BIODESIX INC — Call Transcript 2026

Everyone, good afternoon. Thanks for joining us here on the second full day of the William Blair Growth Stock Conference. If you don't know me, my name's Andrew Brackmann. I'm the diagnostics equity research analyst here at William Blair. Thanks for joining us. We're very happy to have the team from Biodesix joining us for this session. We have the CEO, Scott Hutton, Chief Financial Officer, Robin Harper Cowie, Chief Commercial Officer, Kieran O'Kane, and VP of Marketing, Robbie Lunt. They're going to go through a slide presentation here. That'll last about 30 minutes, and then we'll have the breakout for this session in Burnham B following. With that, one last thing, I am required to tell you that for a full list of research disclosures, please visit williamblair.com. With that, I'll turn it over to the Biodesix team. Thank you, Andrew, and thank you, William Blair team. It's an honor and privilege to be here today. As Andrew referenced, you've got the leadership team here, or members of the leadership team. We really are commercial stage focused on execution, so we thought it would be a great opportunity for everybody to hear directly from our chief commercial officer and head of marketing. For us, we had an exceptionally strong first quarter, continuing a track record of great performance. You can see we delivered greater than 40% revenue growth. We continue to have industry-leading gross margins greater than 80%, the 82% we have guided that will stay in that low to mid-80% range. We continue to make significant progress on our march towards profitability, which we will achieve this fiscal year. You've got four members of the team here, but we're really proud of what we've achieved in building a culture and a team. You can see that we recently received our third consecutive Top Workplaces award, which we take great pride in. Most importantly, as you can see the revenue numbers, we've guided $108 million-$114 million this year. Most importantly, that represents a significant number of patients, and we continue to address an unmet need and have a great opportunity to possibly impact care in the lung cancer space. With that, I'm going to turn it over to Kieran O'Kane to dive into some of the commercial performance. Thank you, Scott. Yeah, really starting off with our growth strategy for this year and coming years. We have the most established commercial team at our core point, which for lung diseases, it's the pulmonologist. We've been really building and investing in our infrastructure over the last five, 6+ years. We believe that has, one, established us really as the leader within our space, established a moat for our business, but also now really as a catalyst for growth as we move forward through this year and beyond. Really, our focus this year is execution. Executing on the opportunity that we have in front of us today with the tests that we have in the bag. As we move through this year and look at what's beyond, really having invested in the infrastructure, in the sales team, having become market leaders and experts in our field, we're in a pole position to leverage that with additional products, whether that's organic through our own pipeline or potentially even inorganic through collaborations, partnerships, or dropping new products into the bag as we move through to next year and beyond. With that, I think I'm going to hand over to Robbie Lunt, who's going to talk about really the challenges that we're addressing today with diseases of the lung and some of our current product offerings that we have in the bag today. Thank you, Kieran. Lung diseases present some unique challenges in that most patients are asymptomatic until their lung disease progresses. When that lung disease does progress, they show up with symptoms like chronic cough or shortness of breath that are really common and don't allow appropriate diagnosis and ultimately treatment. Going forward, we know that diagnostic tests will play a key role in differentiating between those two diseases and supporting early detection of distinct diseases that will ultimately improve patient outcomes. While our commercial focus today is on lung cancer, we know that we have the scientific, clinical, and commercial expertise that will be able to take advantage of diagnostic opportunities well beyond lung cancer and address some of these other unmet needs across lung diseases. Within the lung cancer space, our focus today is on lung nodule risk stratification, where there's 5 million-6 million patients each year that present with newly detected lung nodules. The big unmet need there is identifying the about 5% of those patients that will develop or have lung cancer in a way that prevents delayed diagnoses and avoids any unnecessary procedures on patients that don't ultimately have lung cancer. How that presents in the clinical setting is through this patient journey where there are multiple steps from the initial nodule discovery to the ultimate surgical or other treatment modalities used for those patients that are ultimately diagnosed with lung cancer. The real goal of lung nodule management is to diagnose those lung cancers as fast as possible, yet we know in the current landscape, standard of care can lead to multiple different points of delays that negatively impacts patient outcomes. Recent studies have shown that up to 43% of patients upstage between their nodule discovery and referral and movement through this pathway to that surgery or treatment. We also know that patients that are diagnosed at a later stage have much worse survival. Effective nodule management and accelerating the right patients through this landscape can ultimately lead to earlier stage of diagnosis and improved survival for that subset of patients that do have malignant lung nodules. To talk a little bit more about our Nodify Lung portfolio, I'm going to hand it back to Kieran. Thank you, Robbie. We actually have five on-market tests that span the point of diagnosis of lung cancer. Our three proprietary tests have ADLT status, and really the best way of thinking about that is it gives us a lot more control and protection on pricing. Really today, I'm going to focus on the left side of this slide, though, with Nodify Lung. That is our primary growth driver as an organization. The goal here is really to manage that large number of patients that Robbie referred to, 5 million-6 million patients a year with an identified lung nodule, and make sure that those patients who are high risk are appropriately managed and funneled, really triaged into the specialty point of care, being the pulmonologist, and those who are lower risk can be effectively managed out in the community, whether that's community pulmonology or primary care. What we know today is that about 50% of patients are managed in primary care, 50% are managed at that specialty level. What we're trying to do is differentiate, and you can see on the slide that they're highlighted by the orange figureheads, really the patients who are high risk, as I say, funneling them through, not allowing them to stay out in the community or out in primary care, making sure that they're channeled through to the specialty point of care where they're given appropriate treatment. When we are looking at, and I'll come on and talk about the evolution of our sales strategy, but when we first looked at the 50% of patients who are managed in primary care, what we underappreciated, I think, at launch was that the number of primary care physicians out there, north of 250,000, we challenged whether that was an addressable market for us. I think as time evolved and we understood more of the market through claims data, what we realized is actually those patients with nodules are concentrated in a very addressable number of primary care physicians. You can see on the slide, about 15,000 primary care physicians manage about 80% of pulmonary nodules. That became a much more addressable market for us and something similar to the specialty call point in the universe of pulmonologists that are out there. The goal here, as you can see in this slide, is let's funnel through and concentrate those high-risk individuals at the specialty call point, keep lower-risk individuals out in primary care, out in the community, where they can be safely monitored under a watchful waiting protocol with serial CT scans and imaging. Looking at the evolution of our sales strategy over time, really at launch back in 2020, our goal was to develop advocates. We called on the thought leaders in the space, pulmonologists with a specialty interest and knowledge in diagnosing lung cancer. The goal there was to develop confidence within that call point, within that community, and ultimately develop advocacy so that they would endorse the use of Nodify upstream of themselves. Those KOLs, largely they're proceduralists. They're interested in doing bronchoscopies. That's the diagnostic procedure for lung cancer. They want to see the highest risk patients, right? They want to spend less time in the clinic assessing patients for risk, more time in the bronch suite doing procedures, diagnostic procedures, and ultimately finding those lung cancers. Our goal then moved on from developing advocacy within that call point. Once that was done, we leveraged and mobilized those thought leaders to educate their referral base. Initially, that was pulmonologists, the rest of the pulmonology community, to use Nodify, help triage patients by risk, and then refer in the highest-risk individuals. What we then found as volumes grew and really the advocates and the thought leaders became more and more confident with Nodify, is that their referral base isn't just in community pulmonology, it's also in primary care as well. They pulled us into that environment within their referral network. Educating primary care physicians as well as pulmonologists in the use of Nodify testing, again, to help triage patients by risk and funnel those highest-risk individuals into the specialty call point. Through claims data and other analyses, as I say, we really narrowed that call point down to about 15,000 individuals in primary care who manage 80% of nodules. Very addressable for us and very manageable in terms of an educational goal for using Nodify testing. Looking at the sales structure today, we've split the country into 50 sales territories. The anchor sales position within each of those territories is the pulmonology sales consultant, and as we layer in additional resources, we really look at what the business opportunity and business need is within each of those territories and decide to layer in an account manager where business is maturing. That associate sales consultant, really their job is to go in, farm tests, manage accounts with existing business, potentially grow business in existing accounts, but that frees up the pulmonology sales consultant to go win new business. As we've transitioned into primary care, we've layered in a specialty role there. The general practice sales consultant, as we call them, focused on primary care. Really, they are layered in where we have that advocate in place, that interest in pushing diagnostic testing out into the community into primary care. We