Download - Cari cord presentation 11 25_2015
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November 2015
CONFIDENTIAL
Public, Private, and ResearchCURING TODAY…INNOVATING FOR TOMORROW
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A Comprehensive Approach
Cord Blood Stem Cell Banking
Private Adult Stem Cell Banking
Public Banking
Cellular Therapy
Biological Safety Deposit Box
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FDA
Changing the Model
Cord Blood Banking
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Pillars of the Business3 Divisions
FDA drug license
Cord Blood Banking Adult Banking Public Banking
20 years but still “new” to consumers 1st in class
Multibillion dollar market CU partnerships and collaborations
Strong recurring revenues
Possible exclusivity
National programHigh profit potential
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High PotentialPublic, Private, and Research
Private Banking Adult Banking
• Twenty years of use and technical ability
• Multi-billion dollar consumer business in place and maturing
• Dominated by marketing companies
• Strong recurring revenues
• Opportunity to take share
• New product
• Market introduction
• High end target market
• Collections through blood centers nationwide
Public
• FDA drug license
• Regenerative medicine research
• Leverage university assets
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• 32 acre medical campus • 6.4 million square feet • 7,000+ faculty members
• 21,000+ employees• Serving over 500,000 patients annually• Established in 1883
University of ColoradoThe Medical Campus
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Part of an Integrated Medical Center
The University of Colorado School of Medicine
Bioengineering and Applied Science
Bioscience Park
University of Colorado Hospital
Gates Center for Regenerative Medicine
Children’s Hospital Colorado
At the University of Colorado
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Anschutz Medical Campus
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• Administered by transplant physicians and histocompatibility scientists committed to improving patient transplant outcomes
• Collecting and banking umbilical cord blood since 1996; accredited by the AABB• Class 10,000 cGMP stem cell processing facility• HRSA Contractor for National Cord Blood Inventory (NCBI) since 2006• Cord blood units are available through the NMDP• Confirmatory HLA typing • More than 750 units released for patient transplants• Units shipped to more than 120 transplant programs in Argentina, Australia, Belgium,
Brazil, Canada, China, France, Italy, Mexico, New Zealand, Spain, United Kingdom, Uruguay, and the United States
• 50% of units are from minority donors • FDA License No. 1855, received on May 24th, 2012
Public Cord Blood Banking
Processing Cord Blood Units under License for 3 Years
Processing Donated Cord Blood Units for 18 Years
Inventory of 10,000+ Cord Blood Units
FDA License No. 1855, Received May 24th, 2012
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ClinImmune LabsAt the University Of Colorado
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Dr. Brian FreedExecutive Director and Professor at the University of Colorado’s School of Medicine
Sharon Miller, CHS MTDirector of Regulatory Affairs
Regulatory
MichaelAubrey, MSChief Operating Officer
Operations
TateHermansonDirector of Business Services
Administration
Dr. Ralph QuinonesDirector of Blood and Marrow Processing Laboratory
Co-Medical Director
Dr. JonathanGutmanClinical Director of Allogeneic Transplantation
Co-Medical Director
Executive Director
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ClinImmune is Comprised of Six Laboratories
These laboratories provide services to kidney, heart, lung, pancreas, and hematopoietic stem cell transplant programs including: University of Colorado Hospital, Colorado Children’s Hospital, Presbyterian/St. Luke’s (Denver, Colorado), Northside Hospital (Atlanta, Georgia), and St. Francis Hospital (Charleston, South Carolina).
Providing Services to Hospitals Nationwide
HistocompatibilityClinical ImmunologyFlow Cytometry
CariCordHuman Stem Cell ProcessingPublic Cord Blood Bank is FDA Licensed
18 years
Expertise and Experience
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New Laboratory Opened 2015
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Largest Medical School Construction Project in the USAt the University of Colorado
In 2013, the University of Colorado Board of Regents approved a new Bioscience 2 facility which will contain our state of the art Class 10,000 cGMP lab. The University celebrated with a Grand Opening Ceremony on 11/18 2015. The District’s adjacency to the Anschutz Medical Campus and its formal affiliation with the University of Colorado provides priority access and support for research and product development.
