Caredx, Inc. · NASDAQ:CDNA
Caredx — Investor Presentation (February 2026)
35 slides from Caredx's investor presentation, Feb 12, 2026
Slide 1: AlloHeme: Advancing AI-Enabled Relapse Monitoring in AML & MDS Post-Cell Therapy
AlloHeme : Advancing AI-Enabled Relapse Monitoring in AML & MDS Post-Cell Therapy Positioning CareDx to lead in precision medicine for cell therapy Investor Webcast February 12, 2026
Slide 2: Safe Harbor Statement
Safe Harbor Statement These slides and the accompanying oral presentation contain forward-looking statements. All statements other than statements of historical fact contained in this presentation, including statements regarding the future business plans and objectives, potential growth opportunitie
Slide 3: John Hanna, President & Chief Executive Officer
John Hanna President & Chief Executive Officer 3
Slide 4: Our Vision and Mission
Our Vision A world where every patient receives the transplant they need to live longer, fuller lives. Our Mission Create life-changing solutions that enable transplant patients to thrive.
Slide 5: Our Solutions Transform the Care of Transplant Patients
Our Solutions Transform the Care of Transplant Patients 200K+ 70% NGS-based HLA typing kits sold of US transplant centers use at least annually one CareDx software solution 25 years of transplant technology 1M+ 150K+ innovation XX% Molecular tests performed to Transplant prescriptions filled monitor
Slide 6: CareDx is the Market Leader in Solid Organ Transplant
CareDx is the Market Leader in Solid Organ Transplant IVD Kits, software & patient solutions, and testing services across the care continuum Kidney Liver Heart Lung Multi-Organ Transplants Annually ~28,000 ~12,500 ~4,600 ~3,500 ~860 CareDx Services Over 200 Solid Organ Transplant Centers Across the
Slide 7: The Next Frontier for CareDx: Cell Therapy
The Next Frontier for CareDx: Cell Therapy High-severity High-cost care Care delivered by a Opportunity for CareDx hematologic pathways, with many concentrated group of to be first-to-market and malignancies where patients having received highly specialized cell take a leading role in diagnostic ins
Slide 8: Monitoring Solutions for Two Cell Therapy Modalities
Monitoring Solutions for Two Cell Therapy Modalities CareDx’s first Transplant+ indications are fast-growing and complex care settings Allogeneic HCT CAR-T Cell Therapy • Treat with systemic chemotherapy to eliminate diseased cells • Collect and genetically modify patient’s own T-cells with the Chim
Slide 9: Cell Therapy is a Growing Market
Cell Therapy is a Growing Market CareDx Transplant+ solutions for cell therapy address a significant and expanding share of the hematology market Annual Patient Diagnoses by Hematologic Sub-Type Expected Continued Growth in Allogeneic HCT & CAR-T Allogeneic HCT CAR-T Forecast (2024-2028) Large B-Cel
Slide 10: Addressing Critical Unmet Needs in Cell Therapy
Addressing Critical Unmet Needs in Cell Therapy Designed to monitor relapse and therapeutic efficacy in patients undergoing HCT & CAR-T B AML MDS DLBCL ALL MM Acute Myeloid Leukemias Myelodysplastic Syndromes Diffuse Large B-Cell Lymphoma Acute Lymphoblastic Leukemia Multiple Myeloma Existing Commer
Slide 11: AlloHeme: a Novel Monitoring Test for Cancer Relapse Prediction
AlloHeme: a Novel Monitoring Test for Cancer Relapse Prediction Post-Allogeneic HCT for AML/ MDS Patients Peripheral blood Leverages NGS technology Proprietary AI Provides a Positive or sample to measure micro changes algorithm incorporates Negative result for in cell populations longitudinal data f
Slide 12: Jeff Teuteberg, MD, Chief Medical Officer
Jeff Teuteberg, MD Chief Medical Officer 12
