BiocartisCorporate presentation

H1 2021

2

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31 Guangzhou Wondfo Biotech Co., Ltd. (‘Wondfo’, SHE: 300482) is a fast growing diagnostics leader in China; 2 Defined as the world excluding European direct markets, US, China and Japan

Differentiated technology

Unique Idylla™technology in oncology, expanding in infectious

diseases

Attractive markets

Worldwide commercial footprint

Very strong performance in H1 2021

Positioned for further value creation

• Idylla™: first fully automated sample-to-result qPCR platform• Superior and continued validated performance versus competition• Enabling global decentralization of clinical molecular diagnostics (MDx)

• Cartridge volume ramp-up fueled by continued menu expansion & additional product registrations (incl. US FDA filings) & menu partnerships

• Ongoing geographical expansion (penetration in US market, initiation of commercialization in China & Japan)

• Production of all key oncology assays transferred to the highly automated second cartridge manufacturing line driving cost optimization

• 2021 outlook 40% cartridge growth still in reach: successful mitigation of fire incident, but still subject to full restart ML2 line by 2nd half September & timely availability of reagent raw materials for cartridges

• Cartridge manufacturing: new concept for simplified, cost-efficient cartridge manufacturing under evaluation

• Unique platform features bring strong competitive advantage in oncology testing, broad test menu (solid & liquid biopsies) currently focused on targeted therapies &immunotherapy, gene signatures, move into monitoring

• Validation via oncology (e.g. Amgen, Merck KGaA, AstraZeneca, Bristol-Myers Squibb, Kite/Gilead, GeneproDx, SkylineDx) and infectious disease partners (Immunexpress, Endpoint Health)

• Expansion of pandemic response test menu post H1 2021 with CE-IVD launch of the Idylla™ SARS-CoV-2/Flu/RSV Panel• Innovating the Idylla™ technology for customization of assays and new concept for simplified, cost-efficient cartridge manufacturing

• Direct sales approach in Western Europe, Canada and US

• First oncology assay US FDA submission in April 2021: Idylla™ MSI Test 510(k) US FDA notification

• Strategic partnerships established for China & Japan: joint venture with Wondfo1 (China) and commercial collaboration with Nichirei Bio (Japan)

• Distributor markets3 model: partnerships with local distribution partners for relevant distributor MDx markets supported by Biocartis distributor markets sales team

• 156k commercial Idylla™ cartridges sold in H1 2021, almost twice as high as in H1 2020 (+96%);• Robust growth in oncology in all regions; solid contribution from infectious diseases, comparable to H2 2020 volumes against backdrop of declining global COVID-19 testing

volumes• 189 new Idylla™ placements in H1 2021 (101 in H1 2020) mainly driven by demand in EU and distributor2 markets as well as by content partners• Installed base of 1,770 Idylla™ instruments end of H1 2021• Expanded (AstraZeneca) and new partnerships in oncology (SkylineDx) during H1 2021

• Global MDx market of USD 6.5bn; oncology fastest growing segment with high double digit annual growth rates• Large, global customer base (in pathology labs) with opportunity to expand (e.g. labs that want to step into MDx testing) in oncology and infectious diseases• Proven market access & expanding into infectious disease market: pandemic test menu based on COVID-19 and sepsis testing to support patient journey in

intensive care unit (ICU), longer term developments based on unique multiplexing capabilities of Idylla™ (syndromic panels)

4

• In the US, nearly 80%4 of

cancer patients do not have

genetic mutation results

available at initial oncology

consultation

• Up to 25% of patients begin

treatment before receiving

their results4

UK2 | 14-30 days

AUSTRALIA5

Median 17 days20% more than 4 weeks

USA1

Median 27 daysRange: 14-77 days

FRANCE3,4

21-28 days26% more than 4 weeks

Source: 1 Schwaederle et al. (2014) Oncologist 19, 631 – 636; 2 Saunders et al. ESMO 2016, Abstract #; 3 INCa 2012 Survey, 3 Etude FLASH RAS 2014; 4 JMD, May 2017; 5 Scott et al. (2014) Asia Pac J Clin Oncol. 10(3):261-5.

5

Inst

rum

ent

Conso

le

Cartridge(consumable)

Scan sample

Scan cartridge

Loadsample

Insert cartridge

Clinically-actionable

results

Superior sensitivity and ease-of-use,

combined with sample-to-result turnaroundtime of 65 to 160 minutes*

Unique, versatile platform for dual use in

oncology and infectious disease

* Based on turnaround times of current on-market oncology tests

• Comparison of 13 different KRAS mutation detecting technologies:

• Focused on detection of KRAS mutations in lung cancer based on blinded samples

Highest score for Idylla™ KRAS technology:o Lowest number of manual handling steps in sample

preparation (1 to 2 steps versus 3 to > 20 steps) o Requires lowest level of expertise (1 versus 2-4 for

others*)o Highest score for Idylla™ KRAS technology on total

turnaround time (2 to 4 hours versus 1 day to 3 weeks)

Background

Source: Sherwood JL, Brown H, Rettino A, et al., “Key differences between 13 KRAS mutation detection technologies and their relevance for clinical practice”. ESMO Open 2017;2:e000235. doi:10.1136/ esmoopen-2017-000235NGS technologies included two technologies by Thermo Fisher Scientific. Mass spectrometry technologies included two technologies from AgenaBioscience

Conclusions

6x NGS

3x qPCR

2x mass spec.

1x ddPCR

1x Sanger sequencing

Sensi

tivity

Technology Overall sensitivity

Idylla™ KRAS 96%

Other qPCR (cobas/therascreen) 46-52%

Mass-spectrometry 58-92%

NGS 48-100%

ddPCR 52-60%

Ease

-of-

use

TaT**

* One being the lowest level of expertise and four the highest** TaT = total turnaround time6

7

Only selected studies shown on slide

1 Arcila ME, Yang S-R, Momeni A, Mata DA, Salazar P, Chan R, Elezovic D, Benayed R, Zehir A, Buonocore DJ, Rekhtman N, Lin O, Ladanyi M, Nafa K, Ultra-Rapid EGFR Mutation Screening Followed by Comprehensive Next-Generation Sequencing: A Feasible, Informative Approach for Lung Carcinoma Cytology Specimens with a High Success Rate., JTO Clinical and Research Reports (2020), doi: https://doi.org/10.1016/j.jtocrr.2020.100077., available online 18 July 2020; Arcila ME et al., Rapid EGFR Mutation Detection Using the Single-Institution Experience of 1200 Cases Analyzed by an In-House Developed Pipeline and Comparison with Concurrent Next-Generation Sequencing Results Idylla Platform, J Mol Diagn 2020, Published on 23 December 2020, 1-12; https://doi.org/10.1016/j.jmoldx.2020.11.009; 2 RUO = Research Use Only, not for use in diagnostic procedures; 3 Next Generation Sequencing; 4 Behera et al. Circulating tumor DNA mutation as a prognostic marker in melanoma with brain metastasis. J Clin Oncol 39, 2021 (suppl 15; abstr e21560); 4 Only the abstracts at the virtual AMP Europe congress (Association for Molecular Pathology, virtual congress taking place 14-18 June 2021) and ASCO (American Society of Clinical Oncology) in the US were screened

• One abstract4 presented at the ASCO (American Society of Clinical Oncology) Annual Meeting (4-8 June 2021)

• One abstract on the SeptiCyte© RAPID on Idylla™ presented at the 31st ECCMID(European Congress of Clinical Microbiology & Infectious Diseases) congress (9-12 July 2021)

• Studies included the publication of two studies1 by Memorial Sloan KetteringCancer Center (‘MSKCC’, New York, US)

