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Stem cells and materials technologies

Stem cells and materials technologies. Group 16 - Biomaterials and waste treatment Ciência 2009, 29-30 th July 2009, Lisbon. Strategic Intent.

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Stem cells and materials technologies

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  1. Stem cells and materials technologies Group 16 - Biomaterials and waste treatment Ciência 2009, 29-30th July 2009, Lisbon

  2. StrategicIntent To target clinical needs through the integration of advanced adult stem cell biology and novel biomaterials into innovative therapeutic products for tissue regeneration

  3. History • Academic spin-off of the 3B’s Research Group • Created in November, 2007 • Installed since September 2008 at the European Institute of Excellence for Tissue Engineering and Regenerative Medicine Research, Guimarães, Portugal. • Equipped with a future cGMP compliant facility for the processing of human tissue and cells (2003/94/EC Directive): • 300 m2 of clean room (classes B, C and D); • 250 m2 of R&D and QC laboratories. • 1st funding round estimated to be finished by Sept, 2009 • Start of operations estimated by Oct, 2009

  4. Team • CSO: Rui L. Reis, CEng., MSc., PhD. (n. 1968) – Founder, President and Chief Scientific Officer: is an Associated Professor at the Department of Polymer Engineering and Director 3B’s Research Group. Editor in Chief of the Journal of Tissue Engineering and Regenerative Medicine, John Wiley and Sons Inc. He is author or co-author of more than 900 scientific publications. • CEO: Rui A. Sousa,CEng.,MBA., PhD. (n. 1974) – Chief Executive Officer: is a senior researcher at the 3B’s Research Group. Possesses business experience in several industrial and consultancy domains. He is author or co-author of more than 90 scientific publications and communications. • Dulce Costa • Luísa Pereira • João Oliveira • Adrian Popa

  5. Social Context • The WHO estimates that more than 600 million people are aged above 60, being estimated that this number reaches the 2 billion by 2050. • Growing impact of degenerative or traumatic conditions due to demographic evolution, more dynamic lifestyles, and increased physical activities.

  6. OverallMarket Regenerative Medicine 2 1 3 Adaptado de Julian H S George et alhttp://www.centropede.com/UKSB2006/ePoster 5 4

  7. Use of stem cells from adipose tissue • More than 1.6 billion people are overweight, of which 400 million are considered obese, with treatment costs between 2 and 8% of total health costs. • Steep increase in aesthetical surgical procedures, being Europe responsible for about one third of this global market.

  8. Business Portfolio Stemmatters Therapeutics Stemmatters Life Banking Stemmatters Biomedical

  9. Stemmatters Therapeutics

  10. CurrentMarkets The Market for Cartilage Regeneration • Prevalence of articular cartilage related lesions in Europe • Nearly 250.000 traumatic incidents occur; • About 7 million cases of treatable arthrosis occur each year. • High market potential for cartilage regeneration • Among the biggest markets for connective tissues, being estimated between 1 to 5 billion €/year in Europe alone. • Very high penetration of traditional treatment approaches • Arthroscopic lavage and debridement, microfracture and mosaicplastyrule the treatment of cartilage lesions. • Cell based therapies with reasonable track record in this area • ACT and MACI procedures are considered market references.

  11. Product Pipeline Products Under Development Types of products currently under development:

  12. Product Pipeline Stemmatters Therapeutics | RECART Hydrogel/Adipose derivedadultstemcells Combined advanced therapy medicinal product (1394/2007 Regulation, CBMP EMEA guideline) • Polysaccharide hydrogel as an active implantable device • Exopolysaccharide produced by microbial fermentation: • Straight chain of repeating glucose, rhamnose and glucuronic acid units; • Potential injectable system for minimally invasive surgeries; • Processing under physiogical conditions without any reagents; • Used in vivo for human ophthalmic applications and oral veterinary drug delivery. • Adipose derived adult stem cells • Isolated from harvested adipose tissue: • Dedicated or non-dedicated harvest procedure; • Subpopulation isolated from the stromal vascular fraction; • Good cell yield avoids previous cell expansion.

