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2/23/2023
is accurate only as of the live broadcast February 23rd, 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 bioinformatics 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 of 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 flow cells. This progress goes hand in hand with advancing the quality and customer readiness of our offering. Critical to those advances were our efforts to strengthen the core of our R&D leadership team in 2022, with the addition of Sherry Wilcox as VP of Affinity Reagent Development and Ken Kuhn as VP of Reagent and Platform Development. Ken and Sherry have helped us build out a world-class development team, which will continue to pay dividends in 2023 as we move towards commercialization. 2022 also saw continued focus on advancing our commercial instrument. The process of taking an instrument from concept to build to commercial use involves a number of important phases that are closely orchestrated collaborations between diverse teams, I'm pleased with the progress I saw last year in this regard. Throughout the entire R&D organization, we continue to successfully transition to a manufacturing posture across all elements of the platform as we build towards commercial availability. That work continues and will accelerate in 2023. Early in 2022, we thought to augment our internal probe development efforts with external partnerships. When it became clear that some of those partnerships were underperforming compared to the volume and quality of probes we were seeing from our own internal effort, we made the decision to put our resources where they would yield results in the most capital-efficient manner. Our internal affinity reagent development pipeline continues to proceed well. Data we shared at conferences throughout last year demonstrated that our internal teams are able to generate probes that are extremely strong binders across a range of short epitope targets. These wide-ranging transitions and improvements coupled with advances in our on-platform workflow have allowed us to radically increase our experimental scale. Our internal target for 2022 was to be able to execute on experiments up to 75 cycles. We've not only demonstrated experiments of this scale, but we are now routinely performing experiments of this scale. The progress achieved throughout 2022 enabled us to present six posters at the HUPO World Congress in early December, covering all aspects of our platform, ranging from acidity region development to our single-molecule deposition approach. One of these posters demonstrated decoding of a model protein from an experiment of 24 multi-affinity probes across 70 cycles. This data demonstrated the full end-to-end integration of our experimental and computational workflows. These were exciting results that continue to expand confidence in our science, and we look forward to building on these results in 2023. Also in 2022, we nearly doubled our patent portfolio to over 40 pending patent families filed in the U.S. and abroad with a total of 11 granted U.S. patents thus far. In 2023 and going forward, our IP strategy will remain global in reach as we seek protection in the U.S., and in foreign markets where we expect to commercialize our platform. These and many other accomplishments in 2022 make me excited for our future. While we recognize that much work remains to be done, I'm firm in my belief that these and other foundational efforts will continue to pay off in 2023 and beyond. An important part of revolutionizing proteomics is inspiring others to join us on this journey. And it was with that goal in mind that we announced in Q4 what we're calling the Nautilus First Access Challenge, a contest designed to enable researchers from a broad spectrum of disciplines to uncover new biological insights and explore new areas of the proteome at massive scale. The response from researchers across the globe has been incredibly rewarding. It has unlocked the type of creativity we'd hoped to see when we offered them the chance to explore their samples unbounded by the inherent limitations of both traditional methods and of emerging affinity-based and peptide sequencing methods. We're very excited to review the proposals we've received. The deadline for submissions has passed, and we will announce the winners at the U.S. HUPO 2023 conference in early March. Stay tuned in the very near future for more on the first access challenge and how it has revealed pent-up demand for comprehensive proteomic coverage. Our existing collaborations with Genentech, Amgen, and MD Anderson also represent partners who are joining us on our journey to revolutionize proteomics. Recently, we announced a new partnership with the Translational Genomics Research Institute, TGen, to explore the utility of the Nautilus platform by studying specific protein targets in diffuse intrinsic pontine glioma. DIPG, a rare and often fatal childhood cancer. The goal of this partnership is to better understand the epigenetic mechanisms at work in DIPG by interrogating the proteoform landscape of specific proteins at the single molecule level. Proteoform is not possible to detect by peptide-based protein analysis methods. Work should kick off early this year, and the expectation is that the team will publish its findings when completed. I'm very excited about the work we'll be doing with TGen, and I'm especially excited by the broad set of use cases our collaborators are deploying our platform against. From childhood cancer to aging to neurodegenerative diseases, we are seeing interest from researchers across a wide spectrum of applications and use cases. Our team heard many such use case ideas when, as I mentioned earlier, we participated as a primary sponsor of the Human Proteome Organization's World Congress in early December. Aside from engaging conversations during our six-poster presentations, our booth was buzzing with researchers and PIs discussing how our platform could enable researchers to ask and investigate fundamentally different questions than ever before possible. It was exciting to hear proteomics researchers, many with deep, long-standing ties to mass spectrometry, enthusiastically see the potential of our platform to serve as a valuable complement to their traditional analysis methods. Conversations at HUPO and many others throughout the year, the strong submissions to our first access challenge, and the enthusiastic response of our research partners all served to strengthen my belief that Nautilus will bring to the market a highly differentiated platform with a wide competitive mode, a platform that delivers an unmatched value proposition to researchers seeking to unlock the extraordinary potential of the proteome. These researchers have expressed over and over again a desire for a single molecule solution, one that overcomes the inherent limitations of both traditional methods and of emerging affinity-based and peptide sequencing methods in terms of sensitivity, scale, and reproducibility. I'm excited to get our platform into the hands of researchers and assist them as they drive forward their innovative, impactful biological research. As we've previously discussed, my management team and I continue to proactively adapt to the gravity of the current financial and economic climate. We are tightly managing our resources to maximize our runway well into 2025 and balancing that with investments that will enable us to drive our scientific progress forward. For more on that, let me hand the call over to Anna for a look at our Q4 and full year 2022 financials. Anna.
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 and 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. That 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 timelines 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.
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