Powering and Improving Immunotherapies (OTCQB: SBOTF) (TSX-V: KLH)
Corporate Update Conference Call and Webcast December 11, 2013
www.StellarBiotech.com www.KLHsite.com
1 Safe Harbor
Statements in this presenta on other than purely historical factual informa on, including statements rela ng to revenues or profits, or the Company’s future plans and objec ves, or expected sales, cash flows, and capital expenditures cons tute forward-looking statements. Forward-looking statements are based on numerous assump ons and are subject to all of the risks and uncertain es inherent in the Company’s business, including risks inherent in the technology history. There can be no assurance that such forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those an cipated in such statements. Accordingly, readers should not place undue reliance on such statements. Except in accordance with applicable securi es laws, the Company expressly disclaims any obliga on to update any forward-looking statements or forward-looking statements that are incorporated by reference herein. This presenta on or profile does not cons tute an offer to sell, or a solicita on of an offer to buy any of the Company’s securi es set out herein in the United States, or to, or for the benefit or account of, a U.S. Person or person in the United States. Neither TSX Venture Exchange nor its Regula on Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this profile.
2 Stellar Biotech: Powering and Improving Immunotherapies
Unique, • Only company capable of sustainable supply of the widely-used World-Leading immune-s mula ng protein: Technology Keyhole Limpet Hemocyanin (KLH)
Fastest-Growing • Biopharma Stellar KLH products & technology target immunotherapy and immunodiagnos cs, biopharma’s fastest-growing sectors. Sector
• Strong Growth Mul ple commercial and clinical pathways. • New: Strategic expansion with exclusive immunotherapy Roadmap technology targe ng Clostridium difficile infec on.
Environmental • Our ground-breaking work revolu onized KLH manufacturing Advantage • Unprecedented standards, compe ve edge
3 Keyhole Limpet Hemocyanin (KLH)
• Natural, immune-s mula ng protein. Sole source is rare marine mollusk. • Extensive history: 40+ years safe use in immunology, hundreds of clinical trials. • Vital in preclinical and clinical research. • Rapid growth in immunotherapy = High demand.
www.KLHsite.com Robust, Adaptable Pla orm
• Cancer • Infec ous Disease KLH • Autoimmune (including RA) • Inflammatory disease (Crohn’s & Lupus) • Alzheimer’s • Immune Func on Tes ng
4 You Already Know KLH (you just didn’t know it)
As an API, KLH transforms tiny haptens into KLH-Ac ve effective immunotherapies…. Immunotherapies Celldex, Neovacs, Affiris, OBI, Bayer, Pep nov, H Scripps, NCI, Genentech, KL Vaccine MabVax, Chilka, Biovest, H Pep vir, Baylor, Abramson, + = MSKCC, Stanford
KLH
KLH Carrier ….as a finished product, KLH is widely used to measure immune effects of new drugs.
Using KLH in Immunotoxicology Amgen, Pfizer, Roche, Novar s, Bristol-Myers, Biogen, J&J, Glaxo SmithKline, NIAID, KLH Novo Nordisk, Genentech Alone 5 Unique Posi on, Solid Founda on, High Barriers to Entry
• Only producer worldwide of sustainable, renewable, fully-traceable GMP-grade KLH • Pioneering marine biotechnology – Industry-leading aquaculture – Proprietary KLH protein produc on • Fiscal strength – 8 years R&D funded by $7M in NIH & NSF grants – Plus $23M in equity funding to date • Management and scien fic advisory are experts in KLH, immunology and drug commercializa on
• Stellar’s competitive advantage creates high barriers - 5-10 years and $20+ million investment ahead of any poten al compe tor
6 KLH Growing Demand
Research Ins tu ons & Private Companies in (KLH) Public Companies in (KLH) Ac ve Immune Therapy Trials Ac ve Immune Therapy Trials
Ins tute/Company Indica on Phase Status Company Product Indica on Phase 2/22/13 Abramson Center Mul ple Myeloma II Affiris/ Baylor Research Melanoma I/II GlaxoSmithKline AFF002 Alzheimer’s II Enrolling Clinica Navarra Lymphoma II (UK) Dermatologische Klinik Melanoma I/II Bayer Autologous Non-Hodgkin’s I Ongoing Loyola University Ovarian II (Germany) Vaccine Lymphoma Celldex MabVax Sarcoma II Rindopepimut Glioblastoma III Enrolling (US) NCI Leukemia I/II OBI GloboH-KLH Breast Cancer III Enrolling Rockefeller Brain Tumor I (Taiwan) Roswell Park Glioblastoma I Neovacs TNFα Kinoid Crohn’s Disease II Ongoing (France) Sloan-Ke ering Lung Cancer I Neovacs INFα Kinoid Lupus II Ongoing Sloan-Ke ering Neuroblastoma I/II (France) Neovacs TNFα Kinoid Rheum.Arthri s II Ongoing Sloan-Ke ering Ovarian Cancer I (France)