leverage that advocate, work very closely with them to educate primary care on appropriate use of Nodify testing, and really drive tests out into the community from that standpoint. That has been a tremendous success. I would say, going into primary care, that's a call point that is very familiar with diagnostic testing. They run diagnostic tests every day. They have capability for blood draws in-house, typically. Really it was primed for that educational need, and it's really just a case of educating them on, one, what Nodify is as a test, but really what to do with the results. Who to keep hold of, what that looks like, then who to refer into the specialty call point. Talking more about that, I'm going to hand back to Robbie, who's going to talk about each of the individual Nodify tests and really how they're applied for nodules of different sizes. Between the territory-based sales structure and our product attributes, we're uniquely positioned to penetrate this entire market opportunity. Historically, one of the ways that clinicians looked at this patient population was based on nodule size. Even the pulmonary guidelines separate out this patient population based on nodule size. Our products have been designed to address the unique clinical needs and identify lung cancer earlier within each of these patient populations. On the right side here, with the larger size lung nodules, guidelines suggest more of a dealer's choice based on clinical judgment of what's the appropriate next steps. Our tests are designed there to prioritize and triage patients so that the limited specialty resources can focus on the highest risk patient population, and avoid those delayed diagnoses that we talked about earlier. On the left side here in these smaller nodules, conventionally these are patients that may not receive any follow-up at all, but really the default would be to do some sort of mid to long term follow-up there and see if anything changes, if the nodule grows or becomes more suspicious for lung cancer. With our tests deployed in this patient population, we're enabling this needle in a haystack of finding those very few patients in the small nodule population that should be looked at closer, that should be referred to a specialist faster and not miss that window for early detection of lung cancer and improved patient outcomes. We've seen some great anecdotes in our early experience in primary care, really across both of these patient populations. Some of the excitement is coming in the small nodules, where historically there wasn't much that clinicians could do except for wait and see. Now with our tests, they're able to be more aggressive and find more of those opportunities for early detection of lung cancer. One of the tools that we created early after launch was a data visualization tool for us to be able to monitor in a commercial setting, does test performance match what we saw in early clinical studies. Also to drive adoption and demonstrate utility within individual practices. Here are two different ways that we can visualize the data. In both, on the left side are patients and their risk of having lung cancer prior to Nodify testing, and then next to it is their risk after receiving Nodify testing. What you can see is that many patients were really in the middle of that risk profile. Conventional tools are limited in that many patients do fall into that middle ground where there's not clear next steps. After conducting Nodify testing, you can see that patients are really pushed up or down into more clear clinical next steps, whether that be aggressive with intervention or continue to monitor with CT surveillance, but really providing a lot more clarity at a large scale, across an entire patient population. This tool was so effective in our early conversations with physicians, that we've looked at other ways that we can use that to demonstrate clinical utility and most recently have added the ability to show clinical decision change. Physicians, what they were going to do prior to Nodify testing and then how Nodify testing actually informed a change in decision or change in treatment plan for that patient. This has presented a lot of new opportunities for publications and generating evidence on clinical utility from our commercially tested patient population. Speaking of evidence, we've been publishing for over 10 years on these two tests now, really working through the evolution of clinical data to support clinical and payer adoption. Most recently, just a few months ago, we published the largest clinical validation study for a lung nodule biomarker ever published in "Future Oncology," and have many more opportunities going forward to continue to add to our extensive evidence base. One of the studies I wanted to highlight today is called CLARIFY. CLARIFY also leverages the broad adoption we've seen in the commercial setting, by doing a retrospective chart review of patients that were tested by physicians in the real world. Our ultimate goal for CLARIFY is 3,000-4,000 patients. Because of the study design, it's highly efficient, and we're approaching almost 2,000 patients enrolled in under 24 months in that study. The data from that study actually informed the 2026 publication that large clinical validation with over 1,100 patients in it, was bolstered by an interim analysis of the CLARIFY study. We're not stopping there. We have other planned interim analyses for the CLARIFY study that will allow us to look at new pieces of information like time to diagnosis. If we can demonstrate faster time to diagnosis, then we know we're having a positive impact on patient care and lung nodule management as a whole. One of the conventional risk classification tools is PET imaging. We're also going to look at, through this CLARIFY study, the performance of Nodify tests in combination or in sequence with PET imaging. A lot of exciting opportunities for us to continue to advance this evidence package and continue to establish ourselves in market leaders for lung nodule risk classification. Really the goal here is to continue to drive market penetration. If you look back at the original slides and the numbers, we mentioned that there were 5 million-6 million nodules found annually in the U.S. It's important to point out that about 90% of those are actually found incidentally. That means a patient turns up at the emergency room, having broken a rib, broken a collarbone, something that causes an image, CT, X-ray to be taken of their chest, and that incidentally, they find a pulmonary nodule in there. There's a lot of talk and noise around screening efforts in lung cancer, and unfortunately just with low-dose CT screening, it hasn't been a huge amount of success since those guidelines came into place over a decade ago now. About 10% of nodules are found through screening. Overall, screening penetration is now probably in the mid-teens. About 15% of patients who are eligible for low-dose CT screening actually get screened. There's a lot of noise and a lot of talk around upstream of those low-dose CT imaging blood tests that are coming into play looking at either detecting single-cancer early detection, so dedicated at looking for lung cancer or multi-cancer early detection, really where you're using a blood test to identify individuals who are high risk of cancer, really anywhere in the body. The goal of those tests is to funnel them into, in this case, low-dose CT for detecting lung cancer. What we're looking at there, and we're strong advocates of those tests being successful because they will increase the addressable market. If you think of that paradigm shift going from 10% of screen-detected nodules or nodules being screen-detected, really the more patients that we find that get channeled into screening modalities like low-dose CT, that's only going to increase. The addressable market is increasing and already we have a ton of runway even with the number of nodules that are detected today to drive growth. A tremendous amount of opportunity that's only going to increase with the adoption and the improvements in blood-based tests that are driving patients in for screening. There's also new tests coming out, really AI layers that go on top of CT scans that are going to enhance the ability of a radiologist or a pulmonologist to detect nodules within that CT scan itself. Both of those will continue to develop and grow the market opportunity for Nodify testing in the coming year and beyond. All right. With that, I think I'm going to hand on to Robin, who's going to talk through some of our financials. Thanks, Kieran. As Scott mentioned at the beginning, we had another fantastic quarter with our revenue growing 42% year-over-year. I'll talk a little bit more about the drivers of that here in a moment, primarily driven by the great work being done by Kieran and Robbie and their teams in reaching more physicians and more patients every single quarter. We have really a handful of goals. We're very much focused on driving our top-line revenue growth, but also getting to cash flow positivity. The best way to do that is to be very effective and efficient. We're extraordinarily pleased to be able to share our 82% gross margin for the quarter, which is now several quarters in a row of greater than 80%, which is market leading in diagnostics. That gross margin improvement year-over-year of 300-basis point improvement was driven not only by improvements in our reimbursement and our average revenue per test, but also improvements in our operations. We continued to strive to become more efficient and effective in the lab and in the rest of our operations, and we were able to decrease our average price per test paid. We also made substantial improvements on our path to profitability, where we saw a 35% improvement in Adjusted EBITDA and improvements in our net loss in the quarter. We are anticipating and are projecting that we will, thank you, hit cash flow positivity by the end of the year. As I mentioned, our revenue is being driven by multiple factors, so not just the improvement in volume. We saw 29% growth in test volumes, but we are also seeing strong improvement in average revenue per test, and that is being driven by increasing numbers of private payers covering our tests and improvements in our operations and our revenue cycle management. We saw a large increase in average revenue per test in the third quarter of last year based off of a variety of projects and initiatives in the organization, and that ASP improvement has continued and proven to be durable over the last several quarters, resulting in 37% growth in lung diagnostic revenue for the quarter. Moving to our guidance. As Scott mentioned, we beat and raised, so raised our full-year revenue target to $108 million-$114 million for the year, which represents 25% year-over-year growth. We also reiterated that our gross margins would remain at or above that 80% best-in-class mark. Continued to talk about getting to cash flow positivity by the end of the year. Being effective and efficient is one of our key priorities for the organization, we can give you five minutes back. Great. Thanks, Kieran. We'll wrap there. The breakout will be in Burnham B. Burnham B. Thanks, everyone. Thank you.

