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ISEKI_Food 4 2 nd OVERALL Meeting May 15-16-17, 2013 Kaunas University of Technology Department of Food Technology Kaunas - LITHUANIA 2 nd Overall meeting of the ISEKI_Food 4 project AB-BIOTICS: The way to the success

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Page 1: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

ISEKI_Food 4

2nd OVERALL Meeting

May 15-16-17, 2013

Kaunas University of Technology

Department of Food Technology Kaunas - LITHUANIA 2nd Overall meeting of the ISEKI_Food 4 project

AB-BIOTICS: The way to the success

Page 2: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

1. Executive Summary

2. Strategy

3. 3 Business Units

1. R&D Outsourcing Project Management

2. Functional Ingredients: Probiótics

3. Genomics

4. Team :

4. / 1 : 1 Spin-out biopharmaceutical company

TABLE OF CONTENTS

Page 3: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

COMPANY OVERVIEW – CURRENT SNAPSHOT

Barcelona: Company Headquarters at

Universitat Autonoma Barcelona

Research Park.

Girona: Office and laboratory at Science

Park of Universitat de Girona.

Authorized genetic laboratory of

50m2, and capable of processing

more than 20,000 samples/yr.

Key Figures Locations

723 897 1.105

2.061

3.589

6.162

2006 2007 2008 2009 2010 2011

Revenues (´000s €)

Page 4: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

2004

Universitat Autònoma de Barcelona Spin-off company founded in April

2004

Head Office: Parc Tecnològic del Vallès, Barcelona.

Head of R & D Department: Located at the Medicine Faculty of the

Universitat Autónoma de Barcelona. (Moved to Eureka Building in 2010)

Laboratories: Technological and Science Park of UDG

RESEARCH, DEVELOP, PROTECT AND DELIVER

BIOTECHNOLOGY SOLUTIONS TO THE MARKET IMPROVING

PEOPLES HEALTH & WELFARE.

2008

HISTORY OF THE COMPANY

Page 5: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

Founders

FuturFirms SLU

Founders

Acquisition from

FuturFirms

Business Angels

IPO

3.500.000€

30,7%

12.700.000€

2004 2010 2008 2007 2006 2005 2011

Acquisition of Quantum

1.500.000€

SPO 3,25 M €

17.800.000€

HISTORY OF THE COMPANY

Split of

Ability Pharmaceuticals

Spin Out

of

Ability Pharmaceuticals

Page 6: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

-Bachelor in “Food Science and Technology” by the Universitat Autònoma de Barcelona and graduated in “Human Nutrition and Dietetics” by the Universitat de Barcelona.

•Professional experience in the pharmaceutical sector (Novartis Medical Nutrition)

•MBA part time in ESADE Business School

•Full time dedication to AB-Biotics. CEO&COO.

Sergi Audivert Brugué, MBA, M.Sc.

-Bachelor in Biology and M.Sc . in Biochemistry by the Universitat Autònoma de Barcelona

-Business Sciences” in the Universitat de Girona

-Professional experience in Vanderbilt Microarray Sh. Resource, Nashville TN,

-MBA part time in ESADE Business School.

-Full time dedication to AB-Biotics. CEO&CFO.

Miquel Ángel Bonachera Sierra, MBA, M.Sc.

•Full professor in the Universitat Autònoma de Barcelona and in charge of the Planta de Tecnologia dels Aliments (CERPTA).

•Provided the company with his knowledge and more than 30 years of experience on lactic bacteria, formulation of alimentary products and the key factors for their processing.

•Professor Guamis is the President of the Scientific Committee

Full Professor Buenaventura Guamis López

-Former owner of Gelos SA, a Pharmaceutical Company it was sold to Group Ferrer International in May 2008.

-Private investor in AB-BIOTICS; Business Angel.

-President of the Board of Directors.

Mr. Luís Sanchez-Lafuente Mariol

8%

16%

36%

36%

Mr. José Manuel Valadés Venys

4% -Partner of the law firm Lizarbe Lopez-Sanchez & Valadés

-He is also co-founder of Venture Finanzas Sociedad de Valores (investment bank)

-Private Investor AB-Biotics, Business Angel.

-Member of the Board of Directors

SHAREHOLDERS AT THE TIME OF IPO (2010)

Page 7: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

SHAREHOLDERS

IPO in MAB 20-07-2010 2,53€

Share price 1st year : 3,18€

Symbol:

ABB:SM

2008 2009 2010 2011

Turnover €1,1Million €2,1Million €4,3Million €7,5Million (e)

Workforce 9FTE 13 FTE 31 FTE 48 FTE(e)

PhDs 5 8 14 24

R&D

Expend.

