Aprea Therapeutics (NasdaqCM:APRE) FY Conference February 26, 2026 08:40 AM ET Company ParticipantsOren Gilad - President and CEONone - AssociateNoneMorning, everyone, thanks for joining us. My name is Anthony, and I'm an associate here at Oppenheimer. It's my pleasure to introduce Aprea Therapeutics, a precision oncology company focused on targeting the DNA damage response pathway. Their lead program is APRN-1051, a next-gen WEE1 inhibitor. The company is also advancing ATRN-119, a macrocyclic ATR inhibito ...

Core Insights - NeoGenomics, Inc. has launched a new pan-solid tumor assay called PanTracer Pro, aimed at assisting clinicians in navigating complex molecular testing workflows for patients with advanced-stage solid tumors [1][2] - The company has reported a significant increase in its stock price, with shares rising 82.4% over the past six months, outperforming the industry and the S&P 500 Index [3] - NeoGenomics' revenues have shown a consistent upward trend, with a 36.6% increase from 2021 to 2024, and preliminary results for 2025 indicate a year-over-year sales growth of 10% to $727 million [4][5] Product Development - The PanTracer Pro assay is designed to streamline testing processes in precision oncology, combining DNA and RNA sequencing of over 500 cancer-related genes with tumor-specific ancillary testing [6][10] - This new assay aims to reduce diagnostic complexity and turnaround time, facilitating timely treatment decisions for cancer patients [2][10] - In cases where tissue samples are insufficient, clinicians can transition to the PanTracer LBx liquid biopsy assay without restarting the diagnostic process, thus avoiding delays in patient care [11] Financial Performance - NeoGenomics reported Q4 sales of approximately $190 million, reflecting an 11% increase year over year, and anticipates continued double-digit growth in 2026 [8][12] - The company expects ongoing top-line growth driven by the increasing adoption of precision oncology and its comprehensive suite of oncology tests [5][8] Market Position - The launch of PanTracer Pro is expected to enhance NeoGenomics' competitive position in the precision oncology market by addressing the challenges of fragmented testing workflows and supporting personalized treatment planning [9][10] - The company currently holds a Zacks Rank of 2 (Buy), indicating a favorable outlook compared to other stocks in the medical sector [13]

Core Insights - Nuvalent is advancing its drug development programs for ROS1 and ALK-positive non-small cell lung cancer (NSCLC), focusing on differentiated drug profiles and regulatory strategies to enhance market opportunities [1][4][11]. ROS1 Program - The FDA accepted Nuvalent's New Drug Application (NDA) for zidesamtinib in TKI-pretreated ROS1-positive NSCLC, with a PDUFA date set for September 18 [4]. - The company is prioritizing a broader, line-agnostic ROS1 label, having aligned with the FDA on a six-month follow-up post-response for previously treated patients, which supports an earlier submission [2]. - As of June last year, Nuvalent enrolled 104 patients in the frontline cohort, exceeding requirements and maintaining enrollment due to strong interest [2]. ALK Program - Nuvalent completed a pre-NDA meeting with the FDA for NVL-655 in TKI-pretreated ALK-positive NSCLC and plans to submit an NDA in the first half of the year [3]. - The company is conducting the phase 3 ALCAZAR study in TKI-naïve ALK patients, with a focus on demonstrating durability and safety [3][8]. - Porter highlighted that NVL-655 shows greater durability compared to lorlatinib, with over 60% of patients still responding at 1.5 years [8]. Commercial Strategy - Nuvalent is shifting its strategy to pursue global commercialization independently, citing the importance of maintaining flexibility and optionality in a changing pricing environment [11]. - The company ended the previous year with approximately $1.4 billion in cash, providing operational runway into 2029, although it has not confirmed full funding for its global expansion plans [13]. Market Outlook - The ROS1 market is projected to grow to resemble the current ALK market, estimated at over $2 billion, while the ALK market could expand to be 2-3 times larger than the EGFR market [14]. - Historically, ALK and ROS1 have seen a high share of sales outside the U.S., with 65%-70% attributed to international markets [15]. Pipeline Development - Nuvalent's lead candidates include NVL-520, a selective RET inhibitor, and NVL-655, targeting KRAS G12D mutations, with ongoing efforts to ensure clear clinical narratives for their HER2 program [17][18][16].