Speaker 1: Everyone, good afternoon. Thanks for joining us here on the second full day of the William Blair Growth Stock Conference. If you don't know me, my name's Andrew Brackmann. I'm the diagnostics equity research analyst here at William Blair. Thanks for joining us. We're very happy to have the team from Biodesix joining us for this session. We have the CEO, Scott Hutton, Chief Financial Officer, Robin Harper Cowie, Chief Commercial Officer, Kieran O'Kane, and VP of Marketing, Robbie Lunt. They're going to go through a slide presentation here. That'll last about 30 minutes, and then we'll have the breakout for this session in Burnham B following. With that, one last thing, I am required to tell you that for a full list of research disclosures, please visit williamblair.com. With that, I'll turn it over to the Biodesix team. Everyone, good afternoon. everyone good afternoon Thanks for joining us here on the second full day of the William Blair Growth Stock Conference. thanks for joining us here on the second full day of the william blair growth stock conference If you don't know me, my name's Andrew Brackmann. if you don't know me my name's andrew brackmann I'm the diagnostics equity research analyst here at William Blair. i'm the diagnostics equity research analyst here at william blair Thanks for joining us. thanks for joining us We're very happy to have the team from Biodesix joining us for this session. we're very happy to have the team from biodesix joining us for this session We have the CEO, Scott Hutton, Chief Financial Officer, Robin Harper Cowie, Chief Commercial Officer, Kieran O'Kane, and VP of Marketing, Robbie Lunt. we have the ceo scott hutton chief financial officer robin harper cowie chief commercial officer kieran o'kane and vp of marketing robbie lunt They're going to go through a slide presentation here. they're going to go through a slide presentation here That'll last about 30 minutes, and then we'll have the breakout for this session in Burnham B following. that'll last about 30 minutes and then we'll have the breakout for this session in burnham b following With that, one last thing, I am required to tell you that for a full list of research disclosures, please visit williamblair.com. with that one last thing i am required to tell you that for a full list of research disclosures please visit williamblair.com With that, I'll turn it over to the Biodesix team. with that i'll turn it over to the biodesix team

Speaker 5: Thank you, Andrew, and thank you, William Blair team. It's an honor and privilege to be here today. As Andrew referenced, you've got the leadership team here, or members of the leadership team. We really are commercial stage focused on execution, so we thought it would be a great opportunity for everybody to hear directly from our chief commercial officer and head of marketing. For us, we had an exceptionally strong first quarter, continuing a track record of great performance. You can see we delivered greater than 40% revenue growth. We continue to have industry-leading gross margins greater than 80%, the 82% we have guided that will stay in that low to mid-80% range. We continue to make significant progress on our march towards profitability, which we will achieve this fiscal year. Thank you, Andrew, and thank you, William Blair team. thank you andrew and thank you william blair team It's an honor and privilege to be here today. it's an honor and privilege to be here today As Andrew referenced, you've got the leadership team here, or members of the leadership team. as andrew referenced you've got the leadership team here or members of the leadership team We really are commercial stage focused on execution, so we thought it would be a great opportunity for everybody to hear directly from our chief commercial officer and head of marketing. we really are commercial stage focused on execution so we thought it would be a great opportunity for everybody to hear directly from our chief commercial officer and head of marketing For us, we had an exceptionally strong first quarter, continuing a track record of great performance. for us we had an exceptionally strong first quarter continuing a track record of great performance You can see we delivered greater than 40% revenue growth. you can see we delivered greater than 40% revenue growth We continue to have industry-leading gross margins greater than 80%, the 82% we have guided that will stay in that low to mid-80% range. we continue to have industry-leading gross margins greater than 80% the 82% we have guided that will stay in that low to mid-80% range We continue to make significant progress on our march towards profitability, which we will achieve this fiscal year. we continue to make significant progress on our march towards profitability which we will achieve this fiscal year You've got four members of the team here, but we're really proud of what we've achieved in building a culture and a team. You can see that we recently received our third consecutive Top Workplaces award, which we take great pride in. Most importantly, as you can see the revenue numbers, we've guided $108 million-$114 million this year. Most importantly, that represents a significant number of patients, and we continue to address an unmet need and have a great opportunity to possibly impact care in the lung cancer space. With that, I'm going to turn it over to Kieran O'Kane to dive into some of the commercial performance. You've got four members of the team here, but we're really proud of what we've achieved in building a culture and a team. you've got four members of the team here but we're really proud of what we've achieved in building a culture and a team You can see that we recently received our third consecutive Top Workplaces award, which we take great pride in. you can see that we recently received our third consecutive top workplaces award which we take great pride in Most importantly, as you can see the revenue numbers, we've guided $108 million-$114 million this year. most importantly as you can see the revenue numbers we've guided $108 million-$114 million this year Most importantly, that represents a significant number of patients, and we continue to address an unmet need and have a great opportunity to possibly impact care in the lung cancer space. most importantly that represents a significant number of patients and we continue to address an unmet need and have a great opportunity to possibly impact care in the lung cancer space With that, I'm going to turn it over to Kieran O'Kane to dive into some of the commercial performance. with that i'm going to turn it over to kieran o'kane to dive into some of the commercial performance

Speaker 2: Thank you, Scott. Yeah, really starting off with our growth strategy for this year and coming years. We have the most established commercial team at our core point, which for lung diseases, it's the pulmonologist. We've been really building and investing in our infrastructure over the last five, 6+ years. We believe that has, one, established us really as the leader within our space, established a moat for our business, but also now really as a catalyst for growth as we move forward through this year and beyond. Really, our focus this year is execution. Executing on the opportunity that we have in front of us today with the tests that we have in the bag. Thank you, Scott. thank you scott Yeah, really starting off with our growth strategy for this year and coming years. yeah really starting off with our growth strategy for this year and coming years We have the most established commercial team at our core point, which for lung diseases, it's the pulmonologist. we have the most established commercial team at our core point which for lung diseases it's the pulmonologist We've been really building and investing in our infrastructure over the last five, 6+ years . we've been really building and investing in our infrastructure over the last five 6+ years We believe that has, one, established us really as the leader within our space, established a moat for our business, but also now really as a catalyst for growth as we move forward through this year and beyond. we believe that has one established us really as the leader within our space established a moat for our business but also now really as a catalyst for growth as we move forward through this year and beyond Really, our focus this year is execution. really our focus this year is execution Executing on the opportunity that we have in front of us today with the tests that we have in the bag. executing on the opportunity that we have in front of us today with the tests that we have in the bag As we move through this year and look at what's beyond, really having invested in the infrastructure, in the sales team, having become market leaders and experts in our field, we're in a pole position to leverage that with additional products, whether that's organic through our own pipeline or potentially even inorganic through collaborations, partnerships, or dropping new products into the bag as we move through to next year and beyond. With that, I think I'm going to hand over to Robbie Lunt, who's going to talk about really the challenges that we're addressing today with diseases of the lung and some of our current product offerings that we have in the bag today. As we move through this year and look at what's beyond, really having invested in the infrastructure, in the sales team, having become market leaders and experts in our field, we're in a pole position to leverage that with additional products, whether that's organic through our own pipeline or potentially even inorganic through collaborations, partnerships, or dropping new products into the bag as we move through to next year and beyond. as we move through this year and look at what's beyond really having invested in the infrastructure in the sales team having become market leaders and experts in our field we're in a pole position to leverage that with additional products whether that's organic through our own pipeline or potentially even inorganic through collaborations partnerships or dropping new products into the bag as we move through to next year and beyond With that, I think I'm going to hand over to Robbie Lunt, who's going to talk about really the challenges that we're addressing today with diseases of the lung and some of our current product offerings that we have in the bag today. with that i think i'm going to hand over to robbie lunt who's going to talk about really the challenges that we're addressing today with diseases of the lung and some of our current product offerings that we have in the bag today