• Concluding that Idylla™ EGFR testing (RUO2)

• Enables rapid assessment of the most common EGFR mutations with lowsample input, even on different sample types, without compromisingsubsequent more comprehensive NGS3 testing

• Can be useful in cases where EGFR mutation results were negative and further testing is needed

Two studies on rapidEGFR Idylla™ testing

ASCO and ECCMID

H1 2021 publication highlights

8

Expansion into infectious diseases

• Diversifying the Idylla™ test menu to accelerate further installed base growth, focus on rapid response testing for critical illness

• First expansions in infectious diseases:

• Pandemic menu: Idylla™ SARS-CoV-2 Test, SeptiCyte® RAPID and recent CE-IVD launch of the Idylla™ SARS-CoV-2/Flu/RSV Panel

• Idylla™ Endpoint Test (in development)

• Growing partner business model to accelerate core strategy

Oncology focus

• On market Idylla™ oncology test menu in colorectal, lung, melanoma, with ongoing developments in breast and thyroid cancer

• Selected opportunities to broaden and deepen in oncology through five strategic areas where Idylla™ can make a difference in the cancer treatment continuum:

1. Gene signatures2. Targeted therapy3. Pan-tumor4. Immuno-oncology5. Liquid biopsy

The SeptiCyte® RAPID on Idylla™ is in collaboration with Immunepress. The Idylla™ Endpoint Test is in collaboration with Endpoint Health.

Commercialization through direct sales force

Commercialization through distribution partners

Commercialization through joint venture

Over 70 countries covered through four sales channels:

Direct sales force covering Western European countries, US and Canada

Distributor contracts in place covering ~ 65 countries. Distribution agreement with Nichirei Biosciences for Japanese market

Joint venture in China with Wondfo

Pharma collaborations (e.g. Merck KGaA (Darmstadt, Germany), Amgen, AstraZeneca, BMS and Kite/Gilead) and content partnerships (e.g. Immunexpress, GeneproDx, Endpoint Health, SkylineDx)

1

2

3

1 Situation as per 31 December 20209

4

10

1. Marketed by Roche. 2 Marketed by AstraZeneca. 3. Marketed by Merck KGaA and Eli Lilly. 4. Marketed by Amgen. 5. Marketed by Bayer (licensed from Eli Lilly’s Loxo). 6. Marketed by Merck. 7. Marketed by Roche.

• MDx tests detecting specific tumor mutations used for therapy selection in a specific cancer type

• Significant pharma pipeline of new targeted therapies

• Exampleso Zelboraf®1 (BRAF)o Tagrisso®2 (EGFR)o Erbitux®3 (RAS)o Vectibix®4 (RAS)

• Pan-tumor application of tumor mutation tests for therapies selected based on genetics rather than location of the tumor

• Allows therapy use across multiple cancer types

• Positive impact on underlying test volumes

• Exampleso Vitrakvi®5

o Keytruda®6

o Rozlytrek®7

• MDx tests based on RNA Gene Signatures are used for e.g.:o Diagnosiso Prognosis

• Often high value once validated & clinical value demonstrated

• Exampleso SeptiCyte® RAPIDo ThyroidPrint®

• MDx tests supporting immuno-oncology cancer treatments

• Consists of many different therapies, e.g.:o Immune checkpoint

inhibitorso Cell and viral therapieso Vaccines

• High unmet need for underlying MDx testing

• MDx tests via liquid samples

• Use in diagnosis, prognosis and Molecular Surveillance (i.e. therapy selection, response and recurrence monitoring)

• Can be done through off-the-shelf catalogue panels as well as tumor-informed, personalized panels

Diagnosis Treatment start Treatment stop

Molecular Surveillance

Prognosis & therapy selectionScreening & diagnosis

Response monitoring Recurrence monitoring

Gene signatures Targeted therapy Pan-tumor Immuno-oncology Liquid biopsy

11

Accelerate menu expansion

Increase installed base

Reduce costs, sharper pricing

Global Idylla™ecosystem

Diversification

• What: porting of proprietary biomarker panels developed & validated by 3rd parties on Idylla™ platform

• For Biocartis: proprietary 3rd party content on Idylla™ platform, expanded menu appealing to larger audience

• For partner: accelerated global roll-out of content, focus on content education since no platform education needed, cost efficiencies

• What: (joint) development of CDx1 on Idylla™platform

• For Biocartis: faster commercial adoption, higher market shares

• For partner: better & faster selection of eligible patients for targeted therapies given faster TaT& high sensitivity. Fast TaTreduces competition with therapies not requiring a biomarker, high sensitivity means more patients detected with relevant biomarkers

• What: development of Idylla™ assays with IVD development companies and research institutes

• For Biocartis: lowered menu development costs

• For partner: contribution to medical innovation, knowledge sharing & building

UK based medical research charity2

Singapore’s Agency for Science, Technology and Research3

1. CDx = Companion Diagnostics; 2. On 15 June 2017, MRC Technology changed its name in LifeArc. LifeArc has been involved in helping deliver a number of therapies including Keytruda (pembrolizumab, marketed by MSD) which is an important immunotherapy treatment for various cancers. On 1 September 2020, Biocartis announced the expansion of the partnership with LifeArc in the field of infectious and immune related diseases; 3. Partnership is with ETPL, the commercialization arm of A*STAR

Shared investment

Pharma & biotech partners

Content partners Development partners

KRAS

NRAS-BRAF

ctKRAS

ctNRAS-BRAF

MSI

12

Cartridge Development RUO USA

RUO = Research Use Only, not for use in diagnostic procedures; CE = CE-marked IVD; Product updates = Product updates to ensure IVDR compliance and implementation of Post-Marketing Surveillance feedback; ABC = Advanced Breast Cancer; IO = Immuno-oncology; FNA = Fine Needle Aspirates; PMA = Pre-Market Approval; 510(k) notification = a premarket submission made to the US FDA. Source: US FDA website. All publications, abstracts & posters are available on www.biocartis.com/publications. An IVD-version of the Idylla™ GeneFusion Panel (IVD) is currently under development. NTRK1-3 will be only available in the Idylla™ GeneFusion Assay (RUO). Patents US 7,700,339, 8,168,383, 8,481,279, 8,486,645, 8,232,060, 8,288,102, 8,377,642, 9,988,688, 9,523,130, 9,096,855, 10,526,661, 9,364,477, 9,539,254, 10,551,383 and pending US applications and all their respective foreign equivalents under license from Cell Signaling Technology, Inc. The Merlin Assay on the Idylla™ platform is a collaboration with SkylineDx. The ThyroidPrint Assay on the Idylla™ platform is a collaboration with GeneproDx. Development of Idylla™ EGFR-BRAF+ Mutation Assay suspended awaiting completion of the new simplified, cost-efficient cartridge concept. Timelines will be communicated at a later stage. The Idylla™ development pipeline reflects the different cartridges and biomarkers in development, including cartridges that can be used for research applications. Please see here for more information about the respective studies, or to the specific product labeling for applicable intended use for each individual Biocartis product. Overview is subject to change in amongst others prioritization of test development by Biocartis and/or partners driven by commercial, partnering & operational considerations.

