Successfully reported this slideshow.

PIPEs Conference Presentations, November 2006


Published on


Published in: Technology, Business
  • Be the first to comment

  • Be the first to like this

PIPEs Conference Presentations, November 2006

  1. 1. The PIPEs ConferenceThe PIPEs ConferenceNovember 2006November 2006
  2. 2. 2This presentation contains “forward-looking statements” as defined under thefederal securities laws. Actual results could vary materially. Factors that couldcause actual results to vary materially are described in our filings with the Securitiesand Exchange Commission.You should pay particular attention to the “risk factors” contained in documents wefile from time to time with the Securities and Exchange Commission. The risksidentified therein, as well as others not identified by the Company, could cause theCompany’s actual results to differ materially from those expressed in any forward-looking statements.Cautionary Statement ConcerningForward-Looking StatementsCautionary Statement ConcerningForward-Looking Statements
  3. 3. 3Investment ConsiderationsInvestment ConsiderationsScientific Leader in Regenerative MedicineFirst Proven Alternative Method for Deriving Human Embyronic Stem CellsDriving Human ES Cell Therapies to the ClinicFocus on RPE, Hemangioblast and Dermal Product ProgramsProprietary Human ES Cell TechnologyOver 300 Patents and Patent ApplicationsAward Winning Team of Scientists and ManagementDr. Mike West and Dr. Robert Lanza are Recognized Thought Leaders
  4. 4. 5
  5. 5. 6Blastomere Program – Significant AdvancementsBlastomere Program – Significant AdvancementsTransfer of 2 Blastomere Lines into GMP for Product DevelopmentScientific Work Under-way to Produce Additional Blastomere LinesPlanning to Seek Approval for NIH Federal Funding for hESCResearch Utilizing Blastomere LinesSet-up Collaboration with Wi-Cell to Make Blastomere Lines WidelyAvailable if Eligible for Federal Funding
  6. 6. 7Blastomere divided outgrowthfirst passage second passage established line1.Derivation of hES cells from single blastomeressingle blastomereInitial outgrowthcocultured blastomereblastomere isolation
  7. 7. Why Human Embryonic StemCells?Why Human Embryonic StemCells?
  8. 8. 9Stem Cells are a Proven TherapyStem Cells are a Proven TherapyFirst successful bone marrow transplant (BMT) in 1968Tens of thousands of patients have been cured with BMTHuman embryonic stem cells first isolated in 1998hESC’s have significant potential to treat diseases
  9. 9. 10The Significant Advantage of Embryonic Stem CellsThe Significant Advantage of Embryonic Stem Cells
  10. 10. 11ES Cells Form Complex TissuesES Cells Form Complex TissuesScience 2002 295: 819PNAS 2003, 100 Suppl 1:11911Intestine Muscle RetinaHair / Skin Cartilage Bone
  11. 11. 12Regenerative MedicineCuring Devastating DiseaseRegenerative MedicineCuring Devastating Disease800,000Parkinsons patients 750,000liver disease patients20,000,000heart disease patients20,000,000 diabetespatients5,000,000epilepsy patients4,000,000Alzheimers patients2,000,000stroke patients300,000kidney disease patients
  12. 12. 13Growing Legislative SupportGrowing Legislative SupportCalifornia & Proposition 71Voters approve $3.0 billion in funding over next ten yearsFormation of CA Institute of Regenerative Medicine (CIRM)Recent awards of initial training grantsCourt trial completeCIRM public discussions – funding 2007Other State InitiativesMA, CT, NJ, NY, IL, FLFederal LegislationBi-partisan House of Representatives Bill H.R. 810Federal Funding for Alternative Methods of Deriving Human ES Cells