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• CariCord is a stem cell services company providing best in class cord blood and tissue preservation, focused on improving the health, wellness and quality of life of families who choose to save their baby’s stem cells at birth.
• A component of ClinImmune Labs at the University of Colorado, CariCord combines the latest scientific research with ongoing feedback from both transplant physicians and the research community to maintain its cutting edge quality standards within the newborn stem cell storage market.
• 2014, CariCord launched our initial sales efforts to both the OBGYNs, utilizing an experienced management team and concurrently direct to consumers, via advertising and a call center with sales agents. We have seen rapid acceptance of our offering and core messages: Stability, Quality and Experience.
• 2015, we have built a scalable model and are seeking investment partners to facilitate rapid growth, as we fuel our market launch and upwards growth trajectory.
About CariCordA Unique Model with a Strong Message
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Experienced Leadership TeamOver 50 Combined Years of Cord Blood Industry Knowledge
Calvin ColePresident & CEO
President
Brian McEnroeSr. VP Sales & Marketing
Sales and Marketing
Ranelle EricksonVP of Marketing
Marketing
John GabrielSr. VP Operations
Operations
Dub SittonVP of Sales
Sales
Jim ToddChief Financial Officer
Finance
Global Medical Director
Ratan Bhardwaj MD, PhD, Pediatric Neurosurgery
Medical Director
Donald Vliegenthart MD, Board Certified Orthopedic Surgeon
Scientific
Harry KloorPhD, PhD Chief Scientific Officer
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13Alaska Hawaii
Growing Footprint States We Have Conducted Business In (Light Blue)
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We have been processing cord blood units under federal contract since 2006. We were among the first to elevate our cord blood banking practices to FDA BLA licensure. I’m pleased to announce we are the first to leverage our lab’s best practices to serve private consumers, while sustaining our efforts to build the National Cord Blood Inventory with life-saving transplant ready units. We believe our partnership in CariCord demonstrates a sustainable pathway that is responsive to current and future private and federal sector demands.
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”Brian Freed
Executive Director of ClinImmune Labs and Professor at the University
of Colorado’s School of Medicine
Quality BankingHistory of Expertise Now Available to Families
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Cord Blood BankingFamilies can choose to preserve their baby’s cord blood at the time of birth, utilizing our temperature controlled collection kit. Cord blood is currently used to treat over 80 diseases with many more in research.
Cord Tissue BankingFamilies can also choose to save their baby's cord tissue at delivery, using the CariCord collection kit cup, always available inside our kit. Cord tissue stem cells show promising therapeutic potential in pre-clinical research for diseases such as stroke, diabetes, Parkinson’s disease, ligament repair in sports injuries, liver and lung repair and wound healing.
Product PipelineAdult Stem Cell Banking is currently under development and details of the project are confidential at this time.The project will have broad appeal and will save qualitystem cells, for those who enroll. Announcements regardingthe details are dependent on harvesting, processing and storage and will be coming in the next 90 -180 days,if not sooner.
Our ProductsCurrent Offerings
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CariCord’s goal is to become the # 1 cord blood and tissue company recommended by health care providers, to all patients. We also plan to develop a comprehensive line of stem cell storage options for adult stem cells from alternative sources. Key elements of the CariCord’s strategy to achieve this goal are as follows:
Our Growth StrategyPositioned for Success
Building the National Cord Blood SupplyWe plan to combine the private and public cord blood banks and increase the number of donation hospitals, with a goal of creating large volume, FDA licensed cord blood units, to provide to families and healthcare professionals seeking lifesaving units for transplant.
Focus on ResearchWe plan to expand our efforts on research, clinical trials, and commercialization of stem cell related products. Therapies that improve the quality of life, recovery, and outcomes for diseases treated with stem cells, will increase the demand for stem cell storage and therapeutic treatment options for patients.
Exclusive Current Market Focus Initially, we plan to focus exclusively on cord blood and tissue banking, focusing on superior quality and long term stability, demonstrating to physicians that they can be confident recommending CariCord to patients and families.
