180221 ANANAS pitch feb23rd - Deloitte US · Total PBC patients = 194K Total AIH patients = 215K * Developed countries only Market Values have been calculated based on Cost of current

ANANAS Liver

ANANAS Liver @ Italian Patent Competition, Milan Feb 23rd 2018

Autoimmune Hepatitis (AIH) &

Primary Biliary Cirrhosis (PBC)

Chronic rare Autoimmune Liver Diseases with unmet medical needs: 90% women

PBC• Therapy (UDCA or OCA) does not slow

progression

• Strong Side effects • 15% non respondent

AIH• Therapy (STEROIDS) Severe Side

Effects: • 5 % non respondent• > 10 % stop therapy

AIH-PBC overlap (10% of total)

• NO CURE

Drug therapyFAILS

Liver transplant or death10-15 year after diagnosis

Drug therapy WORKS

Life-long Severe side effects due to off-target drug effects


ANANAS-Liver

A New solution for Autoimmune Liver

Diseases without side effects

Nanoparticle

• Biodegradable and biocompatible

• Releases drugs only @ liver

• Works in animal model

• Low carrier immunogenicity and

inflammatory

• One injection every two weeks


Benefits of ANANAS Liver

� NO more Systemic Drug SIDE EFFECTS

� STOPS DISEASES PROGRESSION

• INHIBITS FIBROSIS

• REDUCES AUTOIMMUNE MARKER

� SCALABLE


Market for Ananas Liver Nanoparticle Rx*

€1,3 B

PBC

Total PBC patients = 194K Total AIH patients = 215K* Developed countries only

Market Values have been calculated based on Cost of current Rx € 45.000/yr

PBC = 29k

€1,1 B

AIH

AIH = 25k

Non-respondentpatients to Rx

ExpandedMarket€8,7 B

ExpandedMarket€9,7 B


Business model ANANAS: B2B with Pharma

Technology Licensing

$XX M

• Upfront and Milestones

• Access to Patent & Data on

Validated Targets

• Sharing of R&D and Manufacturing Practices

Royalty Fees

1-7%

Depends on stage of development and market

conditions


Competitors (drug delivery)

Phosphorex

Iron SPION

ANANAS

Parvus

Topas

Arcturus

Lipocure

NP Platform Biodegradable Liver Targeting No Off Target

aImmune cells &

parenchina bProtein based

Iron SPION

Immune cellsr

r Immune cells

bb

n.a.n.a.

bn.a.

r

r

cationic lipds

polymers

liposomes

b rn.a.

272 total companies, 21 nanoparticle based technologies, 5 addressing systemic or liver autoimmune disease,0 in clinical or preclinical level or exploits a similar approach.


Milestones achieved ANANAS platform

In collaboration with

TOT. INVESTMENTS ~€500K

business competition prizes, consultancies on

other projects, revenues, personal

2007 2016 20172006 2010

Start Cup &PNI prizes

NanoChallangePrize

IP protection -1EU/USA

NP platformconsolidated

Proof-of-Efficacyin AIH model

2015

IP protection-2PCT

UntreatedANANAS-

Liver


Milestones - Future

2018 2019-2020 2021-2022

AIH and PBC Preclinical PoC

Additional IP

PreclinicalGLP

Phase I Clinical trial

EXIT

2023

History

2007-2017

€ 350k(120k alreadycommitted by

founders)


Team

Founders & Operations

Michel BerghBusiness Advisor, Life Sciences, Intellectual

property

Advisory Board

Paolo BiginiMario Negri Institute

Nanobiology Unit Head.

Elena Pigato BS, Candidate

Economics

Chiara TamburiniBS candidate

Economics

Pietro Invernizzi, MDHepatology

Milano Bicocca Univ

Davide Merlin

CEOBusiness consultant, Strategy

and business planning

Margherita Morpurgo

CSONanomedicine

University of Padova

Paolo GubittaBusiness Organization & Investor

Relations

University of Padova

Elisabetta Casarin

CTONanotechnology & Colloidal

Drug Delivery

Giovanni RizzoBusiness Advisor, Life

Sciences, Start-Up

Mario SalmonaMario Negri InstituteHead of Biochemistry

Fabrizio Paganini

CFOFiscal and Tax Accountant


ANANAS-liver

Extract of Scientific Data


IP portfolio

Claims (in brief)

ANANAS linked to drugs containing carbonyl groups through acid reversible hydrazone likers

Application of the above to cancer, inflammatory and autoimmune

diseasesClaims (in brief)

ANANAS general compoisition

Application of the above for medical and diagnostic uses

ANANAS Liver @ Italian Patent Competition, Milan Feb 23rd 2018 13

ANANAS-Hz-Dexametasone

LIVERA

Dexa Dexa_ANANAS

Healthy animal

AIH animal

Patent pending

ANANAS-Liver

The drug is present @ liver only

WIP, In collaboration with Mario Negri Institute and Univ of Padova

ANANAS Liver @ Italian Patent Competition, Milan Feb 23rd 2018 14

ANANAS-Hz-Dex in a AIH model

Effect on

• Fibrosis

• anti-CY2D6IgGs (marker of AIH progression)

• AST/ALT (liverinflamation)

Free dexa

(0.4 mg/kg)

• Prevents

• No effect

• Minor reduction

ANANAS-dexa (0.16 mg/kg dexa equiv.)

• Prevents

• Reduces/preventsbuild-up

• Major reduction

WIP, Courtesy of Dr. Urs Christen (Univ Frankfurt) and Pietro Invernizzi

ANANAS-dexais more efficientthan free dexa


Thank You

Documents

180221 ANANAS pitch feb23rd - Deloitte US · Total PBC patients = 194K Total AIH patients = 215K * Developed countries only Market Values have been calculated based on Cost of current