Sujal Patel
Analyst · Cowen
Thanks, Parag. Since we became a public company in June, we've significantly scaled our team and product development activities. As you heard from Parag, we're very excited about the progress we've made since then. But despite that progress, we have not yet achieved our first broad scale proteomic profiling milestone. That said, we still anticipate reaching comprehensive coverage of the human proteome in the middle of 2023, and we remain confident in an end of 2023 commercial launch. The root of our confidence in our commercial launch schedule requires a bit of explanation. As a reminder, and as described in the foundational manuscript we made available on BioArchive in Q3, the Nautilus platform is based on an integrated computational experimental method that's capable of identifying 95% of the proteome, roughly 19,000 gene encoded proteins. This method serially interrogates the single molecule binding of a collection of several hundred reagents that we call multi-affinity probes. Each of these probes are first discovered through methods like SELEX or phage display. Then prior to use within our platform, they undergo extensive characterization and are coupled to our proprietary fluorescent labels, which enable detection. As described in the manuscript, the number of probes is not linearly correlated with the percent of the proteome that can be identified. Let me explain. Roughly speaking, the first 1/3 of our probe set will only be able to decode a small percentage of the proteome. From there, the second 1/3 of our probe set exponentially increases the percentage of the proteome that's identifiable approaching 60% to 80% of the proteome. Finally, the last 1/3 of the probe set gets us to a comprehensive identification and provides more confidence around protein identification. Additional probes increased confidence in identification and enable more detailed detection of mutations and proteoforms, but do not substantially increase the percentage of the overall proteome that can be identified. Last year, we planned to begin the scale development of the multi-affinity probes as soon as the capital from our public offering was in hand. That scale development entails both internal and external efforts focused on developing aptamers and antibodies via standard and proprietary methods. When we announced our strategic partnership with Abcam on our last quarterly call, I mentioned the likelihood that we'd be signing similar agreements with other partners in an effort to derisk our platform development pipelines. To that end, we've signed agreements with 3 additional strategic partners. These relationships will not only help us most efficiently achieve broad-scale proteomic profiling, but we also anticipate they will enable us to effectively scale reagent production as demand for our platform grows. While the scale-up of our internal and external probe development strategies is exciting, both our internal and external efforts began later than anticipated. Now that we've begun, we are pleased with the development and supply strategies that we have in place, the significant number of planned probe deliveries from these strategies and the early data that we're seeing. With all of this, our probe delivery schedule is compressed into a shorter time period, which is good from the perspective of reaching our commercial launch goal, but it also puts a lot of pressure on our probe characterization and integration efforts, which sit downstream from probe discovery. Recognizing that compression, it no longer makes sense for us to articulate a firm schedule for milestones like when we'll reach 2,000 proteins identified. Indeed, with our probe delivery schedule being compressed in this way, we're unsure whether our first step will be able to identify 1,700 proteins per sample or 5,000 proteins per sample or something in between. Beyond the platform development efforts I've just described, in 2021, we significantly increased the number of detailed conversations we had with customers across biopharma, academic and research and diagnostics. We heard from these customers significant excitement about getting early access to single molecule data, single protein molecule data. These customers are aware, just like we are, that there are many assays out there that perform bulk measurements, which are limited in terms of sensitivity. There are also several newer companies working on early development efforts towards peptide sequencing, which is limited in its dynamic range and ability to accurately map the proteoform landscape. And of course, there is mass spectrometry-based proteomics, which entails a complex workflow and is limited in both sensitivity and dynamic range. We believe more strongly than ever that Nautilus has the potential to provide complete identification and detailed proteoform mapping at the intact protein level, outperforming existing methods and those currently in development elsewhere. Customer conversations in conjunction with a significant amount of market research have increased our conviction that customers are eager to run samples on our platform. We're energized by this feedback and motivated by the chance to make a difference in how biological research is conducted. Hopefully, all of that gives you some additional color around our development path and our confidence in a commercial launch at the end of 2023. We look forward to updating you regularly on our progress and on our product development milestones and publications. In the meantime, we believe that all of the necessary components are in place and everyone at Nautilus is heads down focused on execution. Let me turn the call over to Anna for an update on our financials. Anna?