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Class 10,000 clean rooms
Laboratory capacity
Oversight and management
CLINICAL TRIALS
Clinical Trial Center – Research and DevelopmentAdvancing Stem Cell Science
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COLLABORATION
PATH TO NEW TREATMENTS
Dedicated partner
Researchers
Academic medical center
Commercialization
Testing for safety and efficacy
Creation of novel cellular products
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Crag T. Jordan, MDDr. Jordan serves as the Chief of the Hematology Division and directs a research program focused on the development of novel therapies for the treatment of leukemia.
Brian M. Freed, PhD, DABHIDr. Freed is Executive Director of ClinImmune Labs and a Professor of Medicine and Immunology. ClinImmune Labs consists of the Histocompatibility Lab, the Stem Cell Lab, the University of Colorado Cord Blood Bank, the Flow Cytometry Lab and CariCord. His research focuses on the role of individual HLA amino acid residues in antigen presentation with the goal of providing HLA-specific immunotherapy.
Johnathan Gutman, MDDr. Gutman directs the Allogeneic Bone Barrow Transplant (BMT) program and is a leading expert in the use of umbilical cord blood derived stem cells for BMT. He oversees a broad range of clinical programs and trials.
Clay Smith, MDDr. Smith is the Associate Chief of Hematology and the Clinical Director for the Blood Cancer Program. He is a highly experienced laboratory researcher and directs a program focused on the development of new therapeutic regimens in the treatment of hematologic malignancies.
Jill Slansky, PhDUsing an animal model for colon cancer, Dr. Slansky is determining what substitutions in tumor antigen peptides can be used to improve antitumor immunity. These so-called mimotope peptides (mimics of epitopes) activate T cells that respond to the tumor more effectively than the natural tumor antigen.
Ross Kedl, PhDDr. Kedl is interested in this curious boundary between the innate and adaptive immune systems and seeks to elucidate signals and pathways emanating from the various families of innate receptors most efficiently mediate the transition to the adaptive cellular immune response.
Cellular Therapy Team
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Mesenchymal Stem Cells Could Hold the Key to the Future of Ground Breaking Research
There are many areas of preclinical research4,5,6,7,8,9
Sports Injuries
Lung Disease
Stroke
Liver Repair
Rheumatoid Arthritis
Parkinson’s Disease
Type 1 Diabetes
Burn Victims
Extensive Pipeline of Future Stem Cell Applications
Osteoarthritis
More Diseases in Research with Stem Cells
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• Ataxia telangiectasia • Chronic granulomatous
disease • DiGeorge syndrome • IKK gamma deficiency • Immune dysregulation
polyendocrineopathy • X-linked Mucolipidosis,
Type II • Myelokathexis X-linked
immunodeficiency • Severe combined
immunodeficiency • Adenosine deaminase
deficiency • Wiskott-Aldrich
syndrome • X-linked
agammaglobulinemia • X-linked
lymphoproliferative disease
• Omenn's syndrome • Reticular dysplasia • Thymic dysplasia • Leukocyte adhesion
deficiency
• Sickle-cell anemia (hemoglobin SS)
• HbSC disease • Sickle βo Thalassemia • α-thalassemia major
(hydrops fetalis) • β-thalassemia major • β-thalassemia intermedia • E-βo thalassemia • E-β+ thalassemia• Osteopetrosis • Langerhans cell
histiocytosis • Hemophagocytic
lymphohistiocytosis
• Acute lymphoblastic leukemia
• Acute myeloid leukemia • Burkitt's lymphoma • Chronic myeloid leukemia • Juvenile myelomonocytic
leukemia• Non-Hodgkin's lymphoma • Hodgkin's lymphoma • Lymphomatoid
granulomatosis • Myelodysplastic syndrome • Chronic myelomonocytic
leukemia
Blood DisordersImmunodeficiences Metabolic Disorders
Cancers
Other• Osteopetrosis • Langerhans cell
histiocytosis • Hemophagocytic
lymphohistiocytosis
• Amegakaryocytic thrombocytopenia
• Autoimmune neutropenia (severe)
