Q4 2024 Nautilus Biotechnology Inc Earnings Call
Welcome to the Nautilus fourth quarter and full year 2024 earnings conference call.
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Speaker Change: I would now like to hand, the conference over to your first speaker to de G. On E head of Investor Relations.
Speaker Change: Thank you.
Speaker Change: Earlier today, not only released financial results for the quarter ended December 31 2024.
Speaker Change: Haven't received this news release or if you'd like to be added.
Founder and Chief scientist and Anna Murray 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 our 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 27 2025.
Susan: With that I'll turn the call over to Susan.
Thanks, John and welcome to everyone, joining our Q4 and full year 2024 earnings call.
Susan: They will provide a quick look back at our 2024 progress update you on our work since the last call and present, our fourth quarter 2024 financial results. We will then as always open the call for questions.
Susan: As you know our goal at <unk> is to enable proteomics researchers to study the entirety of the protium at the depth and breadth never before possible.
Susan: And to make the creation accessibility and use of that higher resolution higher quality data easy enough that it will be practical for every lab everywhere to accelerate scientific research enabled the discovery of new Biomarkers, and ultimately power or the development of new therapies and diagnostic tests that will.
Susan: Positively impact human health.
Susan: As you saw in this morning's press release based on the desire to reduce technical risk and bring to market a product with the greatest possible performance. We now expect that the launch of our proteome analysis platform will occur in late 2026.
Susan: Parag will provide detail on the rationale for that timeframe in a few moments.
Susan: Since the achievements of last year serve as a foundation for the work ahead I wanted to take a few moments to walk you through some notable recent accomplishments.
Susan: But before I do it's important to remember that we will be discussing the status of our overall platform development initiatives and share detail on progress against each of the platforms modalities broad scale discovery, which aims to comprehensively quantify the proteome.
Susan: And targeted quantification, which is currently focused on proteoform detection.
Susan: While both modalities share the same core platform each has its own development path.
Susan: With that said in 2024, we had a number of key demonstrations and progress with regard to the core platform.
Susan: Among them, we developed improvements to the scale and quality of our reagent production and.
Susan: An instrument and assay capable of multi cycling reagents over many cycles and observing protein binding events a single molecule level.
Susan: And software capable of processing the data coming off the instrument and through proprietary bioinformatics algorithms, turning that multi cycle data into biological insight.
Susan: With regards to our pursuit of broad scale to coating, we developed a large number of probes that successfully bind epitopes spanning the human proteome. We also performed an ultra deep characterization of a large number of probes to define detailed binding profiles and kinetics.
Susan: Lastly, we demonstrated via western blot, the B's probes can bind to and differentiate protein successfully and that the results strongly correlate to our binding models.
Susan: We also made progress on our integrated Proteoform capabilities at World Hoopoe last October and as Parag reported on our previous call. We shared data on the world's first quantitative measurement of biological variation in Tau Proteoform is potentially associated with Alzheimers disease.
Susan: These preliminary findings have spurred substantive conversations with a number of potential partners interested in exploring how pretty firm landscapes at a resolution never before possible.
Susan: Armed with the learnings and advances of last year and years. Prior we now have greater clarity about what remains to be done to deliver what we believe will be a game changing product to the market.
Susan: We're focused on the good that we anticipate our platform can do and confident in our ability to get there.
Speaker Change: For more detailed update on our R&D efforts, let me turn the call over to parag.
Susan: Yeah.
Parag: Thanks, and good morning, all as Suzhou shared in Q4 and throughout 2024, we continued to make progress against our core development goals.
Parag: We remain focused on increasing scale stability and reproducibility across our consumables assay and platform and continue to see meaningful gains amongst each of those dimensions.
Parag: This progress goes hand in hand, with advancing the reliability quality and customer readiness of our instrument and software along with advancements in our ability to investigate the proteoform landscape as Tao.
Speaker Change: As <unk> mentioned, both our broad scale discovery and targeted Proteoform analyses are built upon the same core platform.
Speaker Change: As such the movement from platform development towards platform application.
Speaker Change: Demonstrated recently for our Proteoform analysis also serves as a general validation of our progress developing a fully integrated end to end platform that starts with sample in immobilizes that sample at the single molecule level robustly interrogates that sample cycle after cycle, and then coalesce as that data through it.
Speaker Change: Data analytics and machine learning pipeline, producing quantitative output that can be a foundation for unlocking biological insight.
Speaker Change: At U S. Hoopoe earlier this week, we presented several posters and a luncheon seminar, which we demonstrated progress towards both our broad scale discovery and targeted proteoform capabilities.
Speaker Change: On the Proteoform side, we demonstrated successful development of a high resolution single molecule Tau Proteoform assay to quantify the molecular heterogeneity of Tau protein forms.
Speaker Change: High accuracy and reproducibility with over three orders of magnitude of dynamic range.
Speaker Change: Precise measurements of specific Tau isoforms, and phosphorylated <unk> levels in Organoid model systems.
Speaker Change: And the first ever measurement of Tau Proteoform profile between neuronal model systems and the human brain that can be used to reveal markers of Alzheimer's disease pathology.
Speaker Change: These results demonstrate our readiness to engage in significant partnerships to explore the role the Tau protein farmers may play in both drug and biomarker development.
Speaker Change: On the broad scale side, we discussed the development and characterization.
Speaker Change: Robust multi affinity probes capable of binding to a variety of proteins.
Speaker Change: Extreme sensitivity into the <unk> range.
Speaker Change: The potential for the platform to be applied not just to human but to a diversity of organisms.
Speaker Change: And a new adaptive decoding algorithm that is able to account for our run to run variation in probe binding.
Speaker Change: In meetings with Kols throughout <unk> and in interviews with a range of potential future customers over recent weeks. We continue to hear researchers discussed the value of data attributes that go far beyond just the number of measurable proteins.
Speaker Change: They consistently discussed the quality of data they seek endpoint to factors such as reproducibility specificity and accuracy.
Speaker Change: We discussed how there is a range of consequences in proteomics data, which vary from proteins identified by essentially a single deep multiplex peak through highly abundant proteins that may be identified by a multiplicity of peptides.
Speaker Change: We Additionally discussed how our approach is substantially different in confidence and quality relative to traditional affinity based approaches and which proteins are identified and quantified by one or two affinity reagents versus dozens.
Speaker Change: One, particularly exciting moment for me he came in discussions of our Proteoform assay.
Speaker Change: When the researcher declared that our approach was something he had always wanted and in his opinion would revolutionize progress in combating neuro degenerative diseases.
Speaker Change: Moving on to our current R&D priorities Youll.
Speaker Change: You'll recall that last quarter, we reported that we are behind on our internal milestones with respect to our next major brad's Google to be capable of quantifying a significant number 501000 2000 proteins from a complex sample XL, let's say on the road to measuring the comprehensive protium <unk>.
Speaker Change: This represents the last piece of validating the broad scale capabilities of our platform.
Speaker Change: Our unique method of identifying proteins protein identification by short epitope mapping where prism for short.
Speaker Change: Involves the development and integration of hundreds of proprietary multi affinity probes, which interrogate single protein molecules.
Speaker Change: Over the last three years, we have spent substantial time and energy building and optimizing our affinity region pipeline and building in characterizing thousands of probe candidates.
Speaker Change: These studies over Q4 in particular have given us increased confidence in the probes. We have built with regards to their ability to bind to a diversity of epitopes within proteins their ability to differentiate amongst proteins, a key requirement for decoding and the predictability of their binding proteins.
Speaker Change: One key ingredient in this with the large scale screening approach against millions of peptides drawn from the human proteome to define theory detailed models of sequence specificity for each probe.
Speaker Change: We Additionally did a significant amount of work on the binding kinetics of these probes and on testing how probes bind to dozens of different proteins through a range of techniques, including western blot and bio layer interferometry.
