HemaCare Corporation Company Overview

HemaCare Corporation Corporate Overview

Comprehensive Solutions for

BioResearch Products and Cellular Therapy

• Started as a blood bank 37 years ago

• Transformed from blood banking and therapeutic apheresis services to bioresearch and cell therapy focus

• Leading provider of apheresis products, human blood cells, and apheresis collection services

• Support preclinical research, clinical studies from Phase I to Phase III, and commercialization

we?are

Whowe?

Our History

Founded as a blood bank

Began therapeutic

apheresis operations

Participated in leukapheresis

clinical trial collections and

stem cell collection programs

Partnered with Dendreon to

provide apheresis

materials for test runs and began cellular

therapy clinical trial collections

Began Provenge® patient collections

Created BioResearch Products & Services

Launched Cell Therapy Solutions portfolio

Ability to provide apheresis starting

material for cell therapy process development

1970s 1980s 1990s 2000s 2010s

The HemaCare Advantage

Accreditations• FDA registered donor center with cGMP and cGTP requirements• State of California – Biologics Production and Clinical Lab• AABB and CLIA accredited• Joint Commission, FACT, DHS, and OSHA compliant

A comprehensive research and cellular therapy offering• Variety of healthy and disease state human derived products• Comprehensive cell therapy products and services• Cell manufacturing process development• Customized cell processing projects• Cold chain management• Apheresis consulting

Our Donors Make The Difference

Donors are the critical source for any research project. We have been recruiting and developing our own healthy donor pool since 1978.

Pedigreed Donor DatabaseWe know our donors

Recall donors / repeat collections

They are qualified and tested each donation Qualification, serological and infectious testing performed

We can recruit donors for specific investigator needs Age, gender, height, weight, ethnicity Medical history – vaccinations, diet, family history Lifestyle characteristics HLA type, other specific laboratory test results Other specific parameters

All donors are qualified per FDA regulations and IRB-approved informed consent.

Products and Services

HUMAN-DERIVED PRIMARY CELLS

BIOPRESERVATION MEDIA

CELLULAR THERAPY SOLUTIONS

• Peripheral Blood• Mobilized

Peripheral Blood• Bone Marrow• Cord Blood

Leukapheresis collections for:• Process development• Immuno-cellular therapy clinical trials• Commercial immuno-cellular therapy (i.e. PROVENGE®)

• Cryostor CS10®• Hypothermosol®

Human-derived Primary Cells

Human-derived Primary Cells

Peripheral Blood

• Leukopaks• Platelets• Whole Blood• Plasma• Serum• Mononuclear Cells• CD3 Pan T Cells• CD4 Helper T Cells• CD8 Cytotoxic T

Cells• CD14 Monocytes• CD19 B Cells• CD4/CD25

Regulatory T Cells• CD56 NK Cells• Dendritic Cells• Macrophages• Neutrophils

Mobilized Peripheral Blood

• Mononuclear Cells• CD14 Monocytes• CD34 Stem Cells• CD34 Depleted

Mononuclear Cells• CD133 Stem Cells

Bone Marrow

• Unprocessed Bone Marrow

• Mononuclear Cells• Mesenchymal Stem

Cells• CD34 Stem Cells• CD34 Depleted

Mononuclear Cells• CD133 Stem Cells

Cord Blood

• Unprocessed Cord Blood

• Mononuclear Cells• CD3 Pan T Cells• CD4 Helper T Cells• CD8 Cytotoxic T

Cells• CD14 Monocytes• CD19 B Cells• CD34 Stem Cells• CD133 Stem Cells• CD56 NK Cells• Neutrophils• Mesenchymal Stem

Cells• Plasma• Dendritic Cells

(CD34 derived)

Human-derived Primary Cells

Human-derived Primary CellsDisease-state Primary CellsHemaCare provides disease-state biological products from the following

indications:(more indications are continuously added)

Autoimmune Disease• Diabetes Mellitus Type 2• Rheumatoid Arthritis• Systemic Lupus Erythematosus (SLE)

Cancer• Acute Myeloid Leukemia (AML)• Breast Cancer• Chronic Lymphocytic Leukemia (CLL)• Colorectal Cancer• Gastric Cancer• Lung Cancer• Multiple Myeloma• Non-Hodgkin’s Lymphoma• Prostate Cancer

