Insight Molecular Diagnostics Inc. · NASDAQ:IMDX
Insight Molecular Diagnostics — Oncocyte — Investor Presentation (October 2024)
43 slides from Insight Molecular Diagnostics's investor presentation, Oct 3, 2024
Slide 1: Investor Presentation
“ONCOCYTE Where Tomorrow LIVES Investor Presentation NASDAQ: OCX
Slide 2: Disclaimers
Disclaimers ia LIVES Disclaimer ty and Disclosures: Ths Posontation(togther wt the ora statements made incennoction herewith ths Presentation’ has bean prepared by Oncecyte Corporation (-ONcoeyto" ortho “Company"}or usin connection with he potential privat placement of securtos (he PE Financing" oth
Slide 3: Disclaimers, continued
Disclaimers, continued ie LIVES Use ot Data ‘The data contains Nereis derived om vious inten nd eteenalsoures. The Cmpan/has nat independent veiies he accursy or completeness ofthe infomation dere rom extenel souess Alo the make detain the Presentation nodes rurberof sumptions and limitations, ane t
Slide 4: Mission
“ONCOCYTE MISSION Democratize access to novel molecular diagnostic testing to improve patient outcomes
Slide 5: Experienced leadership
“ONCOCYTE Experienced leadership Pioneering Molecular Diagnostics & Disruptive Growth a> € Josh Riggs Ekkehard Schiitz, MD, President & Chief Executive PHD, FADLM Officer Chief Science Officer @Bethesda Qses= - i J CHRONIX . BIOMEDICAL oncocyte.com PALVEO ThermoFisher & & Yuh-Min (Johnson) Andrea Ja
Slide 6: Innovative science meets simple business model
“ONCOCYTE Innovative science meets simple business model
Slide 7: Oncocyte Investment Summary
“ONCOCYTE Oncocyte Investment Summary oncocyte.com Disruptive approach to molecular diagnostic testing: Empower local labs with kits, versus central lab model Proven credibility in first strategic market: Kidney transplant Go-to-market strategic partner and equity investment secured Science-driven t
Slide 8: Why invest in molecular diagnostics?
“ONCOCYTE 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 reimbursement High valu
Slide 9: Why kitted products?
Where “ONCOCYTE Tomer 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 e
Slide 10: Innovation flywheel
“ONCOCYTE Innovation flywheel oncocyte.com Research LIVES kits enable researchers and doctors to ask and answer questions Global dissemination | improves outcomes, Inspires more questions New cli applications tested & discovered Local standard of care protocol improves, along with patient quality of
Slide 11: Every clinical indication is a recurring revenue opportunity
“ONCOCYTE Every clinical indication is a recurring revenue opportunity
Slide 12: Oncocyte's first strategic market: Organ Transplant
ONCOCYTE Oncocyte’s first strategic market Organ Transplant oncocyte.com
Slide 13: Transplant testing matters
“ONCOCYTE 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. oncocyte.com AMR within 10 years of transplant and up to 70% of those patients will progress to graf
Slide 14: US transplant market
“ONCOCYTE 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 share’, 7 About 250 kidney transplant centers nationwide. Fewer than 100 generate ~80% Highly concen
Slide 15: Global transplant underserved
“ONCOCYTE Global transplant underserved * Central lab model is difficult to implement outside the M a rket wa nts US, leaving significant unmet demand affordable easy- * More than $1 billion global transplant testing , opportunity” to-use, rapid * Global transplants growing ~9% per year H ¢ Concentr
Slide 16: Oncocyte's product appeal
“ONCOCYTE Oncocyte’s product appeal Transplant centers v easy to use and want a test that is Y returns a same day answer that is Y clinically actionable and Y cost effective Important regulatory note: VitaGraft Kidney LOT has oncocyte.com clinical claim, Oncocyte will be pursuing regulatory IVD [Fa
Slide 17: PCR workflow: Easy, fast, actionable, affordable
“ONCOCYTE PCR workflow: Easy, fast, actionable, affordable Pre-amplification > Digital PCR > Results a in GraftAssure SS , (RESEARCH USE ONLY) SS — strane amos 40 minutes 3-7 hours ». Sequence Analysis and , , > | Example Typical NGS brary Preparation SE > NGS Se ee ie calculations Workflow (Competi
Slide 18: Oncocyte's proven credibility in transplant
“ONCOCYTE Oncocyte’s proven credibility in transplant... iw Transplant Product Design, 2012 ‘CMS ~ Center for Medicaid Services LOT lab Developed Test, fe . oe RUOReseareh Use On & Initial Peer-Reviewed Publication, 2013! FDA-US Food and Drug Administration Ivo~In vir Osgnoste & Definitive Clinical
Slide 19: Transplant credibility, continued
“ONCOCYTE 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 with claims expan
Slide 20: Transplant: Leading the science
“ONCOCYTE Transplant: Leading the science Our centralized assay, VitaGraft, has been validated in clinical studies with an aggregate of ~800 patients and >3,000 samples. THERAPEUTIC RUG WONITORINE 215 Liver Recipients PLoS Med (2017)!, Liver Transpl (2022)? 631 Kidney Recipients Am J Transplant (201
Slide 21: Transplant, continued
“ONCOCYTE Transplant, continued... One IP drives land & expand strategy VitaGraft lS GraftAssure VitaGraft-F" Laboratory Research In Vitro Developed Tests Use Only Kit Diagnostics Kit (LDT) (Givle)) (IVD) Innovation center is 4 Land Expand monetizable oncocyte.com a
Slide 22: Transplant commercialization strategy
Transplant commercialization strategy (1 — 3 years) Innovation center Expand Expand Il Expand Ill Based on manag oncocyte.com Perform testing at our clinical lab. Transplant centers and major research universities adopt research-only product Achieve FDA clearance for the tests to make clinical decis
Slide 23: Transplant total addressable market
“ONCOCYTE Transplant total addressable market Annual recurring revenue potential VitaGraftlS” Graft/Assure VitaGraft+!" Laboratory Research Use In Vitro Developed Tests Only Kit (RUO) Diagnostics Kit (i) (vp) US market supports Main long-term focus $500 million annual revenue, which is currently gen
Slide 24: Key go-to-market strategic partner signed Q2 2024
Where Transplant: Key go-to-market strategic partner signed Q2 2024 Tomorrow SONCOCYTE / Partnership LIVES Leader in life science and clinical diagnostics (BBA) Opportunity to disrupt + established markets Innovative transplant monitoring IP Global salesforce and distribution + ‘Simplified workflow
Slide 25: Transplant strategic partner: Key terms
Transplant strategic partner: Key terms “ONCOCYTE / Partnership * BioRad (NYSE: BIO) became second largest shareholder Bio-Rad to help April 2024 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?
