Insight Molecular Diagnostics Inc. · NASDAQ:IMDX
Insight Molecular Diagnostics — Oncocyte — Investor Presentation (March 2025)
46 slides from Insight Molecular Diagnostics's investor presentation, March 2025
Slide 1: Investor Presentation
Investor Presentation NASDAQ: OCX March 2025 oncocyte.com
Slide 2: Forward looking statements
Where Tomorrow LIVES Forward looking statements Safe-Harbor Statement This presentation and the accompanying oral presentation contain “forward-looking” statements that are based on Oncocyte’s management’s beliefs and assumptions and on information currently available to management. Any statements t
Slide 3: Mission: democratize access to novel molecular diagnostic testing
Where Tomorrow LIVES MISSION Democratize access to novel molecular diagnostic testing to improve patient outcomes oncocyte.com 3
Slide 4: Experienced leadership
Where Tomorrow LIVES Experienced leadership Pioneering Molecular Diagnostics & Disruptive Growth Josh Riggs Ekkehard Schütz, MD, Yuh-Min (Johnson) Andrea James PHD, FADLM Chiang, PHD President & Chief Executive Officer Chief Science Officer Chief Technology Officer Chief Financial Officer oncocyte.c
Slide 5: Innovative science meets simple business model
Where Tomorrow LIVES Innovative science meets simple business model oncocyte.com 5
Slide 6: Oncocyte Investment Summary
Where Tomorrow LIVES • Disruptive approach to molecular diagnostic testing: Empower local labs with kits, versus central lab model • Proven credibility in first strategic market: Kidney transplant Oncocyte • Go-to-market strategic partner and equity investment secured Investment • Science-driven tea
Slide 7: Why invest in molecular diagnostics?
Where Tomorrow LIVES Why invest in molecular diagnostics? Empowers doctors to reduce uncertainty to make better decisions to save lives. High value creation Enables researchers to measure biomarkers to inspire innovation. Intellectual property protects our market position, commands high reimbursemen
Slide 8: Kitted: Designing a lab test for a box
Where Tomorrow LIVES Kitted: Designing a lab test for a box Oncocyte CTO Johnson Chiang holds up GraftAssure at the company’s headquarters oncocyte.com in Irvine, Calif. 8
Slide 9: Why kitted products?
Where Tomorrow LIVES Why kitted products? Disruptive & Empower our customers (the labs) to capture value. Counter-positioned to the superior business central lab model, which is ripe for disruption with high cash burn. model Our decentralized approach puts testing in the hands of researchers to enab
Slide 10: Innovation flywheel
Where Tomorrow Kits enable Research LIVES researchers and Global doctors to ask and answer questions Innovation flywheel Global dissemination improves outcomes, New clinical applications tested & inspires more discovered questions Local standard of care protocol improves, along with Local patient qu
Slide 11: Every clinical indication is a recurring revenue opportunity
Where Tomorrow LIVES Every clinical indication is a recurring revenue opportunity oncocyte.com 11
Slide 12: Healthcare disruptive trends
Where Tomorrow LIVES Healthcare disruptive trends Precision medicine Genomics innovation enables personalized medicine. Diagnostics trend toward the patient. Decentralized healthcare means the Localized care market trends toward point-of-care testing. Rapid care Liquid biopsy is less invasive. Digit
Slide 13: A pure play on genomics & precision medicine
Where Tomorrow LIVES A pure play on genomics & precision medicine oncocyte.com 13
Slide 14: Organ Transplant
Oncocyte’s first strategic market Organ Transplant oncocyte.com
Slide 15: Transplant testing matters
Where Tomorrow LIVES Transplant testing matters Kidney transplant patients face a 1 in 5 chance that their body will reject the donor kidney. Oncocyte’s test finds early evidence of organ damage in the blood. Source on “1 in 5 chance:” Specifically, Antibody-mediated rejection (AMR) is a leading cau
Slide 16: Donor-derived cell-free DNA (dd-cfDNA)
Where Tomorrow LIVES Donor-derived cell-free DNA (dd-cfDNA) We helped to establish this biomarker Sources: Our timeline slide as well as the fact that MolDX, a program that identifies and establishes coverage and U.S. oncocyte.com government reimbursement for molecular diagnostic tests, cited our pu