Core Insights - Guardant Health has launched a Community Colorectal Cancer Screening Grant Program to enhance access to colorectal cancer screening during March, which is Colorectal Cancer Awareness Month [1] - The program will provide selected organizations with up to 100 Shield tests at no cost to support community health fairs, screening events, and educational outreach [1] - Shield is the first FDA-approved blood test for colorectal cancer screening for adults aged 45 and older at average risk, offering a more convenient option compared to traditional methods [1] Company Initiatives - The grant program aims to remove barriers to screening, particularly in underserved communities, and supports organizations that focus on health outreach [1] - Applications for the grant are open until February 17, 2026, with notifications of approval sent on February 20, 2026 [1] - Organizations interested in applying are encouraged to review the Request for Proposals and complete the application form [1] Product Information - Shield is a non-invasive blood-based screening test that detects alterations associated with colorectal cancer, intended for individuals aged 45 and older at average risk [1] - A positive result from the Shield test indicates the need for further evaluation through colonoscopy [1] - Guardant Health is focused on transforming patient care and accelerating cancer therapies through advanced testing and analytics [1]

Core Insights - NeoGenomics has launched PanTracer Pro, a new integrated testing approach aimed at improving the selection of therapies for patients with advanced-stage solid tumors by providing earlier biomarker insights and reducing diagnostic uncertainty [1][2] Group 1: Product Features - PanTracer Pro integrates comprehensive genomic profiling (CGP) with diagnosis-directed immunohistochemistry (IHC) and ancillary testing tailored to tumor type, allowing for a more streamlined testing process [1] - The turnaround time for PanTracer Pro tests is 8–10 days, facilitating timely treatment decisions in real-world clinical settings [1] - The product aims to identify clinically relevant biomarkers that may be overlooked in incomplete testing, thus supporting therapy selection and personalized treatment planning [1] Group 2: Market Context - As precision oncology evolves, clinicians are facing increased complexity in diagnostics and biomarker requirements, necessitating quicker treatment initiation often before complete molecular profiles are available [1] - The fragmented nature of current testing workflows can lead to delays in patient care, which PanTracer Pro seeks to address by providing a coordinated testing approach [1] Group 3: Company Overview - NeoGenomics, Inc. is a leading provider of oncology diagnostic solutions, specializing in cancer genetics testing and information services, with a comprehensive testing menu serving various stakeholders in the oncology field [1]

Core Insights - Lunai Bioworks has launched a new oncology collaboration to analyze data from a Phase 2 metastatic colorectal cancer trial, aiming to identify high-benefit patient subgroups for investigational therapy [1][2] - The collaboration will utilize Lunai's Augusta AI platform to evaluate patient-level clinical and imaging data, focusing on overall survival and disease progression [2][3] - The initiative reflects the growing trend of integrating AI in clinical trials to enhance patient stratification and optimize trial design, potentially accelerating drug approval processes [4][5] Company Strategy - Lunai Bioworks aims to generate data-driven enrichment strategies that will aid in FDA trial design, including optimized inclusion criteria and endpoint strategies [3][4] - The collaboration is initially a pilot project but has the potential to expand into a broader commercial program if successful, with applications across various tumor types and adaptive trial designs [4][5] - The company positions itself at the intersection of machine learning, precision oncology, and clinical trial optimization, responding to the pharmaceutical industry's demand for AI-enabled patient stratification [5][6] Patient Stratification - Patient stratification involves dividing trial participants into subgroups based on characteristics like biomarkers and disease severity, which enhances trial power and minimizes bias [6] - This approach allows for the detection of treatment effects in specific patient subsets, improving the likelihood of identifying those who benefit most from the therapy [6]

Core Viewpoint - Erasca, Inc. is actively participating in investor conferences in February 2026 to enhance visibility and engagement with potential investors [1][2]. Company Overview - Erasca, Inc. is a clinical-stage precision oncology company focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers [3]. - The company aims to "erase cancer" by creating novel therapies and combination regimens that comprehensively target the RAS/MAPK pathway [3]. - Erasca's team includes leading pioneers in precision oncology and is supported by a scientific advisory board of experts in the RAS/MAPK pathway, positioning the company to achieve its mission [3]. Upcoming Events - Erasca will participate in the Guggenheim Emerging Outlook: Biotech Summit 2026 on February 11-12, 2026, with a fireside chat scheduled for February 12 at 1:00 pm Eastern Time [2]. - The company will also be part of the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25-26, 2026, with a fireside chat on February 26 at 11:20 am Eastern Time [2]. - Live audio webcasts of these events will be available on Erasca's website, with archived replays accessible for 30 days post-event [2].