EGFR

ctEGFR

BRAF

KRAS

GeneFusion

EGFR/BRAF+

BRAF

ctBRAF

NRAS-BRAF

Merlin Assay on Idylla™ (SkylineDx)

Idylla™ ABC Assay (LifeArc)

PMA

CE Japan

PMA

China

510(k) submitted Ongoing

Ongoing

Ongoing

Ongoing

Ongoing

KRAS (pancreatic cyst fluid samples)NRAS & BRAF (thyroid FNA samples) MSI (pan-tumor)

IO: MSI

IO: Cell therapy monitoring

ThyroidPrint® on Idylla™ (GeneProDx)

Endometrium

Hematology

Brain

Ongoing

Product update ongoing

Product update ongoing

Product update ongoing

Product update ongoing

Ongoing

Ongoing

Shared design & development project

= liquid biopsy

= solid biopsy

Ongoing

Product update ongoing

= planned start

Legend

= on market

Ongoing

Ongoing

Ongoing

Ongoing

Product update ongoing

PMA Ongoing Ongoing

131 CDx = Companion Diagnostics = A CDx test is a test used as a companion to a therapeutic drug, that helps predict if a patient is likely to respond to a treatment or not; 2 mCRC = Metastatic colorectal cancer; 3 VLAIO = The Flanders Organization for Innovation & Entrepreneurship. The grant is intended tosupport the development of the GeneFusion Assay on the Idylla™ platform, and to support related research studies on different sample and tumor tissue types, including on lung cancer tissue. The Idylla™ GeneFusion Assay will include a highly multiplexed panel of established and emerging biomarkers, and willbe the first FFPE (Formalin fixed, paraffin embedded ) RNA based assay (= RNA or Ribonucleic Acid is one of the three major biological macromolecules that are essential for all known forms of life along with DNA and proteins) on the Idylla™ platform. The Idylla™ GeneFusion Assay is expected to bring results

in approx. 3 hours, with less than 2 minutes hands-on time; 4 GeneproDx is a molecular diagnostics company based in Santiago, Chile; 5 A sentinel lymph node biopsy (SLNB) is a surgical procedure used to determine whether cancer has spread beyond a primary tumor into the lymphatic system. Source: MayoClinic, https://www.mayoclinic.org/tests-procedures/sentinel-node-biopsy/about/pac-20385264, last consulted on 21 April 2021

Partnership AstraZeneca

• Announced 22 January 2020• Master collaboration agreement aimed at rapid & easy

testing in lung cancer• Expansion of partnership to, amongst others, the area of

liquid biopsy testing using the Idylla™ ctEGFR Mutation

Assay

Partnership BMS China

• Announced 5 March 2020• Biocartis announced the expansion of its partnership with

Bristol-Myers Squibb Company, to now also pursue, after theUS, the registration of the Idylla™ MSI test as a CDx1 test in

mCRC2 in China

SkylineDx

• Announced 22 April 2021• Development by SkylineDx of its novel Merlin Assay on Idylla™• Assay aims at predicting a patient’s risk of nodal metastasis in

melanoma, identifying patients who may safely forgo an SLNbiopsy5

• Biocartis will lead commercialization in Europe through itsgrowing Idylla™ network

1 2

4GeneproDx

• Announced 3 November 2020• License, development & commercialization agreement with

GeneproDx4 for development of the ThyroidPrint® on theIdylla™ platform

• GeneproDx will lead the development of the Idylla™ThyroidPrint® test

• Biocartis will be responsible for the distribution of the testthrough growing global commercial infrastructure of Idylla™instruments

3

14

• The current Idylla™ testing offering addresses

approx. 4m annual testing volume

• The new Idylla™ pipeline allows to grow to a

total addressable market of over 10m annual testing volume, excluding molecular surveillance

• High growth areas thanks to the combination of unique Idylla™ characteristics:• Fast time-to-result• Ease-of-use• Highly accurate• Sample versatility• Cost-effectiveness versus existing methods• Suitable technology for monitoring

5,3

10,1

4,8

Current Idylla™ offering Pipeline Future Idylla™ offering

Total addressable market volumes (in millions)1 Unique Idylla™ USPs for rapid oncology Dx

1 Total addressable market includes Europe, the US and distributor markets (including Japan, excluding China)2 Current Idylla™ offering includes Idylla™ assays in Melanoma (BRAF), Colorectal (KRAS, NRAS, BRAF and MSI), Lung (EGFR), GeneFusion3 Pipeline includes assays in Breast (Idylla™ ABC Panel), Pan cancer (MSI), Thyroid (ThyroidPrint® on Idylla™), Endometrium, Hematology and Brain4 Future Idylla™ offering excludes surveillance monitoring

2 3 4

1. COVID-19 3. FUTURE POTENTIAL

• Responsible for est. 11m deaths/year globally2, annual healthcare costs est. at > USD 60bn in the US alone3

• High unmet need: current markers are not rapid (blood cultures) or non-specific (PCT, CRP)4; increased risk in pandemic times

• Fast clinical decisions impact patient outcome

• Idylla™ tests:

• SeptiCyte® RAPID5 (with Immunexpress)

• Idylla™ EndPoint Test (with EndPoint Health): aims at enabling biomarker-based therapeutic decisions in patients with critical illnesses6, such as sepsis

• Pandemic: more decentralized MDx testing, faster installed base building in acute settings

• Support Intensive Care Unit (ICU)1

positioning, together with SeptiCyte®

RAPID5 on Idylla™

• Idylla™ tests:

• Idylla™ SARS-CoV-2 Test (CE-IVD,EUA pending)

• Idylla™ SARS-CoV-2/Flu/RSV Panel (CE-IVD)

15 1 The Idylla™ SARS-CoV-2 Test and the SeptiCyte® RAPID (CE-IVD) test on Idylla™ are intended for use in microbiology labs; 2 The Lancet, https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32989-7/fulltext, last consulted on 29 October 2020; 3 Paoli et al. Crit Care Med (2018): 46: 1889-1897 and https://journals.lww.com/ccmjournal/Fulltext/2020/03000/Sepsis_Among_Medicare_Beneficiaries__3__The.4.aspx, last consulted on 29 October 2020; 4PCT = Procalcitonin (PCT) assay is a biomarker for systemic inflammation; CRP = C-reactive protein, a biomarker for systemic inflammation. Positive bacteriological cultures, including blood cultures, may not be available before 24 to 48 hours; interpretation of local colonization may be ambiguous; and traditional markers of infection, such as body temperature and white blood cell (WBC) count, may not be specific; 5 SeptiCyte® RAPID is a host-response test that distinguishes sepsis from non-infectious systemic inflammation in patients suspected of sepsis; 6 The Idylla™ Endpoint test is intended to be a PCR based mRNA-expression classifier test that aims at enabling biomarker-based therapeutic decisions in patients with critical illnesses. More specifically, the test will be intended to help identify patients with critical illnesses that are likely to benefit from corticosteroid therapy versus patients in which such therapy should be avoided

2. SEPSIS

• Syndromic panel testing:

• One of fastest growing MDxsegments

• Idylla™’s unique multiplexingplatform capabilities allow entryinto this market

Towards easy & rapid Idylla™ infectious disease testing to support the patient journey in the intensive care unit (ICU), including rapid triage and therapy selection of critically ill patients

16 1 A Seattle-based (WA, US) molecular diagnostic company; 2 LifeArc, formerly known as the Medical Research Council Technology (MRC Technology, MRCT) is a London based life science medical research charity; 3 Including research, regulatory oversight, clinical implications, reliability and access; 4 CDx = Companion Diagnostics = A CDx test is a test used as a companion to a therapeutic drug, that helps predict if a patient is likely to respond to a treatment or not; 5 In the US, distribution of the Idylla™ SARS-CoV-2 Test was initiated in Q3 2020 per US FDA Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised), May 2020, Section IV.C. Commercial Manufacturer Development and Distribution of Diagnostic Tests Prior to EUA Submission. The Idylla™ SARS-CoV-2 Test was CE-marked on 10 November 2020 and in August 2020, Biocartis submitted a notification of intent to distribute and request for ‘Emergency Use Authorization’ (EUA) from the US FDA for the Idylla™ SARS-CoV-2 Test; 6 More information here

