NeoGenomics, Inc.

Our recent acquisition of Pathline, a New York State-approved lab based in New Jersey, gives us a meaningful presence in the Northeast, which is the number three cancer care market in the U.S. We believe the addition of Pathline allows us to offer significantly faster turnaround times, a larger and relevant New York State-approved test menu, and an enhanced physician experience in the Northeast region, where we have historically been underpenetrated. The integration continues to proceed according to the plan that we communicated when we announced the transaction in March, including the validation of critical turnaround time-sensitive assays, which was completed during the third quarter. We remain positive about the impact that the acquisition will have in accelerating our growth in the Northeast, and we're on track to capture operational efficiencies and synergies that we anticipate will be accretive to profitability beginning in 2026. Together with our world-class commercial team, we have deep relationships with hospitals, cancer centers, and oncologists across the country. We're winning the customer experience by enabling precision oncology in the community setting, where adoption of next-generation testing has historically lagged behind NCI-designated cancer centers. Our customers increasingly view us as the partner of choice for all of their testing needs as their patients advance along their cancer care journeys. We offer one of the broadest menus in the industry, with more than 500 tests focused solely on oncology. Our menu spans everything from diagnostics to next-generation sequencing for therapy selection to MRD for cancer recurrence and monitoring. This makes NEO an ideal partner for institutions and practices who are looking to consolidate send-down testing to simplify operational workflows and improve patient experience. The therapy selection in MRD markets represent more than $40 billion of addressable market opportunity, both of which are growing rapidly and are relatively underpenetrated. Needless to say, the ongoing investments that we make in R&D, as well as the potential BD partnerships, are focused on these areas. This is particularly true of MRD, where we think we can create significant value while introducing innovation to the cancer testing market where it's needed most, in the community setting. We also remain committed to our next-gen MRD research program, focused on generating IP that is entirely separate and distinct from our radar portfolio. Given our broad menu and strong brand recognition in the community setting, coupled with a competitive MRD test, we believe we will capture market share over time as we add additional indications to this modality. While Jeff will provide a detailed review of our financials in a moment, I'd like to hit a few highlights from our third quarter. Our clinical business continued to perform well, driven by volume and share gains in key segments. As expected, non-clinical revenue declined in the quarter due to lower revenue from pharma and biotech customers. Total revenue for Q3 was $188 million, representing double-digit growth of 12% year-over-year. Our clinical business continued its robust growth, generating revenue growth of 15%, excluding the pathline acquisitions. The clinical performance was driven by effective execution of our commercial strategy, protect, expand, and acquire. In the third quarter, we again saw a sequential improvement in AUP, a record quarter for test volumes and NGS revenue growth of 24%, well ahead of the low to mid-teens NGS market growth rate. The five NGS products launched in 2023 contributed 24% of clinical revenue in the quarter. We continue to see demand for our non-NGS modalities as well, with all modalities growing above market, which resulted in record volumes, up 10.4% versus prior year on a same-store basis. The non-clinical portion of our business accounted for less than 9% of our total revenue in the third quarter and was down from the prior year, consistent with our expectations. Turning now to our radar ST test. In August, the District Court for the Middle District of North Carolina granted our motion for summary judgment that all of Natera's asserted patent claims are invalid for claiming ineligible subject matter. The court dismissed Natera's claims against neogenomics with prejudice and entered a declaratory judgment of invalidity of both of Natera's asserted patents. The ruling paves the way for us to broadly commercialize RadarST, formerly Radar 1.1. We launched RadarST for biopharma customers in Q3, and while some of these efforts could result in bookings in Q4 of 25, the lead times necessary to obtain samples make it more likely that we'll begin recognizing revenue from biopharma customers in 2026. We have received Mold DX approval for RadarST in subsets of head and neck and breast cancer. We're preparing for a robust launch of this important assay in the clinical oncology setting in Q1 of 2026. We estimate that MRD cancer surveillance and monitoring represents a $30 billion addressable market, growing at a 30% CAGR. And with the market penetration of less than 10%, we believe we are well positioned as the cancer testing partner of choice in the community setting. to capitalize on this lucrative market and deliver a differentiated and integrated MRD solution to our oncology customers. In parallel with our Radar ST launch preparedness activities, we continue to focus our R&D investments in next-generation MRD, demonstrating our long-term commitment to the MRD space, as well as complementary targeted partnerships that allow us to fill in MRD product gaps that we don't currently address in an effort to deliver a unique, industry-leading, MRD portfolio to the market. Now turning to Pantrazor LBX, our liquid biopsy genomic profiling test that delivers comprehensive, clinically actionable insights from a simple blood draw. Pantrazor LBX is a non-invasive blood-based test that analyzes circulating tumor DNA to identify key genomic alterations that inform treatment decisions in patients with advanced stage solid tumors. Pantracer LBX, together with our Pantracer tissue test, form a comprehensive portfolio capable of delivering a holistic genomic picture of the patient in support of therapy selection. With an average turnaround time of just seven days, Pantracer LBX empowers real-time decision-making. Recall that last quarter we elected to delay the commercial launch of Pantracer LBX so that we could incorporate learnings from our evaluation assessment program to improve the product profile. In preparation for a full clinical launch, we allowed select physicians to use the assay on a limited basis ahead of commercial availability. The EAP, which was very well subscribed and helped us further enhance the assay clinically and optimize the launch by testing and identifying the opportunities to streamline logistics, reporting, and customer support. With the benefit of valuable lessons we garnered from our EAP, we launched the product in late July, three months later than expected. Based on the interest we're seeing, I believe the delay allowed us to introduce a better product, which will further support the strong NGS volumes we are capturing this year and position us well for continued growth in 2026. We continue to work with MoldDx on our Pantracer LBX submission and will provide additional updates as they become available. As it pertains to our full year 2025 guidance, based on the strength in our clinical business and expected performance in our non-clinical business that I just reviewed, We are reiterating the revised guidance for consolidated revenue, adjusted EBITDA, and net loss that we provided last quarter. I'm incredibly optimistic about our future, particularly as we continue to innovate in the large and rapidly growing NGS and MRD markets, and further leverage our leading presence in the community setting, where as much as 80% of cancer care is delivered to patients. And with that, I'll hand it over to Jeff to further discuss our results from the quarter.

