Nautilus Biotechnology, Inc. (NASDAQ:NAUT) Q4 2023 Earnings Call Transcript

Matt Sykes: Got it. And then just one more, if I may. Just are any sort of the issues or challenges that you’re having related to supplier issues or manufacturing capabilities? I know Parag talked about scale quality reproducibility as sort of some of the factors that you’re looking at, but just want to make sure that it seems like some of the supply issues are long gone. So I’m assuming it’s not really a supplier issue, manufacturing issue, it’s more of just the overall technology in the platform. We want to make sure you get it right when you launch it?

Sujal Patel: Yes, Matt, absolutely, the additional time needed is not related to supplier issues at all. In fact, our operations and manufacturing organization has done a spectacular job here. On the instrument side, making sure that all of our longer lead time parts are available in sufficient supply, building supplier relationships to focus on our launch and longer term. And then on the reagent side, the manufacturing and organization has done a great job really building the partner base that helps build those reagents, but as well as Parag described in his prepared remarks, they’ve done a really exceptional job with the yield and scale of our reagent production in-house, and we’re really excited with that. And so supply chain is not an issue for us.

Matt Sykes: Got it. Thank you very much.

Operator: Our next question comes from the line of Dan Brennan with TD Cowen. Your line is open.

Dan Brennan: Good morning. Thanks for taking the questions. Maybe the first one, just go back to the first question. Would you mind just going back to the factors that led to the decision to push it out. Maybe could you just give us some more concrete aspects of what you expected to have done by now kind of what’s delayed? I know Parag, you talked about scalability, reproducibility consistency. So I guess it’s all encompassed in that, but if there any more maybe granular metrics you can give us on that front? And then b, kind of related to that, when we think about the new time lines, is there like a checklist, if you will, that you could provide about any of the performance features, any of the reproducibility, anything that we should be monitoring so that as we get to Q2 and Q3 and Q4, like we can kind of say where are you on the checklist that gives people kind of a pathway, if you will, towards confidence towards the launch?

Sujal Patel: Parag, once again, why don’t you take the first half of that question? And then once we get to sort of checklist and things to look for milestones on the journey, I’ll take that part of the question.

Parag Mallick: Sure. Absolutely. So I think one of the key — when you ask the question about what are we looking at? Among the key areas that we’ve been focused has been those items that I mentioned before and in particular, the integration of all of those items together. And as we came into the back half of last year, we saw tremendous progress particularly on the integration and noticing that allowed us to really do experiments at a larger scale than we had before. As we work through those experiments, we look at the specific elements I talked before. Like are we able to just make sufficient reagents of sufficient quality and consistent consistency. These are not just for agents, but also flow cells, are we able to ensure that the flow cells have the stability that we want.

And so these are very much factors that ensure that when the product is in the hands of your customers, it’s a reliable, robust measurement instrument. And that’s really been the driver of our decision-making has been that ability to scale the platform to be able to measure a game-changing number of proteins at a sensitivity that we’re targeting.

Sujal Patel: So the second half of that question really is what are the milestones that we should be looking at? I think that as you’ll see in what we put out at U.S. HUPO here coming up in a couple of weeks, we continue to work with model proteins, evolving the scale of the assays that we’re running, meaning more probes, more cycles, decoding more proteins out of simple mixtures. Those — that work as we get through the first half of this year and into next year, we’ll start to evolve into actually decoding proteins out of biological samples that are complex like cell lysate. And as we’ve talked about in the past, at some point, we will have a significant number of proteins that are decoded out of lysate, whether it’s 500, 1,000, 2,000, 2,500 doesn’t matter.

Any significant number of proteins out of lysate means that all of the aspects of our system have come together. Our single molecule hyper-dense array, our multicycling assay. We have sufficient reagents. And because the system works in a computational matter, by the time we get to that point, we have a significant number of reagents, more than half of the way towards a product launch. And so for us, that milestone is a critical milestone that will be pretty close to when we launch an early access program and begin taking customer orders for early access samples. It’ll be about the point that we update Wall Street on timelines and launch specifications. And when I talk to analysts and investors both, that’s the key milestone that I make sure that everyone is looking for, and we are not at that point yet.

But looking at the progress that’s been made, particularly the progress made here in the, the beginning of this year, I think that I’m really enthusiastic and excited about what I’m seeing, and we’ll be back to update you on that as we move through this year and closer to our anticipated 2025 launch.