EA EARLY DI Y DIAG AGNOSI SIS S OF F BR BRAI AIN DISE SEAS ASES ES via liquid id biops psy, base sed d on miRNA NA patter erns ns in micr crogli glial al micr crovesic vesicles les Fabio Bianco, CEO fbianco@braindtech.com www.braindtech.com
Te Team Dr. Pietro Conti , MD, MBA – President Dr. Fabio Bianco , PhD – Chief Executive Officer • • Medicine & MBA Medical Biotech, Pharmacology • • Founder/CEO several startups President/CSO @NeuroZone • • Director Health Int’l Projects @UN +10yr in Biotech/Pharma • • Board Member Board Member Dr. Ennio Ongini , PhD – Chief Scientific Officer Dr. Noemi Tonna , PhD – Lab Manager • • Pharmacology Medical Biotech, Pharmacology • • 20 yrs R&D Director Schering Plough Lab manager @NeuroZone • • 15 yrs VP Research Nicox SA +10yr in drug discovery • +200 peer reviewed papers Dr. Carlo Frati , MBA – Board Member Dr. Laura Ferro , MD, MBA – Board Member • • Medicine & Psychiatry Economics - Bocconi Univ; MBA, INSEAD • • MBA @ Bocconi Univ., Milano McKinsey & Co. (2000-2016): Partner • • Top 10 innovative women managers in Italy Capital Shuttle S.p.A. (2016): CEO • • Founder /CEO several biotechs (including Gentium, IPO at Banca Consulia (2017-present): CFO Nasdaq) Dr. Elisabetta Borello – Board Member • Economics-Bocconi Univ., Milano • +30 yrs in Healthcare Information Management Systems • Founder /Board member many biotechs
The issu Th sue (need need) Currently, diagnosis of brain diseases is carried out observi erving ng clini nical al sympt mptoms oms, which occur when most of the neurodegeneration has already ady occur ured ed 10 10 – 15 15 years ars Brain Brain Clinical al INFLAM AMMA MATION TION DEGENERA ERATI TION SYMP MPTOM TOMS
BrainDTech Br Tech propos osal al BrainDTe DTech ch represents a disrup upti tive ve approach ch to brain disease diagnosis because it detects a signal (MicroR oRNA A in microvesicles rovesicles) released by microglia years s before ore any clinica ical manifestation festation MICROVES ROVESICLES CLES FROM OM MICR CROGL OGLIA Neuroinflammation activates MICROG OGLI LIA Activated microglia produce MICROVESICLES OVESICLES Microvesicles contain microR oRNA Microvesicles can be found in LIQU QUID BIOPSY OPSY Brain INFLAM AMMA MATION TION
Br BrainDTech Tech added added value ue MICROVES ESICLE LES S miRNAs miRNAs are in liqui uid biops psies es in MICROVES ESICLE LES PATH THOLO LOGY Y SPE PECIFIC FIC Healthy Alzheimer’s subjects patients (Agosta et al Ann Neurol 2014) High expression Low expression Methods for diagnosi osis, , progno nosi sis and treatme atment nt monitoring toring of neurologi logical cal, , neurodegenera rative tive and inflamma lammatio tion – based diseases ses via miRNA A inside microg oglia ial microve ovesi sicle cles
Market et Opportu rtuni nity ty: : diagn gnostic ostics in brain n diseases ases BEFORE CLINICAL AFTER CLINICAL MANIFESTATION MANIFESTATION $45,5 B +$ +$ 1 B “miRNA diagnostics fastest growing segment o $45,5 ,5 B of global microRNA market” o (2020) (Persistence market research) +$1 B o o o o o o o Disease staging o Early diagnosis / companion diagnostics o Non-invasive liquid biopsies
Ba Barrier ers to Competition tition PATENT 1 – miRNA from microglia MVs 2015/1 /11 - Itali lian pate tent t submissi ission (AD, , PD, isch chemia) ia) 2016/0 /07 - PCT pate tent t exte tensio sion 2016/1 /11 - Claim im exte tensio sion (+20 path thologie ies) s) 2017/0 /06 – EU pate tent t submissi ission PATENT 2 – new blood-based biomarker 2017/0 /09 - Itali lian pate tent t submissi ission 2018/0 /01 – exp xpecte cted PCT pate tent t exte tensio sion 2018/0 /04 – exp xpecte cted EU pate tent submissi ission PATENT STRATEGY PATHOLO OLOGY GY-SPEC SPECIFIC PATTER ERNS NOVEL EL THERAPEU APEUTIC TARGET GETS DEVELO ELOPM PMEN ENT IDENTIFICAT ATION ON EARLY LY DIAGN AGNOSI OSIS COMPAN PANION DIAGN GNOST OSTICS
From platfo Fr tform rm tech chnol olog ogy … to big data DATABASE: access to big data MCI AD MS AD vs MS miRNA pattern AD vs MCI Licensing MCI vs MS 6 10 15 21 Patterns Patterns Patterns Patterns 2019-20 Perspective PD vs ctrl NP vs ctrl EPIL vs ctrl AD – MCI – MS non-interventional 240 – 240 240 – 240 240 – 240 240 – 240 – 240 CSF 2018 PD vs ctrl NP vs ctrl EPIL vs ctrl AD – MCI – MS Validation 80 – 80 – 80 80 – 80 80 – 80 80 – 80 CSF OS 2 2017 AD – MCI – MS PD NP EPIL Discovery 60 – 60 – 60 60 60 60 CSF AD vs Healthy BLOOD Observational 2 years 2 years 2 years Study 1 (OS1) 60 – 20 CSF
Before neurodegenerative diseases can be treated, they must be detected… …the earlier the better Fabio Bianco fbianco@braindtech.com www.braindtech.com
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