43 slides from Insight Molecular Diagnostics's earnings presentation, Nov 12, 2024
Slide 1: Investor Presentation
Investor Presentation NASDAQ: OCX 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: 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 9: 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 10: Every clinical indication is a recurring revenue opportunity
Where Tomorrow LIVES Every clinical indication is a recurring revenue opportunity oncocyte.com 10
Slide 11: Organ Transplant
Oncocyte’s first strategic market Organ Transplant oncocyte.com
Slide 12: 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 13: 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 14: 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 15: 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 16: 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 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 ~800 patients and >3,000 samples. 215 Liver Recipients PLoS Med (2017)1, Liver Transpl (2022)2 AACC Academy Distinguished Abstract Award presented to Ekk
Slide 20: 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 20
Slide 21: 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 22: 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 23: Beta customer revenue path
Where Tomorrow LIVES Beta customer revenue path Illustrative US transplant center revenue projection $400,000 in (Average size with ~2,500 patients under management) quarterly run Assumes FDA clearance for clinical use in late 2025 rate revenue $400,000 $350,000 $300,000 $250,000 $200,000 Center con
Slide 24: 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 25: Bio-Rad to help commercialize
Where Transplant strategic partner: Key terms Tomorrow LIVES / Partnership • BioRad (NYSE: BIO) became second largest Bio-Rad to help shareholder with upfront equity investment commercialize • Commercial mutual exclusivity in dd-cfDNA monitoring GraftAssure • Coordinated rapid development of IVD pla
Slide 26: What comes after transplant?
Where Tomorrow LIVES What comes after transplant? oncocyte.com 26
Slide 27: 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 27
Slide 28: Oncology
Oncocyte’s second strategic market Oncology oncocyte.com 2 8
Slide 29: $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 30: 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 31: $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 32: Oncology Pipeline: Copy Number Instability
Where Tomorrow LIVES Oncology Pipeline Copy Number Instability (CNI) Published data: 1,300+ samples across 9 tumor types CMS submission expected Q4 2024 Is the cancer therapeutic drug working? Patents issued in US and EU Pre-existing Medicare coverage MolDX: Minimal Residual Disease Testing for Canc
Slide 33: 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 34: 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 35: Thank You
KONCOCYTE Thank You
Slide 36: Appendix
Appendix oncocyte.com
Slide 37: 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 38: 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 39: 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 40: 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 41: 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 42: Q3 2024 GAAP P&L
Where Tomorrow LIVES Q3 2024 GAAP P&L $’s in thousands Results demonstrate prudent capital management and financial discipline ahead of revenue ramp. oncocyte.com 42
Slide 43: Condensed Consolidated Balance Sheets
Where Tomorrow LIVES Condensed Consolidated Balance Sheets $’s in thousands oncocyte.com 43