• Congenital dyserythropoietic anemia
• Cyclic neutropenia • Diamond-Blackfan
anemia • Evan's syndrome • Fanconi anemia • Glanzmann's disease • Juvenile dermatomyositis • Kostmann's syndrome • Red cell aplasia • Shwachman syndrome • Severe aplastic anemia • Congenital sideroblastic
anemia • Thrombocytopenia with
absent radius• (TAR syndrome) • Dyskeratosis congenita
• Adrenoleukodystrophy • Gaucher's disease • (infantile) • Metachromatic
leukodystrophy • Krabbe disease • Gunther disease • Hermansky-Pudlak
syndrome • Hurler syndrome • Hurler-Scheie syndrome • Hunter syndrome • Sanfilippo syndrome • Maroteaux-Lamy
syndrome • Mucolipidosis Type II, III • Alpha mannosidosis • Niemann Pick Syndrome,
type A and B • Sandhoff Syndrome • Tay-Sachs Disease • Batten disease• Lesch-Nyhan disease
Bone Marrow Failure Syndromes
There are Nearly 80 Diseases Treated Today
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And Many More in Research
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1.Moise K Jr. Umbilical Cord Stem Cells, Obstetrics Gynecology, 2005; 106(6):1393-1407 2.Nietfield JJ, Pasquini MC, Logan BR, Verter, Horowitz MM. Lifetime Probabilities of a Hematopietic Stem Cell Transplantation in the US, Biology Blood and Marrow Transplant, 2008; 14:316-322. 3. Based on a 6/6 HLA match. 4. Stroke: Ding DC, Shyu WC, Chiang MF et al. Enhancement of Neuroplasticity through Upregulation of B1-integrin in Human Umbilical Cord Derived Stromal Stem Cell Implanted Stroke Model, Neurobiology Dis. 2007; 27(3):339-353. E-publication 2007 June 18. 5. Parkinson’s Disease: Fu YS, Cheng YC, Lin MY, et al. Conversion of Human Umbilical Cord Mesenchymal Stem Cells in Wharton’s Jelly To Dopaminergic Neurons in Vitro: Potential Therapeutic Application For Parkinson’s Disease, Stem Cells. 2006; 24(1):115-124. E-publication 2005 August. 6.Rheumatoid Arthritis: Liu Y Mu R Wang S et al. Therapeutic Potential of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Rheumatoid Arthritis, Arthritis Res Ther. 2010; 12(6):R210 7. Sports Injuries (cartilage): Wang L. Tran 1, Seshareddy K et al. A Comparison of Human Bone Marrow-Derived Mesenchymal Stem Cells and Human Umbilical Cord Derived Mesenchymal Stromal Cells for Cartilage Tissue Engineering, Tissue Eng. 2009; 15(8)(pt A): 2259-2266. 8.Type 1 Diabetes: Anzalone R, Lo Iacono M, Loria T, et al. Wharton’s Jelly Mesenchymal Stem Cells as Candidates for Beta Cells Regeneration: Extending the Differentiative and Immunomodulatory Benefits of Adult Mesenchymal Stem Cells for the Treatment of Type 1 Diabetes. Stem Cell Rev. October 23, 2010 E-publication. 9. Lung Cancer: Maurya DK, Doi C, Kawabata A, et al. Therapy With Un-engineered Naïve Rat Umbilical Cord Blood Matrix Stem Cells Markedly Inhibits Growth of Murine Lung Adenocarcinoma, BMC Cancer, 2010;10-590. 10. Data on file as of February 2014. 11. Accreditations current as of February 2014. 12.Center for Biologics Evaluation and Research, Food and Drug Administration, US Department of Human and Health Services, Guidance for the Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoetic Reconstitution for Specified Indications, October 2009. 13. Data on file for CariCord and numbers from company websites ViaCord (268) and CBR (262) as of February 2014. 14. Discount applies when cord blood and cord tissue banking are chosen with a prepaid storage plan. Prices effective as of February 2014General Disclaimer: Most of the diseases currently treated with cord blood stem cells are genetic diseases. Banking cord blood does not guarantee that your physicians will choose it as first line course of treatment over a sibling donor or autologous donor depending on the diseases being treated and other factors in consideration of a transplant. Only a treating physician can determine when it should be used on a case by case basis. Cord tissue research is pre-clinical and may have potential in the future but is not used in treatments in humans currently.CONFIDENTIAL