Partnership Immunexpress

• March 2020: agreement with Immunexpress1

expanded with co-commercialization agreement for SeptiCyte® RAPID test for use on Idylla™

• End December 2020, 510(k) submission with US FDA of the SeptiCyte® RAPID, led by Immunexpress, was completed

Partnership LifeArc

• Announced in September 2020• Agreement with LifeArc2 expanded • Now also includes development of highly

innovative prototype assays in infectious and immune related diseases on Idylla™

Partnership Endpoint Health

• Announced in November 2020• Aimed at the development & commercialization

of a novel CDx4 test on Idylla™ for critical illnesses

Idylla™ SARS-CoV-2 Test

• August 2020: notification of intent submitted to distribute & request for ‘Emergency Use Authorization’ (EUA) from US FDA5

• November 2020: CE-IVD launch announced• Ongoing development of Idylla™ SARS-CoV-2

Panel

SeptiCyte® RAPID

• October 2020: Biocartis announced market release of SeptiCyte® RAPID test on Idylla™(CE-IVD)

• December 2020: US FDA 510(k) submission SeptiCyte® RAPID (led by Immunexpress) completed

1 2 3

4 5Idylla™ SARS-CoV-/Flu/RSV Panel

• 2 Sept 2021: launched as CE-IVD• Detects, in 1 single cartridge, SARS-CoV-2,

Flu A/B and RSV nucleic acids, results in ca. 90 minutes, < 2min. hands-on time

• Clinical performance study6: 98% overall concordance compared with other currently used methods

6

SeptiCyte® PLUS on Idylla™

17

Idylla™ Syndromic Panel(> 20-30 pathogens multiplexed)

Idylla™ SARS-CoV-2 Test and Idylla™ SARS-CoV-2 Panel (CE-IVD)

SeptiCyte® RAPID on Idylla™

Idylla™ Endpoint test

Does the patient have an infection? Yes/No

Does the patient have a viral/bacterial infection?

Does the patient have a SARS-CoV-2 infection?Yes/No Which respiratory pathogen is

causing the symptoms?

Which supportive therapy should the patient receive?• Corticosteroids• Immuno-stimulants• Anti-coagulants

Target population

Idylla™menu

Person at riskSymptomatic

patientCritically ill patient Confirmed patient

To develop

With viral/bacterial differentiation

ICU = Intensive Care Unit

SeptiCyte® RAPID on Idylla™

Idylla™ SARS-CoV-2 Test

Idylla™ SARS-CoV-2/Flu/RSV Panel

Idylla™ Endpoint test

Syndromic panels

18

Cartridge Development USACE Japan China

EUA Pending*

Regulatoryprocess ongoing

Ongoing

= planned start

Legend

RUO = Research Use Only, not for use in diagnostic procedures; CE = CE-marked IVD; EUA = Emergency Use Authorization. Source: US FDA website. SeptiCyte® RAPID on Idylla™ in collaboration with Immunexpress. Idylla™ Endpoint test in collaboration with Endpoint HealthThe Idylla™ development pipeline reflects the different cartridges and biomarkers in development, including cartridges that can be used for research applications. Please see here for more information about the respective studies, or to the specific product labeling for applicable intended use for each individual Biocartis product. Overview is subject to change in amongst others prioritization of test development by Biocartis and/or partners driven by commercial, partnering & operational considerations.* In the US, distribution of the Idylla™ SARS-CoV-2 Test was initiated in Q3 2020 per US FDA Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised), May 2020, Section IV.C. Commercial Manufacturer Development and Distribution of Diagnostic Tests Prior to EUA Submission. The Idylla™ SARS-CoV-2 Test was CE-marked on 10 November 2020 and in August 2020, Biocartis submitted a notification of intent to distribute and request for ‘Emergency Use Authorization’ (EUA) from the US FDA for the Idylla™ SARS-CoV-2 Test

Ongoing

Pandemic menu

Pandemic menu

EUA submission timing

TBC

Installed base x

Instrument utilization x

Average selling price = Sales

Key drivers• Commercial footprint• Commercialization

partnerships

Key drivers• Menu of tests• Regulatory approvals

Key drivers• Reimbursement• Competitive advantage Gross margin driven by

• Volume• Manufacturing

automation

19

20

Commercial cartridge volume

Total operating & product income

• Total operating income of EUR 23.1m, versus EUR 17.6m in H1 2020• Product income +62% to EUR 18.5m, versus EUR 11.4m in H1 2020

• 156k commercial Idylla™ cartridges sold, almost twice as high as in H1 2020 (+96%)• Q1 2021 marked by 70% growth, followed by an even stronger +136% in Q2 2021• Robust growth in oncology across all regions• Solid contribution from infectious diseases

• + 189 new Idylla™ placements in H1 2021 (versus 101 in H1 2020)• Installed base of 1,770 Idylla™ instruments end of H1 2021• Increasing average annualized cartridge consumption per Idylla™ instrument (for period H1 2021): 209

Installed base

Partnerships

1 ASP = Average Sales Price; 2 COGS = Costs of Goods Sold; 3 This assay is aimed at predicting a patient’s risk of nodal metastasis in melanoma. Under the terms of the partnership agreement, SkylineDx will lead the development of the Merlin Assay on Idylla™, while Biocartis will lead the commercialization in Europe through its growing Idylla™ network; 4 Defined asthe world excluding European direct markets, US, China and Japan; 5 RUO = Research Use Only, not for use in diagnostic procedures; 6 A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval(PMA). A 510(k) or Premarket Notification (PMN) with the US FDA is required when introducing a device into commercial distribution for the first time. Source: https://www.fda.gov/medical-devices/products-and-medical-procedures/device-approvals-denials-and-clearances, last consulted on 17 August 2021; 7 For the detection of MSI (Microsatellite Instability) and to aidin the differentiation between sporadic colorectal cancer and potential Lynch Syndrome; 8 The Panel detects SARS-CoV-2, Flu A/B and RSV (respiratory syncytial virus) nucleic acids in one single cartridge within approx. 90 minutes and was launched as CE-IVD

Idylla™ test menu

Cash position • Cash and cash equivalents of EUR 85.0m end of H1 2021

Cartridge ASP & gross margin

• Cartridge oncology ASP1 stable: EUR 104; ASP of the Idylla™ SARS-CoV-2 Test lower than last year, in line with expectations and resulting in an overall ASP of EUR 95.

• Gross margin on products: 8% (vs 18% in H1 2020):

• Lower ASP of Idylla™ SARS-CoV-2 Test

• Temporarily higher COGS2 due to lower production volumes on ML2 caused by global shortage of reagent supplies

• Ramp-up of staff in anticipation of increasing volumes in H2 2021

• New partnership SkylineDx: development of Merlin Assay3 on Idylla™• Expanded partnership AstraZeneca: improve access to Idylla™ EGFR testing products in EU and global distributor4 markets

• Encouraging first market demand for the Idylla™ GeneFusion Assay (RUO5), launched end Q1 2021• First oncology assay US FDA submission: 510(k)6 notification for the Idylla™ MSI Test7

• Post the reporting period: successful CE-IVD launch of the Idylla™ SARS-CoV-2/Flu/RSV Panel8

80k

156k

H1 2020 Year-over-year growth H1 2021

21

Installed base (in # instruments) Commercial cartridge volume (x 1,000)

+ 96%

~

• Increasing annualized average cartridge consumption per Idylla™ instrument: 209

• In part reflecting high utilization for infectious disease testing

• Q1 2021 marked by 70% growth• Followed by an even stronger +136% in Q2 2021• Robust growth in oncology across all regions• Solid contribution from infectious diseases, comparable to

