Insight Molecular Diagnostics Inc. · NASDAQ:IMDX
Insight Molecular Diagnostics — OncoCyte — Investor Presentation (November 2020)
40 slides from Insight Molecular Diagnostics's investor presentation, Nov 30, 2020
Slide 1: Investor Presentation Q4 2020
Investor Presentation Q4 2020 “ONCOCYTE Where Tomorrow LIVES
Slide 2: Forward Looking Statement
Forward Looking Statement ‘ry statements that are not historical fact (including, but not limited to statements that contain words such as “wil” "believes," * Santcipates," "expects" "estimates," "may," and similar expressions) are forwarc-ooking statements. These statements atc te betaling © Be com
Slide 3: Mission Statement
Mission Statement Oncocyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum, with the goal of improving patient outcomes by accelerating and optimizing diagnosis and treatment. — SONCOCYTE
Slide 4: Oncocyte Growth Engines
Oncocyte Growth Engines Focus on High Value, Unanswered Clinical Questions Determa RNA .@ Detmmafi™ isthe 1* and only molecular Comprehensive > See, Meee op Ses. delivering a menu of ‘Patients at high risk of recurrence post. J | offering delivering Saat (ee Ol = .. Togposte tests tana i es ee a ee
Slide 5: Well Positioned To Deliver Solid Enterprise Value
Well Positioned To Deliver Solid Enterprise Value Benchmark Market Caps (000s) Three Keys to Value spam Creation in Oncology: pma Pioneering new/underserved oe applications in oncology cae Delivering on key market ore) access or commercial cca) inflecion pons pres Portfolio diversification in ms P p
Slide 6: Oncocyte's Determa Platform Strategy
Oncocyte’s Determa Platform Strategy Delivers Critical Information Throughout the Patient Journey Improving Outcomes and Reducing Costs Diagnosis of Cancer ‘Treatment Decision Patient Monitoring oes patent have seald the Sroudtgre sould ge steteopy te me cancer Goce agian cheno? tages Naapy? muna? w
Slide 7: Solid Pipeline Targeting a Large Served Available Market
Solid Pipeline Targeting a Large Served Available Market Projected Product Launch Timeline DeveRMAc aan DeTERMAB fol : ye i DeTERMAS 2 t se a ee “ONCOCYTE COncocyte has a solid pipeline of tests planned to launch into large and growing “Served Markets” which are subsets of much larger TAMS. We belie
Slide 8: DetermaRx
DetermaRx Proprietary predictive test for early-stage lung cancer “ONCOCYTE
Slide 9: Early-Stage Lung Cancer can be Deadly
Early-Stage Lung Cancer can be Deadly $450M+ Global Market eee 2 Serving ~350k early-stage non-squamous oo. %.9.9.9% BO-5O% or coriy-stave paren with NSCLC recur after surgical resection? @ q @ Recurrence due to presence of occult distant metastases L despite ‘early-stage’ diagnosis 9 noncowmnemas s
Slide 10: Recurrence After Surgery
Recurrence After Surgery ‘ a= sens oe j i B — First event (LR.DA or Pp : I 10 | § i 8 oor Most of these recurrence: o 2 uM = e o metastasis “ONCOCYTE Demicheli, et al: In 1506 patients undergoing surgery with curative intent for early-stage non-small-cell lung cancer, time to any treatment failure d
Slide 11: The Predictive Biomarker Paradox in NSCLC
The Predictive Biomarker Paradox in NSCLC Clinical Application of Predictive Biomarkers sagen Greatest unmet = — need in precision therapy for NSCLC Potential for Cure or Long-Term Survival Saget is in early-stage disease after surgery! Saget sagem “ONCOCYTE ‘There have been incredible advances in u
Slide 12: Prospective Study Design
Prospective Study Design Non-randomized, single-institution ‘real-world’ cohort Medical oncology ° Patient/physician r ° choice to treat ; ? wth adjuvant . ——_+ chemotherapy ~~ —aa $9 250 patients Tested with 14-gene Stage LIA biomarker assay Surgically resected ates “ONCOCYTE In this real-world pro
Slide 13: North American IASLC Update — Patients
North American IASLC Update — 250 Patients Findings persist in larger cohort with majority Stage IA patients + Stage HIIA patients were prospectively followed at a single institution; median time to follow up now 29 months (n=250) 1007 + Majority in cohort are stage IA (n=177) 3 4 + One-third of Sta
