J a n u a r y 20 1 8 SAB Team & Technology Together for 15+ - - PowerPoint PPT Presentation
J a n u a r y 20 1 8 SAB Team & Technology Together for 15+ - - PowerPoint PPT Presentation
J a n u a r y 20 1 8 SAB Team & Technology Together for 15+ Years Technology Purchased by SAB Biotherapeutics originated at the Kirin Pharma, begins independent University of BioDak Acquires IP, operations Massachusetts Kyowa
1998
Sullivan becomes CEO, Hamilton investment, headquarters moved to Sioux Falls, Human antibodies from cloned cattle
2000 - 2005
Sanford Applied Biosciences acquires team and IP Sanford Applied Biosciences & BioDak Merge
2010 - 2014
Phase 1 Clinical Trials Begin, Construction begins on pharm
2016 - 2017
Technology
- riginated at the
University of Massachusetts @ Amherst
2005 - 2010
Purchased by Kirin Pharma, BioDak Acquires IP, Kyowa Hakko Kirin merger
2014 - 2016
SAB Biotherapeutics begins independent
- perations
SAB Team & Technology–Together for 15+ Years
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DECEMBER 2017
Edward Hamilton, DVM
EXECUTIVE CHAIRMAN BOD / CO - FOUNDER
Jerry Pommer, MSc, PAS
CHIEF COMPLIANCE OFFICER SVP REGULATORY & QUALITY ASSURANCE
Charles Randall, Jr.
CHIEF FINANCIAL OFFICER, EVP
Hua Wu, PhD
SENIOR SCIENTIST SVP VACCINE & ANTIBODY DEVELOPMENT
Christoph Bausch, PhD
CHIEF SCIENCE OFFICER PRODUCT DEVELOPMENT & MANUFACTURING
Eddie J. Sullivan, PhD
PRESIDENT & CEO / CO-FOUNDER
Accomplished Leadership Team
Expertise in development, regulatory, vaccinology and cGMP production
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DECEMBER 2017
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DECEMBER 2017
New Source for Natural Proven Treatment
DiversitAbTM fully-human polyclonal antibodies offer the benefits without the issues
HUMANS
Limited amount Difficult to “target”
VIRAL INFECTION
HORSES
Truncated antibodies Very short acting
TOXIN EXPOSURE
GOATS
Poor safety profile Tolerate limited doses of drug
SNAKE VENOM
RABBITS
Small volume Safety concerns for multiple doses
TRANSPLANT REJECTION
PLASMA OR SERUM SOURCES TC BOVINE
High Diversity No Immunogenicity Rapidly Scalable
ALL APPLICATIONS
ANIMAL ANTIBODIES HUMANANTIBODIES
BLOOD DONOR Unique Patient Antigen SERUM CLOT BLOOD SERUM CONTAINING POLYCLONAL ANTIBODIES
DIVERSITAB™ PLATFORM
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DECEMBER 2017
The proprietary platform can rapidly develop and manufacture fully human polyclonal antibodies
Only Scalable Human Polyclonal Immunotherapy Platform
*MATSUSHITA H, SANO A, WU H, WANG Z, JIAO J-A, KASINATHAN P, ET AL. (2015) SPECIES-SPECIFIC CHROMOSOME ENGINEERING GREATLY IMPROVES FULLY HUMAN POLYCLONAL ANTIBODY PRODUCTION PROFILE IN CATTLE. PLOS ONE 10(6): E0130699. DOI:10.1371/JOURNAL.PONE.0130699
Tc BovineTM
Cows genetically designed to produce human antibodies
Immunization
Tc Bovine vaccinated with target disease antigen
Plasmapheresis
Antibodies harvested in the form of plasma
Purification
Separates antibodies from plasma
Antibody Therapeutic
For use as human treatment
- r prophylaxis
Upstream Process Downstream Process (industry standard)
cGMP product can be produced 75 days after first vaccination
Tc Bovine Vaccination Manufacture Quality Control Test Quality Assurance Review
2 WEEKS 3 WEEKS 2-3 WEEKS
Plasma Collection
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DECEMBER 2017
FULLY HUMAN PABS PRODUCT TIMELINE
Condensed development timeline for application on multiple targets
RAPID PRODUCT DEVELOPMENT
WEEK
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 1 2 3 4 5
V1DAY0 V2D8 V2D11 V2D14 V3D8 V3D11 V2D14 V4D8 V4D11 V4D14 V5D8 V5D11 V5D14
Antibody Production Facilities
Many targets from one platform with capacity of 1 million doses/year( ~60-80 animals)
Plasmapheresis collects antibodies in donated plasma.
Animals produce 30-60 liters per month per animal, providing rapid scalability. The disease targeted plasma is then sent to manufacturing for purification and fill finish.
Tc BovineTM produce targeted human antibodies.
Immunotherapy platform targets a virus, bacteria, or toxin, generating high titer, high affinity, human immunoglobulin for monovalent or multivalent targets.
Manufacturing is cGMP industry standard process.
SAB’s immunotherapy platform targets a virus, bacteria, or toxin, generating high titer, high affinity, human immunoglobulin for monovalent or multivalent targets.
