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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER PURSUANT TO RULE 13a-16 AND 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the Month of June 2014
File No. 000-54598
Stellar Biotechnologies Inc.
(Name of Registrant)
332 E. Scott Street, Port Hueneme, CA 93041
(Address of Principal executive offices)
Indicate by check mark whether the Registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): o
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): o
SIGNATURE
Pursuant to the requirements of the securities Exchange Act of 1934, the registrant has duly caused this Form 6-K to be signed on its behalf by the undersigned, thereunto duly authorized.
Stellar Biotechnologies, Inc.
(Registrant)
Dated: 6/24/14 By: /s/ Kathi Niffenegger
Kathi Niffenegger
Chief Financial Officer
Exhibits:
99.1 Stellar Biotech (SBOTF) Corporate Presentation, June 2014
Exhibit 99.1
Stellar
Biotechnologies,
Inc.
Corporate
Presentation
June
2014
www.StellarBiotech.com
www.KLHsite.org
(OTCQB: SBOTF)
(TSX‐V: KLH)
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
BIOTECHNOLOGIES
Powering and Improving Immunotherapy
Stellar
BIOTECHNOLOGIES
Powering and Improving Immunotherapy
1999
Founding
Private, U.S.-based company (Calif.)
Aquaculture facility
$1M NIH grant funding
2004
KLH supply agreements for cancer vaccines
$3M NCI grant funding for development of GMP-grade KLH
2005-2009
Patent for KLH protein extraction methods (U.S., Canada, Europe)
GMP KLH
Vaccine & supply partnerships
2010-2011
Stellar public on TSX Venture Exchange (4/2010)
$3.1M financing
NSF Phase Mb grant funding
Diagnostic codevelopment agreement
2012-2013
Exclusive WW C. diff license
Multiple industry firsts in aquaculture science
Expanded IP (mfg. & adjuvant technologies, C. diff immunotherapy)
KLH Site™
FDA master files
$12M financing
Amaran collaboration
Selected Financials
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
www.klhsite.org
You Already Know KLH (you just didn't know it)
(1) As an API, KLH transforms tiny haptens into effective immunotherapies....
KLH-Active
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
KLH
Alone
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
• Fiscal strength
- 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
Stellar KLH
Protein
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.
Stellar KLH
TM
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
Stellar
Biotech
ITM
• KLH is key ingredient
• Metastatuc Breast Cancer: Phase II/III trials in U.S., Taiwan, South Korea, India, Hong Kong
• Ovarian Cancer: Phase I/II for ovarian cancer in Taiwan
Amaran
Strategic pathway to long-term revenue and clinical potential for Stellar
Strategic pathway to long-term revenue and clinical potential for Stellar KLH™
Stellar Proprietary Immunotherapy
Stellar's Exclusive ImmunotherapyTechnology Clostridium Difficile Infection (C. diff)
• Exclusive WW license to broad patent portfolio
• Game-changing potential
• Technology advantage: Cell-directed therapy
• Positive early preclinical results published
• Secondary preclinical studies completion expected early 2H2014
C. diff
Major, growing cause of hospital death & morbidity
- new cases,
14.0 deaths annually
Hospital stays from C. diff up 3X in last 10 years
C. diff bacteria overgrows due to antibiotic use
Progressive Achievements
• Major aquaculture science milestones
- Ground-breaking industry and environmental firsts
• Intellectual property expanded
- Expert Review of Vaccines journal article (C. diff biochemistry)
- Journal of Immunotoxicology (form and commercial source of KLH matters)
- ClostPath 8 oral presentation (C. diff preclinical preliminary result)
- Vaccine Congress poster (C. diff preclinical preliminary result)
NSF Conference poster (Aquaculture achievements)
Collaboration Develop, License, Advance KLH Technologies • New collaborations and supply contracts with biopharma partners • C. diff immunotherapy program complete preclinical study • Aquaculture production capacity and expansion • Prepare for transition to major U.S. stock exchange Future Milestones & Catalysts Commitment to Innovation KLH-based Immunotherapies Core Business Expansion World‐Class KLH Manufacture
Senior Executive LeadershipFrank Oakes
President & CEO
Herbert Chow, Ph.D.
