MULTIOMYX™ AND VECTRA® POLARIS™ PLATFORMS

MULTIPLEXEDIMMUNOFLUORESCENCE

Cancer-related tests per year

Biomarker projects in development &

testing to date

Completed projects with a backlog of

more than $145MM

In breast cancer testing* in PD-L1

Testing

MDs & PhDs across pathology & scientific

disciplines

>2000

>120 620+~1,000,000

>1500#1 #1*Data from CMS claims database

Oncology & pathology tests ready for order

OUR MISSION IS TO HELP

REDUCE CANCER DEATHSACROSS THE GLOBE.

Because every sixth death in the world is due to cancer, our mission

at NeoGenomics is to partner with pharmaceutical companies to bring

new life-saving oncology drugs to market so we can help reduce

cancer-related deaths worldwide.

2 3

Our unique and comprehensive product and service offerings include:

NeoGenomics’ Pharma Services offer two multiplex immunofluorescence platforms: MultiOmyx™ and Vectra® Polaris™.

• Unparalleled expertise, flexibility and scalability • Largest oncology focused clinical research organization (CRO) in the USA• Complete one-stop testing• Medical and scientific consultation

NEOGENOMICS PHARMA SERVICES

• MultiOmyx is a proprietary, high-order multiplexing methodology that enables visualization and characterization of up to 60 proteins in a single FFPE tissue section.

• Vectra Polaris is an automated system that allows simultaneous detection of 2-6 different markers from a single FFPE tissue slide which would provide a streamlined workflow for implementing refined low-order multiplex panel sets.

Utilizing deep learning and advanced cell classification algorithms, multiplexedimmunofluorescence spatial analysis uncovers the complex interplay betweenmultitudes of immuno-oncology biomarkers, and provides complete analysisof the tumor microenvironment.

Multiplex immunofluorescence has emerged as an effective and proficient approach to simultaneously identify specific proteins and immune cell types, to determine the spatial distribution and activation state of immune cells, as well as the expression of immune modulators, all at the same time. This method is highly beneficial for exploring immune evasion mechanisms and finding potential biomarkers that allow researchers to assess the mechanism of action and predict and monitor drug response.

MULTIPLEXED IMMUNOFLUORESCENCE: A COMPLETE VIEW OF TUMOR BEHAVIOR

MultiOmyx™ Vectra® Polaris™

High order ≥ 7plex Low order 2-6plex

Comprehensive analysis of tumor biology High-throughput & faster TAT

Deep & precise immuno-profiling Assay transfer & validation

4 5

MultiOmyx enables visualization and characterization of up to 60 proteins in a single formalin fixed, paraffin embedded (FFPE) 4μm tissue section. Slides are prepared and stained using MultiOmyx multiplexing IF staining protocol. For each round of staining, conjugated fluorescent antibodies are applied to the slide, followed by image acquisition of stained slides. The dye is erased, enabling a subsequent round of staining with another pair of fluorescent antibodies.

MULTIOMYX:

PROPRIETARY, HIGH-ORDERMULTIPLEXING METHODOLOGY

MultiOmyx also offers:

• Unambiguous immune cell co-expression and co-localization• Advanced quantitative cellular classification• Medical, scientific, & bioinformatics consultation• Custom assay design & verification• Advanced image analysis & visualization tools• Spatial analytics• Integrated with FISH, RNAScope, and NGS• High order: >= 7-plex• Comprehensive analysis of tumor biology• Monitoring of the immune microenvironment for the characterization

of tumors pre- and post- I/O treatment • Comprehensive Immunophenotyping at single cell level from one

FFPE slide

BIOMARKERS BIOMARKERS (CONT.)