  13. Product Pipeline Stemmatters Therapeutics | RECART Hydrogel/Adipose derivedadultstemcells • Novel hydrogel system for TE applications J.T. Oliveira et al, Patent Application

  14. Product Pipeline Stemmatters Therapeutics | RECART Hydrogel/Adipose derivedadultstemcells • Good performance upon subcutaneous implantation 3 WEEKS 1 WEEK 2 WEEKS • No clear macroscopic change after 3 weeks of implantation. • Extremely good integration with the surrounding tissues with a residual and thin fibrotic capsule.

  15. Product Pipeline Stemmatters Therapeutics | RECART Hydrogel/Adipose derivedadultstemcells 8 WEEKS • Human chondrocytes form hyaline-like cartilage in vitro • Col1 was not detected after 8 weeks • Col2 increased ≈ 400 fold from 2-8 weeks • Aggrecan increased ≈ 35 fold from 2-8 weeks • Sox9 decreased close to zero from 2-8 weeks house-keeping gene: GAPDH

  16. Product Pipeline Stemmatters Therapeutics | RECART Hydrogel/Adipose derivedadultstemcells ADIPOSE TISSUE FROM THE INTRASCAPULAR REGION ARTICULAR CARTILAGE FROM THE JOINTS CHONDROGENIC PRE ≠ MEDIUM WITH TGF-Β1 + BMP-2 BASIC MEDIUM WITH NO PRE ≠ PROLIFERATION INDUCING MEDIUM WITH FGF-2

  17. Product Pipeline Stemmatters Therapeutics | RECART Hydrogel/Adipose derivedadultstemcells Implantation site Rabbit articular cartilage Articular cartilage full-thickness defect Subchondral drill (Ø 1 mm) (4 mm x 2-3 mm thickness) Study groups + A. Gellan + adipose tissue derived cells with pre differentiation period (ASC + GF*) B. Gellan + adipose tissue derived cells with no pre differentiation period (ASC) C. Gellan + articular chondrocytes (AC) D.Gellan alone (GELLAN) E. Empty defect (EMPTY) + + *TGF-Β1 + BMP-2 Autologous approach Total implantation time: 8 weeks [Cells]=10x106 cells/ml Characterization • Macroscopic observation • Histology (H&E for cell morphology and tissue formation and alcian blue for cartilage ECM formation) • Histological scoring (Pineda score) • Real-time PCR analysis (Sox9, Collagen type I, Collagen type II, and Aggrecan) J.T. Oliveira et al, Patent Application

  18. Product Pipeline Stemmatters Therapeutics | RECART Hydrogel/Adipose derivedadultstemcells 0 weeks 4 weeks 8 weeks • Combination of hydrogel with ASCs is able to regenerate focal cartilage lesions J.T. Oliveira et al, Patent Application Patent Application/Priority date: 01.2008

  19. Product Pipeline Stemmatters Therapeutics | RECART Hydrogel/Adipose derivedadultstemcells

  20. Product Pipeline Stemmatters Therapeutics | RECART Hydrogel/Adipose derived adult stem cells Advantages of the cartilage repair strategy include: • Potential therapeutic performance • Minimally invasive system to be administered arthroscopically • Avoids the need for a cartilage biopsy • Shorter time to therapy (TTT) • Competitive cost as compared to traditional ACT and MACI procedures

  21. Competition TissueEngineering Products Cartilage application Arthro Kinetics, BioTissue Technologies, Cellgenix, co.don, Curasan, Educell, Fidia Advanced Biopolymers, Geistlich Surgery, Genzyme Biosurgery, Histogenics, Interface Biotech, Karocell Tissue Engineering, Orthogen, TIGenix, TETEC, Verigen Transplantation Service International Cartilage: application Stemmatters (Autologous) Bone application Aastrom Biosciences (Autologous), Osiris Therapeutics (Allogeneic) Skin application Organogenesis, BioTissue Technologies, Advanced BioHealing, Inc., Genzyme Biosurgery, Fidia Advanced Biopolymers, Intercytex, Celltran, Forticell Bioscience, Cambrex Primarycells Progenitor cells Cartilage application Osiris Therapeutics (Allogeneic) Several applications: Advanced Cell Technologies, Geron, ES Cell International, Stem Cell Sciences, Aastrom Biosciences, Aldagen, Angioblast Systems, Athersys , BrainStorm Cell Therapeutics, Cardio3, Cellerant Therapeutics, Cognate Therapeutics , Gamida-Cell, Mesoblast , Neuronyx, Osiris Therapeutics, AdiStem, Bioheart, Cellerix, Cognate Therapeutics, Cytori Therapeutics , ReNeuron Group Plc, Tengion, PharmaFrontiers , Tissue Genesis, Inc , Gamida-Cell, Saneron CCEL Therapeutics, ViaCell Cartilage application co.don, Educell, Geistlich Surgery, Genzyme Biosurgery, Interface Biotech, TIGenix, TETEC OtherCell BasedTherapies

