46 slides from Insight Molecular Diagnostics's investor presentation, August 2025
Slide 1: Investor Presentation
Investor Presentation NASDAQ:IMDX August 2025 iMDxinc.com
Slide 2: Forward-Looking Statements
Forward-Looking Statements Safe-Harbor Statement This presentation and the accompanying oral presentation contain “forward-looking” statements that are based on the Insight Molecular Diagnostics, Inc.’s (iMDx) management’s beliefs and assumptions and on information currently available to management.
Slide 3: Mission: Democratize access to novel molecular diagnostic testing
MISSION Democratize access to novel molecular diagnostic testing to improve patient outcomes 3 iMDxinc.com
Slide 4: Experienced leadership
Experienced leadership Pioneering Molecular Diagnostics & Disruptive Grow th Josh Riggs Ekkehard Schütz, Yuh-Min (Johnson) Andrea President & Chief MD, PHD, FADLM Chiang, PHD James Executive Officer Chief Science Officer Chief Technology Officer Chief Financial Officer iMDxinc.com 4
Slide 5: Innovative science meets simple business model
Innovative science meets simple business model 5 iMDxinc.com
Slide 6: iMDx Investment Summary
• Disruptive approach to molecular diagnostic testing: Empower local labs with kits, versus central lab model • Proven credibility in first strategic market: Kidney iMDx transplant • Go-to-market strategic partner and equity investment Investment secured • Science-driven team, experienced in molecul
Slide 7: Why invest in molecular diagnostics?
Why invest High-value creation Empowers doctors to reduce uncertainty to make better in molecular decisions to save lives. Enables researchers to measure biomarkers to inspire innovation. diagnostics? High-value capture Intellectual property protects our market position, commands high reimbursement
Slide 8: Kitted: Designing a lab test for a box
Kitted: Designing a lab test for a box iMDx CTO Johnson Chiang holds up GraftAssureIQ at the company’s former headquarters in Irvine, Calif. iMDxinc.com 8
Slide 9: Why kitted products?
Why kitted products? Disruptive & superior Empower our customers (the labs) to capture value. Counter-positioned to the central lab model, which is ripe for disruption with high cash burn. business model Compelling Our decentralized approach puts testing in the hands of researchers to enable more st
Slide 10: Innovation flywheel
Kits enable researchers and Research Global doctors to ask and answer questions Innovation Global dissemination New clinical applications flywheel improves tested & outcomes, inspires discovered more questions Local standard of care protocol improves, along Local with patient Clinical quality of lif
Slide 11: Every clinical indication is a recurring revenue opportunity
Every clinical indication is a recurring revenue opportunity 11 iMDxinc.com
Slide 12: Healthcare disruptive trends
Healthcare disruptive trends 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 toward poi
Slide 13: A pure play on genomics & precision medicine
A pure play on genomics & precision medicine 13 iMDxinc.com
Slide 14: Organ Transplant
iMDx’s first strategic market Organ Transplant iMDxinc.com
Slide 15: Transplant testing matters
Transplant testing matters Kidney transplant patients face a 1 in 5 chance that iMDx’s test finds early their body will reject the evidence of organ donor kidney. damage in the blood. Source on “1 in 5 chance:” Specifically, Antibody-mediated rejection (AMR) is a leading cause of kidney allograft fa
Slide 16: Donor-derived cell-free DNA (dd-cfDNA)
Donor-derived We helped to cell-free DNA establish this (dd-cfDNA) biomarker Sources: Our timeline slide 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 publications twice when it establish
Slide 17: iMDx's proven credibility in transplant
iMDx’s proven credibility in transplant . . . 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 Diagn
Slide 18: New England Journal of Medicine study
Transplant credibility, continued . . . 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
Slide 19: Transplant: Leading the science
Transplant: Leading the science Our centralized assay, GraftAssureCore, has been validated in clinical studies with an aggregate of 1,214 patients and 4,917 samples. 226 Liver Recipients PLoS Med (2017)1, Liver Transpl (2022)2 , Transplantation (2014)3,4 901 Kidney Recipients ERA Congress (2025)5, T
Slide 20: 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 auth
Slide 21: US transplant market
US transplant market In the U.S., donor-derived cell free DNA (dd-cfDNA) testing is Ripe for disruption delivered via restrictive central lab service model. Two companies command ~90% market share1. About 250 kidney transplant centers nationwide. Fewer than 100 Highly concentrated generate ~80% of t
Slide 22: Global transplant underserved
Global transplant underserved Market wants • Central lab model is difficult to implement outside the US, leaving significant unmet demand affordable, • More than $1 billion global transplant testing opportunity* easy-to-use, • Global transplants growing ~9% per year rapid testing • Concentrated cust
Slide 23: PCR workflow: Easy, fast, actionable, affordable
PCR workflow: Easy, fast, actionable, affordable Pre- Digital PCR Results available in amplification 4-8 hours* (RESEARCH USE ONLY) *1 sample – 6 samples 40 minutes 3 – 7 hours Sequence Analysis Library Preparation NGS and Result Results available Example Typical NGS Calculations in ~30 hours Workfl
Slide 24: One IP drives 'land & expand' strategy
Transplant, continued . . . One IP drives ‘land & expand’ strategy Laboratory Developed Research Use In Vitro Diagnostics Tests (LDT) Only Kit (RUO) Kit (IVD) (in development) Innovation center is Land Expand monetizable iMDxinc.com 24
Slide 25: Transplant commercialization strategy (1-3 years)
Transplant commercialization strategy (1 – 3 years) Targeted initial Proof points revenue Innovation Perform testing at our clinical lab. Medicare reimbursement achieved August 2023 and boosted to Actively pursuing center $2,753 per result in May 2025 a partner US funnel of confirmed interest repres
Slide 26: Annual recurring revenue potential
Transplant total addressable market Annual recurring revenue potential Laboratory Research In Vitro Developed Tests Use Only Kit Diagnostics Kit (LDT) (RUO) (IVD) Main long-term focus US market supports $1 billion global TAM today1 $500 million annual revenue, which is Can expand to approximately $2
Slide 27: Key go-to-market strategic partner signed Q2 2024
Transplant: Key go-to-market strategic partner signed Q2 2024 / Partnership Leader in life science and clinical diagnostics Opportunity to disrupt established Innovative transplant monitoring IP markets Global salesforce and distribution Potential for rapid adoption Simplified workflow for ease of u
Slide 28: Transplant strategic partner: Key terms
Transplant strategic partner: Key terms / Partnership • Bio-Rad (NYSE: BIO) now a top five shareholder with upfront equity investment Bio-Rad to help and two subsequent equity investments commercialize • Coordinated rapid development of IVD GraftAssure RUO platform • Co-marketing in US and Germany,
Slide 29: What comes after transplant?
