Full Press Release Details
This presentation may contain forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended. Forward-looking statements may be identified by the
use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may,"
"will," "would," "could," "should," "might," "potential," or "continue" and variations or similar
expressions. Readers should not unduly rely on these forward-looking statements, which
are not a guarantee of future performance. There can be no assurance that forwardlooking
statements will prove to be accurate, as all such forward-looking statements involve
known and unknown risks, uncertainties and other factors which may cause actual results
or future events to differ materially from the forward-looking statements. Such risks
include, but may not be limited to: general economic and business conditions; technology
changes; competition; changes in strategy or development plans; governmental regulations
and the ability or failure to comply with governmental regulations; the timing of anticipated
results; and other factors referenced in Stellar's filings with securities regulators. For a
discussion of further risks and uncertainties related to our business, please refer to our
public company reports filed with the TSX Venture Exchange and the U.S. Securities and
Exchange Commission. All forward-looking statements are made as of the date hereof
and are subject to change. Except as required by law, we assume no obligation to update
such statements. This presentation does not constitute an offer or solicitation of an offer
for sale of any securities in any jurisdiction, including the United States. Neither the TSX
Venture Exchange nor its Regulation Services Provider (as that term is defined in the
policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy
of the information contained in this presentation.
Stellar Biotech: Powering and Improving Immunotherapy
Unique, World Leading Technology
Only company capable of sustainable/scalable and fully traceable supply of the widely-used immune stimulating protein: Keyhole Limpet Hemocyanin (KLH)
Fastest Growing Biopharma Sector
Stellar KLH products & technology target immunotherapy and immunodiagnosVcs, biopharma's fastest growing sectors.
Strong Growth Roadmap Multiple commercial and clinical pathways. New: Strategic expansion with exclusive immunotherapy technology targeting Clostridium difficile infection. Environmental Advantage Our ground breaking work revoluVonized KLH manufacturing Unprecedented standards, competitive edge
A History of Building Value
Powering and Improving Immunotherapy
Powering and Improving Immunotherapy
Private, U.S.-based company (Calif.)
Aquaculture facility
$1M NIH grant funding
KLH supply agreements for cancer vaccines
$3M NCI grant funding for development of GMP-grade KLH
Patent for KLH protein extraction methods (U.S., Canada, Europe)
Vaccine & supply partnerships
Stellar public on TSX Venture Exchange (4/2010)
NSF Phase Mb grant funding
Diagnostic co development agreement
Exclusive WW C. diff license
Multiple industry firsts in aquaculture science
Expanded IP (mfg. & adjuvant technologies, C. diff immunotherapy)
Amaran collaboration
Stock Price (5/20/14) $1.15
52 - Week Range $0.43-$2.30
Shares Outstanding 78.1M
90 Day Average Trading Volume 212,484
Market Capitalization $90M Debt (2/28/14) $0 Cash and Short Term Investments (2/28/14) $15.8M Shareholders Equity (2/28/2014) $9.1M TTM Revenue (2/28/14) $518.5K Key Facts & Financials Trading Symbols: OTCQB: SBOTF TSX V: KLH Headquarters: Port Hueneme, CA Fiscal Year End: August 31 Accounting Firm: D & H Group LLP, Vancouver BC, Canada Legal Counsel Greenberg Traurig LLP Stellar Financial Filings: http://ir.stellarbiotechnologies.com/all-sec filings
Keyhole Limpet Hemocyanin
Intricate Topology of KLH Molecular Structure
Natural, immune-stimulating protein.
Sole source is rare marine mollusk.
40+ years safe use in clinical immunology.
Vital in preclinical and clinical research.
Rapid growth in immunotherapy = High demand.
Robust, Adaptable Platform
Cancer Inflammatory disease (Crohn' s, Lupus)
Infectious Disease Alzheimer' s
Autoimmune (RA) Immune Function Testing
You Already Know KLH (you just didn't know it)
(1) As an API, KLH transforms tiny haptens into effective immunotherapies....
