Insight Molecular Diagnostics Inc. · NASDAQ:IMDX
Insight Molecular Diagnostics — Oncocyte — Investor Presentation (April 2024)
26 slides from Insight Molecular Diagnostics's investor presentation, April 2024
Slide 1: Investor Presentation
Investor Presentation NASDAQ: OCX Josh Riggs President and CEO Oncocyte Corporation 1 April 2024 CONFIDENTIAL
Slide 2: Confidentiality and Disclosures
Confidentiality and Disclosures: This presentation has been prepared by Oncocyte Corporation (“Oncocyte” or the “Company”) for use in connection with the potential private placement of securities (the “PIPE Financing”) of the Company, and for no other purpose. This presentation is for informational
Slide 3: No Representation or Warranty
No Representation or Warranty: Neither the Company, nor the placement agent, or their respective representatives, make, and each hereby expressly disclaim, any representation or warranty, express or implied, as to the reasonableness of the assumptions made in this presentation or the accuracy or com
Slide 4: Trademarks
Trademarks: This presentation may also contain trademarks, service marks, trade names and copyrights of third parties, which are the property of their respective owners. The use or display of third parties’ trademarks, service marks, trade names or products in this presentation is not intended to, a
Slide 5: The Offering
The Offering Issuer Oncocyte Corporation Ticker / Exchange OCX / NASDAQ Offering Size $15+ million (100% primary) Offering Type Private Placement in Public Securities (PIPE) Use of Proceeds Series A Preferred / General Corporate and Working Capital Expected Announcement Date Thursday, April 11 Locku
Slide 6: Oncocyte Investment Summary
Oncocyte Investment Summary Disruptive transplant monitoring technology Partnership with and strategic equity investment by industry leader Bio-Rad Laboratories, Inc. (NYSE:BIO) Up-front equity investment Potential milestone-based equity investment CMS reimbursement for VitaGraft Kidney received
Slide 7: Oncocyte's Multi-Channel Approach
Oncocyte’s Multi-Channel Approach Ensuring the broadest possible access to our technology IVD TM Laboratory Research In Vitro Developed Tests Use Only Kit Diagnostics Kit (LDT) (RUO) (IVD) Expected launch Expected 4Q 2025 Launching Now 2Q 2024 Bio-Rad has with Bio-Rad licensing option 7 CONFIDENTIAL
Slide 8: Bio-Rad Partnership
/ Partnership Key Terms Commercial mutual exclusivity in donor-derived cell-free DNA (dd-cfDNA) monitoring Commercialization of GraftAssure RUO product Co-marketing in US and Germany, Oncocyte to act as commercial lead Bio-Rad exclusive commercial and distribution rights in rest of world Coordinated
Slide 9: Partnership At a Glance
/ Partnership At a Glance… 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 use Innovative 6-color dd-PCR Market leading assay
Slide 10: Large Global Transplant Market Opportunity
Large Global Transplant Market Opportunity TM (RESEARCH USE ONLY) By providing a cost-efficient test for dd-cfDNA, we enable researchers to explore new indications 800,000 est.* testing opportunities US market Strong ex-US demand for access to technology 2 million est.* that has largely been trapped
Slide 11: US Clinical Market for Transplant
US Clinical Market for Transplant + IVD Mature clinical market, with strong reimbursement $500M est.* US revenue currently generated by competitors Growing demand for decentralized testing at local lab VitaGraft Kidney LDT US Reimbursement – Single-site de novo pathway to establish $2,222 first cont
Slide 12: 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 Elevated • Expensive compared to blood test Kidney Function Biopsy • Increases risk of complications including hospitalization Tests • Invasive procedure 12 CONFIDENTIAL
Slide 13: But with VitaGraft, many biopsies are unnecessary