€0,6Million €1Million €1,8Million €3,5Million (e)

Patents 1 3 7 15 Market Cap €16MM

Page 8: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

R&D OUTSOURCING

To Small Medium Enterprises

SHORT TERM INFLOW

Low Profitability

Lower Business Risk

IN COMPANY R&D OF PRODUCTS WITH SHORT

TIME TO MARKET;

To Larger Companies

AB-BIOTICS own IP

High Profitability

Higher Business Risk

- PROFITABILITY +

BUSINESS DEVELOPMENT

Page 9: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

I+D OUTSOURCING

To Small Medium Enterprises

SHORT TERM INFLOW

GENOTIPING SERVICE

To Private & Public Healthcare. Pharmacogenomics & Nutrigenómics.

Lower Business Risk

IN HOUSE R&D OF PRODUCTS WITH SHORT TIME TO MARKET;

AB-BIOTICS own IP

High Profitability

Higher Business Risk

DEVELOPMENT OF HIGH EXPECTATION BIOTECH

SOLUTIONS FOR PHARMA INDUSTRIES

Very Hight Risk and Profitability

- PROFITABILITY +

New shareholders:

BUSINESS ANGELS

VENTURE CAPITAL

OUT-LICENCING COLLS.

Board members

that shall give us

EXPERIENCE.

KNOW-HOW

KNOW-WHO

BUSINESS DEVELOPMENT

Page 10: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

3 BUSINESS UNITS – 1 SPIN OUT

Functional ingredients: Probiotics

and Food Suplements

Genetic Diagnostic

NEUROFARMAGEN

BioPharmaceutical company

Lipid derivatives

Anti-cancer drugs

Functional Ingredients

Project Management of R&D

Projects for other companies.

R&D outsourcing

Page 11: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

R&D Outsourcing Project Management

Private and Confidential

This document is intended exclusively for the confidential use of its recipients, based on their recognition and acceptance of the confidentiality of the same.

The reproduction of this information, in whole or in part, is totally forbidden, as well as its communication to third parties without the prior express consent of

the issuer.

Page 13: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

1.- Search in scientific databases

2.- Systematic comparison of protocols

3.- Definition of protocol

4.- Negotiation with laboratories and Target Price setting

5.- Project is executed

6.- Periodical scientific reports

R&D OUTSOURCING PROJECT MANAGEMENT

Page 14: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

Probiotics AB-BIOTICS

Private and Confidential

This document is intended exclusively for the confidential use of its recipients, based on their recognition and acceptance of the confidentiality of the same.

The reproduction of this information, in whole or in part, is totally forbidden, as well as its communication to third parties without the prior express consent of

the issuer.

Page 15: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

FoodInfo Online Features 5 March 2008. Data monitor Analysis

PROBI AB 2008 Annual Report

Business Insights: Innovation in functional food and drinks, 2005,

The Probiotics market is growing

faster while consumers interest for

healthier live style is increasing

Probiotics have applications in

functional food, food supplements

and clinical nutrition

THE MARKET OF PROBIOTICS

Page 16: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

COMPETITORS & POSITIONING

Specific Health Claim

Clin

ical evid

en

ce

Next Generation Probiotics

Source: PubMed References 2009

Investm

en

t

76 papers

45 papers

49 papers

27 papers 9 papers

<5 papers

Page 17: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

Key Nutraceutical Functions

UNCOVERED NEEDS & POTENTIALS

Source: Datamonitor Analysis, 2007 & Nutraceuticals – Targeting consummers. Business Insights..

Cardiovascular diseases

Inflammatory Bowell Syndrome

Vaginal Infections

Periodontal diseases

Infant colic

Gastric ulcer and side effects

Digestive function maintenance

Bone health

Mental & Cognitive performance

Glucose absorption modulation

Oral Freshness

Page 18: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

owns a large collection of bacterial strains, collected from several

places around the world.

This collection contains more than 550 different wild-type strains each of one

patentable for its performance.

Low incidence of autoinmune diseases

Harsh environment for the natural gut microflora

1st Objective 1: To obtain a probiotic formula containing strains

originating in undeveloped countries.

2nd Objective: To demonstrate that the some of our strains

outperforms commercial controls: VSL#3, LGG, v299, Reuteri…

FUNCTIONAL INGREDIENTS: PROBIOTICS

Sistematic in-Vitro Screening for

caracterizeing our strains against commercial

controls.