H2 2020 volumes against backdrop of declining global COVID-19 testing volumes

1,581

1,581

+189 1,770

End 2020 Increase H1 2021 End H1 2021

22

• Commercial cartridge volumes +150%

• Slowdown Idylla™placements: constrained hospital budgets following the pandemic

• Growth driven by increased demand for oncology biomarker testing, return to pre-pandemic oncology biomarker testing volumes more disparate across the US

• Infectious diseases: demand for SARS-CoV-2 testing in H1 2021 significantly down from 2020 levels

• Strong increase new Idylla™placements

• Drives continued growth of EU cartridge volumes

• Strongest growth in oncology

• Combined with acquisition of new European customers in need for rapid SARS-CoV-2 testing for safe access to hospitals, events, travel

Europe

• Registration Idylla™instrument in China expected by end 2021

• Idylla™ assay registrations expected to follow earliest end 2022 in both countries

• Good progress in local manufacturing set-up in China during H1 2021, with local manufacturing of first cartridge volumes needed for local registration of the assays expected in H1 2022

1 Distributor markets = World excluding European direct markets, US, China and Japan;2 In China, Biocartis established a joint venture (‘China JV’) with Guangzhou Wondfo Biotech Co., Ltd (SHE: 300482), a fast-growing diagnostics leader in China. In Japan, Biocartis is collaborating with Nichirei Biosciences

• Strong performance in terms of Idylla™placements

• Cartridge volume regained traction in oncology in all regions

• Registration completed in Russia for the Idylla™platform, Idylla™ BRAF Mutation Test (CE-IVD) and Idylla™ EGFR Mutation Test (CE-IVD)

• Registration completed in Taiwan for the Idylla™ MSI Test (CE-IVD)

Distributor markets1 China & Japan2US

23

• Gene fusions have become important biomarkers for cancer diagnosis, prognosis and selection of targeted therapies1

• The discovery & research for further understanding of fusion genes across multiple cancer types may provide more effective therapies in the future

• Current gene fusion testing techniques are complex: • Require combination of different

technologies2, often only available in different laboratories, to test all biomarkers

• Implies need for sufficient sample quality & quantity: difficult to obtain, esp. for certain cancers including lung cancer

* RUO = Research Use Only, not for use in diagnostic procedures; 1 Stransky et al. The landscape of kinase fusions in cancer. Nat Commun. 5, 4846, 2014; Mertens et al. The emerging complexity of gene fusions in cancer. Nat Rev Cancer 15, 371-381, 2015; 2 Techniques used to detect NTRK gene fusions include DNA-based next-generation sequencing (NGS), RNA-based NGS, reverse-transcriptase PCR (RT-PCR), fluorescence in situ hybridisation (FISH), and immunohistochemistry (IHC). Source: OncologyPro, ESMO, see here, last consulted on 15 March 2021; 3 FFPE = formalin fixed, paraffin embedded; 4 The concordance study was performed on NSCLC (non-small cell lung cancer) and thyroid cancer samples with prototype cartridges but re-analyzed with final Idylla™ GeneFusion Assay (RUO) decision tree. Moreover, the Idylla™ GeneFusion Assay was able to generate accurate results in 29/32 inconclusive IHC and FISH results. Preliminary data can be found on https://www.biocartis.com/en/meetidylla/idylla-oncology-assays General note: An IVD version of the Idylla™ GeneFusion Panel is currently under development. NTRK1-3 will be only available in the Idylla™ GeneFusion Assay (RUO). Patents US 7,700,339, 8,168,383, 8,481,279, 8,486,645, 8,232,060, 8,288,102, 8,377,642, 9,988,688, 9,523,130, 9,096,855, 10,526,661, 9,364,477, 9,539,254, 10,551,383 and pending US applications and all their respective foreign equivalents under license from Cell Signaling Technology, Inc.

Detection of ALK, ROS1, RET & MET Exon 14 skipping plus NTRK1/2/3 fusion screening in one cartridge

Fully automated molecular testing platformOn-demand testing

<2 minutes hands-on time (HOT)Assay turnaround time (TAT) of approx. 180 min.

Directly from 1-3 FFPE3 slices

Preliminary data4 comparing the Idylla™ GeneFusion Assay (RUO) with today’s frequently used technologies such as Immunohistochemistry, FISH or NGS2, show excellent results of the Assay, with concordance up to 100%

The Idylla™ GeneFusion Assay (RUO) highly multiplexed panel of biomarkers, the first FFPE3 RNA4-based assay on Idylla™

24

• Announced 20 April 2021: US FDA 510(k) submission1 of Idylla™ MSI Test2 for use as an IVD diagnostic device intended for the identification of microsatellite instability (MSI) status in colorectal cancer (CRC) to aid in the differentiation between sporadic CRC and potential Lynch syndrome

• Today, MSI testing is recommended in the guidelines for CRC patients for screening for Lynch syndrome3

• MSI testing today still underused due to complexity of current methods

• Idylla™ MSI Test allows fully automated MSI testing, providing info on the MSI status4 of CRC tumors within approx. 150 minutes, without the need of a reference sample

• Once 510(k) clearance is obtained, both large & small US labs are expected to benefit from this fast & easy-to-use Idylla™ MSI testing thanks to fully automated sample-to-result nature of Idylla™ platform

1 A 510(k) or Premarket Notification (PMN) with the US FDA is required when introducing a device into commercial distribution for the first time. Source: US FDA; 2 The Idylla™ MSI Test, for use on theIdylla™ system, is intended for the qualitative identification of microsatellite instability (MSI) in colorectal cancer (CRC) tumors and to aid in the differentiation between sporadic CRC and potential LynchSyndrome. The clinical performance of this device to guide treatment of MSI-H patients has not been established; 3 Van Cutsem et al. (2016) ESMO Consensus Guidelines for the management ofpatients with mCRC. Annals of Oncology 27, 1386; NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Colon Cancer V.2.2018. Accessed 25 July 2018. See www.NCCN.org; 4 TheIdylla™ MSI Test reports results as either microsatellite stable (MSS), or microsatellite instability high (MSI-H) or invalid

• SkylineDx: Dutch & US based private biotech company activein oncology & inflammatory diseases MDx

• Immediate market development ahead of IVD strategy:

• LDT4 version of Merlin Assay through CAP/CLIA certifiedlaboratory in San Diego (CA, US)

• Molecular subtyping test kit for IVD use underdevelopment for Europe

• Commercialization by Biocartis in Europe through itsgrowing Idylla™ network

• Access to SkylineDx’s highly valuable biomarker content:

• Additional novel tests in varying stages of development

• Biocartis to invest up to EUR 10m in secured convertiblenotes issued in different project-based instalmentsthroughout the collaboration

• Expected attractive value-based pricing

25

About melanoma & Merlin Assay on Idylla™ About SkylineDx & the agreement

• Melanoma is deadliest form of skin cancer: prognosis & treatment decisions depend on disease staging

• Current staging methods include an invasive SLN biopsy1:

• Carrying a >10% risk of complications2 whereas

• 80-85% are unnecessary as no nodal metastases are found2

• Principal agreement announced 22 April 2021:

• Development by SkylineDx of its novel Merlin Assay, on Idylla™

• Predicting a patient’s risk of nodal metastasis in melanoma, identifying patients who may safely forgo an SLN biopsy1

• Biocartis will lead commercialization in Europe through its growing Idylla™ network