A20/TNFAIP3

Aiolos

alpha-SMA

AXL

Arginase I

B7-H3/CD276

CD138

B7-H4/VTCN-1

CD141

CA9/CAIX

CD14

c-Caspase 3

CD15

CCR7

CD155/PVR

CD11b

CD16

CD137/4-1BB

CD22

CD209/DC-SIGN

CD103

CD19

CD206CD11C

CD163

CD25/IL2-R

CD226

CD123

CD20

CD208/DC-LAMP

MULTIOMYX™

ANTIBODY LIST

CD299

CD3

CD31

CD33

CD32B

CD34

CD38

CD4

CD45

CD45RO

CD45RA

CD66b

CD56

CD47

CD64

CD68

CD69

CD8

CD83

CD86

CD9

CK-OSCAR

cMet

CK-20

Claudin 6

CK-19

CK-PCK26

CK-AE1

Clec9A

6 7

BIOMARKERS BIOMARKERS (CONT.)

MGMT

MMP-9

MUC1

NY-ESO-1

NaKATPase

Olig2

PNAd

Osteopontin

pSMAD3

OX40/CD134

pSTAT3

OX40L/CD252

S100

p53

SOX-10

PAX5

STING

Perforin

TIGIT

PD-L1

TCF1/TCF7

TTF1

PD-1

SYNDECAN-1/CD138

TIM3

PD-L2/CD273

TGFb1

Vimentin

MULTIOMYX™

ANTIBODIES LIST (CONT.)

Juncker-Jensen A. et al. (2019, April). Pro-Tumorigenic Mechanisms of M2 Tumor-Associated Macrophages in Triple-Negative Breast Cancer. Poster presented at AACR Annual Meeting, Chicago, IL.

Au Q. et al. (2019, April). Characterization of TIGIT Expression Using MultiOmyx™ Hyperplexed Immunofluorescence Assay in NSCLC and melanoma. Poster presented at AACR Annual Meeting, Atlanta, GA.

Juncker-Jensen A. et al. (2019, October). An Integrated Multiplexing Approach for the Immunoprofiling of the Tumor Microenvironment of Ovarian Granulosa Cell Tumors. Poster presented at AACR-NCI-EORTC Annual Meeting, Boston, MA.

PanCK+ CD3+ CD34+ Ki67+

SOX10+ TIGIT+ LAG3+ PD1+

M1 TAM

M2 TAM

S100+ CD68+ HLADR+ CD163+

Collagen I

Collagen IV

CSF-1R

CXCR2

CTLA-4

CXCR4

E-CAD

EGFR

EMA/MUC1

FOXP3

GFAP

Hepatocyte/HepPar1

Glypican-3

GITR

Granzyme B

HHLA2

HLA-ABC

HLA-DR

HSV-1

ICOS

ICOS-L/CD275

Ikaros

LAG3/CD223

IDO-1

IRAK4

IDH1 R132H

iNOS

Mesothelin

IGF1R

Ki67

8 9

BIOMARKERBIOMARKER CO-EXPRESSIONCO-EXPRESSION PHENOTYPESPHENOTYPES

CD3 CD3T helper T helperCD3+CD4+ CD3+CD4+

CD4 CD4T regulatory T regulatoryCD3+CD4+FoxP3+ CD3+CD4+FoxP3+

CD8CD8

Memory T helperCD3+CD4+CD45RO+ CD3+CD4+PD1+

CD3+CD4+TIM3+ T helper TIM-3Immune modulation

Immune modulation

Immune modulation

T cytotoxic TIM-3

CD3+CD4+PD1+

CD3+CD4+CTLA4+

T cytotoxic

T cytotoxic

CD3+CD8+

CD3+CD8+

Memory T cytotoxic

B cell

CD3+CD8+CD45RO+

CD3+CD8+PD1+

CD3+CD8+TIM3+

Immune modulationCD3+CD8+PD1+

Macrophage

Granulocyte

CD68+

CD11b+CD15+Macrophage PD-L1

TAM

CD68+PDL1+

CD68+B cellCD20+

CD20+

CD68+TIM3+ Macrophage TIM3

B cell PD-L1 M2 TAMCD20+PDL1+ CD68+CD163+

Tumor cell PD-L1 Proliferating tumorPanCK+PDL1+ PanCK+Ki67+

Natural Killer cell Macrophage PD-L1

Tumor cell PD-L1

CD3-CD56+ CD68+PDL1+

PanCK+PDL1+

CD45RO

FoxP3

FoxP3

CD20CD20

CD68CD68

CD56

CD11bCTLA-4

CD15

PD-1

PD-1

PD-L1

PD-L1 LAG-3

Ki67

PanCKOX40

PanCK

IMMUNE PANEL (TIL): TIL AND MYELOID PANEL:12 MARKERS 16 MARKERS

Juncker-Jensen A. et al. (2019, December). PD-1 and LAG-3 synergize to drive tumor-infiltration of T cytotoxic cells in NSCLC tumors. Poster presented at ESMO I/O Annual Meeting, Geneva, Switzerland.