Page 19: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

Isolation and recovery of strains

AB-Biotics has a strong experience working with human isolates (saliva and feces). hence we have

optimized the culture media and growth conditions in order to achieve the maximum diversity to have

better functionality results.

AB-Biotics usually works with strains that have their natural habitat in the human gut such as

Lactobacillus spp., Pediococcus spp. or Streptococcus spp.. All these genus have demonstrated a good

balance between fermentative abilities and antimicrobial activity, while all of them maintain a good mucus

adhesion performance.

OUR STRAINS COLLECTION

Page 20: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

Guidelines for the Evaluation of Probiotics in Food

Joint FAO/WHO Working Group Report on Drafting Guidelines for the Evaluation of Probiotics

in Food. London, Ontario, Canada, April 30 and May 1, 2002

Strain-depending effect

Minimal dose 1x10+7 cfu/gr.

Strain identification through golden standard method (PFGE)

Viability >40% after GI transit

Intestinal mucus and epithelial cells adherence (Caco-2)

Antimicrobial activity against pathogenic bacteria

Acute toxicity or a history of consume

Specific health effects clinically proven (Claim)

OUR STRAINS COLLECTION

Page 21: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

AB-LIFE

AB-FORTIS

AB-GINGIBAL

AB-HALITOSIS

AB- I 3.1

AB-COLIC

AB- PYLORIOSIS

AB-INTIMUS

AB-RADIOBAL

AB-ENHANCER

PIPELINE

HIT

SCREENING

IN VITRO

MODELS

ANIMAL

STUDIES

INDUSTRIAL

SCALE UP CLINICAL

FILING PATENTS MARKETED

AB-VITAMIN K

AB-PROBIOSIS

PORTFOLIO DEVELOPMENTS

Page 22: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

Competitive differences on probiotic developement

BIOGAIA AB, PROBI AB Probióticos AB-BIOTICS

1 microorganism

Multiple functionalities.

Multiple microorganisms

1 top-performing functionality

FUNCTIONAL INGREDIENTS: PROBIOTICS

Page 23: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,
Page 24: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

AB-GENOTYPING’s laboratory

AB-GENOTYPING has a 45m2 molecular biology laboratory that has been specially

designed for doing genotyping analysis.

The laboratory is divided in two different work zones to avoid samples cross-

contamination: pre-PCR zone and post-PCR zone

- Laboratory with cutting edge technology for the development

of genetic tests through liquid arrays

- Liquid arrays allow the complete customization of the assay by

AB-GENOTYPING in order to design specific products for

each medical specialty.

- Laboratory with equipments that allow the analysis of 384

genetic variations per sample, and for 96 samples in parallel.

- A complete analysis of 180 samples takes 3-4 days work, and

during a week two of those cycles can be done.

Page 25: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

AB-GENOTYPING’s Laboratory Services

PHARMACOGENETIC services to

Hospitals and Medical professionals

PHARMACOGENETIC services to

Pharmaceutical Companies and CROs

NUTRIGENETIC services to improve

costumer’s quality of life

Development of I+D genotyping

outsourcing services

(1) Herceptin’s Clinical Trial (Roche) Aclara Bioscience (Monogram Bioscience). Business Insights ltd.

Development of specific products that will

allow targeted pharmacogenetic services to

medical specialties.

Services offered directly to medical

professionals in order to improve their

patient’s treatments.

Pharmacogenetics can also improve clinical

trials and drugs development by (1):

• Reducing development costs

• Increasing clinical trials efficiency

• Obtaining better drugs tolerance results

• Assuming more coherent risks

AB-GENOTYPING will participate in the

development of I+D genotyping projects as

developing partners or as genetic laboratory

service.

Nutrigenetics studies the influence that

genetic variations can have on individual’s

response to nutrients.

Development of genetic analysis that will

improve costumer’s quality of life through

personalized nutrition based on their DNA

Page 26: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

Human Genome and Pharmacogenetics

Human Genome Project - http://www.ornl.gov/sci/techresources/Human_Genome/home.shtml

Hap Map Project - http://hapmap.ncbi.nlm.nih.gov/

Deseasome: Marc Vidal; Albert-Laszlo Barabasi; Michael Cusick; Proceedings of the National Academy of Sciences.

Roden, D. M (2006). Pharmacogenomics: challenges and opportunities. Ann Intern Med, 21; 145(10):749-57.

• Human Genome sequencing in 2001 demonstrated that

the DNA of all individuals is 99.9% identical.