Slide 13: AML and MDS patients need relapse surveillance post-HCT
AML and MDS patients need relapse surveillance post-HCT Consolidation Therapy Surveillance Diagnosis Induction therapy Additional chemo and/or targeted Tx Patient diagnosed Goal of achieving and risk stratified complete remission Allogeneic Transplant Surveillance & relapse monitoring Donor selectio
Slide 14: Frequent surveillance & relapse monitoring post allogeneic transplant
Frequent surveillance & relapse monitoring post allogeneic transplant for 1-2 years Transplant Center Follow Up -1yr Shared Care with Primary Hematologist -2yr HCT Month 1 Month 6 Year 1 Year 1.5 Year 2 Frequent monitoring for: Transplant physician monitors for: • Engraftment • Chronic GVHD • Acute
Slide 15: Current Tool Limitations in Universal Relapse Monitoring
Current Tool Limitations in Universal Relapse Monitoring AlloHeme provides a non-invasive, universal, and sensitive detection platform Chimerism (STR-PCR) MRD (MFC, qPCR, NGS) AlloHeme Lower sensitivity for relapse Sensitivity for detection (used to measure Low for MFC-MRD ✓ High Sensitivity Relapse
Slide 16: Dr. Ran Reshef, MD, MSc
Dr. Ran Reshef, MD, MSc Professor of Medicine at Columbia University and Director of Translational Research, Blood and Marrow Transplantation Program at Herbert Irving Comprehensive Cancer Center 16
Slide 17: ACROBAT Results: Peripheral Blood-Based AlloHeme Test Enables Robust Relapse Surveillance
Acrobat Results: Peripheral Blood-Based AlloHeme Test Enables Robust Relapse Surveillance in Post-HCT AML and MDS Patients (2-Year Analysis) • Ran Reshef1*, Stefan Ciurea2*, Ronald Sobecks3, Iskra Pusic4, Nelli Bejanyan5, Sagar S. Patel6, Arpita Gandhi7, Vamsi Kota8, Nabeel Rajeh9, Piyanuch Kongtim2
Slide 18: Relapse Monitoring After Allo-HCT: Persistent Challenges
Relapse Monitoring After Allo-HCT: Persistent Challenges in Improving Survival Outcomes Existing MRD tools have limitations for Universal Relapse Monitoring2,3 Relapse remains the main cause of death at STR-PCR MFC qPCR/dPCR NGS or beyond 100 days post-transplant1 Sensitivity 1-5% ~10⁻³–10⁻⁴ ~10⁻⁴–1
Slide 19: ACROBAT Study Design
ACROBAT Study Design: Prospective observational study to evaluate AlloHeme performance Study • Prospective observational cohort study to evaluate AlloHeme performance to detect Overview relapse in patients with hematologic malignancies (AML, ALL and MDS) Number of • 285 enrolled patients received HC
Slide 20: ACROBAT Study: AML+MDS Cohort
ACROBAT Study: AML+MDS Cohort Patient Disposition AML + MDS Cohort 227 subjects enrolled 29 subjects excluded for early events / inadequate testing by Day 49, precluding AlloHeme results: • 4 subjects with early relapse • 4 subjects with early NRM • 4 subjects with early withdrawals • 17 subjects wi
Slide 21: Landmark analyses: AlloHeme positive at increased risk for relapse
Landmark analyses at 2, 3, and 6 months showed that the subjects positive for AlloHeme are at increased risk for post-HCT relapse 2 months post HCT 3 months post HCT 6 months post HCT HR = 6.3 HR = 11.9 HR = 5.9 (95%CI: 5.0-28.2) (95%CI: 2.1-16.8) (95%CI: 2.6-15.4) The AlloHeme+ group comprises all
Slide 22: Landmark analyses: increased risk of relapse or death
Landmark analyses at 2, 3, and 6 months showed that the subjects positive for AlloHeme are at increased risk for post-HCT relapse or death 2 months post HCT 3 months post HCT 6 months post HCT HR = 5.2 HR = 6.2 HR = 4.1 (95%CI: 2.5-11.2) (95%CI: 3.1-12.4) (95%CI: 1.7-9.6) The AlloHeme+ group compris
Slide 23: AlloHeme Assay Performance
AlloHeme Assay Performance AlloHeme ROC curve Relapse No Relapse AlloHeme positive 34 9 AlloHeme negative 6 109 85% Sensitivity 92% Specificity Test Performance 95% NPV 79% PPV AUC=0.89 Performance Cohort Characterization: • ≥2 valid AlloHeme tests • Excluding NRM and Withdrawals, Total Subjects n=1