Speaker Change: Through that detailed analysis, we can confidently say that our affinity reagent pipeline does indeed produce probes with the characteristics necessary to implement prism.
Speaker Change: Alongside our extensive probe characterization efforts, we have been doing the hard development work to optimize and increase the robustness of the fluorescent labels used within our platform. The chemistry used to attach probes to these labels the chip surfaces themselves to maximize specific binding and the buffers used during binding and measurement.
Speaker Change: We Additionally examined how diverse label types and labeling approach has impacted these metrics unapproved by pro basis.
Speaker Change: Internally, we defined criteria for transitioning probe candidates two platform ready labeled probes.
Speaker Change: As we entered 2025 many of these probe candidates were not meeting the performance targets desired a platform ready labeled probes.
Speaker Change: In an effort to decrease the fallout rate in Q1, we focused on a number of new development work streams related to our label labeling approaches assay buffers in surface chemistry.
Speaker Change: The data from those experiments have made clear the need for us to optimize some elements of our surface chemistry and asset condition in order to achieve better alignment between our probes in our assay in a way that will increase our confidence that a significant number of our existing and to be developed labeled pro candidates can become platform ready.
Speaker Change: It is clear what work is needed and how that work will translate into a simple and robust assay.
Speaker Change: However, appropriately testing these optimizations and integrating any subsequent platform modifications will require time not anticipated when the current launch timeframe was established thus this evolutionary work will push back the anticipated timeline on our ability to quantify a significant number of proteins from a complex sample.
Speaker Change: <unk> like <unk>.
Speaker Change: While we are disappointed with this delay we are encouraged by the large data corpus. We've collected that suggests our probe library is capable of successfully implementing prism and thereby unlocking the protium.
Speaker Change: With that I'll turn the call back to digital.
Digital: Thanks for the update parag.
Digital: <unk> just outlined how the learnings of recent quarters have positioned us to pursue a development path with reduced technical risk.
Digital: And that we believe will yield the greatest possible platform performance, but at the cost of time.
Digital: Based on the efforts required to implement these modifications to our assay configuration surface chemistry and related platform elements that parag articulated we now expect that the launch of our proteome analysis platform instruments and reagents will occur in late 2026.
Digital: All along this development path, we envision significant scientific milestones and value creation inflection points for both modalities of our platform targeted proteoform detection and broad scale discovery proteomics here are a few examples.
Digital: One our major goal in the first half of 2025 is to provide leading researchers with access to our platform for Tau Proteoform related studies, we firmly believe that 2025 will be the year that researchers begin to apply the platform's capabilities to ask and answer important questions about the role of Tau.
Digital: <unk> in Alzheimers disease.
Digital: Two creation and publication of data showcasing the Tau Proteoform assay performance characteristics, such as sensitivity dynamic range and reproducibility.
Digital: Three <unk>.
Digital: Signing at least once how related partnership in the first half of 2025.
Digital: <unk> decoding of an increased number of proteins, beginning with predefined mixtures and progressing towards complex samples such as <unk>.
Digital: And five the sharing of data showcasing the broad scale protium assay performance characteristics, such as stability sensitivity dynamic range and reproducibility.
Digital: We remain focused on driving our scientific and development efforts forward in the most efficient most effective ways possible by.
Digital: By making the decision to pursue modifications to our assay configuration surface chemistry and related platform elements. At this time, we believe that we are positioning nautilus to ultimately make the maximum possible impact on the marketplace and on biological science.
Digital: This elongated development timeframe necessitated that we reevaluate our operating plan and organizational structure to ensure that we are in the best position to execute against both our broad scale and targeted pretty from goals.
Digital: To that end yesterday, we reduced our head count by approximately 16% in order to align the resources, we need to pursue our development goals with the desire to extend our cash runway.
Digital: On these difficult but necessary changes.
Digital: And with ongoing very tight financial management of the business. We now anticipate that our cash runway will extend through 2027.
Digital: For more on that and a full report on our finances.
Anna: Let me now hand, the call over to Anna.
Digital: Anna.
Anna: Thanks Vishal.
Speaker Change: Total operating expenses for the fourth quarter of 2024 or 20.0 million roughly.
Speaker Change: Equal to the fourth quarter of 2023, and 0.9 million above last quarter.
Speaker Change: This flat year over year operating expense for Q4 of 2024 as a result of the focused and ongoing efforts of our team to identify better and more cost effective ways to achieve our goals.
Research and development expenses in the fourth quarter of 2024, or $12 8 million compared to $12 $5 million in the prior year period.
Speaker Change: General and administrative expenses were $7 2 million in the fourth quarter of 2024 compared to $7 $5 million in the prior year period.
Speaker Change: Overall net loss for the fourth quarter of 2024 was $17 6 million compared to $17.0 million in the prior year period.
Speaker Change: For fiscal year 2024, operating expenses were $81 5 million, an increase of $5 3 million or 7% from $76 $2 million in the fiscal year 2023.
Speaker Change: Both research and development expenses and general and administrative expenses also increased by 7% in fiscal year 2024.
Speaker Change: Net loss for the fiscal year 2024 were $70 8 million.
Speaker Change: Compared to $63 7 million in fiscal year 2023, an increase of 11% year over year.
Speaker Change: As <unk> stated previously we now anticipate the launch of our platform in late 2026.
Speaker Change: To ensure our cash runway well exceeds the timeline.
Speaker Change: Yesterday, we made the decision to reduce our head count by approximately 16% impacting all areas in the business.
Speaker Change: We expect this will result in limited onetime costs that will be recorded in the first half of 2025.
Speaker Change: While these steps will lead to cost savings in the short term. It will also allow us to invest in future business needs within a lower spending envelope.
Speaker Change: For fiscal year 2025, we anticipate our total operating expenses to be at or below 2024 levels.
Speaker Change: Turning to our balance sheet, we ended the year with approximately $206 million in cash cash equivalents and investments compared to $264 million at the end of last year.
Speaker Change: The efforts, we took in 2024 to eliminate growth in spending combined with yesterday's workforce reduction means that we now expect our cash runway to extend through 2027.
Sergio: With that I'll turn it back to Sergio.
Sergio: Thanks Anna.
Sergio: And his report clearly demonstrates our total and continued commitment to very tight financial management of this business, we understand what it will take to get Nautilus to commercialization and have developed a culture of rigorous financial discipline that will benefit us both in the short term and long terms.
Sergio: We're excited about what lies ahead for Nautilus and the difference our platform can make in biological science, our mission to positively impact the health and lives of people around the world remains unchanged and serves as the standard to which we hold ourselves.
Sergio: I am grateful to our team our investors our strategic partners and our research collaborators for joining us on this journey to revolutionize proteomics and empower the scientific community in ways never before thought possible.
Sergio: We made good progress in 2024 and look forward to building on those successes as we move through development in 2025 on our way to commercial availability next year.
Sergio: With that I'm happy to open the call up for questions.
Sergio: Operator.
Sergio: Yes.
Sergio: Thank you at this time, we will conduct a question answer session. As a reminder to ask a question you will need to press star one one on your telephone.
Sergio: For your name to be announced to withdraw your question. Please press star one again, please standby, while we compile the Q&A roster.
Sergio: Okay.
Hugo: Our first question comes from Hugo <unk> at Morgan Stanley. Your line is open.
Good morning, and thank you for taking my question.
Speaker Change: Could you further elaborate on your answer.
Hugo: Good morning.
Hugo: Thank you.
Hugo: And in surface chemistry.
Hugo: Hi.
Hugo: Perfect.
Hugo: These changes would address and with these plan changes has anything changed in terms of how youre thinking about initial specs of the platform launch what are your plans to continue to improve the.
Hugo: Subsequent kids.
Rob: Good morning. This is since you wanted to have Rob I'll start with this question and then I'll take the second half.
Hugo: Yeah.
Hugo: Great. Thank you for the question.
Hugo: The.