•This mere 0.1%, in combination with environmental factors

is what makes each individual unique

It has been shown that certain genetic differences can be key to

determine the efficacy and toxicity of a drug in a patient

• Pharmacogenetic studies how genes influence an individual’s response to

drugs

Pharmacogenetics allows the realization of Personalized

Medicine

Page 27: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

Food and Drug Administration - http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm

EMEA - London, 23 April 2009. Doc. Ref. EMEA/CHMP/PGxWP/63270/2009

Ingelman-Sunderberg, M. (2008). Pharmacogenomic Biomarkers for Prediction of Severe Adverse Drug Reactions. N Engl. J. Med, 358, 637-639.

Personalized Medicine

CURRENT THERAPEUTIC MODEL PERSONALIZED MEDICINE

Increase dose drug

Standard dose

Dose reduction

Drastic reduction in dose

or drug change

Same diagnostic

Same treatment Same diagnostic + Genetic test Test benefits

1. Decreased adverse reactions

2. Safer election of drugs

3. Better treatment compliance

4. Increased probability of

therapeutic success

5. Reduced costs for Health Care

System

Since 2006 FDA publishes an official list of drugs for which the

genetic analysis of patients is required prior to drug

prescription.

Nowadays 10% of FDA labeled products already contain

pharmacogenetic information and this percentage will increase

in the future.

Page 28: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

THE MARKET OF FARMACOGENOMICS

Neuropsychiatry Colon & Lung Cancer

Page 29: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

AB-GENOTYPING’S PRODUCTS FOR PHARMACOGENETIC SERVICES

AB-GENOTYPING is developing products that will allow very targeted

pharmacogenetic analysis for specific medical areas and drugs

NEUROPHARMAGENV.2.0 – Pharmacogenetics for Neuropsychiatry

Number of tested drugs 35

Quality controls 48

Number of genetic variations 98

Number of genes analyzed 54

1

Product that makes possible the analysis of SNPs for all neuropsychiatric drugs for

which pharmacogenetic information is available.

• According to World Health Organization, 10% of world population

suffers from a neuropsychiatric disorder

• Drugs used in neuropsychiatry have low efficiency and often lead

to serious adverse effects

• Drugs with usually non-compliance due to adverse effects

NEUROPHARMAGENV.2.0 compiles information for a total of 35 drugs

Amitriptyline Clonazepam Methadone Phenytoin

Aripiprazole Clozapine Mirtazapine Pramipexole

Atomoxetine Escitalopram Naloxone Quetiapine

Carbamazepine Fluoxetine Naltrexone Risperidone

Citalopram Fluvoxamine Nortiptyline Topiramate

Clobazam Haloperidol Olanzapine Valproate

Clomipramine Imipramine Oxcarbazepine Venlafaxine

Clonazepam Lamotrigine Paroxetine Ziprasidone

Clobazam Levetiracetam Perphenazine

Clomipramine Litium Phenobarbital

Page 30: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

Board Of Directors:

Luís Sz Lafuente

José Manuesl Valadés

Sergi Audivert

Miquel Àngel Bonachera

Joan Figueras,

CGMO

B: Economics BA

Lipotech Group

Age: 36

Roger Torrent,

Grant Manager

B: Chemical Engineer

Assesoría I+D+I

Age: 32

Anna Arnau,

Administration

B: Economics BA

Age: 2639

Jordi Espadaler, PhD,

CRO Biochemistry

B: Biochemistry

Univ. Rockefeller NY

Age: 34

Yolanda Echevarría,

Adj. CRO Biochemistry

B: Engineer

Hoogeschool Zeeland

Age: 28

Natàlia Nicolau, PhD,

Laboratory Assistant

B: Food Technology

Age: 35

Jordi Cuñé, PhD,

CRO Microbiology

B: Molecular Biology

Univ. A. Barcelona

Age: 33

Montse Bosch, PhD,

Adjunt, CRO

B: Molecular Biology

iRTA

Age: 36

Maria Rodríguez, PhD

Laboratory Assistant

B: Biology

Age: 30

Jonathan Santas,

Laboratory Assistant

B: Nutrition Degree

Age: 24

Elizabeth Lázaro, PhD,

CRO Chemistry

B: Chemistry

Univ. Barcelona

Age: 33

Roger Escriu, PhD,

Laboratory Assistant

B: Food Technology

Univ A Barcelona

Age: 36

Ariana Salavert, PhD,

CRO Biotechnology

B: Biotechnology

Sloan-Kettering NY

Age: 31

Pedro Echave, PhD,

Head of Laboratory

B: Molecular Biology

University Clge. London

Age: 35

Joan Carles Soberano!,

Medical Sales

Representative

B: Pharmaceutical Ind.