“ONCOCYTE What comes after transplant?
Slide 27: Full R&D pipeline, to fuel a decade of growth
ONCOCYTE Tomerow LIVES Full R&D pipeline, to fuel a decade of growth VitaGraftF" VitaGraftl aGrafth GraftAssure Transplant DETERMAS’ DETERMA&" Onco * oncostt.om | 2 |
Slide 28: Oncocyte's second strategic market: Oncology
ONCOCYTE Oncocyte’s second strategic market Oncology
Slide 29: Oncology Pipeline
ONCOCYTE Oncology Pipeline DETERMAS& $2 billion estimated TAM (US only) 2.6 million estimated annual global testing opportunities US TAM base on US testing opportunities of 872,000/year and estimated reimbursement ASP of $2,0D/est. 872k * $200 = $2 bon oncocyte.com 30
Slide 30: Will patient benefit from immuno-therapy?
ONCOCYTE DETERMAS Will patient benefit from immuno-therapy? ™ Onco What is immune status at tumor site? (RESEARCH USE ONLY) ‘oncocyte.com: Where Tomorrow LIVES @ Published/Presented data: ~1,400 patients across 6 tumor types © Medicare (CMS) coverage submission in Q4 2022 © Ongoing 800+ patient NIH
Slide 31: Oncology Pipeline
ONCOCYTE Oncology Pipeline DETERMAGD $4 billion estimated TAM (US Market) 7.8 million estimated annual global testing opportunities 32
Slide 32: Oncology Pipeline
Where ONCOCYTE Beasts Oncology Pipeline Copy Number Instability (CNI) DETERMA Is the cancer therapeutic drug working? 33
Slide 33: IP attractive to industry partners
IP attractive to industry partners Multiple strategic partnership opportunities IP Category Products Product Partner Service Lab Partner Viera VitaGraft! . . ‘ . Organ Transplant ~ | ¥ Bio-Rad signed Q2 2024 Actively pursuin; . . VitaGraft . id? 2 Graft/Assure DETERMAD” Oncology Therapy Selection On
Slide 34: Oncocyte Investment Summary Recap
Where SONCOCYTE tom 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, M
Slide 35: Thank You
NN XONCOCYTE Thank You ONCOCYTE
Slide 36: Appendix
ONCOCYTE Appendix oncocyte.com
Slide 37: Molecular diagnostic testing
‘Molecular diagnostic testing combines laborotory 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 inc
Slide 38: Transplant: US research market share potential
“ONCOCYTE Transplant: US research market share potential Graft/Assure By providing cient test for dd-cf DNA, we enable (RESEARCH USE ONLY) H researchers to explore new indications ~ ~ one 800,000 2 million Strong international demand for access to technology that estimated testing estimated testing
Slide 39: Transplant: US clinical market share potential
“ONCOCYTE Transplant: US clinical market share potential VitaGraftS + VitaGraft-+-" ~$500 million US revenue currently generated by competitors VitaGraft Kidney LDT US Reimbursement — Single-site de novo pathway to $2,222 first contact**, $1,030 repeat establish predicate device at FDA reimbursement
Slide 40: VitaGraft: For-cause testing example
VitaGraftla For-cause testing example Without better testing, most high-risk patients require invasive biopsy @ ¢;3 fe Potential Problems with Biopsy * Expensive compared to blood test Elevated => Biopsy * Increases risk of complications Kidney Function including hospitalization Tests * Invasive pro
Slide 41: VitaGraft: For cause testing example
VitaGraftl For cause testing example But with VitaGraft, many biopsies are unnecessary 7 tm oom, — RAREETTTTT 7 big m> VitaGraftlS ae Up to 86% idney Function (lower Cl: 59%) Tests of biopsies in patients with elevated Creatinine may possibly be avoided by using VitaGraft? concocyte.com a
Slide 42: Q2 2024 GAAP P&L
“ONCOCYTE raeren Q2 2024 GAAP P&L Unaunren conpenseneoRtaioNtt a Tests OF OFERATTONS LIVES {Un thowsands, except per shar dat) $’s in thousands Three Months Ended ‘Six Months Ended dune, une 3 Ta Ta Ta 7 aoa s wos was aos 260 ara 2 16 “i 4 Coste evenes~ amortization of acquired inangbes 2 2 ‘a “ Gro
Slide 43: Condensed Consolidated Balance Sheets
HONCOCYTE: Condensed Consolidated Balance Sheets $’s in thousands oncocyte.com ONCOCYTE CORPORATION {Un hounds except pr sare dats) Asser (Cohan s 9256 ‘owen eeable tet of alwance for cio ones of $1 ant $5, repcney s Prpaueapee aber ce anes os ight neon Gane le atc aso Inunpieaets et 63st TOTALASSET