Hugo: The key aspect of the assay.
Hugo: Involves a couple of different components. One is the that all are targeted at driving the specific binding of <unk> reagents to proteins that.
Hugo: That contain an epitope of interest.
Hugo: And to differentiate the nonspecific binding away from proteins that don't contain an epitope.
Hugo: Some of the key factors that influence that are for instance, how those particular probes are labeled with a floor of four.
Hugo: For example, if those probes are labeled in a way that is slightly suboptimal you might end up conjugated floor for into the into the binding region of the antibody and interfering with its ability to bind to the target in.
Hugo: In addition, depending upon the surface chemistry, it's possible that as you add fluorescent <unk> you might drive towards nonspecific binding and so those are the kind of of separations that we're working to enhance and many different small factors.
Hugo: Can influence those asset configurations, such as how the surfaces passivate it such as how.
Hugo: How the what the actual chemical structure of the fluorescent label is and how it is attached to the to the program interest.
Hugo: Yeah.
Hugo: Thanks progresses future, let me just take the second half of your question you go which was related to specifications and I think the key thing here that I want to point out is.
Hugo: So the two key pieces right one is it.
Hugo: The assay configuration change that parag is discussing is really meant to allow us to get the large number of probe candidates that we have built and that we are building to have a higher yield where they function well on our platform and enable us to get the type of information.
Hugo: And that we need to decode the complete protocol and so.
Hugo: When we say in the prepared remarks that this is an approach that has less technical risk and allows us to optimize.
Hugo: Our performance that's what we really mean, which is we're trying to get a much higher yield out of the probes that are developed already and then it groups. We're developing so that we can deliver a high specification in terms of coverage of the party.
Hugo: Now in other parts of our specification things like dynamic range sensitivity reliability instrument I think that the additional time that it's taken us to develop our first instrument reagents at full commercial launch of our protium products that additional time gives us more time for those other areas to bake until we anticipate.
Hugo: Those will be.
Hugo: Closer to lunch.
Hugo: <unk> seed once back by the time that we get out by the end of 2020 year late in 2026.
Hugo: Great.
Hugo: Helpful color. Thank you for that.
Hugo: Good question.
Hugo: Does the plan changes to the assay configuration, all over the surface chemistry change, how you're thinking about cost structure of the platform of consumables.
1 million bundled pricing is still the right way to think about the price of the platform.
Hugo: Yes, that's a great question in terms of what.
Hugo: What the changes that we are developing now due to our cost structure they have.
Hugo: They have no negative impact and may even have some positive impact, particularly on the consumable side in terms of cost and with that we do anticipate that our pricing is is roughly <unk>.
Hugo: Correct based on the previous guidance that we've given you which is that we expect that instrument deal which includes instrument. The software the services support kind of the initial deal to get you going is roughly $1 million and sample hospital dairy based on the configuration of the product and what youre looking for but could start it.
Hugo: A few thousand dollars per sample and then decline over time, and we think we think that those price points based on continued conversations with customers or the right price points given the differential date.
Hugo: Data that our platform produces in the quality of the data.
Hugo: Great. Thank you.
Speaker Change: Our next question comes from Cebu <unk> at Guggenheim Securities.
Cebu: Hey, guys. Thank you for taking my question.
Cebu: This is good news for you I'm confused a little bit shouldnt surface chemistry of uniforms for all proteins and Instyle worked so well why does central quiet optimization for a different audience and my understanding was you use the same surface chemistry, that's one and then why shouldn't labeling of Florida, Florida. The FC region of antibody required optimization isn't that.
Cebu: Pretty standard as well.
Cebu: Yeah.
Cebu: Hi.
Cebu: Hey, guys can you hear me okay.
Cebu: We kept some of broker you're on mute.
Speaker Change: I apologize I was only able to hear the second part of your question could you. Please repeat the first part of your question.
Cebu: Absolutely so.
Cebu: Just a little bit shouldnt surface chemistry uniforms for all proteins and if you were able to attach style to a surface. So can we assume that it should be the same chemistry for all different proteins to attach on the slide on the chip.
Cebu: Second is our labeling of Florida for two <unk> antibody is pretty standardized and how does that kick wide optimization.
Cebu: Sure so.
Cebu: Yeah.
Cebu: With regards to the surface chemistry, and passivation thereof.
Cebu: Really what we're not talking about the mobilization of the proteins via the nanoparticles to the surface.
Cebu: That youre, absolutely correct that that is identical between any assay and speaks to how we mobilize proteins from the sample onto the chip.
Cebu: On the other hand, depending upon the the.
Cebu: The labeling strategy the number of cycles and the buffers there our inner plays between the.
Cebu: The fluorescent <unk> on that may be used to label the probes.
Cebu: And their interaction with the surface.
Cebu: Different different buffers mean lead to increases in nonspecific binding to the surface.
Cebu: Or to you.
Cebu: Two other targets.
Cebu: Likewise, even factors like temperature and time of measurement can play into that differentiation between specific and nonspecific binding.
Cebu: And with regards to fluorescence labeling youre, absolutely correct that far since labeling in general is a is a very well established.
Cebu: Method that there is a number of different conjugation chemistries for labeling of antibodies.
Cebu: Within our system one.
Cebu: One of our key considerations is that we want to be able to perform the measurement.
Cebu: Repeatedly and we've shown hundreds of cycles of repeated measurements and so maintaining that balance of specific binding cycle after cycle.
Cebu: The thing that we really have have optimized tremendously and that we believe further advancements in our configuration will allow for greater differentiation for <unk>.
Cebu: A wide number of our approved.
Cebu: And really this is about aligning the probe characteristics to the assay configuration.
Cebu: Oh, thank you for that.
Cebu:
Cebu: Each protein in Skokie right. So.
Cebu: How are you considering that what type of optimization, you do there's going to be applicable on a broad scale.
Cebu: In terms of specificity.
Cebu: Absolutely. So I think while each protein is it is quirky in.
Cebu: Internally in the building, we think of them as is.
Cebu: Essentially their own beautiful snowflake.
Cebu: The.
Cebu: The optimizations are really about the interaction between.
Cebu: Labeled probe and a protein.
Cebu: And at that point, that's really driven by.
Cebu: You know very fundamental physics of of binding where if you increase the concentration you increased the.
Cebu: Extensive on if you increase the time prior to measurement then you decrease the amount of bound and so.
Cebu: So those those fundamental kinetics of the system.
Cebu: Are at play and so those apply across protein and so those are just general principles of binding.
Cebu: And we've seen thank you.
Cebu: We see that actively in the platform.
Cebu: Okay.
Speaker Change: Our next question comes from Dan Brennan at TD Cowen.
Speaker Change: Great. Thank you.
Speaker Change: Could you just review I know you did in the prepared remarks, just kind of what are the key.
Speaker Change: While stones and timing over say 25, maybe in the 26 that are two or three checkpoints.
Speaker Change: That the market will see whether the customers or investors that we could kind of give a further update if you're meeting your expectations or will it just come at some point in early 2006, with how theyre going to be.
Speaker Change: Kind of reveal and then we'll get a sense. If you are on track or not.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Thanks for the question, let me try to.
Speaker Change: Let me try to answer the question in two different directions for you remember the core platform has two different modalities. One is a mode, where you take a deep dive in a single protein or a small number of proteins and that today is really focused on proteoform detection and then there is another modality where.
Speaker Change: We're looking for what we call broad scale discovery proteomics, which is get the all of the <unk> approach means that you have within the sample and each of those modalities has different catalysts.
Speaker Change: We think or are coming up here over the course of the next call. It four to six quarters I wont willing to find individual timelines necessarily to all the pieces of it.
Speaker Change: So on the Tao, let's start with a pretty firm side first the first proteoform that we really have a great deal of interest in it is tau, which is the key biological.
Speaker Change: Marker <unk>.