Speaker 3: Thank you, Kieran. Lung diseases present some unique challenges in that most patients are asymptomatic until their lung disease progresses. When that lung disease does progress, they show up with symptoms like chronic cough or shortness of breath that are really common and don't allow appropriate diagnosis and ultimately treatment. Going forward, we know that diagnostic tests will play a key role in differentiating between those two diseases and supporting early detection of distinct diseases that will ultimately improve patient outcomes. While our commercial focus today is on lung cancer, we know that we have the scientific, clinical, and commercial expertise that will be able to take advantage of diagnostic opportunities well beyond lung cancer and address some of these other unmet needs across lung diseases. Thank you, Kieran. thank you kieran Lung diseases present some unique challenges in that most patients are asymptomatic until their lung disease progresses. lung diseases present some unique challenges in that most patients are asymptomatic until their lung disease progresses When that lung disease does progress, they show up with symptoms like chronic cough or shortness of breath that are really common and don't allow appropriate diagnosis and ultimately treatment. when that lung disease does progress they show up with symptoms like chronic cough or shortness of breath that are really common and don't allow appropriate diagnosis and ultimately treatment Going forward, we know that diagnostic tests will play a key role in differentiating between those two diseases and supporting early detection of distinct diseases that will ultimately improve patient outcomes. going forward we know that diagnostic tests will play a key role in differentiating between those two diseases and supporting early detection of distinct diseases that will ultimately improve patient outcomes While our commercial focus today is on lung cancer, we know that we have the scientific, clinical, and commercial expertise that will be able to take advantage of diagnostic opportunities well beyond lung cancer and address some of these other unmet needs across lung diseases. while our commercial focus today is on lung cancer we know that we have the scientific clinical and commercial expertise that will be able to take advantage of diagnostic opportunities well beyond lung cancer and address some of these other unmet needs across lung diseases Within the lung cancer space, our focus today is on lung nodule risk stratification, where there's 5 million-6 million patients each year that present with newly detected lung nodules. The big unmet need there is identifying the about 5% of those patients that will develop or have lung cancer in a way that prevents delayed diagnoses and avoids any unnecessary procedures on patients that don't ultimately have lung cancer. How that presents in the clinical setting is through this patient journey where there are multiple steps from the initial nodule discovery to the ultimate surgical or other treatment modalities used for those patients that are ultimately diagnosed with lung cancer. Within the lung cancer space, our focus today is on lung nodule risk stratification, where there's 5 million-6 million patients each year that present with newly detected lung nodules. within the lung cancer space our focus today is on lung nodule risk stratification where there's 5 million-6 million patients each year that present with newly detected lung nodules The big unmet need there is identifying the about 5% of those patients that will develop or have lung cancer in a way that prevents delayed diagnoses and avoids any unnecessary procedures on patients that don't ultimately have lung cancer. the big unmet need there is identifying the about 5% of those patients that will develop or have lung cancer in a way that prevents delayed diagnoses and avoids any unnecessary procedures on patients that don't ultimately have lung cancer How that presents in the clinical setting is through this patient journey where there are multiple steps from the initial nodule discovery to the ultimate surgical or other treatment modalities used for those patients that are ultimately diagnosed with lung cancer. how that presents in the clinical setting is through this patient journey where there are multiple steps from the initial nodule discovery to the ultimate surgical or other treatment modalities used for those patients that are ultimately diagnosed with lung cancer The real goal of lung nodule management is to diagnose those lung cancers as fast as possible, yet we know in the current landscape, standard of care can lead to multiple different points of delays that negatively impacts patient outcomes. Recent studies have shown that up to 43% of patients upstage between their nodule discovery and referral and movement through this pathway to that surgery or treatment. We also know that patients that are diagnosed at a later stage have much worse survival. Effective nodule management and accelerating the right patients through this landscape can ultimately lead to earlier stage of diagnosis and improved survival for that subset of patients that do have malignant lung nodules. To talk a little bit more about our Nodify Lung portfolio, I'm going to hand it back to Kieran. The real goal of lung nodule management is to diagnose those lung cancers as fast as possible, yet we know in the current landscape, standard of care can lead to multiple different points of delays that negatively impacts patient outcomes. the real goal of lung nodule management is to diagnose those lung cancers as fast as possible yet we know in the current landscape standard of care can lead to multiple different points of delays that negatively impacts patient outcomes Recent studies have shown that up to 43% of patients upstage between their nodule discovery and referral and movement through this pathway to that surgery or treatment. recent studies have shown that up to 43% of patients upstage between their nodule discovery and referral and movement through this pathway to that surgery or treatment We also know that patients that are diagnosed at a later stage have much worse survival. we also know that patients that are diagnosed at a later stage have much worse survival Effective nodule management and accelerating the right patients through this landscape can ultimately lead to earlier stage of diagnosis and improved survival for that subset of patients that do have malignant lung nodules. effective nodule management and accelerating the right patients through this landscape can ultimately lead to earlier stage of diagnosis and improved survival for that subset of patients that do have malignant lung nodules To talk a little bit more about our Nodify Lung portfolio, I'm going to hand it back to Kieran. to talk a little bit more about our nodify lung portfolio i'm going to hand it back to kieran

Speaker 2: Thank you, Robbie. We actually have five on-market tests that span the point of diagnosis of lung cancer. Our three proprietary tests have ADLT status, and really the best way of thinking about that is it gives us a lot more control and protection on pricing. Really today, I'm going to focus on the left side of this slide, though, with Nodify Lung. That is our primary growth driver as an organization. The goal here is really to manage that large number of patients that Robbie referred to, 5 million-6 million patients a year with an identified lung nodule, and make sure that those patients who are high risk are appropriately managed and funneled, really triaged into the specialty point of care, being the pulmonologist, and those who are lower risk can be effectively managed out in the community, whether that's community pulmonology or primary care. Thank you, Robbie. thank you robbie We actually have five on-market tests that span the point of diagnosis of lung cancer. we actually have five on-market tests that span the point of diagnosis of lung cancer Our three proprietary tests have ADLT status, and really the best way of thinking about that is it gives us a lot more control and protection on pricing. our three proprietary tests have adlt status and really the best way of thinking about that is it gives us a lot more control and protection on pricing Really today, I'm going to focus on the left side of this slide, though, with Nodify Lung. really today i'm going to focus on the left side of this slide though with nodify lung That is our primary growth driver as an organization. that is our primary growth driver as an organization The goal here is really to manage that large number of patients that Robbie referred to, 5 million-6 million patients a year with an identified lung nodule, and make sure that those patients who are high risk are appropriately managed and funneled, really triaged into the specialty point of care, being the pulmonologist, and those who are lower risk can be effectively managed out in the community, whether that's community pulmonology or primary care. the goal here is really to manage that large number of patients that robbie referred to 5 million-6 million patients a year with an identified lung nodule and make sure that those patients who are high risk are appropriately managed and funneled really triaged into the specialty point of care being the pulmonologist and those who are lower risk can be effectively managed out in the community whether that's community pulmonology or primary care What we know today is that about 50% of patients are managed in primary care, 50% are managed at that specialty level. What we're trying to do is differentiate, and you can see on the slide that they're highlighted by the orange figureheads, really the patients who are high risk, as I say, funneling them through, not allowing them to stay out in the community or out in primary care, making sure that they're channeled through to the specialty point of care where they're given appropriate treatment. What we know today is that about 50% of patients are managed in primary care, 50% are managed at that specialty level. what we know today is that about 50% of patients are managed in primary care 50% are managed at that specialty level What we're trying to do is differentiate, and you can see on the slide that they're highlighted by the orange figureheads, really the patients who are high risk, as I say, funneling them through, not allowing them to stay out in the community or out in primary care, making sure that they're channeled through to the specialty point of care where they're given appropriate treatment. what we're trying to do is differentiate and you can see on the slide that they're highlighted by the orange figureheads really the patients who are high risk as i say funneling them through not allowing them to stay out in the community or out in primary care making sure that they're channeled through to the specialty point of care where they're given appropriate treatment When we are looking at, and I'll come on and talk about the evolution of our sales strategy, but when we first looked at the 50% of patients who are managed in primary care, what we underappreciated, I think, at launch was that the number of primary care physicians out there, north of 250,000, we challenged whether that was an addressable market for us. I think as time evolved and we understood more of the market through claims data, what we realized is actually those patients with nodules are concentrated in a very addressable number of primary care physicians. You can see on the slide, about 15,000 primary care physicians manage about 80% of pulmonary nodules. That became a much more addressable market for us and something similar to the specialty call