• Complements Biocartis’ current BRAF assay offering3

1 A sentinel lymph node biopsy (SLNB) is a surgical procedure used to determine whether cancer has spread beyond a primary tumor into the lymphatic system. Source: Mayo Clinic, https://www.mayoclinic.org/tests-procedures/sentinel-node-biopsy/about/pac-20385264, last consulted on 21 April 2021; 2 Ascha M, et al. Ann Plast Surg 79:509-515, 2017, https://journals.lww.com/annalsplasticsurgery/Abstract/2017/11000/Identification_of_Risk_Factors_in_Lymphatic.22.aspx; Bellomo et al. JCO Precision Oncology, https://ascopubs.org/doi/10.1200/PO.19.00206; 3 The Idylla™ BRAF Mutation Test (CE-IVD) is validated for use in metastatic melanoma; 4 A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. Source: US FDA, last consulted on 19 August 2021

• Panel showed excellent performance in the clinical

performance study with 98% overall agreement

compared with other currently used methods

• Timing of Emergency Use Authorization (‘EUA’)

submission with the US FDA to be decided

26

About the Panel Clinical performance

• Fully automated rRT-PCR1 test intended forqualitative detection of SARS-CoV-2, Flu A/B andRSV nucleic acids in nasopharyngeal swabspecimens from individuals suspected ofrespiratory infections by their healthcare provider

• Collected in viral transport medium2, can bepipetted directly into the cartridge

• Panel includes fully automated nucleic acidtesting with the extraction, amplification anddetection in a single-use cartridge

• Less than 2 minutes hands-on time, results inapprox. 90 minutes

1 Real-Time Reverse Transcription-Polymerase Chain Reaction; 2 Of which 400 µl VTM is used in Idylla™; 2 Performance was evaluated across two arms of a clinical evaluation, all samples were residual nasopharyngeal swab in viral transport media. In the first arm 322 specimens were collected to evaluate the performance of the Idylla™ COVID-19/Flu/RSV Panel compared to the DiaSorin Molecular Simplexa™ Flu A/B & RSV Direct. In the second arm 341 specimens were collected to evaluate the performance of the Idylla™ COVID-19/Flu/RSV Panel compared to the Luminex Aries® SARS-COV-2 Assay. More information here

27

• Successful transfer Idylla™ EGFR Mutation Test (CE-IVD) to second manufacturing line ‘ML2’ during H1 2021

• Key oncology assays now all on ML2 line

• Product gross margin improvement temporarily held up, global pandemic shortage of certain reagents limited planned production volumes

ML2 cartridge manufacturing line facts• Located in Mechelen (BE)• Additional annual capacity of + 1,000,000

cartridges• Fully automated assembly workstations

(vs semi-automated on 1st line, annual capacity +200k cartridges)

• Plastic parts with new multi-cavity molds (vs single cavity on 1st line)

• Key to support volume growth & cost effectiveness

H1 2021: Key oncology assays on ML2 line

28

Fire incident on 30 July 2021

• Immediate actions taken to mitigate loss of finished products & raw materials, and temporary unavailability of high-throughput ML2 line

• Actions to safeguard continued supply to customers:

• Redirection of additional personnel & resources to the unaffected ML1 line to temporarily increase production

• Orders placed to replenish critical reagents lost in fire to minimize production delay

• Prioritization of oncology & partner project tests, which also reduces the number of available Idylla™SARS-CoV-2 Test cartridges

Despite impact of the fire...

• Biocartis to confirm a 40% cartridge volume growth for 2021:

• Subject to timely and sufficient availability of reagents

• Subject to full restart of the ML2 line, now expected by 2nd half of September

• Delays in supply of assay-specific reagents may cause certain Idylla™ products to be temporarily unavailable to meet the entire customer demand

29

• Evaluation of new concept ongoing for simplified, cost-efficient Idylla™ cartridge

• In the mid-to long term, expected to acceleratereduction of cartridge manufacturing cost alongside ongoing development of new Idylla™technology1 for offline customization of Idylla™cartridge

• Reduced complexity of the cartridge for infectious diseases and likely also for certain oncology assays

• Fully compatible with existing Idylla™ platform

1 With the support of VLAIO, Flanders Agency for Innovation and Entrepreneurship. The technology is aimed to tap into new market opportunities with customized and personalized products

What and why Status & timelines

• Feasibility already externally confirmed by reputable global contract manufacturing organization

• Investment decision still subject to completion of concept design

• Ongoing and future assay menu investments in infectious diseases and oncology under review

Idylla™ standard: 40+ parts

New Idylla™: ~12 parts

30

Despite impact of the fire, Biocartis confirms its 2021 guidance at 40% growth target for commercial cartridge volumes:

• Commercial cartridge volume: Targeting a year-over-year growth of 40%, or commercial cartridge volumes of 320k.

• Subject to timely availability of reagent raw materials for Idylla™ cartridges

• Subject to restart of the ML2 line by 2nd half of September

• Installed base: Targeting 300-350 new Idylla™ instrument placements

• Cash position: Targeting at least EUR 50m cash position at year-end, provided timely collection of insurance claims related to the fire incident

31

Oncology test menu Infectious disease (partner) test menu

510(k) clearance with US FDA of

SeptiCyte® RAPID on Idylla™

(Immunexpress) is pending

Timing of Emergency Use Authorization

(‘EUA’) submission of Idylla™ SARS-

CoV-2/Flu/RSV Panel with the US FDA

to be decided

New simplified, cost-efficient CART concept

Concept design still to be completed

Will impact decision to invest in

manufacturing equipment and the actual

development of new and existing Idylla™

assays based on this concept

Outcomes of the assessment and

associated development timelines will be

communicated at a later stage

Launch Idylla™ EGFR-BRAF+ Mutation

Assay:

• Suspended awaiting completion of

the new simplified, cost-efficient

cartridge concept

• Timelines will be communicated at

a later stage

Launch Idylla™ ABC (Advanced Breast

Cancer) Assay in collaboration with

LifeArc expected in H2 2022

Idylla™ MSI Test US FDA 510(k)

pending

Shareholder overview (as per 13 Sept 2021) Coverage

Note: The percentages above are based on the most recent transparency notifications received by Biocartis. See the Biocartis investor website for more details.

Listing: Euronext BrusselsISIN: BE0974281132 Ticker: BCART

Stock facts

Dylan van Haaften

Kris Kippers

Thomas Vranken

Alexandru Cogut

Daan Vandenberk

32

Shareholder >3% table # shares % shares

Invesco, Ltd. (1) 6,969,077 12.10%

Johnson & Johnson Innovation – JJDC, Inc (2) 5,481,128 9.5%

ParticipatieMaatschappij Vlaanderen NV (Flemish Region) (3) 2,342,345 4.07%

Credit Suisse Group AG (4) 1,818,193 3.16%

Other institutional and retail investors 40,934,920 71.17%

Total outstanding shares (non-diluted) 57,545,663 100,00%

• 10 November 2021 Q3 2021 Business Update

• 24 February 2022 2021 full year results

• 31 March 2022 Publication 2021 annual report

33

Biocartis Investor RelationsGeneraal de Wittelaan 11B

2800 Mechelen

BELGIUM

tel. +32 15 63 17 29

ir@biocartis.com

www.biocartis.com

34

Annexes

36

Additional details (in EUR 1,000)

Product sales revenue H1 2021 H1 2020

Idylla™ system sales 3,715 1,837

Idylla™ cartridge sales 14,749 9,584

Product sales revenue 18,463 11,421

Collaboration revenue H1 2021 H1 2020

R&D services 2,590 4,623

License fees 50 123

Milestones 0 0

Collaboration revenue 2,640 4,746

Breakdown total operating income

In EUR 1,000 H1 2021 H1 2020

Product sales revenue 18,463 11,421

Collaboration revenue 2,640 4,746

Service revenue 748 530

Total revenue 21,851 16,697

Grants and other income 1,206 909

Total operating income 23,057 17,606

37

Condensed income statement

In EUR 1,000 H1 2021 H1 2020

Total operating income 23,057 17,606

Cost of goods sold (17,059) (9,233)