Speaker Change: Implicated in diseases, like Alzheimer's disease, and as we move through the first half of 2025, we expect to provide the platforms capabilities to researchers to do Tau Proteoform related studies and.
Speaker Change: <unk> talked a little bit about some of the data that we've produced.
Speaker Change: Over the course of the last few months in his prepared remarks, and we will update our investor deck here over the course of the next day and there's continues to be some more.
Speaker Change: Information there on what we're doing on the top rating from front.
Speaker Change: As we.
Speaker Change: As we continue on the Tau pretty firm side, we expect to also through the year continue to show more data and publish more data related to our performance characteristics sensitivities of Amazon range reproducibility, and so forth and we expect that in the first half of.
Speaker Change: 2025, we will also signed our first tower related partnership and stay tuned for more on that front.
Speaker Change: So on the tower front I think that that's kind of what you should look for in that in the near and medium term. So let me change my.
Speaker Change: Strip my attention to broad scale on the broad scale side I think that.
Speaker Change: One of the things that you heard us say is that the big milestone on the broad scale side is when we can.
Speaker Change: T code a significant number of proteins that it felt like it doesn't have to be a lot 501000, 2000 proteins and by the time, we get to that point all of the platform pieces have come together all of the assay performance is required for decoding in there and we will at that point had a very firm grasp on the timeline remaining and.
Speaker Change: Final specifications, and so forth and I think that will be a data update.
Speaker Change: For our investors and our analysts on the road to being able to do that once we are able to move through this assay configuration change in surface chemistry change, you'll see us have some intermediate milestones such as decoding predefined mixtures of proteins as we come as we progress towards.
Speaker Change: Well I think as a company as an example, the complex sample and then ultimately to that 500000 2013 milestone.
Speaker Change: And so as we start moving through those predefined mixtures will bring the scientific community and our Investor community along so that there are some interim checkpoints before we get to that that big data readout and as well as we move through the year I expect we will continue to.
Speaker Change: Once we make our ASIC integration change continue to share data, particularly at scientific conferences related to our broad scale capabilities stability sensitivity reproducibility of dynamic range coverage in our assay.
Speaker Change: Great.
Speaker Change: Maybe just one on <unk> since youre going to be.
Speaker Change: Gauging with customers now in the first half and planning a partnership.
Speaker Change: From what you.
Speaker Change: Produced so far could you just speak to the I think you said youre going to provide some details obviously the sensitivity specificity. The key measurement tools could you just speak to the number of players.
Speaker Change: Players emerging in the market, there's a lot of specs out there just kind of how you think your performance would compare to some of the other kind of leaving.
Speaker Change: Tau protein platforms.
Speaker Change: Maybe I'll take this one.
Speaker Change: I think one of the key the key.
Speaker Change: Key and most important differentiator of our platform relative to everything else out in the world.
Speaker Change: Is that we are we aren't the only commercial platform that can measure.
Speaker Change: <unk> forums in high throughput and high sensitivity.
Speaker Change: From complex samples, so that that aspect of being able to comment on the combination of isoforms plus potentially triple phosphorylated Tau.
Speaker Change: Or quadruple phosphorylation of Tau at sites, a b C and D or a b C and E is a unique capability of our platform and something that our customers are extremely excited about because.
Speaker Change: Because that allows you to reveal the order and timing of events that are on the way to Alzheimer's. It allows you to unveil substructure and subtypes that are potentially indicative of response to therapy of one therapeutic versus another and also potentially allow you to.
Speaker Change: You define differences between Ah patients, who have aggressive rapidly progressing disease versus not so it's really in the resolution of the measurements that is incredibly unique winter.
Speaker Change: With regards to other specifications some of the things that we've been looking at are the dynamic range within the measurement of an individual proteoform.
Speaker Change: So keep in mind there are two different measures of dynamic range. One is the across analyte dynamic range and the other is the within analyte dynamic range.
Speaker Change: And typically for instance in TMT assays in mass spectrometry, you have what's called range compression and so you're within analyte dynamic range is typically below one order of magnitude we've demonstrated dynamic range of upwards of three orders of magnitude within our win within analyte dynamic range.
Speaker Change: With regards to reproducibility.
Speaker Change: Showing reproduced abilities of with Cvs.
Speaker Change: Well below 20%.
Speaker Change: And then one other.
Common factor that.
Speaker Change: Youll see people look at is just what are the range of analytes that you are able to look at and that's that's where as I highlighted we're able to access analytes that are simply an accessible to other platforms.
Speaker Change: Great. Thank you.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: Our next question comes from Mac Sykes at Goldman Sachs.
Speaker Change: Good morning. This is myron from outside thanks for taking our questions I appreciate the commentary around the probe optimization, taking some time and pushing out.
Speaker Change: The launch date, but just wanted to clarify is that late 2026 launch for both the broad scale discovery and the more targeted platform or are those timelines different.
Speaker Change: Hi, Good morning, well, let me try to take that one.
Speaker Change: Both of our modality.
Speaker Change: Are heading to the market with different strategies and so on.
Speaker Change: Let's take the broad scale side first on the broad skill side, we are moving towards a model where late in 2026, we have our commercial launch and from that point forward, we're largely selling instruments with solid consumables were selling software.
Speaker Change: That's the business model going forward and we'll provide some services capability after that point as an on ramp to buying instruments and burst.
Speaker Change: Yeah.
On the protium form side.
Speaker Change: The hernia form data coming off our platform is.
Speaker Change: Type of data that level of detail that you can't get with other assets.
Speaker Change: We've chosen not to just product tied to it as a service or just selling an instrument that is pretty important.
Speaker Change: Instead at.
Speaker Change: Focused on partnering with organizations, we're looking for this level of detail and jointly exploring the space.
Speaker Change: Tao initially.
Speaker Change: That pretty a form in understanding what are the implications by all biologically habits are informed therapeutic development are there potential diagnostic applications and so on the protium form front, we are today talking to a number of organizations around partnerships on the tower pretty form those analysis.
Speaker Change: This will be done in our facility and we will work with our customers and return with both of them and then work with them on the next phase of their project and then ultimately certainly over the course of 2025 and 2026. We will also add additional biomarkers bomb that are driven by customer conversations and some driven by hour.
Speaker Change: Our own research and desires for that product and you know for the foreseeable future those proteoform capabilities, our capabilities that we're going to introduce the customers via partnerships and collaborations.
Speaker Change: Got it that's super helpful. Thank you.
Speaker Change: And then just following up on that you mentioned, giving researchers access to proteoform in the first half of 'twenty five.
Speaker Change: But then I just wanted to see if the launch day impacts your expectations for the early access program, maybe on the broad scale side in relation to instrument placements as well. Thank you so much.
Speaker Change: So.
Speaker Change: The early access period is just to kind of define it for those that may not remember the early access period is approximately six to nine months prior to the commercial launch of our instrument on the broad scale wide and that is an opportunity for customers to see the data that our platform produces.
Speaker Change: He is with their own samples and so thats, a model, where the cost where potential customers will send us samples will analyze them using the the preproduction.
Speaker Change: Broad scale capabilities and the goal of those engagements as wanted to generate data and excitement and have a set of data that we can leverage as we move towards launch, but even more importantly to get customers excited enough to want chair.
Speaker Change: Placed orders for the instrument once we get to that commercial launch and so you should think about.
Speaker Change: And commercial launch late 2026, and early access periods, starting from six to nine months.
Speaker Change: Great. Thank you so much.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: I am showing no further questions at this time. Thank you for your participation in today's conference. This does conclude the program you may now disconnect.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: Hum.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Sure.
Speaker Change: [music].
Speaker Change: [music].
Speaker Change: Good day, and thank you for standing by.
Speaker Change: Welcome to the Nautilus fourth quarter and full year 'twenty 'twenty four earnings conference call at.
Speaker Change: At this time all participants are in a listen only mode.
