligning well with the capabilities of our platform to deliver proteoform level resolution and highly reproducible measurement in complex biological systems. Overall, Q4 represented a strong quarter of technical execution as we continued advancing our Voyager instrument and end-to-end platform. We made meaningful progress on the broadscale assay configuration change and began generating initial data from the new approach while also advancing our proteoform portfolio with tau on track for early access sample processing by the end of this quarter. At the same time, the growing body of externally generated data from collaborators like the Buck Institute and the Allen Institute continues to validate both the robustness of our measurements and the unique biological insight enabled by Iterative Mapping. Taken together, these developments reflect continued platform maturation and reinforce our confidence in the technical foundation required to scale our assays, broaden our target portfolio and support future commercial deployment. With that, I'll turn the call over to Anna to review our financials.

Thanks, Parag. Turning to our financial results. We continue to demonstrate strong operating discipline in Q4 and throughout 2025. Total operating expenses were $15.4 million for the fourth quarter of 2025, a decrease of 23% from the prior year period and $66.8 million for the fiscal year 2025, a decrease of 18% year-over-year. Research and development expenses were $41.1 million for fiscal year 2025 compared to $50.5 million in fiscal year 2024, representing a decrease of $9.4 million or 19%. This decrease was driven primarily by a $4.5 million reduction in laboratory supplies and equipment expenses, reflecting operating efficiencies, lower development-related costs and continued cost optimization efforts. We also saw a $2.4 million decrease in salaries and related benefits, driven by savings from the reduction in force implemented in the first quarter of 2025, along with a $1.9 million decrease in stock-based compensation expense. General and administrative expenses were $25.7 million for fiscal year 2025 compared to $31.0 million in fiscal year 2024, a decrease of $5.3 million or 17%. This decrease was primarily due to a $3.9 million reduction in stock-based compensation expense, along with a $1.3 million decrease in professional services, largely attributable to lower legal and consulting costs. We ended the quarter with $156.1 million in cash, cash equivalents and investments. Cash burn in 2025 was $50.2 million, down from $57.8 million in 2024, reflecting the benefit of lower headcount and development expenses. Looking ahead, we expect total operating expenses for the full year 2026 to increase as we continue investing in platform development, support the expansion of our Early Access Program and advance commercial readiness activities. We currently anticipate total operating expense growth of approximately 15% to 20% in 2026, and we expect full year 2026 cash burn to be in the range of $65 million to $70 million. Based on these assumptions, we continue to believe our financial plan supports a cash runway that extends through 2027. Following the launch of our Early Access Program in January, our initial customer engagements are primarily with academic key opinion leaders seeking early access to the tau offering to support exploratory research and grant applications. While we expect modest services revenue later in 2026, we anticipate the primary revenue ramp will begin in 2027 once we start shipping instruments. As a reminder, instrument placements drive our recurring consumables business and together, they create a scalable top line. We believe the instrument and consumables ramp will accelerate meaningfully once both our proteoform and broadscale capabilities are generally available, enabling customers to deploy the full power of the platform and driving broader commercial adoption. As Sujal noted earlier, we also announced grant funding from The Michael J. Fox Foundation to support development of an alpha-synuclein proteoform assay. Under this agreement, we expect to receive approximately $1.2 million with development and sample analysis work occurring over approximately 18 months across 2026 and 2027. Revenue will be recognized as the underlying work progresses. Back to you, Sujal.

Thanks, Anna. As we wrap up, 2025 was a year of meaningful progress for Nautilus as we continued advancing the platform and began transitioning toward external engagement. That momentum carried into early 2026 with the launch of our Iterative Mapping Early Access Program and was further highlighted this week by the debut of the Voyager instrument at US HUPO, where we introduced the system directly to the proteomics community. Together, these milestones represent important steps in putting the platform into the hands of researchers. Looking ahead, we expect 2026 to be a pivotal execution year. We plan to begin progressing early access customers into tau services projects, expand early access to include a second proteoform assay focused on an oncology target and introduce broadscale capabilities into early access later in the year. In parallel, we expect to place Voyager instruments externally through beta deployments as an important validation step ahead of commercialization. We expect to initiate our commercial launch in late 2026 by opening the Voyager platform for preorders with instrument installations at customer sites beginning in early '27. At launch, we expect general availability to include the Voyager instrument, our Tau proteoform assay and a second proteoform assay. We anticipate general availability of our broadscale capabilities in the first half of '27 as we continue expanding our platform's assay portfolio. We're encouraged by the momentum we continue to see from collaborators and partners applying Nautilus' Iterative Mapping technology to complex disease-relevant biology, and by the steady progress we've made across our assay development and operational priorities. Together, these efforts position us to begin translating years of investment in what we believe will be meaningful scientific and ultimately commercial impact. I'm proud of the work that our team has accomplished and grateful to our collaborators for their partnership and trust. With a strong foundation in place and a clear path forward, we remain focused on disciplined execution as we advance the platform towards broader deployment. Thank you for joining us today. With that, we'll be happy to take your questions. Operator?

[Operator Instructions] Our first question comes from Subbu Nambi from Guggenheim.