Age: 60

MiquelA Bonachera,

MoS, MBA, CEO-CFO

B: Biochemistry

Vanderbilt Microarray SR

Age: 33

Sergi Audivert,

MoS, MBA, CEO-COO

B: Nutrition & Food Tech.

Novartis PH

Age: 34

ORGANIZATION CHART

Page 31: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

Ability Pharmaceuticals, SL

Page 32: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

Proprietary Information belonging exclusively to Ability Pharmaceuticals, SL - ©

May 2013 32

Eureka Building - Research Park Bellaterra - Barcelona

→ Biopharmaceutical company based in Barcelona

→ Founded in November 2009 by AB-BIOTICS, Carles Domènech and Jordi Espadaler

→ € 3.4 M raised (2010-2012) → Investors: Inveready Capital Company (Venture Capital) Founders and Business Angels

New drug class – Potential as Medical Food:

LIPID ANALOGUE THERAPEUTICS

Building a development pipeline

ABTL0812:

FIRST IN CLASS: - mTORC1/C2 inhibitor

- DHFR gene expression inh.

Phase I/Ib in July 2013 – CTA presented in April 2013

→ Non-small cell lung carcinoma (1st indication)

→ Pancreatic cancer (2nd indication)

→ High efficacy → Low toxicity → Few adverse events → Oral administration → Once daily → Chronic treatment → Patent Protection (2030) → Potential sales > €1.6 B

Page 33: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

Proprietary Information belonging exclusively to Ability Pharmaceuticals, SL - ©

May 2013 33

2 yrs as Chief Financial Officer of Sevibe Cells,

Carles Domènech, PhD CEO & co-founder José Alfón, PhD VP Research and Development Jordi Espadaler, PhD Scientific Advisor & co-founder Vanessa Ruz, BEc/MEc) Director, Finance Marc Cortal, MD Medical Director

Business Development and Licensing Venture Capital /Science Research Memorial Sloan-Kettering CC /Almirall /Lacer

Science Research Rockefeller Univ. / Univ. California San Francisco Univ. Autònoma de Barcelona / AB Biotics

Drug Development / Science Research Hebrew Univ. Jerusalem / Univ. Barcelona Palau Pharma / Uriach.

Clinical Practice, Clinical Trials, Health Management Clínica Quirón / Hospital Mutua de Terrassa / Middlesex Hospital / Saint Mary London / Red Cross Geneva

Toni Pérez MD. Clinical Development Almirall - Novartis - Basilea Pharmaceuticals - Esteve 2 drugs approved internationally. Several products in phase III (FDA – EMA)

Peter Wyld MD. Clinical Development

Amgen - Biogen-IDEC - J&J Oncology – Novartis

Laura Vidal MD. Clinical Oncology Coordinator, Investigational Therapy Unit - Oncology and Hematology,

IDIBAPS and Hospital Clínic de Barcelona Universitat de Barcelona

Jesús Llenas PhD. Preclinical Dev, GLPTox, Reg. Affairs Almirall - 3 drugs approved internationally (FDA – EMA)

José Luís Fábregas PhD. Pharmaceutical Development Almirall - 3 drugs approved internationally (FDA – EMA)

José Miguel Lizcano PhD. Signal Transduction Professor, Universitat Autònoma de Barcelona Formerly at Philip Cohen’s laboratory in Dundee (Scotland)

TEAM

EXECUTIVE TEAM ADVISORY BOARD

BOARD OF DIRECTORS

L. Sánchez-Lafuente M.A. Bonachera S. Audivert R.Piqué J.M. Echarri C.Domènech J.M. Valadés

Page 34: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

Proprietary Information belonging exclusively to Ability Pharmaceuticals, SL - ©

May 2013 34

MARKET

Lung cancer causes 30% of all cancer deaths.

42% of patients survive after one year, but only 15% survive after 5 years. Non-Small Cell Lung Carcinoma (NSCLC) accounts for the 25% of all drugs sales for cancer treatment. NSCLC sales from $4 billion in 2009 to > $6.5 billion in 2019 (USA, France, Germany, Italy, Spain, UK and Japan).

Pancreatic cancer has a very low survival (less than 5% after 2 years).

The US pancreatic cancer drug market will grow to $1.1 billion by 2013.