Speaker Change: After the speaker's presentation, there will be a question and answer session to ask a question. During this session you will need to press star one one on your telephone.
Speaker Change: We'll then hear an automated message advising your hand is raised.
Speaker Change: Or withdraw your question. Please press star one again, please be advised that today's conference is being recorded.
Speaker Change: I would now like to hand, the conference over to your first speaker to de G. On E head of Investor Relations.
Speaker Change: Thank you.
Speaker Change: Earlier today Nautilus released financial results for the quarter ended December 31 2024.
Speaker Change: If you haven't received this news release or if you'd like to be added to the Companys distribution list. Please send an email to investor relations at Nautilus stockpile.
Speaker Change: Joining me today from Nautilus are Suzhou Patel, co founder and CEO Parag, Milich co founder and Chief scientist and Annemarie 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.
Speaker Change: These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated.
Speaker Change: Additional information regarding these risks and uncertainties appears in the section entitled forward looking statements in the press release Nautilus issued today.
Speaker Change: 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.
Speaker Change: This conference call contains time sensitive information and is accurate only as of the live broadcast on February 27 2025.
Susan: With that I'll turn the call over to Susan.
Susan: Thanks, John and welcome to everyone, joining our Q4 and full year 2024 earnings call. Today, we will provide a quick look back at our 2024 progress update you on our work since the last call and present, our fourth quarter 2024 financial results. We'll then as always open the call for questions.
Susan: As you know our goal at Nautilus is to enable proteomics researchers to study the entirety of the proteome at a depth and breadth never before possible and to make the creation accessibility and use of that higher resolution higher quality data easy enough that it will be practical for every lab.
Susan: Everywhere to accelerate scientific research enabled the discovery of new Biomarkers and ultimately how are the development of new therapies and diagnostic tests that will positively impact human health.
Susan: As you saw in this morning's press release based on the desire to reduce technical risk and bring to market a product with the greatest possible performance. We now expect that the launch of our proteome analysis platform will occur in late 2026 parag.
Susan: Parag will provide detail on the rationale for that timeframe in a few moments.
Susan: Since the achievements of last year serve as a foundation for the work ahead I wanted to take a few moments to walk you through some notable recent accomplishments.
Susan: But before I do it's important to remember that we will be discussing the status of our overall platform development initiatives and share detail on progress against each of the platforms modalities broad scale discovery, which aims to comprehensively quantify the proteome.
Susan: And targeted quantification, which is currently focused on proteoform detection.
Susan: While both modalities share the same core platform each has its own development path.
Susan: With that said in 2024, we had a number of key demonstrations and progress with regard to the core platform.
Susan: Among them, we developed improvements to the scale and quality of our reagent production and.
Susan: An instrument and assay capable of multi cycling reagents over many cycles and observing protein binding events single molecule level.
Susan: And software capable of processing the data coming off the instrument and through proprietary bioinformatics algorithms, turning that multi cycle data into biological insight.
Susan: With regards to our pursuit of broad scaled the coding we developed a large number of probes that successfully bind epitopes spanning the human proteome. We also performed an ultra deep characterization of a large number of probes to define detailed binding profiles and kinetics.
Susan: Lastly, we demonstrated via western blot that these probes can bind to and differentiate proteins successfully and that the results strongly correlate to our binding models.
Susan: We also made progress on our integrated Proteoform capabilities.
Susan: At World Hoopoe last October and as Parag reported on our previous call. We shared data on the worlds first quantitative measurement of biological variation in Tau protein forms potentially associated with Alzheimers disease.
Susan: These preliminary findings have spurred substantive conversations with a number of potential partners interested in exploring how pretty firm landscapes at a resolution never before possible.
Susan: Armed with the learnings and advances of last year and years. Prior we now have greater clarity about what remains to be done to deliver what we believe will be a game changing product to the market.
Susan: We're focused on the good that we anticipate our platform can do and confident in our ability to get there.
Parag: For a more detailed update on our R&D efforts, let me turn the call over to parag.
Susan: <unk>.
Parag: Thanks, and good morning, all as <unk> shared in Q4 and throughout 2024, we continued to make progress against our core development goals, we remain focused on increasing scale stability and reproducibility across our consumables assay in platform and continue to see meaningful gains along each of those demur.
Susan: <unk>.
Susan: This progress goes hand in hand, with advancing the reliability quality and customer readiness of our instrument and software along with advancements in our ability to investigate the proteoform landscape as Tao.
Susan: As Sudhakar mentioned, both our broad scale discovery and targeted Proteoform analyses are built upon the same core platform.
Susan: As such the movement from platform development towards platform application.
Susan: Demonstrated recently for our Proteoform analysis also serves as a general validation of our progress developing a fully integrated end to end platform that starts with sample in immobilizes that sample at the single molecule level robustly interrogates that sample cycle after cycle, and then coalesces that data through it.
Susan: Data analytics and machine learning pipeline, producing quantitative output that can be a foundation for unlocking biological insight.
Susan: At <unk> earlier this week, we presented several posters and a luncheon seminar, which we demonstrated progress towards both our broad scale discovery and targeted proteoform capabilities.
Susan: On the Proteoform side, we demonstrated successful development of a high resolution single molecule Tau Proteoform assay to quantify the molecular heterogeneity of Tau pretty of farms.
Susan: High accuracy and reproducibility with over three orders of magnitude of dynamic range.
Susan: Precise measurements of specific Tau isoforms and phosphorylation levels in Organoid model systems.
Susan: And the first ever measurement of Tau Proteoform profile between neuronal model systems and the human brain that can be used to reveal markers of Alzheimer's disease pathology.
Susan: These results demonstrate our readiness to engage in significant partnerships to explore the role that Tau protein farmers may play in both drug and biomarker development.
Susan: On the broad scale side, we discuss the development and characterization.
Susan: Robust multi affinity probes capable of binding to a variety of proteins.
Susan: Extreme sensitivity into the <unk> range.
Susan: The potential for the platform to be applied not just to human but to a diversity of organisms.
Susan: And a new adaptive coding algorithm that is able to account for run to run variation in probe binding.
Susan: In meetings with Kols throughout U S hoopoe and in interviews with a range of potential future customers over recent weeks. We continue to hear researchers discuss the value of data attributes that go far beyond just the number of measurable proteins.
Susan: They consistently discussed the quality of data they seek and point to factors such as reproducibility specificity and accuracy.
Susan: We discussed how there is a range of confidence as in proteomics data, which vary from proteins identified by essentially a single day multiplex peak through highly abundant proteins that may be identified by a multiplicity of peptides.
Susan: We Additionally discussed how our approach is substantially different in confidence and quality relative to traditional affinity based approaches and which proteins are identified and quantified by one or two affinity reagents versus dozens.
Susan: One, particularly exciting moment for me he came in discussions of our Proteoform assay.
Susan: When the researcher declared that our approach with something he had always wanted and in his opinion would revolutionize progress in combating neuro degenerative diseases.
Susan: Moving on to our current R&D priorities Youll.
Susan: You'll recall that last quarter, we reported that we are behind on our internal milestones with respect to our next major brad's Google to be capable of quantifying a significant number 501000 2000 proteins from a complex sample like cell assay on the road to measuring the comprehensive proteome.
Susan: This represents the last piece of validating the broad scale capabilities of our platform.
Susan: Our unique method of identifying proteins protein identification by short epitope mapping where prism for short.
Susan: Involves the development and integration of hundreds of proprietary multi affinity probes, which interrogate single protein molecules.
Susan: Over the last three years, we have spent substantial time and energy building and optimizing our affinity reagent pipeline and building in characterizing thousands of probe candidates.
These studies over Q4 in particular have given us increased confidence in the pros we have built with regards to their ability to bind to a diversity of epitopes within proteins their ability to differentiate amongst proteins, a key requirement for decoding and the predictability of their binding proteins.