7 Stellar KLH Commercial Poten al
Indica on Annual Sales in Large Biopharma Pot. Annual Revs Category Involvement
Rheumatoid $10 -12 Billion Abbo , J&J, Amgen $200M Arthri s (Decision Resources)
Alzheimer’s $170 Billion Pfizer, J&J, Lilly $200M
Autoimmune $40-45 Billion Abbo , Amgen, Bayer $70 - $100M Diseases (Research & Markets)
Infec ous $80-90 Billion Pfizer, Sanofi, Merck $100 - $150M Diseases (BCC Research) Oncology $23 Billion Roche, Sanofi, GSK $40 - $60M $100 Million Immune Func on (Clinical & Preclinical None $10 - $15M Markets)
8 Stellar’s Commercial Strategy Mul ple High-Value Pathways
• Supply & Direct Sales • Joint Venture • Strategic Alliances • Research Collabora on • Long-Term Supply • Out-License Fees & • Preclinical & Clinical Agreements Milestones Studies • Intellectual Property • Royal es
Immunology Major Biopharma Major Biopharma Immunotoxicology Therapeu c Vaccines & Infec ous Disease, Cancer, Vaccine Immunotherapies Immune Disorders Development Stellar KLH Stellar KLH Stellar Proprietary Finished Products Carriers/Adjuvants Immunotherapies*
World-Leading Stellar KLH™ Pla orm KLH Produc on R&D IP Bus.Dev.
* Ex: C. Diff Vaccine Program 9 Stellar Milestones and Success
2013 Year-End Corporate Summary Stellar Performance Year-End 2013
Milestones in Every Company Sector Corporate & Financial
Research & Development
KLH Produc on
11 Successful Financing – September 2013
• US $12 Million gross proceeds – Included US $5 Million by biopharma industry investor • Use of proceeds – Product research – Aquaculture and KLH produc on development – Capital expenditures – Working capital • Support from exis ng and new shareholders • Valida on from biopharma industry • Broadened recogni on for Stellar • Strong balance sheet
12 Strategic Expansion 2013
Stellar Exclusive Immunotherapy Technology Clostridium Difficile Infec on (C. diff) C. diff • Exclusive worldwide license to broad patent por olio; KLH-conjugate C. diff vaccines & Major, growing cause of diagnos cs hospital death & morbidity • 300,000 new cases, Game-changing poten al 14,000 deaths annually – Major infec ous disease immunotherapy developed by Stellar Hospital stays from C. diff – Concurrently proving KLH u lity as carrier & agonist for up 3X in last 10 years new genera on vaccines • C. diff bacteria overgrows Technology advantage: Cell-directed therapy due to an bio c use – KLH carrier + selected polysaccharide – Cell-directed to reduce bacterial burden and limit both extent and spread of infec on (unlike other approaches targe ng symptoms)
13 C. Diff Program: Posi ve Preclinical Data 2013
Oral Presenta on • Preliminary preclinical results ClostPath 8 Conference presented at two conferences October 2013 – PSII-KLH vaccine is effec ve in conferring Poster Presenta on protec ve immunity against C. diff infec on Vaccine and ISV Congress in mice October 2013 – Preclinical work demonstra ng PSII-KLH conjuga on, immunogenicity, and consistent an body response Peer-Review Journal Expert Review of Vaccines April 2013 • Peer-review journal ar cle – Biochemical characteris cs of C. diff support Stellar’s KLH-polysaccharide vaccine approach
14 Aquaculture Science Milestones
• Ground-breaking industry and environmental first • Stellar successfully sustained complete life cycle of Giant Keyhole Limpet • Mul ple genera ons thriving in Stellar aquaculture • Significance: – Renewable, scalable supply – Fully-traceable – Unprecedented control over KLH source
Stellar Ensures KLH Supply, Quality and Confidence
15 Regulatory
• New Master File submi ed to FDA • Master Files – Confiden al, detailed dossiers on Stellar KLH™ protein products containing manufacturing and safety informa on – Stellar con nually maintains and updates • Significance: – Expedite regulatory processes for Stellar’s customers – Control access to company proprietary informa on
16 Stellar’s Intellectual Property Expanded
• December 2013 – Two Patents Issued for C. diff Technology – U.S. Patent No. 8,597,663 – China patent No. 200880115518.2 – Novel cell surface polysaccharides and chemical structures – Broad claims covering an gen and vaccine composi ons for treatment, preven on, diagnosis of C. diff • February 2013 – U.S. provisional patent applica on for new innova ons related to Stellar KLH combinatorial adjuvant technology