point in the universe of pulmonologists that are out there. When we are looking at, and I'll come on and talk about the evolution of our sales strategy, but when we first looked at the 50% of patients who are managed in primary care, what we underappreciated, I think, at launch was that the number of primary care physicians out there, north of 250,000, we challenged whether that was an addressable market for us. when we are looking at and i'll come on and talk about the evolution of our sales strategy but when we first looked at the 50% of patients who are managed in primary care what we underappreciated i think at launch was that the number of primary care physicians out there north of 250,000 we challenged whether that was an addressable market for us I think as time evolved and we understood more of the market through claims data, what we realized is actually those patients with nodules are concentrated in a very addressable number of primary care physicians. i think as time evolved and we understood more of the market through claims data what we realized is actually those patients with nodules are concentrated in a very addressable number of primary care physicians You can see on the slide, about 15,000 primary care physicians manage about 80% of pulmonary nodules. you can see on the slide about 15,000 primary care physicians manage about 80% of pulmonary nodules That became a much more addressable market for us and something similar to the specialty call point in the universe of pulmonologists that are out there. that became a much more addressable market for us and something similar to the specialty call point in the universe of pulmonologists that are out there The goal here, as you can see in this slide, is let's funnel through and concentrate those high-risk individuals at the specialty call point, keep lower-risk individuals out in primary care, out in the community, where they can be safely monitored under a watchful waiting protocol with serial CT scans and imaging. Looking at the evolution of our sales strategy over time, really at launch back in 2020, our goal was to develop advocates. We called on the thought leaders in the space, pulmonologists with a specialty interest and knowledge in diagnosing lung cancer. The goal there was to develop confidence within that call point, within that community, and ultimately develop advocacy so that they would endorse the use of Nodify upstream of themselves. Those KOLs, largely they're proceduralists. They're interested in doing bronchoscopies. That's the diagnostic procedure for lung cancer. The goal here, as you can see in this slide, is let's funnel through and concentrate those high-risk individuals at the specialty call point, keep lower-risk individuals out in primary care, out in the community, where they can be safely monitored under a watchful waiting protocol with serial CT scans and imaging. the goal here as you can see in this slide is let's funnel through and concentrate those high-risk individuals at the specialty call point keep lower-risk individuals out in primary care out in the community where they can be safely monitored under a watchful waiting protocol with serial ct scans and imaging Looking at the evolution of our sales strategy over time, really at launch back in 2020, our goal was to develop advocates. looking at the evolution of our sales strategy over time really at launch back in 2020 our goal was to develop advocates We called on the thought leaders in the space, pulmonologists with a specialty interest and knowledge in diagnosing lung cancer. we called on the thought leaders in the space pulmonologists with a specialty interest and knowledge in diagnosing lung cancer The goal there was to develop confidence within that call point, within that community, and ultimately develop advocacy so that they would endorse the use of Nodify upstream of themselves. the goal there was to develop confidence within that call point within that community and ultimately develop advocacy so that they would endorse the use of nodify upstream of themselves Those KOLs, largely they're proceduralists. those kols largely they're proceduralists They're interested in doing bronchoscopies. they're interested in doing bronchoscopies That's the diagnostic procedure for lung cancer. that's the diagnostic procedure for lung cancer They want to see the highest risk patients, right? They want to spend less time in the clinic assessing patients for risk, more time in the bronch suite doing procedures, diagnostic procedures, and ultimately finding those lung cancers. Our goal then moved on from developing advocacy within that call point. Once that was done, we leveraged and mobilized those thought leaders to educate their referral base. Initially, that was pulmonologists, the rest of the pulmonology community, to use Nodify, help triage patients by risk, and then refer in the highest-risk individuals. What we then found as volumes grew and really the advocates and the thought leaders became more and more confident with Nodify, is that their referral base isn't just in community pulmonology, it's also in primary care as well. They want to see the highest risk patients, right? they want to see the highest risk patients right They want to spend less time in the clinic assessing patients for risk, more time in the bronch suite doing procedures, diagnostic procedures, and ultimately finding those lung cancers. they want to spend less time in the clinic assessing patients for risk more time in the bronch suite doing procedures diagnostic procedures and ultimately finding those lung cancers Our goal then moved on from developing advocacy within that call point. our goal then moved on from developing advocacy within that call point Once that was done, we leveraged and mobilized those thought leaders to educate their referral base. once that was done we leveraged and mobilized those thought leaders to educate their referral base Initially, that was pulmonologists, the rest of the pulmonology community, to use Nodify, help triage patients by risk, and then refer in the highest-risk individuals. initially that was pulmonologists the rest of the pulmonology community to use nodify help triage patients by risk and then refer in the highest-risk individuals What we then found as volumes grew and really the advocates and the thought leaders became more and more confident with Nodify, is that their referral base isn't just in community pulmonology, it's also in primary care as well. what we then found as volumes grew and really the advocates and the thought leaders became more and more confident with nodify is that their referral base isn't just in community pulmonology it's also in primary care as well They pulled us into that environment within their referral network. Educating primary care physicians as well as pulmonologists in the use of Nodify testing, again, to help triage patients by risk and funnel those highest-risk individuals into the specialty call point. Through claims data and other analyses, as I say, we really narrowed that call point down to about 15,000 individuals in primary care who manage 80% of nodules. Very addressable for us and very manageable in terms of an educational goal for using Nodify testing. Looking at the sales structure today, we've split the country into 50 sales territories. They pulled us into that environment within their referral network. they pulled us into that environment within their referral network Educating primary care physicians as well as pulmonologists in the use of Nodify testing, again, to help triage patients by risk and funnel those highest-risk individuals into the specialty call point. educating primary care physicians as well as pulmonologists in the use of nodify testing again to help triage patients by risk and funnel those highest-risk individuals into the specialty call point Through claims data and other analyses, as I say, we really narrowed that call point down to about 15,000 individuals in primary care who manage 80% of nodules. through claims data and other analyses as i say we really narrowed that call point down to about 15,000 individuals in primary care who manage 80% of nodules Very addressable for us and very manageable in terms of an educational goal for using Nodify testing. very addressable for us and very manageable in terms of an educational goal for using nodify testing Looking at the sales structure today, we've split the country into 50 sales territories. looking at the sales structure today we've split the country into 50 sales territories The anchor sales position within each of those territories is the pulmonology sales consultant, and as we layer in additional resources, we really look at what the business opportunity and business need is within each of those territories and decide to layer in an account manager where business is maturing. That associate sales consultant, really their job is to go in, farm tests, manage accounts with existing business, potentially grow business in existing accounts, but that frees up the pulmonology sales consultant to go win new business. As we've transitioned into primary care, we've layered in a specialty role there. The general practice sales consultant, as we call them, focused on primary care. Really, they are layered in where we have that advocate in place, that interest in pushing diagnostic testing out into the community into primary care. The anchor sales position within each of those territories is the pulmonology sales consultant, and as we layer in additional resources, we really look at what the business opportunity and business need is within each of those territories and decide to layer in an account manager where business is maturing. the anchor sales position within each of those territories is the pulmonology sales consultant and as we layer in additional resources we really look at what the business opportunity and business need is within each of those territories and decide to layer in an account manager where business is maturing That associate sales consultant, really their job is to go in, farm tests, manage accounts with existing business, potentially grow business in existing accounts, but that frees up the pulmonology sales consultant to go win new business. As we've transitioned into primary care, we've layered in a specialty role there. that associate sales consultant really their job is to go in farm tests manage accounts with existing business potentially grow business in existing accounts but that frees up the pulmonology sales consultant to go win new business. as we've transitioned into primary care we've layered in a specialty role there The general practice sales consultant, as we call them, focused on primary care. the general practice sales consultant as we call them focused on primary care Really, they are layered in where we have that advocate in place, that interest in pushing diagnostic testing out into the community into primary care. really they are layered in where we have that advocate in place that interest in pushing diagnostic testing out into the community into primary care We leverage that advocate, work very closely with them to educate primary care on