Au Q. et al. (2016, April). MultiOmyxTM multiplexed tumor infiltrating lymphocyte panel provides comprehensive immunophenotyping from a single FFPE slide. Poster presented at AACR Annual Meeting, New Orleans, LA.

PanCK+ CD8+ PD-L1+ CD68+ FoxP3+

PanCK+ LAG-3+ PD-1+ CD8+

10 11

SOFTWARE FOR MULTIOMYXWHOLE SLIDE SCANNING

VECTRA® POLARIS™:NEOVUE™

IMAGE AND DATA HIGH THROUGHPUTVISUALIZATION

IMAGE VISUALIZATION

DATA VISUALIZATION

AUTOMATED MULTISPECTRAL

With the NeoVUE image and data visualization software the MultiOmyx end-user can rapidly view and manage the multiplexed images as well as the comprehensive biomarker profiling on a single-cell level.

Vectra Polaris is a fully-enclosed instrument with touchless slide automation that allows simultaneous detection of 2-6 different markers from a single FFPE tissue slide—providing a streamlined staining, imaging and analysis workflow for implementing refined low-order multiplex panel sets.

• Whole slide multispectral images at high throughput with up to 6 markers• Assay transfer and validation• Continuous slide loading workflows (80+ slides)• 6-8 slides per hour for 20x FL whole slide scan• High signal:noise ratio• Analysis: - InForm: spectrally unmixing images - Halo or VisioPharm: tissue seg, cell seg, phenotyping, scoring, spatial distribution analysis, pathology views

• Use any validated antibody panel• Fluorophore is covalently bonded to tissue• Antibodies are efficiently stripped between

staining rounds

How opal staining works:

VECTRA POLARIS OFFERS:

12 13

INDICA HALO®

VISIOPHARM

• User-friendly UI & Custom Development Workflow

• Library of pre-configured modules available

• HaloLink allows slide review and direct annotation by pathologists

• Better fit for clinical trials because of the nature of the quality/ regulatory requirements

• Marketing partnership with NeoGenomics

• Generates results very quickly for common tasks/simple analytics/ single-plex

• Library of prebuilt apps available

• Powerful tool set, optimal for more complex and custom analytics requirements

• Can define non-cell objects in the tissue

• AI packages that can be used for cell classification to increase accuracy• Clinical trial testing is feasible but requires more time and effort

• AI-based framework proprietary to NeoGenomics

• Optimized for MultiOmyx

• Highly customizable with complete control to accommodate new requirements

• Adapted for IHC/CISH/dual IHC

• NeoVUE compatible

• RUO (software not validated to FDA standards)

NEO IMAGE ANALYSIS

PLATFORM INDICA HALO VISIOPHARM NEO IA

Currently SupportingClinical Studies (retro)

Clinical Studies (enrollment)

Low order mIF, 2-6-plex (Polaris)

Complexity of analytics tasks

High-plex mIF, ≥7 (MO)

