Insight Molecular Diagnostics Inc. · NASDAQ:IMDX
Insight Molecular Diagnostics — Investor Presentation (August 2026)
39 slides from Insight Molecular Diagnostics's investor presentation, August 2026
Slide 1: Investor Presentation
Investor Presentation NASDAQ:IMDX August 2026 iMDxinc.com
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains certain “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “w
Slide 3: Mission
MISSION Decentralize access to novel molecular diagnostic testing to improve patient outcomes iMDxinc.com
Slide 4: iMDx Investment Summary
• Science-driven team, experienced in molecular diagnostics and managing rapid growth • Full R&D pipeline to fuel portfolio expansion over the iMDx next decade • IP portfolio attractive to partners and enables value protection Investment • Disruptive approach to molecular diagnostic testing: Empower
Slide 5: Experienced Leadership
Experienced Leadership Pioneering Molecular Diagnostics & Disruptive Growth Josh Riggs Ekkehard Schütz, Yuh-Min (Johnson) Andrea President & Chief MD, PHD, FADLM Chiang, PHD James Executive Officer Chief Science Officer Chief Technology Chief Financial Officer Officer iMDxinc.com 5
Slide 6: Sending patient samples across the country is a waste of time
Sending patient samples across the country is a waste of time. iMDxinc.com
Slide 7: Kitted: Designing a lab test for a box
Kitted: Designing a lab test for a box iMDx CTO Johnson Chiang holds up GraftAssureIQ kitted test iMDxinc.com 7
Slide 8: Building a kitted product engine
Building a kitted product engine ✓ High Clinical Demand Will doctors order it? ✓ Strong Reimbursement Can we get paid? ✓ IP Protected Do we have a right to sell it? iMDxinc.com
Slide 9: Innovative science meets simple business model
Innovative science meets simple business model iMDxinc.com
Slide 10: Compelling business model
High-value creation Compelling Empowers doctors to reduce uncertainty to make better decisions to save lives. Enables researchers to measure business biomarkers to inspire innovation. model High-value capture Intellectual property protects our market position, commands high reimbursement rates, and
Slide 11: A pure play on major industry tailwinds
A pure play on major industry tailwinds Precision Localized Rapid medicine care care Genomics Diagnostics trend Liquid biopsy is less innovation enables toward the patient. invasive. Digital PCR is personalized Decentralized simple, fast, and easy to medicine. healthcare means the use. market trends
Slide 12: Full R&D pipeline to fuel decade of growth
Full R&D pipeline to fuel decade of growth Transplant Transplant Oncology Oncology The rest of the presentation will focus on iMDxinc.com transplant, our near-term priority 12
Slide 13: GraftAssureDx: Advancing since 2012, available soon
GraftAssureDx: Advancing since 2012, available soon Transplant Product Design, 2012 CMS – Center for Medicaid Services Initial Peer-Reviewed Publication, 20131 LDT – Lab Developed Test RUO – Research Use Only Definitive Clinical Publication, 20192 FDA – US Food and Drug Administration IVD – In Vitro
Slide 14: Transplant hospitals already perform most tests in house
Transplant hospitals already perform most tests in house. Our kits are a natural fit. Matching Immediate Post-Op Intermediate Long-Term Ongoing ABO Blood Typing Therapeutic Drug Monitoring (TDM) dd-cfDNA (Liquid Biopsy) Metabolic Panel Pre-Op HLA Typing PRA / DSA Screen Day 1-7Graft Markers (Kidney)
Slide 15: IP Protected
IMDx’ Insight Molecular Diagno: a2) United States Patent Schutz et al. (10) Patent No.: (45) Date of Patent: US 11,155,872 B2 Oct. 26, 2021 DETECTION AND QUANTIFICATION OF DONOR CELL-FREE DNA IN TH CIRCULATION OF ORGAN TRANSPLANT RECIPIENTS Applicant: CHRONIX BIOMEDICAL, San Jose, CA US) Inventors:
Slide 16: IP attractive to industry partners
IP attractive to industry partners Multiple strategic partnership opportunities IP Category Products Product Partner Service Lab Partner National reference lab Bio-Rad signed Q2 signed Q1 2026, Organ Transplant 2024, potential for potential for additional expansion partners and expansion Development
Slide 17: Customers want a kitted transplant assay
Customers want a kitted transplant assay Large market opportunity iMDxinc.com
Slide 18: High Clinical Demand
High Clinical Demand “High-quality, standardized decentralized dd-cfDNA testing is the essential prerequisite for conducting real-world evidence- generating multicenter studies to establish the appropriate context of use for this promising assay.” – January 2026 conclusion by the American Society of
Slide 19: Strong Reimbursement
Strong Reimbursement U.S. Medicare reimbursement listing of $2,753 per result based on MolDx Test Registry pricing for GraftAssureCore – per CPT code 81479 and DEX Z-code Z0507 (https://app.dexzcodes.com) iMDxinc.com
Slide 20: ~$3B greenfield global opportunity
Regulated transplant testing is a ~$3B greenfield global opportunity Sources: 2024 GODT data supports 128,990 global annual transplants (110,467 for kidney, 10,287 for heart, and 8,236 for lung transplants.) Median graft survival rate of 11.7 years for kidney per SRTR, 11.9 years for heart per ISHLT
Slide 21: Large growing opportunity
Large growing opportunity Concentric Circles: ~$3B Total Addressable Market Upside $500M U.S. kidney, baseline $3.0B Living kidney transplant patients receiving 2 tests per year over the median kidney graft survival rate supports a $500 million TAM $800M $600M + 2026 MolDx Local Coverage Determinati
