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RECEPTA RECEPTA biopharmabiopharma

Partnering for cancer drug Partnering for cancer drug development: Why in development: Why in

Brazil?Brazil?Jose Fernando PerezJose Fernando Perez

CEOCEO

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VisionVision

To bring innovation in cancer drug development to Brazil To bring innovation in cancer drug development to Brazil in several stages of the value chain:in several stages of the value chain:

– mAb generation mAb generation – mAb developmentmAb development– mAb productionmAb production– Pre-clinical TrialsPre-clinical Trials– Phase I and Phase II Cancer Clinical TrialsPhase I and Phase II Cancer Clinical Trials

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PhilosophyPhilosophy

Provide quality-of-life enhancing therapeutics to Provide quality-of-life enhancing therapeutics to cancer patients in Brazil and worldwide, while cancer patients in Brazil and worldwide, while offering a rewarding value proposition to our offering a rewarding value proposition to our shareholders. shareholders.

Build the necessary skills and resources to develop, Build the necessary skills and resources to develop, produce and profitably market oncology products produce and profitably market oncology products generated from our research and development generated from our research and development activities, both in-house and through external activities, both in-house and through external collaborative strategic and commercial alliances. collaborative strategic and commercial alliances.

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Why in Brazil?: Leveraging of local Why in Brazil?: Leveraging of local advantagesadvantages

Highly qualified human resources: scientists and technicians: Highly qualified human resources: scientists and technicians: Brazil’s scientific output represents 3% of total world Brazil’s scientific output represents 3% of total world production production

Excellent hospital facilities and qualified physicians with Excellent hospital facilities and qualified physicians with documented experience in the conduction of clinical trialsdocumented experience in the conduction of clinical trials

Lower costs of operation in Brazil than in traditional research Lower costs of operation in Brazil than in traditional research regions for required personnel at all levels. regions for required personnel at all levels.

Excellent infrastructure of services: CROs & LogisticsExcellent infrastructure of services: CROs & Logistics

Easier access to a diverse selection of informed patients and Easier access to a diverse selection of informed patients and tumor samples for Phase I and II clinical trials as compared tumor samples for Phase I and II clinical trials as compared with the more traditional testing regions of the US, EU and with the more traditional testing regions of the US, EU and Japan.Japan.

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Why in Brazil?: Leveraging of local Why in Brazil?: Leveraging of local advantagesadvantages

Engagement of required R&D talent through research Engagement of required R&D talent through research fellowships and scholarships in public educational institutions fellowships and scholarships in public educational institutions at low cost. at low cost.

The New Culture towards innovation: Priority in funding The New Culture towards innovation: Priority in funding opportunities from several governmental sources (such as opportunities from several governmental sources (such as FINEP, BNDES, FAPESP) through R&D grants or low interest FINEP, BNDES, FAPESP) through R&D grants or low interest loans. Drug development is one the four stated priorities of the loans. Drug development is one the four stated priorities of the Brazilian industrial policy (PITCE) and biotechnology is also a Brazilian industrial policy (PITCE) and biotechnology is also a priority as one the areas treated as carriers of the future. priority as one the areas treated as carriers of the future.

The Brazilian market needs new cancer drugs manufactured The Brazilian market needs new cancer drugs manufactured in the country to reduce importsin the country to reduce imports

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Partnership with the Ludwig InstitutePartnership with the Ludwig Institute

The Ludwig Institute for Cancer Research (LICR) has The Ludwig Institute for Cancer Research (LICR) has licensed four antibodies to Recepta and is a major licensed four antibodies to Recepta and is a major shareholder of the company.shareholder of the company.

The agreement with the LICR creates conditions for The agreement with the LICR creates conditions for an effective transfer of scientific and technological an effective transfer of scientific and technological knowledge from the global network of scientists knowledge from the global network of scientists associated with the LICR to Recepta. associated with the LICR to Recepta.

The close collaboration with LICR’s scientists The close collaboration with LICR’s scientists provides an extra validation of scientific and provides an extra validation of scientific and technological procedures. technological procedures.

The presence of LICR as a shareholder offers The presence of LICR as a shareholder offers Recepta an immediate international insertion. Recepta an immediate international insertion.

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Portfolio of ProductsPortfolio of Products

– Antibody hu3S193 – Anti-Lewis Y Successful IHC, Pre-Clinical and Phase I trials carried out by LICR as an Ovarian

Cancer, with potential for ALL epithelial tumors.

– Antibody MX-35Successful IHC trials carried out for early Ovarian cancer by LICR and potential for

other cancer remedies

– Antibody hu58-1066 – Anti-Lewis B (Leb)Successful IHC trials carried out for Breast and Colorectal cancers by LICR and

potential for other cancer remedies.