Direct annotation & slide review

+++ ++

N/A++ +

+++

+++

+

+++

++

++

+++

N/A

+++ +++

N/A

N/A

+++

DATA IMAGE ANALYSIS

14 15

NEO AI

CHARACTERIZATION OFMARKERS & PHENOTYPES

NEAREST NEIGHBOR ANALYSIS

Phenotype BPhenotype A

1.6

Lung1

Lung2

Lung3

Lung4

Lung5

Lung6

Lung7

Lung8

Lung9

Melanoma1

Melanoma2

Melanoma3

Melanoma4

Melanoma5

Melanoma6

Melanoma7

Melanoma8

CD

3 +

CD

4 +

CD

3 +

CD

8 +

TIG

IT +

CD

4 +

TIG

IT +

CD

8 +

TIG

IT +

CD

4 +

FOXP

3 +

TIG

IT +

CD

4 +

FOXP

3 -

TIG

IT +

CD

45RO

+ C

D4

+

TIG

IT +

CD

45RO

+ C

D8

+

TIG

IT +

CD

56 +

TIG

IT +

PD

1 +

TIG

IT +

LAG

3 +

TIG

IT +

TIM

3 +

TIG

IT +

PD

1 +

LAG

3 +

TIG

IT +

PD

1 +

TIM

3 +

TIG

IT +

PD

1 +

TIM

3 +

LAG

3 +

TIG

IT +

PD

1 +

CD

4 +

TIG

IT +

PD

1 +

CD

8 +

TIG

IT +

PD

1 +

CD

4 +

FOXP

3

#per mmsq

0.8

0.0

-0.8

-1.6

TIGIT+CD4+FOXP3- TO TUMOR

TIGIT+CD4+FOXP3+ TO TUMOR

# of

cel

ls

Average distance of 5 nearest “B” neighbors to “A”

5 Nearest Neighbor Analysis

1000

2000

3000

4000

5000

6000

10 20 30 40 50 60 70

0

5000

10000

15000

20000

25000

10 20 30 40 50 60 70

16 17

QUANTIFICATION FOR

LOW-PLEX MULTIPLEXEDIF BY HALO

PD-L1+

CD8 INTENSITY HISTOGRAM

SPATIAL PLOT: CD8+ T CELLS TO PDL1+ CD68+ CELLS

CD8 (Opal 620) Positive = ‘1’ Phenotype 2 = ‘1’

CD68+ PD-L1+

18 5

& LAB LOCATIONS

OUR GLOBAL HEADQUARTERS

1

5

7

6

2

3

4

1

2

3 4

5

7

6

ALISO VIEJO (ORANGE COUNTY), CA

GENEVA, SWITZERLAND

CHINA

SINGAPOREHOUSTON, TX

FT. MYERS, FL

LA JOLLA, CA

Anatomic Pathology, Molecular, Multiplexed IF, Flow Cytometry, FISH & Cytogenetics

Anatomic Pathology, Molecular*, Flow Cytometry, Immunoassays, FISH & Cytogenetics

Anatomic Pathology*, Molecular*, Flow Cytometry*, Immunoassays*, FISH & Cytogenetics*

Anatomic Pathology, Flow Cytometry, Molecular* FISH & CytogeneticsAnatomic Pathology, Molecular, Immunoassays, FISH & Cytogenetics

Anatomic Pathology, FISH & Cytogenetics

Molecular, FISH & Cytogenetics

* Through Collaborations

19

NeoGenomics is a premier cancer diagnostics and pharma services company that provides innovative diagnostic, prognostic and predictive testing with uncompromising quality, exceptional service and innovative solutions—all to help save lives byimproving patient care.

2131 Faraday Ave.Carlsbad, CA 92008United States

Phone: 760.268.6200Fax: 760.268.6201

TO SEE HOW WE CAN COLLABORATE

NEOGENOMICS LABORATORIES

CONTACT US

NeoGenomics Laboratories is a specialized oncology reference laboratory providing the latest technologies, testing, partnership opportunities, and interactive education to the oncology and pathology communities. We offer the complete spectrum of diagnostic services in molecular testing, FISH, cytogenetics, flow cytometry, and immunohistochemistry through our nation-wide network of CAP-accredited, CLIA-certified laboratories. Committed to research as the means to improve patient care, we provide Pharma Services for pharmaceutical companies, in vitro diagnostic manufacturers, and academic scientist-clinicians. We promote joint publications with our client physicians. NeoGenomics welcomes your inquiries for collaborations. Please contact us for more information.

NeoGenomics.com © 2020 NeoGenomics Laboratories, Inc. All Rights Reserved. All other trademarks are the property of their respective owners. Rev. 05/22/2020

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