Inflammatory Bowel Disease• Crohn's Disease

Infectious Disease• Hepatitis B Virus (HBV)• Hepatitis C Virus (HCV)• Herpes Simplex Virus 1• Herpes Simplex Virus 2• Human Immunodeficiency Virus (HIV)• Syphilis

Customizable

Targeted Donor RecruitmentOur diverse donor pool enables us to provide the match customers need to successfully complete their study:

• Healthy donors• Disease-state donors and patients• HLA specific (low and high resolution)• CMV negative/positive• Blood type specific• Diverse demographics• Gender and/or age specific• Specific lifestyle characteristics• Ability to provide both repeat and unique donors

All products are collected from donors and patients who are qualified for participation in accordance with Institutional Review Board (IRB)-approved informed consents.

Customizable

Customized Collections And Cell/Tissue ProcessingFollowing cGMP and cGTP collection guidelines is key to successful research. We provide:

• Protocol-specific collections - Your Way• Fulfillment of specific cell requests• Multiple cell types from same donor• Density separation of white blood cells• Positive or negative immunomagnetic cell selection methods• Custom primary cell cultures• Fresh or frozen cell formats• Custom cell number/volume per unit• Packaging and shipping to customer specifications (i.e. shipping media, buffers,

containers)• Cold chain services for shipments anywhere globally

Count (x106) ± SD

Total Nucleated Cells 14,400 550

Mononuclear Cells 12,100 600

n= 1,202 leukapheresis products

High-quality Leukapheresis Raw Material Collected at HemaCare

Longevity Study - LeukoPak

Peripheral Blood Mononuclear Cells (PBMCs)

Sources for Mononuclear cells• Peripheral blood• Mobilized peripheral blood• Bone Marrow• Cord blood

n = 20

Best in Class Partners = High Quality Products

HemaCare aligns itself with partners who maintain high quality standards

HypoThermosol® and CryoStor®.

Prodigy®, CliniMACS®, and AutoMACS®

CoolCell®

Cellular Therapy Solutions

Cellular Therapy Solutions

Apheresis Collection Network

Cold Chain and Logistics

Cryopreservation and Biopreservation Services

Patient Collections within a Standardized

Apheresis Network

Process Development Clinical Trials

A highly flexible, modularized portfolio of Cellular Therapy Solutions

Customized Apheresis for Process

Development• CAR-T comparability runs• Fresh and frozen• Customized to meet varying

donor specs (e.g. high neutrophils)

CommercializationClinical Trials Process Development

Apheresis Expertise in a Quality Systems Framework

Optimize cell collection by controlling and qualifying the apheresis processes based on cGMP and cGTP requirements• Qualification of donors • Qualification of vendors, equipment, supplies and sites• Monitoring equipment, supplies and environment • Development and maintenance of procedures• Comprehensive staff training and qualification• Documentation and records management• Management of exceptions and deviations• Monitoring quality indicators for process improvement• Internal and external inspections

Apheresis Collection Network

The HemaCare Advantage• Established network of collection centers• Standardized protocols and procedures across

all sites • 24/7/365 support from clinical, logistics,

regulatory, and training experts• Single point of contact

Apheresis Collection Network

Vision: A Global Solution• HemaCare is building partnerships that can be

leveraged to support clinical trials globally • Working toward providing the same level of

standardization on a global scale as you would expect from US based collection centers

• Leverage biopreservation experience and partnerships to maintain product integrity during global transport

Logistics Management

The HemaCare Advantage• Strict oversight of temperature to cold chain

logistics• Complete oversight of samples from

collection to final destination• Best-in-class clinical grade biopreservation

media– Cryostor® CS10– Hypothermosol® FRS

• Global manage transport of collection samples

Cryopreservation and Storage Support

The HemaCare Advantage• Cryopreservation and storage (Cryostor®

CS10) • Just-in-time shipment upon request

• Close cooperation with QA and Operations staff to assure quality, control, and chain of custody

Cryostor®

Clinical grade freeze media made under cGMP to device and

relevant drug standards

At Hemacare, we're not just about the science. We are committed to charting a path of growth by expanding our comprehensive portfolio of research and cell therapy products that will touch the lives of patients everywhere.

We demonstrate this through a compelling value proposition that cannot be easily replicated:

• Vertically integrated supplier to the industry• FDA-registered, cGMP and cGTP clinical collection capabilities• Donor management and apheresis collection expertise spanning• 37 years of performing over 250,000 collections

GROW WITH US!

In Conclusion…

THANK YOU!