Company Overview - Natera (NTRA) has submitted a premarket approval (PMA) application to the FDA for its Signatera CDx test, a personalized molecular residual disease (MRD) assay for muscle-invasive bladder cancer (MIBC) [1][6] - The PMA submission is a significant regulatory milestone for Natera, positioning Signatera CDx as a companion diagnostic to guide adjuvant immunotherapy decisions in MIBC [6][8] Clinical Data and Implications - The application is supported by positive phase 3 IMvigor011 trial data, which demonstrated improved survival outcomes in MRD-positive patients treated with Tecentriq, while MRD-negative patients showed a low risk of recurrence without additional therapy [2][9] - The trial results were strong enough to be featured in a Presidential Symposium at the ESMO Congress and published in The New England Journal of Medicine, enhancing credibility within the oncology community [10] Market Position and Growth Potential - If approved, Signatera CDx could serve as a long-term growth catalyst for Natera by expanding its MRD platform's role from monitoring to treatment decision-making [4][11] - The companion diagnostic status is expected to increase adoption among oncologists, strengthen partnerships with pharmaceutical companies, and support broader reimbursement coverage, leading to higher testing volumes and more sustainable revenue streams [4][11] Financial Performance - Natera's stock has surged 69.2% over the past six months, significantly outperforming the industry growth of 18.1% and the S&P 500's rise of 12.4% [3] - The current market capitalization of Natera stands at $31.97 billion [5] Industry Outlook - The global precision oncology market is projected to grow from an estimated $115.80 billion in 2024 to $201.96 billion by 2030, with a compound annual growth rate (CAGR) of 8.05% from 2025 to 2030 [12] - Growth in the market is driven by technological advancements, increasing demand for diagnostic solutions that provide clinically actionable insights, and the ability to reduce treatment-related side effects for cancer patients [13]

Core Insights - Prelude Therapeutics has received FDA clearance to proceed with a Phase 1 study for PRT12396, a mutant-selective JAK2V617F inhibitor aimed at treating myeloproliferative neoplasms (MPNs) [1][2] - The company plans to begin dosing the first patient by Q2 of 2026, marking a significant milestone in its strategic focus on JAK2 and KAT6 programs [2] Company Developments - The Phase 1 study will be an open-label, multi-center trial assessing safety, efficacy, and pharmacokinetics in patients with high-risk polycythemia vera (PV) and intermediate to high-risk myelofibrosis (MF) [2] - Prelude's JAK2V617F inhibitor program is under an exclusive option agreement with Incyte, which was announced in November 2025 [3] Scientific Background - JAK2V617F is a key mutation affecting approximately 95% of patients with polycythemia vera, 60% of those with essential thrombocythemia, and 55% of myelofibrosis patients [4] - Prelude has developed novel allosteric inhibitors that specifically target V617F+ cells, which may reduce mutant allele burden and improve treatment outcomes for MPN patients [4] Company Overview - Prelude Therapeutics is focused on precision oncology, developing innovative medicines for cancer patients with high unmet needs [5] - The company's pipeline includes selective KAT6A degraders and JAK2V617F inhibitors, aiming to leverage targeted protein degradation for next-generation therapies [5]

Core Thesis - Gilead Sciences, Inc. is transitioning its focus from HIV and hepatitis C treatments to oncology as a new growth engine, utilizing a strategy of licensing and targeted acquisitions rather than large-scale buyouts [1][2] Oncology Strategy - The recent agreement with Repare Therapeutics enhances Gilead's pipeline in DNA-repair-targeted cancer therapies, with projections indicating that oncology could generate several billion dollars in annual revenue by the latter half of the decade [2] - Gilead's disciplined approach to selective licensing deals and smaller acquisitions reflects a broader trend among pharmaceutical companies facing patent expirations [2] Investment in Emerging Therapies - By investing in RNA therapies, in vivo cell therapies, and long-acting antivirals, Gilead aims to secure multibillion-dollar revenue streams extending into the early 2030s, allowing for quick adaptation to scientific opportunities while maintaining strong cash flow [3] Growth Potential - The combination of an expanding oncology footprint and ongoing innovation in high-value therapeutic areas positions Gilead for sustained growth and significant upside for shareholders over the next decade, presenting an attractive risk/reward profile [4] Historical Performance - Gilead's stock price has appreciated by approximately 36.38% since February 2025, reflecting resilience amid challenges and a strong focus on precision oncology and targeted licensing as long-term growth drivers [5]