Susan: One key ingredient in this with the large scale screening approach against millions of peptides drawn from the human proteome to define theory detailed models of sequence specificity for each probe.
Susan: We Additionally did a significant amount of work on the binding kinetics of these probes and on testing how probes bind to dozens of different proteins through a range of techniques, including western blot and bio layer interferometry.
Susan: Through that detailed analysis, we can confidently say that our affinity reagent pipeline does indeed produce probes with the characteristics necessary to implement prism.
Susan: Alongside our extensive probe characterization efforts, we have been doing the hard development works to optimize and increase the robustness of the fluorescent labels used within our platform. The chemistry used to attach probes to these labels the chip surfaces themselves to maximize specific binding and the buffers used during binding and measurement.
Susan: We Additionally examined how diverse label types and labeling approach has impacted these metrics unapproved bipolar basis.
Susan: Internally, we defined criteria for transitioning probe candidates two platform ready labeled probes.
Susan: As we entered 2025 many of these probe candidates were not meeting the performance targets desired a platform ready labeled probes.
Susan: In an effort to decrease the fallout rate in Q1, we focused on a number of new development work streams related to our label labeling approaches assay buffers in surface chemistry.
Susan: The data from those experiments have made clear the need for us to optimize some elements of our surface chemistry and asset condition in order to achieve better alignment between our probes in our assay in a way that will increase our confidence that a significant number of our existing and to be developed labeled pro candidates can become platform ready.
Susan: It is clear what work is needed and how that work will translate into a simple and robust assay.
Susan: However, appropriately testing these optimizations and integrating any subsequent platform modifications will require time not anticipated when the current launch timeframe was established thus this evolutionary work will push back the anticipated timeline on our ability to quantify a significant number of proteins from a complex sample.
Susan: <unk>.
Susan: While we are disappointed with this delay we are encouraged by the large data corpus. We've collected that suggests our probe library is capable of successfully implementing prism and thereby unlocking the protium.
Speaker Change: With that I'll turn the call back to neutral.
Neutral: Thanks for the update parag.
Neutral: <unk> just outlined how the learnings of recent quarters have positioned us to pursue a development path with reduced technical risk.
Neutral: And that we believe will yield the greatest possible platform performance, but at the cost of time.
Neutral: Based on the efforts required to implement these modifications to our assay configuration surface chemistry and related platform elements that parag articulated we now expect that the launch of our proteome analysis platform instruments and reagents will occur in late 2026.
Neutral: All along this development path, we envision significant scientific milestones and value creation inflection points for both modalities of our platform targeted proteoform detection and broad scale discovery proteomics here are a few examples.
One our major goal in the first half of 2025 is to provide the leading researchers with access to our platform for Tau Proteoform related studies, we firmly believe that 2025 will be the year that researchers begin to apply the platform's capabilities to ask and answer important questions about the role of Tau.
Neutral: <unk> in Alzheimers disease.
Neutral: Two creation and publication of data showcasing the Tau Proteoform assay performance characteristics, such as sensitivity dynamic range and reproducibility.
Neutral: Three.
Neutral: Signing at least one how related partnership in the first half of 2025.
Neutral: For the coding of the increased number of proteins, beginning with predefined mixtures and progressing towards complex samples such as <unk>.
Neutral: And five the sharing of data showcasing the broad scale protium assay performance characteristics, such as stability sensitivity dynamic range and reproducibility.
Neutral: We remain focused on driving our scientific and development efforts forward in the most efficient most effective ways possible by.
Neutral: By making the decision to pursue modifications to our assay configuration surface chemistry and related platform elements. At this time, we believe that we are positioning nautilus to ultimately make the maximum possible impact on the marketplace and on biological science.
Neutral: This elongated development timeframe necessitated that we reevaluate our operating plan and organizational structure to ensure that we are in the best position to execute against both our broad scale and targeted approach from goals.
Neutral: To that end yesterday, we reduced our head count by approximately 16% in order to align the resources, we need to pursue our development goals with the desire to extend our cash runway.
Neutral: On these difficult but necessary changes.
Neutral: And with ongoing very tight financial management of the business. We now anticipate that our cash runway will extend through 2027.
Neutral: For more on that and a full report on our finances.
Anna: Let me now hand, the call over to Anna.
Neutral: Anna.
Anna: Thanks Danielle.
Anna: Total operating expenses for the fourth quarter of 2024 or 20.0 million rough.
Anna: Equal to the fourth quarter of 2023, and zero point $9 million above last quarter.
Anna: This flat year over year operating expense for Q4 of 2024 as a result of the focused and ongoing efforts of our team to identify better and more cost effective ways to achieve our goals.
Anna: Research and development expenses in the fourth quarter of 2024 were $12 8 million compared to $12 $5 million in the prior year period.
Anna: General and administrative expenses were $7 2 million in the fourth quarter of 2024 compared to $7 $5 million in the prior year period.
Anna: Overall net loss for the fourth quarter of 2024 was $17 6 million compared to $17.0 million in the prior year period.
Anna: For fiscal year 2024, operating expenses were $81 5 million, an increase of $5 3 million or 7% from $76 $2 million in the fiscal year 2023.
Anna: Both research and development expenses and general and administrative expenses also increased by 7% in fiscal year 2024.
Anna: Net loss for the fiscal year, 2024 was $70 8 million compared to $63 7 million in fiscal year 2023, an increase of 11% year over year.
Anna: As <unk> stated previously we now anticipate the launch of our platform in late 2020.
Anna: To ensure our cash runway well exceeds the timeline.
Anna: Yesterday, we made the decision to reduce our head count by approximately 16% impacting all areas of the business.
Anna: We expect this will result in limited one time costs that will be recorded in the first half of 2025.
Anna: While these steps will lead to cost savings in the short term. It will also allow us to invest in future business needs within a lower spending envelope.
Anna: For fiscal year 2025, we anticipate our total operating expenses to be at or below 2024 levels.
Anna: Turning to our balance sheet, we ended the year with approximately $206 million in cash cash equivalents and investments compared to $264 million at the end of last year.
Anna: The efforts, we took in 2024 to limit growth in spending combined with yesterday's workforce reduction means that we now expect our cash runway to extend through 2027.
Joe: With that I'll turn it back to Joe.
Joe: Thanks Anna.
Speaker Change: And his report clearly demonstrates our total and continued commitment to very tight financial management of this business, we understand what it will take to get Nautilus to commercialization and have developed a culture of rigorous financial discipline that will benefit us both in the short term and long terms.
Speaker Change: We're excited about what lies ahead for Nautilus and the difference our platform can make in biological science, our mission to positively impact the health and lives of people around the world remains unchanged and serves as the standard to which we hold ourselves I'm grateful to our team our investors our strategic partners and our.
Speaker Change: Our research collaborators for joining us on this journey to revolutionize proteomics and empower the scientific community in ways never before thought possible.
Speaker Change: We made good progress in 2024 and look forward to building on those successes as we move through development in 2025 on our way to commercial availability next year.
Speaker Change: With that I'm happy to open the call up for questions.
Speaker Change: Later.
Speaker Change: Yes.
Speaker Change: Thank you at this time, we will conduct a question answer session. As a reminder to ask a question you will need to press star one one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.
Speaker Change: By while we compile the Q&A roster.
Speaker Change: Okay.
Our first question comes from the Yugo accrue at Morgan Stanley. Your line is open.
Speaker Change: Good morning, and thank you for taking my question.
Speaker Change: Can you further elaborate on your guidance you monetize the assay configuration and surface chemistry.
Speaker Change: Specific issues are currently facing.
Speaker Change: These changes would address and with these plan changes has anything changed in terms of how youre thinking about initial specs of the platform launch.
Speaker Change: We'll continue to improve those subsequent kids.
Joe: Good morning. This is Joe why don't I start with this question and then I will take the second half.
Speaker Change: Okay.
Speaker Change: Great. Thank you for the question.
Speaker Change: The key aspect of the assay.