– Antibody A-34 Successful IHC trials carried out for Gastric and Kidney cancers by LICR and

potential for other cancer remedies.

– Four new Antibodies in development Resulting from Recepta’s own R&D in Brazil

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Virtue out of Necessity: An Unique Virtue out of Necessity: An Unique Approach through Strategic PartnershipsApproach through Strategic Partnerships

Recepta’s novel R&D partnership model derives from thoroughly understanding academia potential and market needs, combined with the capacity to establish mutually beneficial partnerships.

In contrast to other efforts, where entrepreneurs identify and sell existing research, Recepta starts from market needs and identifies academic resources inside universities and research centers for specific projects.

In other words, academia’s technological innovation is oriented to respond to market demand.

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LICR´s research programs:LICR´s research programs:Antigen discovery &Antigen discovery &

characterizationcharacterization

Cell line production,Immunohistochemical assays, Clinical trials Phase I

Phase II trials and new high yield cell line production

RECEPTA’s OperationRECEPTA’s Operation

New mAbs generated by Recepta’s research Programs: Antigen discovery and characterization

AntiAnti- Lewis YLewis Y

MX-35MX-35Anti- Anti- Lewis BLewis BAAnti- nti- A-34 A-34 4 new mAbs 4 new mAbs

Lab assays, Pre-clinicals and humanization

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RECEPTA´s Operational StructureRECEPTA´s Operational Structure

MAb R&D divisionMAb R&D division

• Identification of new targetsIdentification of new targets

• Generation of new antibodiesGeneration of new antibodies• High yield cell line construction High yield cell line construction

• Cell banks constructionCell banks construction

• GMP clinical grade large scale GMP clinical grade large scale • production (outsource)production (outsource)

Oncology divisionOncology division

• Clinical Trials Management Clinical Trials Management

• ImmunohistochemistryImmunohistochemistry

• Preclinical TrialsPreclinical Trials

• Clinical trials Phase I (CRO, Clinical trials Phase I (CRO, patients, hospital)patients, hospital)

• Clinical trials Phase II CRO, Clinical trials Phase II CRO, patients, hospital)patients, hospital)

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Recepta´s Researchers and Project Recepta´s Researchers and Project SupportSupport

Due to its aggressive partnership strategy, Recepta has already assembled an impressive group of qualified researchers:– 18 PhD– 17 MSc– 2 MD– 6 graduates– Total: 43

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Operational Structure & PartnershipsOperational Structure & Partnerships

RECEPTA RECEPTA biopharmabiopharma

Oncology - CTOncology - CTRecepta – Dr. Óren SmaletzRecepta – Dr. Óren Smaletz

Selected hospitalsSelected hospitals

Oncology - IHCOncology - IHCFac Med USP Fac Med USP

Dr. Venancio AvanciniDr. Venancio Avancini

Oncology – Pre-clinicalOncology – Pre-clinicalSilvia OrtizSilvia Ortiz

mAb divisionmAb divisionInstituto ButantanInstituto Butantan

Dr. Ana Maria MoroDr. Ana Maria Moro

mAb divisionmAb divisionLICR´s SP branchLICR´s SP branch

Dr. Anamaria CamargoDr. Anamaria CamargoDr. Sandro de SouzaDr. Sandro de Souza

Dr. O. Keith OkamotoDr. O. Keith OkamotoScientific CoordinatorScientific Coordinator

Dr.Juçara ParraDr.Juçara ParraAssoc. Proj. ManagerAssoc. Proj. Manager

Prof. Dr. Luiz TravassosProf. Dr. Luiz TravassosSenior Program DirectorSenior Program Director

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Recepta´s Partner InstitutionsRecepta´s Partner Institutions

Ludwig Institute for Cancer ResearchGlobalLocal Branch – SP (new targets and mAbs)

Instituto Butantan (Cell Biology)

Medical School of the University of São Paulo (Immunohistochemistry)

Hospitals (Clinical Trials): Sírio-Libanês, Alemão Oswaldo Cruz, Albert Einstein, National Institute of Cancer (INCA), Brazilian Institute for Cancer Control (IBCC), Baleia (BH)

MIT’s G-lab – Sloan School of Administration (valuation model)

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RECEPTA´S mAb R&D Division:RECEPTA´S mAb R&D Division:Partnership with Instituto ButantanPartnership with Instituto Butantan

Instituto Butantan is a center of excellence for biomedical research maintained by the State of São Paulo Secretary of Health. Butantan conducts, both, basic and applied research in areas related to public health and is responsible for the production of more than 80% of the total amount of sera and vaccines used in Brazil

Recepta’s R&D project for financial support has been approved by FINEP to partially fund the installation and operation of a lab facility for the generation of high yield cell lines and cell banks. The researcher and project manager will be Dr. Ana Maria Moro, PhD, who works for Butantan and is one of Brazil’s most knowledgeable mAb experts. Dr. Ana Moro has worked as a consultant for Recepta from April to December 2005 during her license from Butantan. This circumstance places Dr. Moro in a privileged position to match the technological needs of the project with the challenges of the company.