Thanks, Tony, and good morning. Third quarter total revenue grew sequentially by 4% from Q2 and increased by 12% over prior year to $188 million. Total clinical revenue continued with strong double-digit growth and increased by 18% from prior year. This strong clinical growth was partially offset by non-clinical revenue climbing by 27% versus prior year, driven by weakness in the pharma revenue Tony spoke about. Adjusted gross profit improved by $5.2 million, or 7% over prior year. Adjusted EBITDA was $12.2 million, the ninth consecutive quarter of positive earnings. Clinical volumes and revenues continued with robust growth in the quarter. Total test volumes increased by 15% in the third quarter, with AUP growth of 3%. Same-store revenue without contribution from Pathline was $167 million, representing growth of 15%, driven by a 10% increase in test volumes and a 4% increase in AUP. We are continuing to see strength across our portfolio with above-market growth rates across the modalities we offer. NGS revenues grew by 24% over a prior year and a quarter and accounted for 33% of total clinical revenue. Year-to-date NGS revenues grew by 22% over a prior year. Average revenue for clinical tests increased sequentially from Q2 by $15, or 3%, and was up by 3% from prior year. Excluding Pathline, AUP increased by $17, or 4% from Q2, and was also up 4% over prior year. A larger percentage of higher value tests, including NGS, as well as recent managed care pricing increases, are helping to drive higher AUP. Total operating expenses in the quarter were $107 million, an increase of $11 million or 12%. We recorded an additional $7 million in impairment charges related to the planned sale of Trapello, with the balance of the cost increased due to higher compensation costs driven by the expansion of the commercial sales team. Cash flow from operations was a positive $9 million in the quarter, and we ended the quarter with total cash of $164 million, up slightly from Q2. Our balance sheet and expected cash flow will enable us to continue to invest in our business to drive organic growth, increase operating efficiencies, and fund future business development opportunities, including licensing and partnerships. We continue to see traction from the investments we have made to expand and enhance our commercial organization with our strong test volume growth. The LIMS project remains on track, and we expect to deliver operating efficiencies in 2026 and 2027 through the consolidation of multiple LIMS systems and reduction in redundant operating costs, as well as streamlining our lab operations. We remain committed to driving long-term shareholder value through targeted investments in the business and improved operational execution. As Tony noted, we are reiterating our full-year guidance that we updated in the second quarter We expect full-year consolidated revenue will be in the range of $720 to $726 million, representing growth of 9 to 10% over full-year 2024. We anticipate adjusted EBITDA to be in the range of $41 to $44 million, representing growth of 3 to 10%. And we expect full-year net loss to be in the range of $116 to $108 million, representing an increase of 37% to 47% as compared to our full-year 2024 net loss of $79 million. We will release our 2026 guidance when we report our full 2025 full-year earnings in February of 2026. With that, I'll turn the call back to Tom. Thanks, Jeff.

To recap, during the third quarter, we again delivered strong clinical volumes in revenue, while advancing NGS and MRD initiatives that we believe will contribute to accelerating growth in 2026 and beyond. We believe our unwavering focus on delivering a superior customer experience in the community setting is resonating in the marketplace. And as we continue to expand our menu of tests, community oncologists and pathologists will continue to view us as a partner of choice for their cancer testing and send out consolidation needs. We remain committed to innovation and operational excellence, which we believe will drive sustainable and profitable growth for our company and improve outcomes for patients. Thank you for your continued interest in neogenomics. Operator, this concludes our prepared remarks, so please open the line for questions.