UNMET MEDICAL NEEDS

OPPORTUNITY TO IMPROVE HUMAN HEALTH

MARKET OPPORTUNITY (Sales of ABTL0812 > €1.6 B)

Page 35: AB-BIOTICS: The way to the success - Welcome | ISEKI Food 4 ·  · 2014-04-163 Business Units 1. R&D Outsourcing Project Management 2. ... Technological and Science Park of UDG RESEARCH,

Proprietary Information belonging exclusively to Ability Pharmaceuticals, SL - ©

May 2013 35

Proprietary new drug class called Lipid Analogue Therapeutics → New chemical entities → Chemically synthesized analogues of naturally occurring lipids

NEW DRUG CLASS

→ Influence the activity of proteins which are central to cellular replication and oncogenesis

→ Alter the signaling of specific pathways

NOVEL MECHANISM OF ACTION

LIPID ANALOGUE THERAPEUTICS

→ Patent filed in 2009 → PCT initiated in March 2010 → Published in October 2010

→ National phases: AU, BR, CA, CH, CN, EP, IN, IL, JP, KR, MX, RU, ES, US.

PATENT PROTECTION UNTIL MARCH, 15, 2030

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May 2013 36

DEVELOPMENT PIPELINE

ABTL0812

ABTL1014

Discovery Preclinical Phase I/Ib Phase IIa Phase IIb

ABTL0813

Program 1

Program 2

Lung and pancreatic cancer

Hematological cancers

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May 2013 37

Simultaneous action on 2 clinically validated targets for cancer chemotherapy:

Dihydrofolate reductase (DHFR)

Mammalian Target Of Rapamycin (mTORC1/C2) →AUTOPHAGY

ABTL0812 – MECHANISM OF ACTION

Inhibition of DHFR expression

Inhibition of mTOR-C1

mTOR-C2

TUMOR CELL DEATH

ABTL0812

AUTOPHAGY

inhibition of DNA synthesis

NOVEL MECHANISM OF ACTION

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May 2013 38

ABTL0812 - HIGH EFFICACY IN LUNG CANCER

0 5 10 15 20 25 30 350

20

40

60

80

100

120

140

Control oral

AT12 low oral

AT12 high oral

Control ip

Docetaxel ip

Day

Tu

mo

r vo

lum

e (

% b

asal)

0

0 5 10 15 20 25 30 35-30

-25

-20

-15

-10

-5

5

10

15

0

Control oral

AT12 low oral

AT12 high oral

Control ip

Docetaxel ip

Day

Weig

ht

Vari

ati

on

(%

)

AT12 vs. docetaxel, tumor volume AT12 vs. docetaxel, body weight

n=1n=1n=2

n=1

n=1

n=2

Active in a wide range of human cancer cell lines: → Lung cancer, pancreatic cancer, hepatoma, melanoma and glioblastoma

→ High efficacy in animals models of human lung cancer, ORAL: → As potent as docetaxel (TaxotereTM) → ABTL0812 is much safer → Superiority to erlotinib (TarcevaTM) → ABTL0812 is active in broader populations

PK/PD correlation: → Steady state plasma levels of ABTL0812 in mice correlate with tumor volume

PK-PD relationship for ABTL0812Trough concentration

100 250 500 750 10001250100

125

150

175

200

225

High dose

Low dose

r2 = 0.58

p < 0.05*

*Pearson correlation

Ctrough (ng/ml)

Tu

mo

r siz

e (

mm

2)

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Strengths

Formation , commitment and motivation of the team.

Flexibility, almost no tangible assets investments.

Team work with different backgrounds.

Weaknesses

Lack of experience of a very young team.

Lack of financial resources to develop our pipeline.

Diversification of pipeline and solutions.

Opportunities

Biotechnology is full of opportunities to cover needs. IP solutions.

Well organized international sources of scientific information.

Pharma Industries are interested in Biotech Solutions.

Global markets, led us seek for clients and VC outside Spain.

EU and Spanish government grants are lowering R&D investment risk.

Threats

Spain is not branded as a Biotech solution generator (Medikon is not in Barcelona)

Most of Venture Capital in Spain has not many contacts with big industries.

Big industries in Spain are not willing to innovate. (Difficult base market)

Lack of financial tools for new fast growing enterprises in Spain (no alternative public

markets)

HOLDING SWOT ANALYSIS

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Carles Domènech, PhD - CEO [email protected] - Mob. +34 606 433 824 – www. abilitypharma.com

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THANK YOU!