Slide 22: Large, Concentrated Testing Market
Large, Concentrated Testing Market AN N U AL T R AN S P L AN T S T AR G E T E D C H AN N E L S C E N T E R C O N C E N T R AT I O N M E D I C AR E C O V E R AG E 27,000 2 80% 14 surveillance tests per patient in the first three years U.S. adult kidney recipients in 2025 National reference laboratori
Slide 23: How we win: Deliver what decision makers want
How we win: Deliver what decision makers want Transplant Lab Hospital Physicians Directors Administrators ✓ Control ✓ In-house testing ✓ Revenue ✓ Fast turnaround ✓ Simple workflow generation times ✓ Full data access opportunities ✓ Ability to ✓ Research- conduct their forward own research reputatio
Slide 24: GraftAssure Deployments
GraftAssure Deployments Transplant Center Laboratory Location RUO Pilot FDA Trial (names redacted for competitive sensitivity) 22 9 3 Thomas Jefferson University Pennsylvania, US ✓ ✓ University Hospital Lab Singapore ✓ Large Hospital Lab Switzerland ✓ Sites Countries Continents The Charité, Humboldt
Slide 25: We are not building this alone
+ Strategic Partnership ✓ Bio-Rad (NYSE: BIO) is a top five shareholder and has made four equity investments in iMDx ✓ Our test runs on the Bio-Rad platform ✓ Coordinated rapid development of test kits ✓ Opportunity for partnership expansion, milestone-based investments We are not building this alon
Slide 26: iMDx + Bio-Rad
iMDx + Bio-Rad ✓Demonstrating clinical utility of digital PCR ✓Opening academic hospital core and HLA labs to Bio-Rad platform ✓2026: Expect to receive FDA clearance for GraftAssureDx (kidney) for the QX600Dx ✓Goal of showcasing the digital PCR advantage in heart transplant management iMDx product d
Slide 27: Not stopping at kidney
Not stopping at kidney . . . . . . Goal of expanding rapidly into heart transplant testing >$100 million estimated TAM in the United States Pre-Op ~$250 million estimated TAM globally Day 1-7 Month 1-6 Year 1+ ✓ Rapid development: GraftAssure is designed to be organ-agnostic ✓ Higher testing frequen
Slide 28: Heart: The Digital PCR Advantage
Heart: The Digital PCR Advantage Analytical Performance 0.25% Threshold for acute 0.20% rejection in heart recipients (5) 0.15% 0.10% Lower is better 0.05% because you can pick up signal before there is a 0.00% problem Limit of Blank Lower Limit of Detection Lower Limit of Quantification GraftAssure
Slide 29: iMDx Investment Summary Recap
iMDx Investment Summary Recap Science-driven team, Full R&D pipeline IP portfolio protects experienced in molecular to fuel growth and market position and is diagnostics and rapid portfolio expansion attractive to potential growth over the next decade partners Disruptive approach to Proven credibili
Slide 30: Appendix
MDx Insight Molecular Diagnostics Appendix iMDxinc.com
Slide 31: Molecular diagnostics 101
Molecular diagnostics 101 Molecular – relating to or consisting of molecules, which are groups Molecular diagnostic testing combines laboratory testing of atoms bonded together, representing the smallest fundamental with the precision of molecular biology and has revolutionized the unit of a chemica
Slide 32: Transplant testing matters
Transplant testing matters Kidney transplant patients face a 1 in 5 iMDx’s test finds early chance that their body evidence of organ will reject the donor damage in the blood. kidney. Source on “1 in 5 chance:” Specifically, Antibody-mediated rejection (AMR) is a leading cause of kidney allograft fa
Slide 33: Donor-derived cell-free DNA (dd-cfDNA)
Donor - derived We helped to cell - free DNA establish this (dd - cfDNA) biomarker Sources: Our timeline slide supports this statement, as well as the fact that MolDX, a program that identifies and establishes coverage and U.S. government reimbursement for molecular diagnostic tests, cited our publi
Slide 34: New England Journal of Medicine study
New England Journal of Medicine study • Favorable iMDx GraftAssureCore study results published in NEJM, May 30, 2024 • Data show potential to monitor for therapeutic efficacy and recurrence • Potential repeat testing opportunities with claims expansion iMDxinc.com 34
Slide 35: Transplant: Leading the science
Transplant: Leading the science Our centralized assay, GraftAssureCore, has been validated in clinical studies with an aggregate of 1,248 patients and 5,025 samples. 226 Liver Recipients PLoS Med (2017) 1, Liver Transpl (2022) 2 , Transplantation (2014) 3,4 935 Kidney Recipients Kidney International
Slide 36: Our formula
Our formula Regulated +Reimbursed +Clinically Useful =Rapid Adoption iMDxinc.com
Slide 37: iMDx's product appeal
iMDx’s product appeal Transplant ✓ easy to use and centers want ✓ returns a same day answer that is ✓ clinically actionable and a test that is ✓ cost effective Important regulatory note: GraftAssureCore , formerly known as VitaGraft Kidney LDT, has clinical claim. iMDx is pursuing regulatory IVD aut
Slide 38: Compelling Patent Portfolio
Compelling Patent Portfolio TEST TITLE COUNTRY STATUS PATENT NUMBER ISSUED DATE PATENT EXPIRATION DetermaCNI* Prostate Cancer Associated Circulating Nucleic Acid Biomarkers United States of America Issued 10214775 Feb 26, 2019 Dec 7, 2032 + 687 days PTA DetermaCNI Breast Cancer Associated Circulatin
Slide 39: Insight Molecular Diagnostics
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