Celldex, Neovacs, Affiris, OBI, Bayer, Peptinov, Scripps, NCI, Genentech, MabVax, Chilka, Biovest, Peptivir, Baylor, Abramson, MSKCC, Stanford
...or (2) as an injectable product, KLH is widely used to measure immune effects of new drugs.
Using KLH in Immunotoxicology
Amgen, Pfizer, Roche, Novartis, Bristol-Myers, Biogen, J&J, NIAID GSK, Novo Nordisk, Genentech
High Barriers to Entry
High Barriers to Entry
5-10 years and $20+ million investment ahead of any potential competitor
Stellar is only producer WW of sustainable, scalable and fully-traceable GMP-grade KLH
Pioneering marine biotechnology
- Only-in-class aquaculture + proprietary KLH production
IP covering core KLH business + new R&D
- 8 years R&D funded by $7M in NIH & NSF grants
- Plus $23M in equity funding to date
Expert management and advisory
KLH, immunology, drug commercialization
Supply Dynamics Favor Stellar Biotech
KLH molecule is large and complex; has not been synthesized
One marine source, one location
Commercial scale constraints
- Giant Keyhole Limpet requires 5 years until fully mature
- Protein-rich hemocyanin can be extracted 3X/year
1 gram GMP KLH has commercial value of $40,000-$50,000
Stellar KLH Products
Molecular structure provides for multiple product configurations. Stellar KLH known for high quality and consistency.
KLH protein for Vaccine conjugation KLH Protein for TDAR & Immune Function Testng KLH custom formulations & services Bulk and vial configurations
Commercial Strategy Joint Venture Long Term Supply Agreements Intellectual Property Major Biopharma Therapeutic Vaccines & Immunotherapies Stellar KLH Carriers/Adjuvants Strategic Alliances Out License Fees & Milestones Royalties Major Biopharma Infectious Disease, Cancer, Immune Disorders Stellar Proprietary Immunotherapies* Supply & Direct Sales Research Collaboration Preclinical & Clinical Studies Immunology Immunotoxicology Vaccine Development Stellar KLH Finished Products Multiple High Value Pathways * Ex: C. Diff Vaccine Program
World Leading Stellar KLH Platform
Clinical Status Indication Company or Institute Phase III Glioblastoma Breast Cancer Celldex (Rindopepimut) OBI Pharma (OBI 822) Phase II Crohn's Disease Lupus Rheumatoid Arthritis Alzheimer's Multiple Myeloma Melanoma Lymphoma Melanoma Ovarian Cancer Sarcoma Leukemia Neovacs (TNF Kinoid) Neovacs (IFNa Kinoid) Neovacs (TNF Kinoid) Affiris/GSK (AFF002) Abramson Center Baylor Research Clinica Navarra Dermatologische Klinik Loyola University MabVax NCI Phase I N H Lymphoma Brain Tumor Glioblastoma Lung Cancer Neuroblastoma Ovarian Cancer Bayer (Autologous) Rockefeller Roswell Park Sloan Kettering Sloan Kettering Sloan-Kettering KLH Growing Demand & Market Potential Sources: Clinicaltrials.gov, corporate news and websites, Decision Resources, Research & Markets, BCC Research, KLH Site. Major Disease Categories Cancer Inflammatory Disease Immune Disorders Alzheimer's Infectious Disease KLH Market Potential $10M to $200M per Disease Category KLH Based Active Immunotherapy Trials* Major Biopharma Use Celldex, Neovacs, Affiris, OBI, Bayer, PepVnov, Scripps, NCI, Genentech, MabVax, Chilka, Baylor, Biovest, Peptivir, Abramson, MSKCC, Stanford Pfizer, Sanofi, Merck, J&J Not a comprehensive list Does not include KLH immunotoxicology use
Strategic Corporate Partner
Amaran Biotechnology in Taiwan
Immunotherapy developer/manufacturer
Invested US$ 5 Million in Stellar's Sep. 2013 financing
Collaborative agreement signed Dec. 2013 to evaluate and development manufacturing methods for OBI-822 immunotherapy using Stellar KLH
OBI-822 Active Immunotherapy breast cancer
KLH is key ingredient