What comes after transplant? 29 iMDxinc.com
Slide 30: Full R&D pipeline, to fuel a decade of growth
Full R&D pipeline, to fuel a decade of growth Transplant Transplant Oncology Oncology iMDxinc.com 30
Slide 31: Oncology
iMDx’s second strategic market Oncology iMDxinc.com
Slide 32: Oncology Pipeline
Oncology Pipeline $2 billion estimated TAM (US only) 2.6 million estimated annual global testing opportunities Sources: Haslam, et al. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7063495/ Study estimates 43.6% of all cancer cases are eligible for immunotherapy. American Cancer Society estimates 2.0
Slide 33: Oncology Pipeline
Oncology Pipeline Tumor Immune Micro-Environment Published/Presented data: ~1,400 patients across 6 tumor types Will patient benefit from immuno-therapy? Medicare (CMS) coverage submission in Q4 2022 Ongoing 800+ patient NIH funded study What is immune status at tumor site? (RESEARCH USE ONLY) Favor
Slide 34: Oncology Pipeline
Oncology Pipeline $4 billion estimated TAM (US Market) 7.8 million estimated annual global testing opportunities Haslam, et al. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7063495/ Study estimates 43.6% of all cancer cases are eligible for immunotherapy and CNI IO therapy monitoring. American Cance
Slide 35: Oncology Pipeline
Oncology Pipeline Copy Number Instability (CNI) Published data: 1,300+ samples across 10 tumor types Favorable study regarding the potential of liquid biopsy for brain Is the cancer therapeutic drug tumors, published in 2024 working? Patents issued in US and EU MolDX: Minimal Residual Disease Testin
Slide 36: IP attractive to industry partners
IP attractive to industry partners Multiple strategic partnership opportunities IP Category Products Product Partner Service Lab Partner Organ Transplant Bio-Rad signed Q2 2024 Actively pursuing Development letter of Oncology Therapy intent with major Selection instrument maker signed Q2 2025 Oncolo
Slide 37: iMDx Investment Summary Recap
iMDx Investment Summary Recap Disruptive approach to Proven credibility in Go-to-market strategic molecular diagnostic first strategic market: partner and equity testing Kidney transplant investment secured • Empower local labs with kits • U.S. Medicare (CMS) • Industry leader Bio-Rad • Better busin
Slide 38: Insight Molecular Diagnostics
TM X Insight Molecular Diagnostics
Slide 39: Appendix
MDx Insight Molecular Diagnostics Appendix iMDxinc.com
Slide 40: Molecular diagnostics 101
Molecular diagnostics 101 Molecular – relating to or consisting of molecules, which Molecular diagnostic testing combines laboratory are groups of atoms bonded together, representing the testing with the precision of molecular biology and has smallest fundamental unit of a chemical compound that can
Slide 41: Transplant: US research market share potential
Transplant: US research market share potential By providing a cost-efficient test for dd-cf DNA, we enable researchers to explore new indications ~800,000 ~2 million Strong international demand for access to technology that has largely been trapped in estimated testing estimated testing central lab
Slide 42: Transplant: US clinical market share potential
Transplant: US clinical market share potential Mature clinical market, with strong + reimbursement ~$500 million US revenue currently generated by competitors Growing demand for decentralized testing at local lab US Reimbursement – $2,753 per result Single-site de novo pathway to establish predicate
Slide 43: Without better testing, most high-risk patients require invasive biopsy
For-cause testing example Without better testing, most high-risk patients require invasive biopsy Potential Problems with Biopsy • Expensive compared to blood test • Increases risk of complications Elevated Kidney Biopsy • Invasive Function Tests iMDxinc.com 43
Slide 44: But with GraftAssureCore, many biopsies are unnecessary
For cause testing example But with GraftAssureCore, many biopsies are unnecessary + Biopsy Elevated Kidney - No Biopsy Up to 86% Function Tests (lower CI: 59%) of biopsies in patients with elevated Creatinine may possibly be avoided by using 1. Oellerich M, Shipkova M, Asendorf T, et al. (2019) Abso
Slide 45: Q2 2025 GAAP P&L
Q2 2025 GAAP P&L $s in thousands Results demonstrate prudent capital management and financial discipline. iMDxinc.com 45
Slide 46: Consolidated Balance Sheets
Consolidated Balance Sheets $s in thousands iMDxinc.com 46