Chief Technology Officer
Catherine Brisson, Ph.D.
Chief Operating Officer
Kathi Niffenegger
Chief Financial Officer
Mark McPartland
VP, Corporate Development & Communications
35 years experience; biotechnology and aquaculture. Aquaculture industry leader and KLH manufacturing expert. Formerly CEO of Abalone Farms, Inc.; leader through R&D, capitalization and commercialization to become first profitable and largest abalone producer in U.S.
25 years experience; pharmaceutical product development & commercialization in therapeutic and diagnostic markets. Key senior management positions at both start-up biotech and major pharma companies including at Abbott Labs and Johnson & Johnson. Ph.D. Immunology.
20 years experience; biotech, pharma and medical device industries, including at Sicor Pharmaceuticals (Teva Parenteral Products). Expertise in QA, QC, Regulatory and Manufacturing. Ph.D. Organic Chemistry.
30 years experience; accounting and finance, range of industries including pharma. Outside CPA to Stellar since Company founding. Previously partner at Glenn Burdette, CFO at Martin Aviation, Peat Marwick, Mitchell (KPMG LLP).
16 years experience; business development, capital markets advisory, corporate communications. Previously Senior VP at MZ Group, VP and Partner at Alliance Advisors LLP, and Regional VP of Hayden Communications.
Key Points Summary
Industry-leading and unequaled core competency in KLH
Versatile technology platform and products
KLH essential to immunotherapy, fastest-growing biopharma sector
Stellar
BIOTECHNOLOGIES
Multiple, high-value commercial pathways
Progressive achievements and collaborations
Environmental champion
Exclusive R&D drives pipeline: C. diff Immunotherapy Program
Fiscal strength = ability to execute
Stellar IP & Proprietary Assets
KLH Manufacture & Aquaculture
• US 6852338 (2005) Non-lethal method for extracting crude hemocyanin from gastropod molluscs
• Patent filings for production methods and adjuvant technologies
• Proprietary methods for control of M. crenulata life cycle including culture systems, nutrition, seawater purification
• First-ever industry achievement of multiple generations of source animal within land-based aquaculture
• Commercial-scale aquaculture facility
Clostridium difficile Immunotherapy
• US 8,597,663 (2013) Polysaccharide Immunogens from Clostridium difficile
• China CN ZL 200880115518.2 Novel Polysaccharide Immunogens from Clostridium difficile
Japan 5501969 Novel Polysaccharide Immunogens from Clostridium difficile
Key Supporting Links
Company Website
www.stellarbiotech.com
Investor Overview
http://ir.stellarbiotechnologies.com/
KLH Knowledge Base www.KLHsite.org
KLH Definition
http://en.wikipedia.org/wiki/Kevhole limpet hemocvanin
Key KLH
Immunotherapies in Development*
Neovacs: http://neovacs.fr/products/technology/
OBI Pharma:
http://www.obipharma.com/index.aspx?lang=eng&fn=pipeline content&no=3
Celldex: http://www.celldex.com/pipeline/rindopepimut.php
Biovest:
http://www.businesswire.com/news/home/20140113005588/en/European-Medicines-
Agencv-Accepts-Marketing-Authorization-Application#.UlrOPI10WUk
Not a comprehensive list
Powering and Improving Immunotherapy with Stellar KLH™
(OTCQB:
SBOTF)
(TSX‐V:
KLH)
Frank
R.
Oakes
President
&
CEO
Office
+1
(805)
488-2800
IR@stellarbiotech.com
Mark
A.
McPartland
V.P.
Corporate
Development
&
Communications
Office
+1
(805)
488-2800
ext.
103
markmcp@stellarbiotech.com
www.StellarBiotech.com
www.KLHsite.org