17 Peer-Review and Scien fic Recogni on
Recent Stellar presenta ons and publica ons:
October 2013 8th Interna onal Conference on Oral Presenta on – C. diff posi ve Molecular Biology & Pathogenesis of preclinical Clostridia (ClostPath 8) October 2013 7th Vaccine and ISV Congress Poster – C. diff posi ve preclinical May 2013 Annual Na onal Science Founda on Poster – Stellar aquaculture achievements (NSF) Conference March 2013 Society of Toxicology (SOT) Poster – KLH preclinical performance April 2013 Expert Review of Vaccines Journal Ar cle – C. diff biochemistry Sep 2012 World Congress on Marine Oral Presenta on – Stellar aquaculture Biotechnology achievements Sep 2012 Annual Interscience Conference on Poster – KLH biochemistry An microbial Agents and Chemotherapy (ICAAC) Aug 2012 Annual Immunotherapeu cs & Poster – KLH immune responses Vaccine Summit (ImVacS)
18 U.S. Exchange Lis ng
• January 2013, Stellar stock listed for trading in U.S. on OTCQB Marketplace Exchange symbol SBOTF
Stellar Biotechnologies, Inc. Canadian TSX-V: KLH U.S. OTCQB: SBOTF
• Preparing to transi on from IFRS to U.S. GAAP repor ng standards
19 Execu ve Team: Strong Leadership
Frank Oakes • 35 years experience; biotechnology and aquaculture. Aquaculture industry leader and KLH manufacturing expert. Formerly CEO of President & CEO Abalone Farms, Inc.; leader through R&D, capitaliza on and commercializa on to become first profitable and largest abalone producer in U.S. Herbert Chow, Ph.D. • 25 years experience; pharmaceu cal product development & commercializa on in therapeu c and diagnos c markets. Key Chief Technology Officer senior management posi ons at both start-up biotech and major pharma companies including at Abbo Labs and Johnson & Johnson. Ph.D. Immunology.
Catherine Brisson, Ph.D. • 20 years experience; biotech, pharma and medical device industries, including at Sicor Pharmaceu cals (Teva Parenteral Chief Opera ng Officer Products). Exper se in QA, QC, Regulatory and Manufacturing. Ph.D. Organic Chemistry.
Kathi Niffenegger • 30 years experience; accoun ng and finance, range of industries including pharma. Outside CPA to Stellar since Company founding. Chief Financial Officer Previously partner at Glenn Burde e, CFO at Mar n Avia on, Peat Marwick, Mitchell (KPMG LLP).
Mark McPartland • 16 years experience; business development, capital markets advisory, corporate communica ons. Previously Senior VP at MZ VP, Corporate Development & Group, VP and Partner at Alliance Advisors LLP, and Regional VP of Communica ons Hayden Communica ons.
20 2014 Corporate Objec ves
Powering and Improving Immunotherapies with KLH
1. Expand Stellar KLH™ technology through R&D and selec ve acquisi on. 2. Seize opportuni es for commercial growth that build on Stellar’s strengths in KLH and immunotherapy. 3. Iden fy strategic pathways that leverage Stellar KLH™ into breakthrough immunotherapy products. 4. Expand corporate image and reputa on through increased transparency, corporate governance, financial repor ng and communica ons.
21 Poten al Catalysts
Upcoming • New collabora ons and/or supply contracts with biopharma partners • Aquaculture capacity expansion • C. diff immunotherapy preclinical progress • Prepare for move to major U.S. stock exchange
22 Investment Summary
Powering and Improving Immunotherapies with Stellar KLH™
• Industry-leading and unequaled core competency – World leader in sustainable KLH protein manufacture • KLH pla orm & products – Commercializa on stage – Strong IP por olio, high barriers to entry • Essen al to immunotherapy, fastest-growing biopharma sector • Mul ple high-margin commercial pathways • Advancing strategic and collabora ve interests • Environmental champion • Exclusive R&D drives pipeline: Proprietary C. diff vaccine program • Fiscal strength = execu on
23 Contact Informa on
Frank R. Oakes www.StellarBiotech.com President & CEO www.KLHSite.com Office +1 (805) 488-2800 investorrela [email protected]
Mark A. McPartland V.P. Corporate Development & Communica ons Office +1 (805) 488-2800 ext. 103 [email protected]
24 (OTCQB: SBOTF) (TSX-V: KLH)
Powering and Improving Immunotherapies
www.StellarBiotech.com www.KLHsite.com
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