appropriate use of Nodify testing, and really drive tests out into the community from that standpoint. That has been a tremendous success. I would say, going into primary care, that's a call point that is very familiar with diagnostic testing. They run diagnostic tests every day. They have capability for blood draws in-house, typically. Really it was primed for that educational need, and it's really just a case of educating them on, one, what Nodify is as a test, but really what to do with the results. Who to keep hold of, what that looks like, then who to refer into the specialty call point. We leverage that advocate, work very closely with them to educate primary care on appropriate use of Nodify testing, and really drive tests out into the community from that standpoint. we leverage that advocate work very closely with them to educate primary care on appropriate use of nodify testing and really drive tests out into the community from that standpoint That has been a tremendous success. that has been a tremendous success I would say, going into primary care, that's a call point that is very familiar with diagnostic testing. i would say going into primary care that's a call point that is very familiar with diagnostic testing They run diagnostic tests every day. they run diagnostic tests every day They have capability for blood draws in-house, typically. they have capability for blood draws in-house typically Really it was primed for that educational need, and it's really just a case of educating them on, one, what Nodify is as a test, but really what to do with the results. really it was primed for that educational need and it's really just a case of educating them on one what nodify is as a test but really what to do with the results Who to keep hold of, what that looks like, then who to refer into the specialty call point. who to keep hold of what that looks like then who to refer into the specialty call point Talking more about that, I'm going to hand back to Robbie, who's going to talk about each of the individual Nodify tests and really how they're applied for nodules of different sizes. Talking more about that, I'm going to hand back to Robbie, who's going to talk about each of the individual Nodify tests and really how they're applied for nodules of different sizes. talking more about that i'm going to hand back to robbie who's going to talk about each of the individual nodify tests and really how they're applied for nodules of different sizes

Speaker 3: Between the territory-based sales structure and our product attributes, we're uniquely positioned to penetrate this entire market opportunity. Historically, one of the ways that clinicians looked at this patient population was based on nodule size. Even the pulmonary guidelines separate out this patient population based on nodule size. Our products have been designed to address the unique clinical needs and identify lung cancer earlier within each of these patient populations. On the right side here, with the larger size lung nodules, guidelines suggest more of a dealer's choice based on clinical judgment of what's the appropriate next steps. Our tests are designed there to prioritize and triage patients so that the limited specialty resources can focus on the highest risk patient population, and avoid those delayed diagnoses that we talked about earlier. Between the territory-based sales structure and our product attributes, we're uniquely positioned to penetrate this entire market opportunity. between the territory-based sales structure and our product attributes we're uniquely positioned to penetrate this entire market opportunity Historically, one of the ways that clinicians looked at this patient population was based on nodule size. historically one of the ways that clinicians looked at this patient population was based on nodule size Even the pulmonary guidelines separate out this patient population based on nodule size. even the pulmonary guidelines separate out this patient population based on nodule size Our products have been designed to address the unique clinical needs and identify lung cancer earlier within each of these patient populations. our products have been designed to address the unique clinical needs and identify lung cancer earlier within each of these patient populations On the right side here, with the larger size lung nodules, guidelines suggest more of a dealer's choice based on clinical judgment of what's the appropriate next steps. on the right side here with the larger size lung nodules guidelines suggest more of a dealer's choice based on clinical judgment of what's the appropriate next steps Our tests are designed there to prioritize and triage patients so that the limited specialty resources can focus on the highest risk patient population, and avoid those delayed diagnoses that we talked about earlier. our tests are designed there to prioritize and triage patients so that the limited specialty resources can focus on the highest risk patient population and avoid those delayed diagnoses that we talked about earlier On the left side here in these smaller nodules, conventionally these are patients that may not receive any follow-up at all, but really the default would be to do some sort of mid to long term follow-up there and see if anything changes, if the nodule grows or becomes more suspicious for lung cancer. With our tests deployed in this patient population, we're enabling this needle in a haystack of finding those very few patients in the small nodule population that should be looked at closer, that should be referred to a specialist faster and not miss that window for early detection of lung cancer and improved patient outcomes. We've seen some great anecdotes in our early experience in primary care, really across both of these patient populations. On the left side here in these smaller nodules, conventionally these are patients that may not receive any follow-up at all, but really the default would be to do some sort of mid to long term follow-up there and see if anything changes, if the nodule grows or becomes more suspicious for lung cancer. on the left side here in these smaller nodules conventionally these are patients that may not receive any follow-up at all but really the default would be to do some sort of mid to long term follow-up there and see if anything changes if the nodule grows or becomes more suspicious for lung cancer With our tests deployed in this patient population, we're enabling this needle in a haystack of finding those very few patients in the small nodule population that should be looked at closer, that should be referred to a specialist faster and not miss that window for early detection of lung cancer and improved patient outcomes. with our tests deployed in this patient population we're enabling this needle in a haystack of finding those very few patients in the small nodule population that should be looked at closer that should be referred to a specialist faster and not miss that window for early detection of lung cancer and improved patient outcomes We've seen some great anecdotes in our early experience in primary care, really across both of these patient populations. we've seen some great anecdotes in our early experience in primary care really across both of these patient populations Some of the excitement is coming in the small nodules, where historically there wasn't much that clinicians could do except for wait and see. Now with our tests, they're able to be more aggressive and find more of those opportunities for early detection of lung cancer. One of the tools that we created early after launch was a data visualization tool for us to be able to monitor in a commercial setting, does test performance match what we saw in early clinical studies. Also to drive adoption and demonstrate utility within individual practices. Here are two different ways that we can visualize the data. In both, on the left side are patients and their risk of having lung cancer prior to Nodify testing, and then next to it is their risk after receiving Nodify testing. Some of the excitement is coming in the small nodules, where historically there wasn't much that clinicians could do except for wait and see. some of the excitement is coming in the small nodules where historically there wasn't much that clinicians could do except for wait and see Now with our tests, they're able to be more aggressive and find more of those opportunities for early detection of lung cancer. now with our tests they're able to be more aggressive and find more of those opportunities for early detection of lung cancer One of the tools that we created early after launch was a data visualization tool for us to be able to monitor in a commercial setting, does test performance match what we saw in early clinical studies. one of the tools that we created early after launch was a data visualization tool for us to be able to monitor in a commercial setting does test performance match what we saw in early clinical studies Also to drive adoption and demonstrate utility within individual practices. also to drive adoption and demonstrate utility within individual practices Here are two different ways that we can visualize the data. here are two different ways that we can visualize the data In both, on the left side are patients and their risk of having lung cancer prior to Nodify testing, and then next to it is their risk after receiving Nodify testing. in both on the left side are patients and their risk of having lung cancer prior to nodify testing and then next to it is their risk after receiving nodify testing What you can see is that many patients were really in the middle of that risk profile. Conventional tools are limited in that many patients do fall into that middle ground where there's not clear next steps. After conducting Nodify testing, you can see that patients are really pushed up or down into more clear clinical next steps, whether that be aggressive with intervention or continue to monitor with CT surveillance, but really providing a lot more clarity at a large scale, across an entire patient population. This tool was so effective in our early conversations with physicians, that we've looked at other ways that we can use that to demonstrate clinical utility and most recently have added the ability to show clinical decision change. What you can see is that many patients were really in the middle of that risk profile. what you can see is that many patients were really in the middle of that risk profile Conventional tools are limited in that many patients do fall into that middle ground where there's not clear next steps. conventional tools are limited in that many patients do fall into that middle ground where there's not clear next steps After conducting Nodify testing, you can see that patients are really pushed up or down into more clear clinical next steps, whether that be aggressive with intervention or continue to monitor with CT surveillance, but really providing a lot more clarity at a large scale, across an entire patient population. after conducting nodify testing you can see that patients are really pushed up or down into more clear clinical next steps whether that be