R&D expenses (23,389) (20,303)

S&M expenses (7,740) (7,931)

G&A expenses (7,935) (6,491)

Total operating expenses (56,132) (43,958)

Operating result (33,075) (26,352)

Net financial result (4,249) (5,129)

Share in results of associates (101) -195

Income taxes 149 118

Net result (37,276) (31,558)

Comments

• Total operating income of EUR 23.1m, versus EUR 17.6m in H1 2020:o Product revenues +62% to EUR 18.5m in H1 2021

o Cartridge sales revenues +54%o Instrument sales revenues doubled on the back of 189 new

instrument placements, +88 year-over-yearo Collaboration revenues EUR 2.6m (R&D services to partners):

highly sensitive to timing of collaboration projects

• Higher COGS mostly driven by volume growth

• Gross margin on products 8% versus 18% in H1 2020:• Lower ASP of the Idylla™ SARS-CoV-2 Test • Lower than expected production volumes on ML2

• Operating expenses (excl. cost of sales) EUR 39.1m in H1 2021 (H1 2020: EUR 34.7m): planned acceleration & diversification of the Idylla™ test menu, both in oncology & in infectious diseases

• Net result EUR 37.3m compared to EUR 31.6m in H1 2020

38

Condensed cash flow statement Remarks

1. Excludes the effect of exchange rate differences on the cash balances held in foreign currencies2. Including EUR 1.2m restricted cash related to KBC Lease financing

• The net cash outflow from operating and investing activities amounted to EUR 35.8m in H1 2021 compared to EUR 25.6m in H1 2020

• Increased outflow is attributable to:

• Increased operating loss

• Large one-off collection of EUR 5.2m tax credit in 2020

• Cash and cash equivalents at 30 June 2021 amounted to EUR 85.0m

In EUR 1,000 H1 2021 H1 2020

Result for the period (37,276) (31,558)

Depreciation and amortization 4,799 5,010

Impairment losses 598 721

Net financial result & other adjustments

4,636 5,411

Working capital changes (3,282) (525)

Taxes & interests paid (3,227) (3,585)

CF operating activities (33,752) (24,526)

CF investing activities (2,087) (1,028)

CF financing activities (3,518) (3,456)

Total net cash flow1 (39,357) (29,010)

Cash and cash equivalents2 84,905 149,674

Financial debt 149,412 165,259

• Most common cancer worldwide: 13% of all cancers1, 85% are non-small cell lung cancers (NSCLC)2

• EGFR mutation testing: recommended in all patients with advanced NSCLC of a non-squamous subtype3

• Current lung cancer molecular testing is complex:

• Can take up to several weeks4, as labs often send out samples

• Samples often small, with limited amount of available lung tumor tissue

1. Navani et al. Lancet Respir Med (2015); 2. American Cancer Society. Global Cancer Facts & Figures 2nd Edition (2011); 3. NCCN Clinical Practice Guidelines in Oncology – NSCLC – Version 6.2017. Novello S. et al. Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology 2016; 4. Neal I. Lindeman et al. Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors, Guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology (2014); 5 *Idylla™ EGFR Mutation Test is validated for metastatic NSCLC (Non-Small Cell Lung Cancer); 6 NCCN Guidelines version 8.2020 Non-small Cell Lung Cancer; 7 An IVD-version of the Idylla™ GeneFusion Panel is currently under development. NTRK1-3 will be only available in the Idylla™ GeneFusion Assay (RUO). Patents US 7,700,339, 8,168,383, 8,481,279, 8,486,645, 8,232,060, 8,288,102, 8,377,642, 9,988,688, 9,523,130, 9,096,855, 10,526,661, 9,364,477, 9,539,254, 10,551,383 and pending US applications and all their respective foreign equivalents under license from Cell Signaling Technology, Inc.

Idylla™ ctEGFR Mutation Assay (RUO)

About lung cancer and existing lung cancer testing

Idylla™ EGFR Mutation Test (CE-IVD)

• Fully automated, directly on 1 FFPE tissue slice from metastatic NSCLC5

• Less than 2 minutes hands-on time• Covers 51 mutations in 1 single cartridge • Approx. 150 minutes sample-to-result• Mutation detection for patient management

assessment

39

• Standard of care: slow, complex, costly

• Combination of different techniques (IHC, FISH & qPCR) to cover relevant biomarkers: many samples needed, time-consuming if tests are performed sequentially

• Next-generation sequencing (NGS)

• Stringent sample requirements: low sample quality & quantity might lead to high invalid rates

• Long turnaround time

• BioIT complexity is major hurdle

• Fully automated, directly on 2 ml plasma

• Approx. 2 minutes hands-on time• Covers 51 mutations in 1 single

cartridge • Approx. 160 minutes sample-to-result

Idylla™ GeneFusion Panel7

(RUO)

• Chromosomal translocations can produce gene fusions leading to uncontrolled tyrosine kinase activity

• Tyrosine kinase inhibitors are recommended by international guidelines6 for NSCLC patients with a specific gene fusion

• Idylla™ GeneFusion Assay launched on 22 March 2021

The Idylla™ EGFR/BRAF+ Mutation Assay and the Idylla™ GeneFusion Assay can be used in a different sequential order. The Idylla™ EGFR/BRAF+ Mutation Assay and the Idylla™ GeneFusion Assay should be performed following international recommended guidelines. * The Idylla™ EGFR/BRAF+ Mutation Assay will first be launched as RUO. An IVD version of the Idylla™ GeneFusion Panel is currently under development. NTRK1-3 will be only available in the Idylla™ GeneFusion Assay (RUO). Patents US 7,700,339, 8,168,383, 8,481,279, 8,486,645, 8,232,060, 8,288,102, 8,377,642, 9,988,688, 9,523,130, 9,096,855, 10,526,661, 9,364,477, 9,539,254, 10,551,383 and pending US applications and all their respective foreign equivalents under license from Cell Signaling Technology, Inc.1 NSCLC = Non small cell lung cancer; 2 25% of NSCLC are KRAS and 41% of KRAS mutations is G12C. Source: Mol. Cancer 2018, M. Roman et al., KRAS oncogene in non-small cell lung cancer: clinical perspectives on the treatment of an old target

IN DEVELOPMENT: Idylla™ EGFR/BRAF+ Mutation Test*

• Detection of >60 targets in one single Idylla™ cartridge• Detects vast majority of actionable mutations in DNA• Targets include markers in EGFR and BRAF, as well as a.o. KRAS G12C which covers ~41% of KRAS mutations in

NSCLC2

• Completes the Idylla™ lung menu and extends partnering opportunities

TWO-STEP LUNG CANCER TESTING ON IDYLLA™

The Idylla™ EGFR/BRAF+ Mutation Assay & the Idylla™ GeneFusion

Assay intend to cover the vast majority of the actionable

mutations in NSCLC1

+

40

Initial performance expectations as from early testing of prototypes. The Idylla™ call is a result of a preliminary decision tree algorithm.An IVD version of the Idylla™ GeneFusion Panel is currently under development. Not all markers may be present in the Idylla™ GeneFusion Panel. Patents US 7,700,339, 8,168,383, 8,481,279, 8,486,645, 8,232,060, 8,288,102, 8,377,642, 9,988,688, 9,523,130, 9,096,855, 10,526,661, 9,364,477, 9,539,254, 10,551,383 and pending US applications and all their respective foreign equivalents under license from Cell Signaling Technology, Inc