> PLASMA STABLE FOR 10 YRS.
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DECEMBER 2017
Integrating Operations with New Production Facility
First-of-its kind greenfield biological pharm provides infrastructure for growth
THE PHARM, AN AGRICULTURAL-BASED PRODUCTION UNIT WHOSE OUTPUT IS BIOLOGICALS FOR THE BENEFIT OF HUMAN HEALTH, IS THE FIRST FACILITY OF ITS KIND DESIGNED SPECIFICALLY FOR CATTLE. THE GREENFIELD CONSTRUCTION PHASE HOUSES CURRENT PRODUCTION ANIMALS WITH INFRASTRUCTURE TO GROW TEN-FOLD
PHARM IS KEY COMPONENT TO OWNING THE ENTIRE SUPPLY CHAIN
Office, surgery, nursery & grower building completed Q1 2018
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DECEMBER 2017
Scalability = 2,500,000 - 5,000,000 doses / year
THE 80-ACRE BIOPHARMACEUTICAL PRODUCTION PHARM AT FULL BUILD-OUT WILL HOUSE APPROXIMATELY 400 ANIMALS AND EMPLOY 40 PEOPLE.
20% of pharm production capacity could supply entire seasonal influenza market
Tc Bovine – Barn 1 12.08.17 New cGMP manufacturing facilities in development
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DECEMBER 2017
Tc Bovine at Pharm1 (P1)
THE 80-ACRE BIOPHARMACEUTICAL PRODUCTION PHARM AT FULL BUILD-OUT WILL HOUSE APPROXIMATELY 400 ANIMALS AND EMPLOY 40 PEOPLE.
First wing of first barn complete and housing production animals.
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- Retain All IP in Platform
- Retain Manufacturing Revenue
- No Limit to SPE’s
LARGE ACCESSIBLE MARKETS
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DECEMBER 2017
Investor Value Proposition
DEFINED MARKET & GOVERNANCE / SIGNIFICANT SAB EQUITY / EXIT OPPORTUNTIES SPECIALIZED EXPERTISE / ABILITY TO MODEL VALUE / 3RD PARTY INVESTMENT CAPITAL STRATEGY & REVENUE MODEL ADVANCED SKILL SETS
CASH & EQUITY PRODUCING SPECIAL PURPOSE ENTITIES (SPE) Influenza SPE $1B/YR ATG $800M/YR Cancer $Bs/YR MRSA $500M/YR
DiversitAb™ Platform
MULTIPLE REVENUE STREAMS, EQUITY OPPORTUNITIES & EXITS
SPE’s CAN CAPITALIZE PLATFORM GROWTH
- No Restrictions on New Programs
- Ability to Develop To Larger Value Inflection
- Flexibility - Retain any Portion of Value
CASH FLOW & EQUITY FROM PRODUCT SPE’S
- Infectious Disease
- Oncology
- Autoimmune
- Toxins
- Anti-Microbial Resistance
- cGMP Manufacturing
- Clinical Regulatory
- Animal Management
- Intellectual Property
- R&D
PRODUCT TARGETS ($100B+ MARKET)
SAb Funding Strategy
SAb Platform DTI, Inc.
Milestones for Funding
- 1. Clinical Data Most Important Driver
- 2. Funding from Recognized Partner
2014
$6.6M at $70M
2019
$??M at $???M
2018
$12M at $157M
2017
$4.5M at $125M
Annual Funding to Cover $6M Burn Rate Growth Funding to Cover Expansion $100M Req Commercial/Strategic Partner that is Recognized in Industry
Term Sheet $30M Phase 2 Date $100M
2020 Helpful 2015 2016
$- $20,000,000 $40,000,000 $60,000,000 $80,000,000 $100,000,000 $120,000,000 $140,000,000 $160,000,000 $180,000,000 Hematech Series A Stock Buyback LFB Term Sheet Series A1 Series A2 2005 2014 2015 2016 2017 2018
Company Value Increase
$0.00 $0.50 $1.00 $1.50 $2.00 $2.50 $3.00 $3.50 Hematech Series A Stock Buyback LFB Term Sheet Series A1 Series A2 2005 2014 2015 2016 2017 2018
Stock Value Increase
63% 12% 4% 7% 14%
Common Series A Series A-1 Series A-2 Options
Downstream Process Upstream Process
Cost Centers SPEs Profit Centers
Midstream Process
QA/QC Recip Herd Tc Bovine Prod’t Pharm Tc Capra Prod’t Pharm Cloning Lab SAB Capra, LLC
Grant Funding Entity Single Member
cGMP Mfg Ag Prod’t Lab R & D SG&A DTI, Inc
Joint Venture, Equity
Tc Bovine & Capra SPEs
100% Equity
Dakota Ag Ventures, LLC
Financing Entity 7% Equity
SAb Biotherapeutics, Inc.
BOD Controlled, Platform Investors 3rd Party Investors
Mkt License Only Separate BOD
Product Cost Lic/Control Equity Capital SAB, LLC
IP Holding Single Member
Revenue/Grants Platform Investors A, A-1, A-2