aggressive with intervention or continue to monitor with ct surveillance but really providing a lot more clarity at a large scale across an entire patient population This tool was so effective in our early conversations with physicians, that we've looked at other ways that we can use that to demonstrate clinical utility and most recently have added the ability to show clinical decision change. this tool was so effective in our early conversations with physicians that we've looked at other ways that we can use that to demonstrate clinical utility and most recently have added the ability to show clinical decision change Physicians, what they were going to do prior to Nodify testing and then how Nodify testing actually informed a change in decision or change in treatment plan for that patient. This has presented a lot of new opportunities for publications and generating evidence on clinical utility from our commercially tested patient population. Speaking of evidence, we've been publishing for over 10 years on these two tests now, really working through the evolution of clinical data to support clinical and payer adoption. Most recently, just a few months ago, we published the largest clinical validation study for a lung nodule biomarker ever published in "Future Oncology," and have many more opportunities going forward to continue to add to our extensive evidence base. One of the studies I wanted to highlight today is called CLARIFY. Physicians, what they were going to do prior to Nodify testing and then how Nodify testing actually informed a change in decision or change in treatment plan for that patient. physicians what they were going to do prior to nodify testing and then how nodify testing actually informed a change in decision or change in treatment plan for that patient This has presented a lot of new opportunities for publications and generating evidence on clinical utility from our commercially tested patient population. this has presented a lot of new opportunities for publications and generating evidence on clinical utility from our commercially tested patient population Speaking of evidence, we've been publishing for over 10 years on these two tests now, really working through the evolution of clinical data to support clinical and payer adoption. speaking of evidence we've been publishing for over 10 years on these two tests now really working through the evolution of clinical data to support clinical and payer adoption Most recently, just a few months ago, we published the largest clinical validation study for a lung nodule biomarker ever published in "Future Oncology," and have many more opportunities going forward to continue to add to our extensive evidence base. most recently just a few months ago we published the largest clinical validation study for a lung nodule biomarker ever published in "future oncology," and have many more opportunities going forward to continue to add to our extensive evidence base One of the studies I wanted to highlight today is called CLARIFY. one of the studies i wanted to highlight today is called clarify CLARIFY also leverages the broad adoption we've seen in the commercial setting, by doing a retrospective chart review of patients that were tested by physicians in the real world. Our ultimate goal for CLARIFY is 3,000-4,000 patients. Because of the study design, it's highly efficient, and we're approaching almost 2,000 patients enrolled in under 24 months in that study. The data from that study actually informed the 2026 publication that large clinical validation with over 1,100 patients in it, was bolstered by an interim analysis of the CLARIFY study. We're not stopping there. We have other planned interim analyses for the CLARIFY study that will allow us to look at new pieces of information like time to diagnosis. If we can demonstrate faster time to diagnosis, then we know we're having a positive impact on patient care and lung nodule management as a whole. CLARIFY also leverages the broad adoption we've seen in the commercial setting, by doing a retrospective chart review of patients that were tested by physicians in the real world. clarify also leverages the broad adoption we've seen in the commercial setting by doing a retrospective chart review of patients that were tested by physicians in the real world Our ultimate goal for CLARIFY is 3,000- 4,000 patients. our ultimate goal for clarify is 3,000- 4,000 patients Because of the study design, it's highly efficient, and we're approaching almost 2,000 patients enrolled in under 24 months in that study. because of the study design it's highly efficient and we're approaching almost 2,000 patients enrolled in under 24 months in that study The data from that study actually informed the 2026 publication that large clinical validation with over 1,100 patients in it, was bolstered by an interim analysis of the CLARIFY study. the data from that study actually informed the 2026 publication that large clinical validation with over 1,100 patients in it was bolstered by an interim analysis of the clarify study We're not stopping there. we're not stopping there We have other planned interim analyses for the CLARIFY study that will allow us to look at new pieces of information like time to diagnosis. we have other planned interim analyses for the clarify study that will allow us to look at new pieces of information like time to diagnosis If we can demonstrate faster time to diagnosis, then we know we're having a positive impact on patient care and lung nodule management as a whole. if we can demonstrate faster time to diagnosis then we know we're having a positive impact on patient care and lung nodule management as a whole One of the conventional risk classification tools is PET imaging. We're also going to look at, through this CLARIFY study, the performance of Nodify tests in combination or in sequence with PET imaging. A lot of exciting opportunities for us to continue to advance this evidence package and continue to establish ourselves in market leaders for lung nodule risk classification. One of the conventional risk classification tools is PET imaging. one of the conventional risk classification tools is pet imaging We're also going to look at, through this CLARIFY study, the performance of Nodify tests in combination or in sequence with PET imaging. we're also going to look at through this clarify study the performance of nodify tests in combination or in sequence with pet imaging A lot of exciting opportunities for us to continue to advance this evidence package and continue to establish ourselves in market leaders for lung nodule risk classification. a lot of exciting opportunities for us to continue to advance this evidence package and continue to establish ourselves in market leaders for lung nodule risk classification

Speaker 2: Really the goal here is to continue to drive market penetration. If you look back at the original slides and the numbers, we mentioned that there were 5 million-6 million nodules found annually in the U.S. It's important to point out that about 90% of those are actually found incidentally. That means a patient turns up at the emergency room, having broken a rib, broken a collarbone, something that causes an image, CT, X-ray to be taken of their chest, and that incidentally, they find a pulmonary nodule in there. There's a lot of talk and noise around screening efforts in lung cancer, and unfortunately just with low-dose CT screening, it hasn't been a huge amount of success since those guidelines came into place over a decade ago now. About 10% of nodules are found through screening. Really the goal here is to continue to drive market penetration. really the goal here is to continue to drive market penetration If you look back at the original slides and the numbers, we mentioned that there were 5 million-6 million nodules found annually in the U.S. if you look back at the original slides and the numbers we mentioned that there were 5 million-6 million nodules found annually in the u.s It's important to point out that about 90% of those are actually found incidentally. it's important to point out that about 90% of those are actually found incidentally That means a patient turns up at the emergency room, having broken a rib, broken a collarbone, something that causes an image, CT, X-ray to be taken of their chest, and that incidentally, they find a pulmonary nodule in there. that means a patient turns up at the emergency room having broken a rib broken a collarbone something that causes an image ct x-ray to be taken of their chest and that incidentally they find a pulmonary nodule in there There's a lot of talk and noise around screening efforts in lung cancer, and unfortunately just with low-dose CT screening, it hasn't been a huge amount of success since those guidelines came into place over a decade ago now. there's a lot of talk and noise around screening efforts in lung cancer and unfortunately just with low-dose ct screening it hasn't been a huge amount of success since those guidelines came into place over a decade ago now About 10% of nodules are found through screening. about 10% of nodules are found through screening Overall, screening penetration is now probably in the mid-teens. About 15% of patients who are eligible for low-dose CT screening actually get screened. There's a lot of noise and a lot of talk around upstream of those low-dose CT imaging blood tests that are coming into play looking at either detecting single-cancer early detection, so dedicated at looking for lung cancer or multi-cancer early detection, really where you're using a blood test to identify individuals who are high risk of cancer, really anywhere in the body. The goal of those tests is to funnel them into, in this case, low-dose CT for detecting lung cancer. What we're looking at there, and we're strong advocates of those tests being successful because they will increase the addressable market. Overall, screening penetration is now probably in the mid-teens. overall screening penetration is now probably in the mid-teens About 15% of patients who are eligible for low-dose CT screening actually get screened. about 15% of patients who are eligible for low-dose ct screening actually get screened There's a lot of noise and a lot of talk around upstream of those low-dose CT imaging blood tests that are coming into play looking at either detecting single-cancer early detection, so dedicated at looking for lung cancer or multi-cancer early detection, really where you're using a blood test to identify individuals who are high risk of cancer, really anywhere in the body. there's a lot of noise and a lot of talk around upstream of those low-dose ct imaging blood tests that are coming into play looking at either detecting single-cancer early detection so dedicated at looking for lung cancer or multi-cancer early detection really where you're using a blood test to identify individuals who are high risk of cancer really anywhere in the body The goal of those tests is to funnel them into, in this case, low-dose CT for detecting lung cancer. the goal of those tests is to funnel them into in this case low-dose ct for detecting lung cancer What we're looking at there, and