41

Idylla™ vs comprehensive NGS panel Idylla™ vs amplicon-based NGS panel

• Comparator: comprehensive NGS technology, optimized for detection of gene fusions

• Strong agreement across all markers:- Overall Percentage Agreement: 97-100% - Positive Percentage Agreement: 93-100%- Negative Percentage Agreement: 97-100%

• Comparator: amplicon-based NGS technology

• Excellent agreement across all markers:- Overall Percentage Agreement: 99-100% - Positive Percentage Agreement: 100%- Negative Percentage Agreement: 99-100%

vs vs

1 FFPE sliceIdylla™ GeneFusion

Panel

1 FFPE slice

Idylla™ EGFR/BRAF+ Mutation Test

Patient management decision

1

2

NGS

Idylla™ in lung diagnostics, complementary to NGS

• Idylla™ as the go-to platform for fast results on actionable biomarkers, enabling rapid initiation of targeted therapy with minimal sample input and superior ease-of-use

• If no actionable biomarkers are detected with Idylla™, NGS can be performed to complete the profiling and support experimental therapies

42 The Idylla™ EGFR/BRAF+ Mutation Assay and the Idylla™ GeneFusion Assay can be used in a different sequential order. The Idylla™ EGFR/BRAF+ Mutation Assay and the Idylla™ GeneFusion Assay should be performed following international recommended guidelines. An IVD version of the Idylla™ GeneFusion Panel is currently under development. NTRK1-3 will be only available in the Idylla™ GeneFusion Assay (RUO). Patents US 7,700,339, 8,168,383, 8,481,279, 8,486,645, 8,232,060, 8,288,102, 8,377,642, 9,988,688, 9,523,130, 9,096,855, 10,526,661, 9,364,477, 9,539,254, 10,551,383 and pending US applications and all their respective foreign equivalents under license from Cell Signaling Technology, Inc.NGS = Next Generation Sequencing. A patient management decision is usually already made to provide immunotherapy if PD-L1 positive, without the need for NGS

+

-

Patient management decision

+

-

43

• Pan-tumor implies that therapy selection is driven by genetics rather than location of the tumor

• Allows therapy use across multiple cancer types

• Also pharmaceutical trials based on pan-tumor testing

• Positive impact on underlying test volumes

What is pan-tumor? Pan-cancer applications

• Idylla™ assays for research in pan-tumor applications

Idylla™ cartridge

• KRAS/NRAS/BRAF

• MSI

• GeneFusion

Select potential applications

• Lung, pancreas, breast

• Gastric, prostate, endometrial

• Gastro-intestinal, thyroid

Efficient access to pan-tumor setting: validation of existing products

MSI data from papers published in peer-reviewed journals

Colorectal

Endometrial

Gastric

Urinary tract

Duodenal pancreatic

Concordance: 93%-100%Sample size: 683

Concordance: 97%Sensitivity: 95%Specificty: 100%

Concordance: 97%Sensitivity: 96%Specificty: 100%

Concordance: 100%Sensitivity: 94%Specificty: 100%

Concordance: 100%Sensitivity: 94%Specificty: 100%

Farmkiss et al. JCP Oct 2020Pécriaux et al. JCP Jun 2020

Gilson et al. Sci Rep Oct 2020Pécriaux et al. JCP Jun 2020

Pécriaux et al. JCP Jun 2020

Pécriaux et al. JCP Jun 2020

Gilson et al. Sci Rep 2020; Mindiola-Romera et al. Exp Mol Path 2020; Malapelle et al Cells 2020: Pécriaux et al. JCP 2020; Zwaenepoel et al JMD 2020; Lee et al J Pat Trans Med 2019; Samasion et al JCP 2019; Li et al Clin Col Can 2019

44

1. Marketed by Roche. 2 Marketed by AstraZeneca. 3. Marketed by Merck KGaA and Eli Lilly. 4. Marketed by Amgen. 5. Marketed by Bayer (licensed from Eli Lilly’s Loxo). 6. Marketed by Merck. 7. Marketed by Roche

• MDx tests detecting specific tumor mutations used for therapy selection in a specific cancer type

• Significant pharma pipeline of new targeted therapies

• Exampleso Zelboraf®1 (BRAF)o Tagrisso®2 (EGFR)o Erbitux®3 (RAS)o Vectibix®4 (RAS)

• Pan-tumor application of tumor mutation tests for therapies selected based on genetics rather than location of the tumor

• Allows therapy use across multiple cancer types

• Positive impact on underlying test volumes

• Exampleso Vitrakvi®5

o Keytruda®6

o Rozlytrek®7

• MDx tests based on RNA Gene Signatures are used for e.g.:o Diagnosiso Prognosis

• Often high value once validated & clinical value demonstrated

• Exampleso SeptiCyte® RAPIDo ThyroidPrint®

• MDx tests supporting immuno-oncology cancer treatments

• Consists of many different therapies, e.g.:o Immune checkpoint

inhibitorso Cell and viral therapieso Vaccines

• High unmet need for underlying MDx testing

• MDx tests via liquid samples

• Use in diagnosis, prognosis and Molecular Surveillance (i.e. therapy selection, response and recurrence monitoring)

• Can be done through off-the-shelf catalogue panels as well as tumor-informed, personalized panels

Diagnosis Treatment start Treatment stop

MOLECULAR SURVEILLANCE

Prognosis & therapy selectionScreening & diagnosis

Response monitoring Recurrence monitoring

Gene signatures Targeted therapy Pan-tumor Immuno-oncology Liquid biopsy

1

2

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1st generation Idylla™ products: PERFORMANCE & VERSATILITY

Establish Idylla™ as the most versatile MDx testing platform

Superior ease-of-usewith <2 min hands-on time

Fast turn-around-timedelivering 10 days faster

Broad sample versatilitygives results on 80% of samples that failed on NGS

Superior performancewith >95 % concordanceand <2 % invalids

Purpose Technology Applications

All basic building blocks for sample preparation, qPCR(DNA/RNA) and melting curveanalysis are available

Solid biopsies (e.g. FFPE, cytological samples)

Liquid biopsies (e.g. plasma, urine)

Pathogens (e.g. swabs, viral transport medium)

Sepsis (e.g. blood)

• Expanding Idylla™ menu

• Growing number of Idylla™partnerships

FFPE = formalin fixed, parrafin embedded

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2nd generation Idylla™ products: FASTER & CHEAPER DEVELOPMENT

Idylla™ FLEX technology (in development), a new revolution under the hood of Idylla™

• Mass manufactured Idylla™ FLEX cartridges that can be used acrossmultiple panels

• Panel-specific Idylla™ FLEX reagents for off-line customization of the cartridge

• Reagent and software design based on proprietary Artificial Intelligence algorithms

Purpose Technology Applications

Develop more Idylla™ productsfaster, at a lower cost

• Eliminate in-line cartridge customization, to reduce development lead times and cost

• Industrialize and accelerate thedesign of reagents and software for new panels

• Enable efficient customization of the Idylla™ cartridge

Improved development lead times, cost and scalabilityenables:

• Acceleration of Idylla™ menu growth

• Further expansion into currently unserved oncology markets

• Customized Idylla™ panels

Biocartis designs the Idylla™ FLEX reagents

User defines the Idylla™ panel

3. User inserts cartridge into Idylla™ instrument

1. User adds Idylla™ FLEX reagents and

sample …

4. User retrieves results with fast TAT

2. … into the Idylla™FLEX cartridge

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STEP 1Design of new panels

STEP 2Routine use

The IdyllaTM FLEX technology complements the core strengths of Idylla™(ease-of-use, speed, performance and sample versatility)

with off-line customization