Speaker Change: A couple of different components one is the.
Speaker Change: That all are targeted at driving the specific binding of our affinity reagents to proteins that.
Speaker Change: That contain an epitope of interest.
Speaker Change: And to differentiate the nonspecific binding away from proteins that don't contain an epitope.
Speaker Change: Some of the key factors that influence that are for instance, how those particular probes are labeled with a floor of four.
Speaker Change: For example, if those probes are labeled in a way that is slightly suboptimal you might end up conjugates floor for into the into the binding region of the antibody and interfering with its ability to bind to the target in.
Speaker Change: In addition, depending upon the surface chemistry, it's possible that as you add fluorescent <unk> you might drive towards nonspecific binding and so those are the kind of of separations that we're working to enhance and many different small factors.
Speaker Change: Can influence those assay configurations, such as how the surfaces passivate it such as how.
Speaker Change: How the what the actual chemical structure of the fluorescent label is and how it is attached to the to the probe of interest.
Speaker Change: Yeah.
Next part this is due to let me just take the second half of your question, which was related to specifications and I think the key thing here that I want to point out is.
Speaker Change: So the two key pieces right one is it.
Speaker Change: The assay configuration change that per August discussing is really meant to allow us to get the large number of probe candidates that we have built and that we are building to have a higher yield where they function well on our platform and enable us to get the type of information.
Speaker Change: That we need to decode the complete protein and so.
Speaker Change: When we say in the prepared remarks that this is an approach that has less technical risk and allows us to optimize.
Speaker Change: Our performance that's what we really mean, which is we're trying to get a much higher yield out of the probes that are developed already and then it groups. We're developing so that we can deliver a high specification in terms of coverage of the program.
Speaker Change: Now in other parts of our specification things like dynamic range sensitivity reliability instrument I think that the additional time that it's taken us to develop our first instrument reagents at full commercial launch of our protium products that additional time gives us more time for those other areas to bake until we anticipate.
Speaker Change: That will be.
Speaker Change: Closer to lunch at <unk> by the time that we get out by the end of 2020 late in 2026.
Speaker Change: Great that was helpful color. Thank you for that.
Speaker Change: Question does the plan changes to the assay configuration, all over the surface chemistry change, how youre thinking about cost structure of the platform of consumables.
Speaker Change: 1 million bundled pricing is still the right way to think about the price of the platform.
Speaker Change: Yes, that's a great question in terms of what.
Speaker Change: <unk>.
Speaker Change: What the changes that we are developing now due to our cost structure they have.
Speaker Change: They have no negative impact and may even have some positive impact, particularly on the consumable side in terms of costs and with that we do anticipate that our pricing is is roughly.
Correct based on the previous guidance that we've given you which is that we expect that instrument deal which includes instrument. The software the services support kind of the initial deal to get you going is roughly $1 million and sample costs will vary based on the configuration of the product and what youre looking for but could start it.
Speaker Change: A few thousand dollars per sample and then decline over time, and we think we think that those price points based on continued conversations with customers or the right price points given the differential date.
Speaker Change: Data that our platform produces in the quality of the data.
Speaker Change: Great. Thank you.
Speaker Change: Our next question comes from Cebu <unk> at Guggenheim Securities.
Speaker Change: Hey, guys. Thank you for taking my question.
Speaker Change: This is good for you I'm confused a little bit shouldnt surface chemistry of uniforms for all proteins and Instyle worked so well why does that require optimization for different proteins. My understanding was you would use the same surface chemistry, that's one and then why shouldn't labeling of throw the floor to the FC region of antibody required optimization isn't that.
Speaker Change: For the standard as well.
Speaker Change: Hey, guys can you hear me okay.
Speaker Change: If a broker you on mute.
Speaker Change: I apologize I was only able to hear the second part of your question could you. Please repeat the first part of your question.
Speaker Change: Okay. So.
Speaker Change: I'm confused a little bit shouldnt surface chemistry uniforms for all proteins and if you were able to attach style to our surface. So can we assume that it should be the same chemistry for all different proteins to attach on the slide.
Speaker Change: The second is enabling a floor for the <unk> antibody is fully standardized and how does that kick wide optimization.
Speaker Change: Sure So maybe I'll.
Speaker Change: With regards to the surface chemistry, and passivation thereof.
Speaker Change: Really what we're not talking about the mobilization of the proteins via the nanoparticles to the surface.
Speaker Change: That youre, absolutely correct that that is identical between any assay and speaks to how we mobilize proteins from the sample onto the chip.
Speaker Change: On the other hand, depending upon the.
Speaker Change: Labeling strategy, the number of cycles and the buffers there our inner plays between.
Speaker Change: The fluorescent <unk> that may be used to label the probes and their interaction with the surface.
Speaker Change: Different different buffers may lead to increases in nonspecific binding to the surface.
Speaker Change: Or to you.
Speaker Change: Other targets likewise, even factors like temperature and time of measurement can play into that differentiation between specific and nonspecific binding.
Speaker Change: And with regards to fluorescence labeling youre, absolutely correct that flattens labeling in general is a is a very well established.
Speaker Change: Method that there is a number of different conjugation chemistries for labeling of antibodies.
Speaker Change: Within our system.
Speaker Change: One of our key considerations is that we want to be able to perform the measurement.
Speaker Change: Repeatedly and we've shown hundreds of cycles of repeated measurement and so maintaining that balance of specific binding cycle after cycle.
Speaker Change: Thing that we really have have optimized tremendously and that we believe further advancements in our configuration will allow for greater differentiation for <unk>.
Speaker Change: A wide number of our approach.
Speaker Change: And really this is about aligning the probe characteristics to the assay configuration.
Speaker Change: Thank you for that.
Speaker Change: Each protein in Skokie right. So.
Speaker Change: How are you considering that what type of optimization that you're doing is going to be applicable on a broad scale.
Speaker Change: In terms of specificity.
Speaker Change: Absolutely. So I think while each protein is as quirky and we internally in the building we think of them as is.
Speaker Change: Essentially their own beautiful snowflake.
Speaker Change: The.
Speaker Change: The optimizations are really about the interaction between.
Speaker Change: Labeled probe and a protein.
Speaker Change: And at that point, that's really driven by.
Speaker Change: Very fundamental physics of of binding where if you increase the concentration you increase the <unk>.
Speaker Change: The extent of on if you increase the time prior to measurement then you decrease the amount of bound and so those those fundamental kinetics of the system.
Speaker Change: Are at play and so those apply across protein and so those are just general principles of binding.
Speaker Change: And we've seen thank you.
Speaker Change: We see that actively in the platform.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Our next question comes from Dan Brennan at TV Cowen.
Speaker Change: Great. Thank you.
Speaker Change: Could you just review I know you did in the prepared remarks, just kind of what are the key.
Speaker Change: Milestones and timing over say 25, maybe in the 26 other two or three checkpoints.
Speaker Change: That the market will see whether the customers or investors that we could kind of give a further update if you're.
Speaker Change: Meeting your expectations or will it just come at some point in early 2006, since how theyre going to be.
Speaker Change: Kind of reveal and then we'll get a sense. If you are on track or not.
Speaker Change: Yes.
Speaker Change: Thanks for the question, let me try to.
Speaker Change: Let me try to answer the question in two different directions for you remember the core platform has two different modalities. One is a mode where you are.
Speaker Change: Take a deep dive in a single protein or a small number of proteins and that today is really focused on proteoform detection and then there is another modality, where we're looking for what we call broad scale discovery proteomics, which is get the all of the Gd kind approach means that you have within the sample and each of those modalities has difference.
Speaker Change: With that we think are coming up here over the course of the next call. It four to six quarters I won't we won't find individual timelines necessarily to all the pieces of it.
Speaker Change: So on the Tao, let's start with a pretty firm side first the first proteoform that we really have a great deal of interest in it is tau, which is the key biological marker.