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RECEPTA´S mAb R&D Division:RECEPTA´S mAb R&D Division:Partnership with LICR’s SP branch Partnership with LICR’s SP branch

The São Paulo Branch of the Ludwig Institute for Cancer Research was established in 1983 at the Hospital do Cancer in São Paulo, Brazil. The Branch's research centers around furthering our understanding of human cancer genetics and the epidemiology of certain human cancers. The Branch has been integrally involved in several state-wide research initiatives, most notably the internationally acclaimed Human Cancer Genome Project, which linked many small facilities together to yield sequence data on genes expressed in cancer.

Recepta has established a research and development partnership with the branch which includes:– identification of new targets, and; – generation of new monoclonal antibodies

Two highly respected scientists, Dr. Anamaria Camargo, specialist in molecular genetics and Dr. Sandro de Souza, expert in bioinformatics will be leading the project.

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RECEPTA´S Oncology DivisionRECEPTA´S Oncology Division

Immunopathology: Immunohistochemical assays

A partnership agreement with the Medical School of the University of São Paulo was signed.

Recepta has provided the funding and the IHC research is

currently being conducted by a team lead by Dr.Venancio Avancini Alves, PhD, MD and professor for pathology, with more than 30 yrs of experience in IHC.

Dr. Avancini’s team and facilities at the FMUSP has been site visited and approved by Dr. Achim Jungblüth, a renowned pathologist from MSKCC and LICR

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RECEPTA´S Oncology DivisionRECEPTA´S Oncology DivisionClinical Trials

A protocol design for an ovarian tumor Phase II Clinical Trial with Lewis Y has been prepared by Dr. Oren Smaletz in close collaboration with Dr. Alberto Wainstein from Biocancer, Dr. Eric Hoffman from the LICR New York Office and Dr. Andrew Scott from the LICR Melbourne Center.

Dr. Óren Smaletz, MD - oncology specialist with extensive experience in clinical trials at MSKCC currently working at the Einstein Hospital - has been hired to act as clinical coordinator for Recepta in clinical trials.

Recepta has identified several CROs and selected EuroTrials Scientific Consultants for the first Lewis Y clinical trial.

New Lewis Y Phase II Clinical Trials are already being developed

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RECEPTA´S Oncology DivisionRECEPTA´S Oncology Division

Clinical Trials Hospitals

Recepta has established partnerships with hospitals known for their excellence in conducting clinical trials for its first Phase II clinical trial with anti-Lewis Y mAb.

– Instituto de Ensino e Pesquisa do Hospital Sírio Libanês (SP)– Instituto de Ciências do Hospital Osvaldo Cruz (SP)– Instituto de Pesquisa Albert Einstein (SP)– National Institute of Cancer (INCA-RJ)– Hospital da Baleia (BH)– Brazilian Institute for Control of Cancer (IBCC-SP)

This model will be replicated in the oncoming clinical trials

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RECEPTA´S FundingRECEPTA´S Funding

Recepta has been awarded several grants under different programs funded by the federal and Sao Paulo state government.

- Federal programs:FINEP: Program to fund partnership of Companies & Research Institutions

FINEP: Subvention program

- State Program:

FAPESP: Program to fund partnership of Companies & Research Institutions

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Funding Agencies for R&D in Funding Agencies for R&D in companies in Brazilcompanies in Brazil

Federal agencies:FINEP – the agency for innovation

CNPq – National Research Council

BNDES – National Bank for Economic and Social Development

State Agency - São Paulo: FAPESP – The State of Sao Paulo Research Foundation

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RECEPTA´S FundingRECEPTA´S Funding

By using these federal and state programs to

fund technological innovation Recepta’s investors account for an average of only 20% of the direct costs of R&D.

Recepta has been awarded a total of R$ 17.2 million (US$ 10 million) grants from FINEP and FAPESP´s programs to fund parnerships between companies and research institutions.

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www.receptabiopharma.comwww.receptabiopharma.com

Thank you!Thank you!