Slide 17: Oncocyte's proven credibility in transplant
Where Tomorrow LIVES Oncocyte’s proven credibility in transplant . . . Transplant Product Design, 2012 CMS – Center for Medicaid Services LDT – Lab Developed Test RUO – Research Use Only Initial Peer-Reviewed Publication, 20131 FDA – US Food and Drug Administration IVD – In Vitro Diagnostic Definiti
Slide 18: New England Journal of Medicine study
Where Tomorrow LIVES Transplant credibility, continued . . . New England Journal of Medicine study • Favorable Oncocyte VitaGraft kidney study results published in NEJM, May 30, 2024 • Data show potential to monitor for therapeutic efficacy and recurrence • Potential repeat testing opportunities wit
Slide 19: Transplant: Leading the science
Where Tomorrow LIVES Transplant: Leading the science Our centralized assay, VitaGraft, has been validated in clinical studies with an aggregate of >900 patients and >3,700 samples. 226 Liver Recipients PLoS Med (2017)1, Liver Transpl (2022)2 , Transplantation (2014)3,4 AACC Academy Distinguished Abs
Slide 20: Oncocyte's product appeal
Where Tomorrow LIVES Oncocyte’s product appeal Transplant centers ü easy to use and want a test that is ü returns a same day answer that is ü clinically actionable and ü cost effective Important regulatory note: VitaGraft Kidney LDT has oncocyte.com clinical claim. Oncocyte will be pursuing regulato
Slide 21: US transplant market
Where Tomorrow LIVES US transplant market In the U.S., donor-derived cell free DNA (dd-cfDNA) testing is delivered in Ripe for disruption restrictive central lab service model. Two companies command ~90% market share1. Highly concentrated About 250 kidney transplant centers nationwide. Fewer than 10
Slide 22: Global transplant underserved
Where Tomorrow LIVES Global transplant underserved • Central lab model is difficult to implement outside the Market wants US, leaving significant unmet demand affordable, easy- • More than $1 billion global transplant testing opportunity* to-use, rapid • Global transplants growing ~9% per year testi
Slide 23: PCR workflow: Easy, fast, actionable, affordable
Where Tomorrow LIVES PCR workflow: Easy, fast, actionable, affordable Results available in Pre-amplification Digital PCR 4-8 hours* (RESEARCH USE ONLY) *1 sample – 6 samples 40 minutes 3 – 7 hours Sequence Analysis and Results available in Example Typical NGS Library Preparation NGS Result Calculati
Slide 24: One IP drives land & expand strategy
Where Tomorrow LIVES Transplant, continued . . . One IP drives land & expand strategy Laboratory Research In Vitro Developed Tests Use Only Kit Diagnostics Kit (LDT) (RUO) (IVD) Innovation center is Land Expand monetizable oncocyte.com 24
Slide 25: Transplant commercialization strategy (1-3 years)
Where Transplant commercialization strategy (1 – 3 years) Tomorrow LIVES Targeted initial Proof points revenue Innovation Perform testing at our clinical lab. Medicare reimbursement achieved August 2023 Actively pursuing a center partner US funnel of confirmed interest represents 25% of transplant T
Slide 26: Annual recurring revenue potential
Where Tomorrow LIVES Transplant total addressable market Annual recurring revenue potential Laboratory Research Use In Vitro Developed Tests Only Kit (RUO) Diagnostics Kit (LDT) (IVD) US market supports Main long-term focus $500 million annual revenue, which is currently generated by competitors1 $1
Slide 27: Transplant: Key go-to-market strategic partner signed Q2 2024
Where Transplant: Key go-to-market strategic partner signed Q2 2024 Tomorrow LIVES / Partnership Leader in life science and clinical diagnostics Opportunity to disrupt established markets Innovative transplant monitoring IP Global salesforce and distribution Potential for rapid adoption Simplified w
Slide 28: Transplant strategic partner: Key terms
Where Transplant strategic partner: Key terms Tomorrow LIVES / Partnership • Bio-Rad (NYSE: BIO) now a top five shareholder with Bio-Rad to help upfront equity investment and two subsequent commercialize equity investments GraftAssure RUO • Coordinated rapid development of IVD platform • Co-marketin
Slide 29: What comes after transplant?