  13. 13. 14The Next Frontier in MedicineThe Next Frontier in Medicine"If the potential of stem cell research is realized, it would mean an end to the suffering ofmillions of people. If stem cell research succeeds, there isn’t a person in the country whowon’t benefit, or know somebody who will."Michael J. Fox“[Stem cell research] is the most promising research in healthcare perhaps in this history of theworld and we should not be left behind in this research.”Senator Orin Hatch, (R-Utah)“Science has presented us with a hope called stem-cell research, which may provide ourscientists with answers that have so long been beyond our grasp.”Nancy Reagan“This is not a matter of using a human embryo that has the potential to produce life. Rather,these otherwise discarded embryos have the potential to save lives.”Senator Arlen Specter (R-PA)
  14. 14. Driving Human ES CellTherapies to the ClinicDriving Human ES CellTherapies to the Clinic
  15. 15. 16Driving Human ES Cell Therapies to the ClinicDriving Human ES Cell Therapies to the Clinic
  16. 16. 17Our Product Development PathwayOur Product Development PathwayCell Discovery and ValidationFinding Cell Types with Therapeutic PotentialSelect Target Indications“GMP” Cell ProductionDerive Human ES Cells under GMPDifferentiate Target Cell Type under GMPPreclinical and Clinical TestingFunctional and Safety Preclinical TestingDevelop Plan with FDA for Human Clinical Trialstarget cell typestarget cell typestarget cell linestarget cell lines20062006200720072004200420052005
  17. 17. 18Our GMP StrategyOur GMP StrategyWorcester GMP Lab – utilize for pilot mfg of differentiated cell types(RPE, Hemangioblasts, etc.) for pharm/tox studies and Phase IstudiesAlameda GMP Lab – utilize for larger scale mfg of differentiated celltypes for all phases of preclinical and human clinical studiesNov 2005 – Commenced build-out of small GMP lab in WorcesterFeb 2006 – Opened research facility in Alameda, CA – 10,000 sq ft ofGMP capable labApril 2006 – Completed build-out of GMP lab in WorcesterMay 2006 – Commenced Scientific Work under GMP
  18. 18. 19Our RPE ProgramOur RPE ProgramCompleted Build-out of GMP Facility/ Commenced Scientific WorkPublished Paper on Proof of ConceptRPE Study in RCS RatHired Regulatory and RPE ClinicalAdvisorsDeveloped Clinical Study Outlines /Commenced AdditionalPharmacology StudiesPlan to Commence ToxicologyStudies in early 2007Target IND Filing by Year-end 2007
  19. 19. 20
  20. 20. 23Our Dermal ProgramOur Dermal ProgramProduced scalable hESC-deriveddermal lines in Alameda facilityCollaborations under-way for proof ofconcept studiesCurrently considering regulatoryframework for dermal applicationsLarge applications in burns, woundrepair and surgeryCollaboration with Xgene Corp. totest dermal cell line
  21. 21. 242006 Corporate Milestones (How are we doing?)2006 Corporate Milestones (How are we doing?)AchievedCompleted Build-out of GMP Facility / Began “GMP” Cell ProductionLaunched Preclinical and Clinical Testing PlansExpanded Technology Platform with Scientific BreakthroughsRaised Significant Additional CapitalStill To ComeAchieve Listing on AMEX or NASDAQ Capital MarketAnnounce Corporate Partnership
  22. 22. 252007 Corporate Milestones2007 Corporate MilestonesSetting the Bar HighRaise Additional Capital / Achieve Listing on National ExchangeAnnounce Significant Corporate PartnershipFile IND for our RPE ProgramComplete Substantial Preclinical Work for our Hemangioblast andDermal ProgramsBuild-out our Development OrganizationGain Approval from NIH for Federal Funding for hESC Researchutilizing Blastomere LinesAnnounce Scientific Breakthrough on Solving Histocompatibility
  23. 23. 26Senior Management TeamSenior Management TeamMr. William Caldwell, IV, Chief Executive Officer30 Year Career in Management and FinanceDr. Michael West, President and Chief Scientific OfficerFounder of Geron and ACTDr. Robert Lanza, VP of Medical & Scientific Development25 Year Career in Biomedical and Scientific ResearchMr. Ivan Wolkind, VP of Finance, Chief Accounting Officer25 Year Career in Accounting, FinanceMr. Jon Atzen, SVP, General Counsel15 Year Legal Career in Corporate and Securities Law