Slide 24: AlloHeme Positive Signal Occurred a Median 41 Days Before Clinical Relapse
AlloHeme Positive Signal Occurred a Median 41 Days Before Clinical Relapse Relapses with AlloHeme Positive (n=34) Lead time Median (IQR) 41 (19 – 85) Lead Time Mean ± SD 101 ± 153 Median: 41 days Note: No statistical difference was observed between lead time in AML and MDS cohorts
Slide 25: AlloHeme performance is consistent across subgroups
AlloHeme performance is consistent across subgroups strata Sub-group N total N relapse Sensitivity Specificity PPV NPV AUC P sens P spec Disease Group (AML vs AML 114 27 0.85 0.92 0.77 0.95 0.89 1 1 MDS) MDS 44 13 0.85 0.94 0.85 0.94 0.89 Related 55 15 0.87 0.93 0.81 0.95 0.90 1 1 Donor Type Unrelat
Slide 26: AlloHeme has higher sensitivity and longer lead time than real-world chimerism
AlloHeme has significantly higher sensitivity and longer lead time in detecting relapse compared to real-world chimerism testing Tests per Lead time patient N N to Relapse Test (Median Sensitivity Specificity PPV NPV AUC Total Relapse (Median IQR) IQR) AlloHeme 158 40 11 (8-12) 0.85 0.92 0.79
Slide 27: AlloHeme superior to real-world MRD testing in ACROBAT
AlloHeme showed a superior sensitivity, NPV and improved lead time compared to real-world MRD testing in ACROBAT Lead time Tests per to Total Relapse patient Test Sensitivity Specificity PPV NPV AUC Relapse (n) (n) (Median (Median IQR) IQR) AlloHeme 158 40 11 (8-12) 0.85 0.92 0.79 0.95 0.89 4
Slide 28: Case study from ACROBAT
Case study from ACROBAT • 77yo Female • AML with minimal differentiation (FAB M0). ELN 2017 – adverse risk. Relapse (8% blasts per IHC) FISH: -5, -17/abn(17p); Mol: DNMT3A, TP53, NF1 • Disease status: CR MRD+ before HCT • Donor: MUD, Male Days post transplant to clinical relapse • Conditioning: Non-
Slide 29: Conclusions
Conclusions 1. AlloHeme is a blood-based, NGS-driven, multi-analyte test powered by AI for early and accurate relapse detection in post-HCT AML and MDS patients. 2. ACROBAT 2-year follow up shows strong performance in relapse detection: AUC 89%, Sensitivity 85%, Specificity 92%, NPV 95% and PPV 79%.
Slide 30: John Hanna, President & Chief Executive Officer
John Hanna President & Chief Executive Officer 30
Slide 31: Allogeneic HCT is a Growing Market
Allogeneic HCT is a Growing Market Transplant Growth Drivers: 2030 Projected AML & MDS Incidence and Estimated Proportion Eligible for HCT Growing AML & MDS population MDS HCT Eligible TAM Est. MDS Non- 5,000 ~$1Bn Increasing referrals for Cell Therapy HCT Eligible AML HCT 6,000 Eligible 16,500 AML
Slide 32: AlloHeme Launch Timeline
AlloHeme Launch Timeline Planned path to commercialization & revenue contribution 2026 2027 2028 • ACROBAT Publication • Commercial Launch • Medicare Coverage Est. Submission • Coverage Submission • Revenue Contribution • CLIA Readiness
Slide 33: Total Solutions Strategy
Total Solutions Strategy Cell therapy expected to integrate seamlessly into the comprehensive, end-to-end strategy employed in solid organ transplantation Pre-Transplant Peri-Transplant Post-Transplant Cell Therapy Relapse Detection & Therapy Monitoring Lab Products – HLA Kits Testing Services CareD
Slide 34: Thank you.
Thank you. © 2025 CareDx, Inc. All service marks or trademarks are owned or licensed by CareDx, Inc. or its affiliates. All rights reserved. VXXX-XXX-XXXXX-vX. Effective 2025-XX.
Slide 35: Q&A
Q&A © 2025 CareDx, Inc. All service marks or trademarks are owned or licensed by CareDx, Inc. or its affiliates. All rights reserved. VXXX-XXX-XXXXX-vX. Effective 2025-XX.