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 amp technology together for
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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


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SLIDE 1

J a n u a r y 20 1 8

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SLIDE 2

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

2

DECEMBER 2017

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SLIDE 3

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

3

DECEMBER 2017

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SLIDE 4

4

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

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SLIDE 5

DIVERSITAB™ PLATFORM

5

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)

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SLIDE 6

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

6

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

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SLIDE 7

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.

7

DECEMBER 2017

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SLIDE 8

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

8

DECEMBER 2017

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SLIDE 9

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

9

DECEMBER 2017

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SLIDE 10

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.

10

DECEMBER 2017

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SLIDE 11
  • Retain All IP in Platform
  • Retain Manufacturing Revenue
  • No Limit to SPE’s

LARGE ACCESSIBLE MARKETS

11

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)

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SLIDE 12

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

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SLIDE 13

$- $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

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SLIDE 14

$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

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SLIDE 15

63% 12% 4% 7% 14%

Common Series A Series A-1 Series A-2 Options

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SLIDE 16

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