Slide 14: DetermaRx Improves Survival
DETERMAGS® Improves Survival ate Sone HA DETERMAS Nochemo Ina published prospective study, DetermaRx demonstrated improvement in disease-free survival (DFS) when high-risk Patients were treated with chemotherapy + Determaficdracad chematharapy ‘wes found t prevent the majority of ‘ecutrences among h
Slide 15: DetermaRx Outperforms NCCN Criteria
DETERMAGS®’ Outperforms NCCN Criteria = Determanx reclassified 4890 of NCCN “low Risk” Unrated Detar lw ik paints exited beter patients to high-risk Sunival thon unveaed NCCN lows poets + Upon treatment, DetermaRx high-risk patients had a Ra ea re) Disease Free Survival of 92.89% = 1005 100 z z J 20
Slide 16: DetermaRx...Emerging Standard of Care
DETERMAG ...Emerging Standard of Care DETERMAS Stage FIle Seer, Comprehensive ~— Early-Stage DETERMA® Management Gaining clinically actionable resuts tomanage your early-stage potlents NCE puna eather ‘and small sue utilation and rapia SSlewranclractesteepresmesnt) ons aeawont turnaround time. “ONCO
Slide 17: Clinical Papers
Clinical Papers Supporting Emerging Standard of Care DETERMAS’ SEGER Analytical Validity Well-Validated and Reimbursed Clinical Validity Validated in Multiple ses hearer Independent Studies in over 1600 Patients Received High-Value CMs Reimbursement Glinical Utility, August 2020 EGFR Reimbursed by C
Slide 18: EGFR Mutations and DetermaRx
EGFR Mutations and DetermaRx Disease Free Survival (%) Early-stage NSCLC Molecla Risk Early stage NSCLC Molecular Rsk Tore Wigtype EOFR Mutant fas 1005 ers 27 20 3 204 2 o- @ 604 40-| — Hor Rise no chemetherapy 0-28) £ 04 Hah isk wth chemotherapy 8 ; 20-| — tow: oo cemeohnerapy 86) § 20-4] — tcwarec
Slide 19: Available at 70+ Health Systems
Available at 70+ Health Systems ] Since February Launch “ONCOCYTE 19
Slide 20: 2021 Salesforce Scaling to Drive Mass Adoption
2021 Salesforce Scaling to Drive Mass Adoption aS > — Headcount ‘Avainble Market Number ofSurgeors Number of Paints Current Sales Algnment 6 Reps,1 Med Ed 35% 209 15,05 an 2021 10 Reps, 2M, 1 Med Ea 7% 450 34,000 = “ONCOCYTE 20
Slide 21: DetermaRx Impacting Patient Care and Driving Revenue
DETERMAS®’ Impacting Patient Care and Driving Revenue Ss = Market Overview Large global market (>$450M) in an ‘underserved patient population Commercial Traction -CMS coverage provides coverage for 70% of the U.S. NSCLC market. “ONLY test avadable for indication -EGFR Launched in Combination with De
Slide 22: DetermaIO
DetermalO Predictive Test for Immune-therapy Response “ONCOCYTE 22
Slide 23: DetermaIO Addresses Important Unmet Need
DETERMAB) Addresses Important Unmet Need There is a need for an effective clinical biomarker for IO therapy to improve response and decrease cost of care... DETERMA® delivers on both wet 750,000 ~ $120B Parts re eligible for 10 Pokal al herapaic srecorenttsting ental i Spend on 10 crue by 225 ~$3B v
Slide 24: FIRST Test to Measure the ENTIRE Tumor Micro-Environment
DETERMA® FIRST Test to Measure the ENTIRE Tumor Micro-Environment DetermalO measures three distinct components of = ae the tumor micenvronment ne orenee No 1 tmmnomahdtayttinese) 2. Epithelial Mesenchymal Tranion Ceol") v ax . [3 ECM/CAF Fortification eal”) v se 2 mow-conripenrat ONCOCYTE L 2. Compe
Slide 25: Understanding Hot vs. Cold Tumors
Understanding Hot vs. Cold g Tumors * Actionable Test To Inform Patient Selection for Immune Checkpoint Inhibitor or 2 Gen Therapeutics DETERMAD Targetable by 2nd Gen Tait 6/- Checkpoint innibkore “ONCOCYTE Tumors Evolve to Survive: ‘+ Express PD-L1 to suppress the immune system + Evolve/Mutate Evad
Slide 26: NSCLC Checkpoint Inhibitor Clinical Performance Data
NSCLC Checkpoint Inhibitor Clinical Performance Data 71 Advanced Lung Cancer Patients Treated with Keytruda® or Opdivo® All patients had completed eight Progression Free Survival (PFS) = weeks of treatment Time to disease progre = Endpoints — SB Prectnerooy | After eight weeks, [iiiiuibletarcsuiacsd
Slide 27: DetermaIO Identifies More Patients for Progression Free Survival