Speaker Change: <unk> in diseases, like Alzheimer's disease, and as we move through the first half of 2025, we expect to provide the platform capabilities to researchers to do Tau Proteoform related studies and.
Speaker Change: <unk> talked a little bit about some of the data that we've produced.
Speaker Change: Over the course of the last few months in his prepared remarks, and we will update our investor deck here over the course of the next day and there's continues to be some more.
Speaker Change: Information there on what we're doing on the top rating from front.
Speaker Change: As we.
Speaker Change: As we continue on the Tau pretty firm side, we expect to also through the year continue to show more data and publish more data related to our performance characteristics sensitivities of amick range reproducibility, and so forth and we expect that in the first half of <unk>.
Speaker Change: 2025, we will also signed our first tower related partnership and stay tuned for more on that front.
Speaker Change: So on the tower front I think that's kind of what you should look for in that in the near and medium term. So let me finish by.
Speaker Change: Our strip my attention to broad scale on the broad scale side I think that.
Speaker Change: One of the things that you've heard us say.
Speaker Change: Is that the big milestone on the broad scale side is when we can.
Speaker Change: The code is a significant number of proteins that it felt like it doesn't have to be a lot 501000, 2000 proteins and by the time, we get to that point all of the platform pieces come together all of the assay performance is required for the coding is there and we will at that point had a very firm grasp on the timeline remaining and.
Speaker Change: Final specifications, and so forth and I think that will be a data update.
Speaker Change: For our investors and our analysts on the road to being able to do that once we are able to move through this assay configuration change in surface chemistry change, you'll see us have some intermediate milestones such as decoding predefined mixtures of proteins as we come as we progress towards.
Speaker Change: <unk> as a key.
Speaker Change: As an example, the complex sample and then ultimately to that 500000 in 2014 milestone.
Speaker Change: And so as we start moving through those predefined mixtures will bring the scientific community and our Investor community along so that there are some interim checkpoints before we get to that that big data readout and as well as we move through the year I expect we'll continue to.
Speaker Change: Once we make our ASIC integration change continue to share data, particularly at scientific conferences related to our broad scale capabilities stability sensitivity reproducibility of dynamic range coverage in our assay.
Speaker Change: Great.
Speaker Change: Maybe just one on <unk> since youre going to be.
Speaker Change: Engaging with customers now in the first half and planning a partnership.
Speaker Change: From what you.
Produced so far could you just speak to the center.
Speaker Change: I think you said youre going to provide some details obviously the sensitivity specificity. The key measurement tools could you just speak to the number of.
Speaker Change: Players emerging in the market, there's a lot of specs out there just kind of how you think your performance would compare to some of the other kind of leading.
Speaker Change: Kind of Tau protein platforms.
Speaker Change: Maybe I'll take this one.
Speaker Change: I think one of the key.
Speaker Change: The key and most important differentiator of our platform relative to everything else out in the world.
Speaker Change: Is that we are we aren't the only commercial platform that can measure.
Speaker Change: Protein forms in high throughput and high sensitivity.
Speaker Change: From complex samples, so that that aspect of being able to comment on the combination of isoforms plus potentially triple phosphorylation of Tau.
Speaker Change: Or quadruple phosphorylation of Tau at sites, a b C and D or ABC and he is a unique capability of our platform and something that our customers are extremely excited about.
Speaker Change: Because that allows you to reveal the order and timing of events that are on the way to Alzheimer's. It allows you to unveil substructure and subtypes that are potentially indicative of response to therapy of one therapeutic versus another.
Speaker Change: And also potentially allow you to define differences between Ah.
Speaker Change: <unk>, who have aggressive rapidly progressing disease versus not so it's really in the resolution of the measurement that is incredibly unique.
Speaker Change: With regards to other specifications some of the things that we've been looking at are the dynamic range within the measurement of an individual proteoform.
Speaker Change: So keep in mind there are two different measures of dynamic range. One is the across analyte dynamic range and the other is the within analyte dynamic range and typically for instance in TMT assays in mass spectrometry, you have what's called range compression and so youre within analyte dynamic range is typically below one.
Speaker Change: Order of magnitude, we've demonstrated dynamic range of upwards of three orders of magnitude within our win within analyte dynamic range.
Speaker Change: With regards to reproducibility, showing reproduced abilities of with Cvs.
Speaker Change: Well below 20%.
Speaker Change: And then one other.
Speaker Change: Common factor that you.
Speaker Change: Youll see people look at is just what are the range of analytes that you are able to look at and that's that's where as I highlighted we're able to access analytes that are simply inaccessible to other platforms.
Speaker Change: Great. Thank you.
Speaker Change: Yeah.
Speaker Change: Our next question comes from Mac Sykes at Goldman Sachs.
Speaker Change: Good morning. This is <unk> on for Matt Thanks for taking our questions.
Speaker Change: I appreciate the commentary around the probe optimization, taking some time and pushing out.
Speaker Change: The launch date, but just wanted to clarify is that late 2026 launch for both the broad scale of discovery and the more targeted platform or are those timelines different.
Speaker Change: Hi, Good morning, well, let me try to take that one.
Speaker Change: Both of our modality.
Speaker Change: Are heading to the market with brands strategy. So on.
Speaker Change: So let's take the broad scale side first on the broad skill side, we are moving towards a model where late in 2026, we have our commercial launch and from that point forward, we're largely selling instruments were selling consumables were selling software.
Speaker Change: That's the business model going forward and we will provide some services capability after that point as an on ramp to buying instruments and burst.
Speaker Change: Yeah.
Speaker Change: On the protium form side.
Speaker Change: The proteoform data coming off our platform is.
Speaker Change: Type of data that level of detail that you can't get with other assets.
Speaker Change: We've chosen not to just product tied to it as a service or just selling an instrument that is pretty important.
Speaker Change: Instead at.
Speaker Change: Focused on partnering with organizations, we're looking for this level of detail and jointly exploring the space.
Speaker Change: Tao initially.
Speaker Change: That pretty a form in understanding what are the implications by all biologically habits are informed therapeutic development are there potential diagnostic applications and so on the protium forefront.
Speaker Change: Our today talking to a number of organizations around partnerships on the Tau pretty form those analyses will be done in our facility and we will work with our customers and returns to them and then work with them on the next phase of their project.
Speaker Change: And then ultimately.
Certainly over the course of 2025 and 2026, we will also add additional biomarkers.
Speaker Change: That are driven by customer conversations and some driven by our our own research and desires for that product and for the foreseeable future those proteoform capabilities, our capabilities that we're going to introduce the customers via partnerships and collaboration.
Speaker Change: Got it that's super helpful. Thank you.
Speaker Change: And then just following up on that.
Speaker Change: You mentioned, giving researchers access to proteoform in the first half of 'twenty five.
Speaker Change: But then I just wanted to see if the launch date impacts your expectations for the early access program, maybe on the broad scale side in relation to instrument placements as well. Thank you so much.
Speaker Change: Yeah.
Speaker Change: No.
Speaker Change: The early access period is just to kind of define it for those that may not remember the early access period is approximately six to nine months prior to the commercial launch of our instrument on the broad scale wide and that is an opportunity for customers to see the data that our platform produced.
Speaker Change: Is with their own samples and so thats, a model, where the cost where potential customers will send us samples will analyze them using the preproduction.
Speaker Change: Broad scale capabilities and the goal of those engagements as wanted to generate data and excitement and have a set of data that we can leverage as we move towards launch, but even more importantly to get customers excited enough to want yet.
Speaker Change: Placed orders for the instrument once we get to that commercial launch and so you should think about.
Speaker Change: And commercial launch late 2026, and early access periods, starting from six to nine months.
Speaker Change: Great. Thank you so much.
Speaker Change: Okay.
Speaker Change: I am showing no further questions at this time. Thank you for your participation in today's conference. This does conclude the program you may now disconnect.