Insight Molecular Diagnostics Inc. · NASDAQ:IMDX
Insight Molecular Diagnostics — Investor Presentation (March 2026)
37 slides from Insight Molecular Diagnostics's investor presentation, March 2026
Slide 1: Investor Presentation
Investor Presentation NASDAQ:IMDX March 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: Decentralize access to novel molecular diagnostic testing
MISSION Decentralize access to novel molecular diagnostic testing to improve patient outcomes 3 iMDxinc.com
Slide 4: 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 4
Slide 5: iMDx Investment Summary
• Disruptive approach to molecular diagnostic testing: Empower local labs to test in-house with kits, versus sending out to central labs iMDx • Proven credibility in first strategic market: Kidney transplant(1) • Go-to-market strategic partner and investor, Bio-Rad Investment Laboratories • Science-
Slide 6: Sending patient samples across the country is a waste of time
Sending patient samples across the country is a waste of time. 6 iMDxinc.com
Slide 7: Innovative science meets simple business model
Innovative science meets simple business model 7 iMDxinc.com
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 kitted test iMDxinc.com 8
Slide 9: Building a kitted product engine
Building a kitted product engine ü High Clinical Demand ü Strong Reimbursement ü IP Protected 9 iMDxinc.com
Slide 10: Full R&D pipeline to fuel decade of growth
Full R&D pipeline to fuel decade of growth Transplant Transplant Oncology Oncology iMDxinc.com The rest of the presentation will focus 10 on transplant, our near-term priority
Slide 11: Regulated transplant testing is a $2B+ greenfield global opportunity
Regulated transplant testing is a $2B+ greenfield global opportunity Source: 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 12: 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 13: 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 14: IP Protected
iIMDx" insight Molecular Diagnostics IP Protected «2, United States Patent Schutz et al. ‘USO1I155872B2 US 11,155,872 B2 Oct. 26, 2021 20) Patent No.: (45) Date of Patent: ($4) DETECTION AND QUANTIFICATION OF DONOR CELL-FREE DNA IN THE CIRCULATION OF ORGAN TRANSPLANT RECIPIENTS (71) Applicant: CHRON
Slide 15: Customers want a kitted product
Customers want a kitted product Large market opportunity iMDxinc.com
Slide 16: GraftAssureDx planned for 2026
GraftAssureDx … planned for 2026 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 Diagnostic US Pate
Slide 17: How we win: Deliver what decision makers want
How we win: Deliver what decision makers want Transplant Lab Hospital Physicians Directors Administrators ü Control ü In-house testing ü Revenue ü Fast turnaround ü Simple workflow generation times ü Full data access opportunities ü Ability to ü Research- conduct their forward own research reputatio
Slide 18: 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 HLA Typing Graft Markers (Kidney) Viral Load PCR DSA Screen PRA
Slide 19: We are not building this alone
+ Strategic Partnership ü Bio-Rad (NYSE: BIO) is a top five shareholder and has made four equity investments in iMDx ü Our test runs on the Bio-Rad platform ü Coordinated rapid development of test kits ü Opportunity for partnership expansion, milestone-based investments We are not building this alon
Slide 20: iMDx + Bio-Rad
iMDx + Bio-Rad üDemonstrating clinical utility of digital PCR üOpening academic hospital core and HLA labs to Bio-Rad platform ü2026: Expect to receive FDA clearance for GraftAssureDx (kidney) for the QX600Dx üGoal of showcasing the digital PCR advantage in heart iMDx product development team member
Slide 21: GraftAssure Deployments
GraftAssure Deployments Ø 22 Sites Transplant Center Laboratory Customer Location RUO FDA Pilot Trial Ø 9 Countries Thomas Jefferson University Pennsylvania, US ü ü University Hospital Lab Singapore ü Ø 3 Continents Large Hospital Lab Switzerland ü Ø Institutes planning to publish The Charité, Humbo
Slide 22: Goal of expanding rapidly into heart transplant testing
After FDA submission for GraftAssureDx (kidney) in March 2026 Goal of expanding rapidly into heart transplant testing $105 million estimated TAM in the United States $240 million estimated TAM globally ü Significance of cfDNA results of heart will increase site adoption ü Higher testing frequency pe
Slide 23: Heart: The Digital PCR Advantage
Heart: The Digital PCR Advantage Analytical Performance 0.25% 0.20% Threshold for acute rejection in heart 0.15% recipients (5) 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 Detectio n Lower Limit of Quantification GraftAssur
Slide 24: IP attractive to industry partners
IP attractive to industry partners Multiple strategic partnership opportunities IP Category Products Product Partner Service Lab Partner Bio-Rad signed Q2 National reference lab Organ Transplant 2024, potential for signed Q1 2026, expansion potential for expansion Development letter of Oncology Ther
Slide 25: Compelling business model
Compelling High-value creation Empowers doctors to reduce uncertainty to make better business decisions to save lives. Enables researchers to measure biomarkers to inspire innovation. model High-value capture Intellectual property protects our market position, commands high reimbursement rates, and
Slide 26: 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 27: 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 investor • Empower local labs with kits • U.S. Medicare (CMS) reimbursement • Industry leader Bio-Rad • Stronger
Slide 28: Appendix
MDx Insight Molecular Diagnostics Appendix iMDxinc.com
Slide 29: Molecular diagnostics 101
Molecular diagnostics 101 Molecular – rela/ng to or consis/ng of molecules, which are groups Molecular diagnostic testing combines laboratory tes/ng of atoms bonded together, represen/ng the smallest fundamental with the precision of molecular biology and has revolu/onized the unit of a chemical com
Slide 30: 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 31: 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 publication
Slide 32: 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 32
Slide 33: 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 AACC Academy Distinguished Abstract Award pre
Slide 34: Our formula
Our formula Regulated +Reimbursed +Clinically Useful =Rapid Adoption 34 iMDxinc.com
Slide 35: iMDx's product appeal
iMDx’s product appeal Transplant ü easy to use and centers want ü returns a same day answer that is ü clinically actionable and a test that is ü cost effective Important regulatory note: GraftAssureCore, formerly known as VitaGraft Kidney LDT, has clinical claim. iMDx is pursuing regulatory IVD auth
Slide 36: Compelling Patent Portfolio
Compelling Patent Portfolio !"#! !$!%" &'()!*+ #!,!(# -,!")!.)(I0"* $##("1.1,!" -,!")!."2-$*,!$') !"#"$%FG()* +$,-#F#".GFI0"$.1--,02F#"3.G2$045F#2I6.(405"20.1023.72,%F$8"$- 9I2#"3.J#F#"-.,;.1%"$20F )--4"3 <=><?@@A B"C.>MN.>=<F !"0.@N.>=G>.H.MI@.3FJ-.+O1 !"#"$%FG() 7$"F-#.GFI0"$.1--,02F#"3.G2$045F#2I
Slide 37: Insight Molecular Diagnostics
Insight Molecular Diagnostics
Insight Molecular Diagnostics — Investor Presentation (March 2026) on 6ix