For cause testing example But with VitaGraft, many biopsies are unnecessary Up to 86% (lower CI: 59%) of Elevated + Biopsy biopsies in patients with elevated Kidney Function - No Biopsy Creatinine may possibly be Tests avoided by using VitaGraft1 13 1. Oellerich M, Shipkova M, Asendorf T, et al. (20
Slide 14: Significant Progress on Path to Commercialization
Significant Progress on Path to Commercialization Transplant Product Design, 2012 Initial Peer-Reviewed Publication, 20131 Definitive Clinical Publication, 20192 US Patent Issued, 20213 US LDT Validation, 2022 CMS Reimbursement, 2023 LDT Launching and RUO Expected 2024 CMS – Center for Medicaid Serv
Slide 15: Global Revenue Opportunity
Global Revenue Opportunity Strong pre-launch interest in RUO assay from leading transplant centers in multiple global markets: East U.S. Europe Asia 15 CONFIDENTIAL
Slide 16: Untapped Demand at US Transplant Institutions
Untapped Demand at US Transplant Institutions dd-cfDNA testing delivered in restrictive central lab service model Highly Concentrated Market <100 transplant centers in U.S. market generate approximately 80% of the transplant volume1 Recent market research shows >90% of U.S. transplant surgeons order
Slide 17: Growing Untapped Global Market
Growing Untapped Global Market Central lab model is difficult to export, leaving significant unmet demand >$1B global transplant testing opportunity* Number of transplants globally growing 9.1% per year Fewer than 1,000 call points globally Up to 90% of the potential market is unserved Market is loo
Slide 18: Improving Transplant Monitoring with PCR
Improving Transplant Monitoring with PCR Easy to use, easy to adopt, rapid turn-around time (RESEARCH USE ONLY) 40 minutes 3 – 7 hours 6 hours 21 hours 1.5 hours * Example NGS Workflow PCR = Polymerase Chain Reaction NGS = Next Generation Sequencing * Based on management estimate CONFIDENTIAL
Slide 19: Capital Light Business Model
Capital Light Business Model Scalable with high margins and profitability Low PCR variable costs Freeze-dried reagent kit for easy global shipping Commitment to partnering across product lines to maintain low operational overhead Globally scalable business model, without the need for a large and exp
Slide 20: Oncology IP Pipeline
Oncology IP Pipeline Tumor Immune Micro-Environment Published/Presented data: ~1400 patients across 6 tumor types 2.6M est. annual global testing opportunities* $2B est. US Market** CMS submission in Q4 2022 Will patient benefit from immuno-therapy? Ongoing 800+ patient NIH funded study What is immu
Slide 21: Oncology IP Pipeline
Oncology IP Pipeline Copy Number Instability (CNI) Published data: 1,300+ samples across 9 tumor types 7.8M est. annual global testing opportunities* $4B est. US Market** CMS submission expected Q4 2024 Is the cancer therapeutic drug working? Established LCD for Therapy Efficacy# How much copy numbe
Slide 22: Non-GAAP Condensed Consolidated Income Statements
Non-GAAP Condensed Consolidated Income Statements $’s in thousands Significant decreases in operating spend can be seen year over year as the Company shifts strategy in 2023. Recent Cash Burn - Q3 2023: $3.6MM Q4 2023: $4.4MM Q1 2024: $3.8MM est. 22 CONFIDENTIAL
Slide 23: Non-GAAP Condensed Consolidated Balance Sheets
Non-GAAP Condensed Consolidated Balance Sheets $’s in thousands 23 CONFIDENTIAL
Slide 24: Anticipated Major Milestone Opportunities
Anticipated Major Milestone Opportunities - 1H24 Launch GraftAssure RUO assay - 2H24 Publication of DSA+ data in kidney transplant - 2H24 Submit VitaGraft Kidney for claim expansion - 2H24 Publication of pancreatic data for DetermaCNI - 2H24 Submit DetermaCNI for reimbursement - 2H25 VitaGraft Kidne
Slide 25: Experienced Leadership Team
Experienced Leadership Team Pioneering Molecular Diagnostics JOSH RIGGS EKKEHARD SCHÜTZ, YUH-MIN (JOHNSON) MD, PHD, FAACC CHIANG, PHD President & Chief Chief Science Officer Chief Technology Officer Executive Officer 25 CONFIDENTIAL
Slide 26: Thank You!
Thank You! Josh Riggs President and CEO Oncocyte Corporation NASDAQ: OCX 26 CONFIDENTIAL