Where Tomorrow LIVES What comes after transplant? oncocyte.com 29
Slide 30: Full R&D pipeline, to fuel a decade of growth
Where Tomorrow LIVES Full R&D pipeline, to fuel a decade of growth Transplant Transplant Oncology Oncology oncocyte.com 30
Slide 31: Oncology
Oncocyte’s second strategic market Oncology oncocyte.com 3 1
Slide 32: $2 billion estimated TAM (US only)
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: Tumor Immune Micro-Environment
Where Tomorrow LIVES 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? (RE
Slide 34: $4 billion estimated TAM (US Market)
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: Copy Number Instability
Where Tomorrow LIVES Oncology Pipeline Copy Number Instability (CNI) Published data: 1,300+ samples across 10 tumor types Favorable study regarding the Is the cancer therapeutic drug working? potential of liquid biopsy for brain tumors, published in 2024 Patents issued in US and EU MolDX: Minimal Re
Slide 36: IP attractive to industry partners
Where IP attractive to industry partners Tomorrow LIVES Multiple strategic partnership opportunities IP Category Products Product Partner Service Lab Partner Organ Transplant ü Bio-Rad signed Q2 2024 Actively pursuing Oncology Therapy Selection Actively pursuing Oncology Therapy Monitoring oncocyte.
Slide 37: Oncocyte Investment Summary Recap
Where Tomorrow LIVES Oncocyte Investment Summary Recap Disruptive approach to Proven credibility in first Go-to-market strategic molecular diagnostic testing strategic market: Kidney partner and equity investment • Empower local labs with kits transplant secured • Better business model • U.S. Medica
Slide 38: Thank You
KONCOCYTE Thank You
Slide 39: Appendix
Appendix oncocyte.com
Slide 40: Molecular diagnostics 101
Molecular diagnostic testing combines laboratory testing with the precision of molecular biology and has revolutionized the way clinical and public health laboratories investigate the human, viral, and microbial genomes, their genes, and the products they encode. Molecular diagnostic tests are incre
Slide 41: Transplant: US research market share potential
Where Tomorrow LIVES Transplant: US research market share potential By providing a cost-efficient test for dd-cf DNA, we enable (RESEARCH USE ONLY) researchers to explore new indications ~800,000 ~2 million Strong international demand for access to technology that estimated testing estimated testing
Slide 42: Transplant: US clinical market share potential
Where Tomorrow LIVES Transplant: US clinical market share potential + Mature clinical market, with strong reimbursement ~$500 million Growing demand for decentralized US revenue currently generated by competitors testing at local lab VitaGraft Kidney LDT US Reimbursement – Single-site de novo pathwa
Slide 43: Without better testing, most high-risk patients require invasive biopsy
Where Tomorrow LIVES For-cause testing example Without better testing, most high-risk patients require invasive biopsy Potential Problems with Biopsy • Expensive compared to blood test Elevated Biopsy • Increases risk of complications Kidney Function including hospitalization Tests • Invasive proced
Slide 44: But with VitaGraft, many biopsies are unnecessary
Where Tomorrow LIVES For cause testing example But with VitaGraft, many biopsies are unnecessary + Biopsy Elevated - No Biopsy Up to 86% Kidney Function (lower CI: 59%) Tests of biopsies in patients with elevated Creatinine may possibly be avoided by using VitaGraft1 1. Oellerich M, Shipkova M, Asen
Slide 45: Q4 2024 GAAP P&L
Where Tomorrow LIVES Q4 2024 GAAP P&L $s in thousands Results demonstrate prudent capital management and financial discipline ahead of revenue ramp. oncocyte.com 45
Slide 46: Consolidated Balance Sheets
Where Tomorrow LIVES Consolidated Balance Sheets $s in thousands oncocyte.com 46