DETERMAGB" Identifies More Patients for Progression Free Survival Assessment of TME clearly separates responders vs non-responders to Immune Checkpoint Inhibitors (ICI) | Lung Cancer Progression Free Survival Comparing DetermalO (IM) to PD-L1 and TMB (SITC 2019) Determal0 is independent of: Therapy
Slide 28: DetermaIO TNBC Data From MD Anderson
DETERMAB” TNBC Data From MD Anderson DetermalO-positive patients are 4x more likely to respond than DetermalO-negative patients Study Design (Phase 1/11 trial -NCT02489448) + Phase I/T tial - NCTO2489448: 55 patients with stage EIT primary TNEC PCR: n=25 (45%); No PCR: n=30 (55%) + Treated with neoa
Slide 29: DetermaIO Proprietary Assay for Broad Clinical Use
DETERMA® Proprietary Assay for Broad Clinical Use + Real-time PCR test measuring expression of 27 genes from FFPE biopsy specimens + Proprietary algorithm processes gene expression data into a ‘quantitative scale with a threshold to determine if a sample is a “likely responder” or "non-responder” to
Slide 30: DetermaIO Road to Commercialization
DETERMABD Road to Commercialization Biopharma Clinical Trials * Biopharma companies with clinical trials for checkpoint inhibitors or 2n¢ therapeutics + Contract Research Organizations and ‘Academic and co-operative groups leading cinical tials + Currently working with MD Anderson, Yale, The West Cl
Slide 31: Biopharma Services
Biopharma Services ‘Comprehensive Capabilities Delivering Revenues Today “ONCOCYTE 31
Slide 32: Comprehensive Biopharma Services Offering
Comprehensive Biopharma Services Offering *CLIN/CAP Laboratory focused on revenue- generating biopharma + Solid track record of developing and validating novel assays across the spectrum of, molecular platforms and technologies (singleplex, multiplex, NGS) + Expertise with ‘multiple non-invasive ‘me
Slide 33: Partnership from Concept Through Regulatory to Commercialization
Partnership from Concept —— . Through Regulatory to Commercialization Tailoring our offering to best match client's project and clinical needs across Collaborative A genetics, oncology, and broad diagnostic Project Design development & Planning Commercial Expertise romeo “ONCOCYTE
Slide 34: Utility of Our Proprietary Tests for Biopharma Research and Clinical Trials
Utility of Our Proprietary Tests for Biopharma Research and Clinical Trials Enable trial success for earlier stage cancer = DetermalO may identify responders vs. non-respe tw checkpoint inhibitors in rhy-stage disease fick pationts who may harbor metastatic disease post surgery vs low-risk patients
Slide 35: Oncocyte has Tremendous Organizational Velocity
Oncocyte has Tremendous Organizational Velocity Significant Accomplishments Over Past 12 Months eid compete] Seem | (Reece cis a rr c Pac ome = roemer | peers “ONCOCYTE 35
Slide 36: Oncocyte Growth Drivers
Oncocyte Growth Drivers Strategic Milestone Targets Accelerate Enterprise Value 1H 2021 [ ) . ‘tec bcatans pth Sys Sesser aa @ 3038 2022/2023 cer ome tse deen te DAE ct — 2H 2021 =e Sooner ‘See @ etermald Cnc Sees. Smee Detrmc anche or ———— ONCOCYTE We believe that our strategy to building a portfol
Slide 37: “ONCOCYTE
“ONCOCYTE 37
Slide 38: New Data on EGFR TKI in Adjuvant Setting
New Data on EGFR TKI in Adjuvant Setting Sa a | in Resected EGFR-Mutated = "ae a3, Osimertini Non-Small-Cell Lung Cancer ——, | Sener ier (ee = - cma | simi ‘ . | “This article wes pulsed on September 19, 2020 at NEIMLOrg. (ete “ “ + ADAURA study evaluated 3 years of adjuvant Osimertinib vs placebo t
Slide 39: Experienced Leadership Team
Experienced Leadership Team Pioneering Molecular Diagnostics pore A omen Lomi Demnefister ®, — @OUROINT —@CollMartite Obes he a Jenner ale “ONCOCYTE 39
Slide 40: DetermaIO Derived from a Well-Published Molecular Classifier
Determal0 Derived from a Well-Published Molecular Classifier 2011: shan et al publica 2480 oan molar sbdafctin sytem for {Na tors bee ongene expression pater 2016 Ring ea reduced the assert 101 genes 2016- Ring ata nd Lehmann etal ated that the IM (TL) and MSL classifications (Stroma signature) were