  22. Product Pipeline RECART Hydrogel/Adipose derived adult stem cells Marketing Authorization MA Applic. R&D andnon-clinicaldevelopment Clinicaldevelopment Biomaterial R&D Phase I Phase II Invitrotesting Phase III InVivoTesting GMP grade Phase IV 2007-2010 2010-2018 2019 2020

  23. Product Pipeline RECART Hydrogel/Adipose derived adult stem cells Marketing Authorization MA Applic. R&D andnon-clinicaldevelopment Clinicaldevelopment Biomaterial R&D Phase I Phase II Invitrotesting Phase III InVivoTesting GMP grade Phase IV Stemmatters Life Banking Stem cell isolation and storage services Stemmatters Biomedical Products and services for R&D 2007-2010 2010-2018 2019 2020

  24. Contacts Rui A. Sousa CEO Tel. +351-253-540100 Fax. +351-253-540199 E-mail: rasousa@stemmatters.com

  25. Stemmatters Life Banking

  26. CurrentMarkets Main application markets for stem cells Current uses of stem cells are made in 3 distinct medical related markets: • Cell banking; • Therapeutic development; • Cell therapies. (source: Frost & Sullivan).

  27. Current Offering Stemmatters Life Banking | Stem cell isolation and storage services • Bone marrow (onstem service – B2C); • Adipose tissue (adstem service – B2C): • The treatment of tissues and biological residues generated in surgical procedures assures a cell banking opportunity not yet addressed. • Market potential for the isolation and storage of adipose derived adult stem cells for autologous application is estimated to worth: • 75 million €/year for Spain, France, Germany, UK, Italy and Portugal; • 120 million €/year for EU15. • Assures a polyvalent platform for regenerative technologies; • Assures positive cash flow and supports leveraging of R&D pipeline.

  28. Competition Stemmatters Life Banking | Stem cell isolation and storage services

  29. CurrentOffering Stemmatters Life Banking | Stem cell isolation and storage services Acquisition Drivers • Increased value of the surgical procedure; • Potential application in future autologous regenerative therapies; • Allows for off the shelf availability of personalized regenerative products; • Decreases time for clinical delivery of therapy. Current applications of adipose derived adult stem cells • Radiation Necrosis • Breast Reconstruction • Heart Attack • Chronic Heart Disease • Crohn’s Disease • Tracheal Fistula Healing • Calvarial Repair • Marrow Transplant Complications • Diabetes

  30. Stemmatters Biomedical

  31. Current Offering • Isolation and processing services of human cells: • Human stromal vascular fraction isolated from adipose tissue containing human adipose derived stem cells (all samples are characterized for cell number and viability); • Human adipose derived stem cells (all samples are characterized for cell number and viability, as well as multipotent mesenchymal stem cell markers: CD29, CD105, CD34 and CD45); • Pre-clinical research in regenerative medicine accounts for a market volume of about 700 million €/year. • Cell culturing products; • Hydrogel support systems for 3D cell culturing; • Very high R&D visibility among the potential buyer community; • The global market potential for the commercialization of 3D supports for non-clinical R&D is estimated to worth between 7 and 35 million €/year. • Device for dynamic cell seeding and culturing. Stemmatters Biomedical | Products and services for R&D

  32. CorporateStrategy

  33. CorporateStrategy

  34. Financial projections

  35. Financial Projections 2009-2016

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