we're strong advocates of those tests being successful because they will increase the addressable market. what we're looking at there and we're strong advocates of those tests being successful because they will increase the addressable market If you think of that paradigm shift going from 10% of screen-detected nodules or nodules being screen-detected, really the more patients that we find that get channeled into screening modalities like low-dose CT, that's only going to increase. The addressable market is increasing and already we have a ton of runway even with the number of nodules that are detected today to drive growth. A tremendous amount of opportunity that's only going to increase with the adoption and the improvements in blood-based tests that are driving patients in for screening. There's also new tests coming out, really AI layers that go on top of CT scans that are going to enhance the ability of a radiologist or a pulmonologist to detect nodules within that CT scan itself. If you think of that paradigm shift going from 10% of screen-detected nodules or nodules being screen-detected, really the more patients that we find that get channeled into screening modalities like low-dose CT, that's only going to increase. if you think of that paradigm shift going from 10% of screen-detected nodules or nodules being screen-detected really the more patients that we find that get channeled into screening modalities like low-dose ct that's only going to increase The addressable market is increasing and already we have a ton of runway even with the number of nodules that are detected today to drive growth. the addressable market is increasing and already we have a ton of runway even with the number of nodules that are detected today to drive growth A tremendous amount of opportunity that's only going to increase with the adoption and the improvements in blood-based tests that are driving patients in for screening. a tremendous amount of opportunity that's only going to increase with the adoption and the improvements in blood-based tests that are driving patients in for screening There's also new tests coming out, really AI layers that go on top of CT scans that are going to enhance the ability of a radiologist or a pulmonologist to detect nodules within that CT scan itself. there's also new tests coming out really ai layers that go on top of ct scans that are going to enhance the ability of a radiologist or a pulmonologist to detect nodules within that ct scan itself Both of those will continue to develop and grow the market opportunity for Nodify testing in the coming year and beyond. All right. With that, I think I'm going to hand on to Robin, who's going to talk through some of our financials. Both of those will continue to develop and grow the market opportunity for Nodify testing in the coming year and beyond. both of those will continue to develop and grow the market opportunity for nodify testing in the coming year and beyond All right. all right With that, I think I'm going to hand on to Robin, who's going to talk through some of our financials. with that i think i'm going to hand on to robin who's going to talk through some of our financials

Speaker 4: Thanks, Kieran. As Scott mentioned at the beginning, we had another fantastic quarter with our revenue growing 42% year-over-year. I'll talk a little bit more about the drivers of that here in a moment, primarily driven by the great work being done by Kieran and Robbie and their teams in reaching more physicians and more patients every single quarter. We have really a handful of goals. We're very much focused on driving our top-line revenue growth, but also getting to cash flow positivity. The best way to do that is to be very effective and efficient. We're extraordinarily pleased to be able to share our 82% gross margin for the quarter, which is now several quarters in a row of greater than 80%, which is market leading in diagnostics. Thanks, Kieran. thanks kieran As Scott mentioned at the beginning, we had another fantastic quarter with our revenue growing 42% year-over-year. as scott mentioned at the beginning we had another fantastic quarter with our revenue growing 42% year-over-year I'll talk a little bit more about the drivers of that here in a moment, primarily driven by the great work being done by Kieran and Robbie and their teams in reaching more physicians and more patients every single quarter. i'll talk a little bit more about the drivers of that here in a moment primarily driven by the great work being done by kieran and robbie and their teams in reaching more physicians and more patients every single quarter We have really a handful of goals. we have really a handful of goals We're very much focused on driving our top-line revenue growth, but also getting to cash flow positivity. we're very much focused on driving our top-line revenue growth but also getting to cash flow positivity The best way to do that is to be very effective and efficient. the best way to do that is to be very effective and efficient We're extraordinarily pleased to be able to share our 82% gross margin for the quarter, which is now several quarters in a row of greater than 80%, which is market leading in diagnostics. we're extraordinarily pleased to be able to share our 82% gross margin for the quarter which is now several quarters in a row of greater than 80% which is market leading in diagnostics That gross margin improvement year-over-year of 300-basis point improvement was driven not only by improvements in our reimbursement and our average revenue per test, but also improvements in our operations. We continued to strive to become more efficient and effective in the lab and in the rest of our operations, and we were able to decrease our average price per test paid. We also made substantial improvements on our path to profitability, where we saw a 35% improvement in Adjusted EBITDA and improvements in our net loss in the quarter. We are anticipating and are projecting that we will, thank you, hit cash flow positivity by the end of the year. As I mentioned, our revenue is being driven by multiple factors, so not just the improvement in volume. That gross margin improvement year-over-year of 300-basis point improvement was driven not only by improvements in our reimbursement and our average revenue per test, but also improvements in our operations. that gross margin improvement year-over-year of 300-basis point improvement was driven not only by improvements in our reimbursement and our average revenue per test but also improvements in our operations We continued to strive to become more efficient and effective in the lab and in the rest of our operations, and we were able to decrease our average price per test paid. we continued to strive to become more efficient and effective in the lab and in the rest of our operations and we were able to decrease our average price per test paid We also made substantial improvements on our path to profitability, where we saw a 35% improvement in Adjusted EBITDA and improvements in our net loss in the quarter. we also made substantial improvements on our path to profitability where we saw a 35% improvement in adjusted ebitda and improvements in our net loss in the quarter We are anticipating and are projecting that we will, thank you, hit cash flow positivity by the end of the year. we are anticipating and are projecting that we will thank you hit cash flow positivity by the end of the year As I mentioned, our revenue is being driven by multiple factors, so not just the improvement in volume. as i mentioned our revenue is being driven by multiple factors so not just the improvement in volume We saw 29% growth in test volumes, but we are also seeing strong improvement in average revenue per test, and that is being driven by increasing numbers of private payers covering our tests and improvements in our operations and our revenue cycle management. We saw a large increase in average revenue per test in the third quarter of last year based off of a variety of projects and initiatives in the organization, and that ASP improvement has continued and proven to be durable over the last several quarters, resulting in 37% growth in lung diagnostic revenue for the quarter. Moving to our guidance. As Scott mentioned, we beat and raised, so raised our full-year revenue target to $108 million-$114 million for the year, which represents 25% year-over-year growth. We also reiterated that our gross margins would remain at or above that 80% best-in-class mark. We saw 29% growth in test volumes, but we are also seeing strong improvement in average revenue per test, and that is being driven by increasing numbers of private payers covering our tests and improvements in our operations and our revenue cycle management. we saw 29% growth in test volumes but we are also seeing strong improvement in average revenue per test and that is being driven by increasing numbers of private payers covering our tests and improvements in our operations and our revenue cycle management We saw a large increase in average revenue per test in the third quarter of last year based off of a variety of projects and initiatives in the organization, and that ASP improvement has continued and proven to be durable over the last several quarters, resulting in 37% growth in lung diagnostic revenue for the quarter. we saw a large increase in average revenue per test in the third quarter of last year based off of a variety of projects and initiatives in the organization and that asp improvement has continued and proven to be durable over the last several quarters resulting in 37% growth in lung diagnostic revenue for the quarter Moving to our guidance. moving to our guidance As Scott mentioned, we beat and raised, so raised our full-year revenue target to $108 million-$114 million for the year, which represents 25% year-over-year growth. as scott mentioned we beat and raised so raised our full-year revenue target to $108 million-$114 million for the year which represents 25% year-over-year growth We also reiterated that our gross margins would remain at or above that 80% best-in-class mark. we also reiterated that our gross margins would remain at or above that 80% best-in-class mark Continued to talk about getting to cash flow positivity by the end of the year. Being effective and efficient is one of our key priorities for the organization, we can give you five minutes back. Continued to talk about getting to cash flow positivity by the end of the year. continued to talk about getting to cash flow positivity by the end of the year Being effective and efficient is one of our key priorities for the organization, we can give you five minutes back. being effective and efficient is one of our key priorities for the organization we can give you five minutes back

Speaker 1: Great. Thanks, Kieran. We'll wrap there. The breakout will be in Burnham B. Great. great Thanks, Kieran. thanks kieran We'll wrap there. we'll wrap there The breakout will be in Burnham B. the breakout will be in burnham b

Speaker 2: Burnham B. Burnham B. burnham b

Speaker 1: Thanks, everyone. Thanks, everyone. thanks everyone

Speaker 2: Thank you. Thank you. thank you