There was a lot of focus on the technical milestones you achieved in Q4 that provide you with the foundation for further technical improvements. Building off of that, I have a couple of questions. What comes next? By that, I mean, what are the next milestones and what metrics materially get better building off of the technical milestones you achieved in Q4? And second, have you shared these milestones with any of the key customers, especially those focused on tau? And if so, have these new developments catalyzed the path to placements?

Thanks, Subbu. I'll take that one. I think there are a couple of key sets of technical milestones, and I'll try and describe each of them. One of the really key technical milestones was the completion of the final studies of the Tau proteoform assay to make sure that it was ready and an incredibly performing assay for our Early Access Program. That data has been shared back with early customers. They're excited about the quality of the assay and really thrilled that we're -- at the data that we're able to produce. The second set of progress were on instrument readiness. And as we mentioned, coming out of our evaluation instrument at the Buck, the data we learned from that. And internally, that was really what positioned us for the announcement of the reveal of the instrument at the US HUPO conference earlier this week, and tremendous excitement about folks really being able to get their hands on the instrument and see it was great. I think the other aspect that we've been discussing in terms of moving forward are the expansion of the proteoform platform to additional targets. We mentioned alpha-synuclein and an oncology-focused target. And I think the people are -- remain very excited about proteoforms across domains. And so seeing progress towards other proteoforms validating that the platform is not just a neuro platform, but is a platform that can apply across different domains is something that we've heard a lot of positive excitement about. And then on the broadscale side, as we mentioned, the expansion of both the scale of assays that we're performing as well as the further progress on the configuration change. I think all of those things are really key contributors. As we look forward, what we're looking at are levers like increase -- further increasing on-target binding, minimizing off-target binding. We continue to progress working on assay stability of the new configuration chips that are stable over hundreds of cycles. All of these are challenges that require optimization, not innovation.

[Operator Instructions] our next question comes from Dan Brennan from TD Cowen.

This is Kyle on for Dan. So starting with this year, I know you said no material contribution from early access in terms of revenue and a modest contribution later this year from service and reiterated the commercial launch for later this year. But do you anticipate any revenue at all from a commercial launch later this year? I think the Street was modeling a few million dollars in revenue all the way out in the fourth quarter. And then maybe building off of that, have you discussed anything new around pricing for the Voyager instrument?

Kyle, I can definitely give you a little bit more color there. As you reiterated, we don't see our early access engagements as a major driver of revenue that although we do expect some modest services revenue later in the year, our revenue for 2026 will really come from two sources. First, I'm anticipating a portion of The Michael J. Fox grant funding to be recognized as revenue in 2026 with the remainder flowing into 2027. While the work that we do for that grant may vary depending on the quarter, I think it's reasonable to expect some revenue coming in from that. On top of that, with a handful of early access customers converting to revenue within the year. I'm looking at a target of closer to, say, $0.5 million for 2026. The revenue ramp tied to instruments is really coming in 2027. On the pricing front, we don't have anything in addition to any changes from what we've talked about previously.

Got it. And then maybe can you just give a little bit more color on how the Early Access Program is going, maybe some of the feedback you've received from these early customers? And then I guess building on that, can you speak to how your sales funnel is building ahead of the commercial launch later this year?

Yes. Let me tackle -- Kyle, let me tackle, this is Sujal. I'll tackle the commercial pieces of that, and Parag can give you some of the early feedback because really the early feedback is just from the Buck Institute and the Allen Institute who've been working with us in the very early stages of the early access or the late stages of their collaborations. In terms of funnel, when we launched that Early Access Program, one of the things that we said in our prepared remarks was that we elected to launch it earlier than previously communicated. And that is because the data quality and the excitement that we are seeing from customers based on the early data from the Buck and from the Allen Institute, and our own internal data as well as through our partners who were -- who worked with us on the preprint that is out now, which is MSCI and Mount Sinai. All of that data was really exciting. We elected to get out to launch. Now it's a little bit earlier than we were thinking. It's important to point out, we have absolutely 0 sales capacity in the company right now. There's not a single salesperson in the company. And so the funnel build is something in earnest that we really just began. And so HUPO was a great opportunity to get in front of a lot of potential customers. And in earnest, we will begin the sales capacity build this quarter and then continuing through the year with just a few targeted headcount. And so it's a pretty much a surgical strike sort of approach, right? It's not going to be a lot of commercial build, but we'll start to see that funnel build. Parag, do you want to talk about the feedback that we've received?

Yes, absolutely. I think a highlight of the US HUPO meeting was very much Birgit Schilling's presentation of her latest data, looking at both different brain regions of -- that complemented across these 3-xTg mice models. And then a study where she was looking at genetic alterations that predispose people -- well, either predispose people to Alzheimer's disease or are protective. And that has been a really big open question in the field about why there was this link between this gene called ApoE and Alzheimer's disease, what actually occurred, how was this linked to tau. And her data this proteoform level detail really highlighted that those genotypes potentially led to changes in tau phosphorylation and that was a critical predisposing factor. Now it's very early data, but it is exciting to have a tool that can allow us to finally see what the downstream consequences of this either protective or extremely deleterious mutation might be. And so I think we've heard from other folks at the conference, both how excited they were to see the data, how much they appreciated the quality of the data that the story itself and the multiomic link was extremely exciting to them and something that they want the ability to be able to forge those connections and see things they haven't been able to see before. So it was really exciting to get that feedback from the community.