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www.VivioneBiosciences.com Symbol “VBI” (TSX Venture Exchange) 1 C ONFIDENTIAL I NVESTMENT P RESENTATION
F ORWARD -L OOKING S TATEMENTS 2 Some of the statements contained herein including, without limitation, financial and business prospects and financial outlooks, may be forward-looking statements that reflect management’s expectations regarding future plans and intentions, growth, results of operations, performance, and business prospects and opportunities. Words such as “may,” “will,” “should,” “could,” “anticipate,” “believe,” “expect,” “intend,” “plan,” “potential,” “continue,” and similar expressions have been used to identify these forward-looking statements. These statements reflect management’s current beliefs and are based on uncertainties. A number of factors could cause actual results to differ materially from the results discussed in the forward-looking statements including changes in general economic and market conditions and other risk factors. Although the forward-looking statements contained within this presentation are based upon what management believes to be reasonable assumptions, management cannot assure that actual results will be consistent with these forward-looking statements. Investors should not place undue reliance on forward-looking statements. These forward-looking statements are made as of the date hereof and we assume no obligation to update or revise them to reflect new events or circumstances.
Company Overview Vivione Biosciences is a technology and life sciences company focused on rapid bacterial detection The company has developed a proprietary diagnostic system called RAPID-B, which tests bacteria in critical environments and provides quantitative results in seven hours or less We believe that RAPID-B is the fastest, most accurate, and most cost-effective diagnostic testing system currently available for detecting bacteria Vivione is in the process of commercializing the RAPID-B system for several multi-billion dollar markets, including clinical in-vitro diagnostics, oil & gas, and food safety 3
C OMPANY B ACKGROUND 4 Vivione Biosciences was founded in 2006 under a Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration RAPID-B was developed in collaboration with the FDA’s National Center for Toxicological Research Vivione and the FDA have jointly filing patent applications Vivione has received exclusive licensing rights from the FDA Vivione Biosciences became a public entity in April 2013 through a Capital Pool Company (CPC) merger – Raised $6 million concurrently with the merger – Currently listed on TSX-V Headquartered in Dallas, Texas – with world class labs in Little Rock, Arkansas
Investment Highlights Vivione has been gaining traction in the Oil & Gas market – and is currently negotiating approximately $5mm in purchase orders – Quotes already sent to several Fortune 500 companies Vivione is currently launching clinical pilot studies at the Cleveland Clinic and Northwestern University Vivione is seeking to acquire Trillium Diagnostics – a company focused on discovering and commercializing novel cellular biomarkers used in flow cytometric analysis. The Trillium acquisition will be immediately accretive - and will add revenues, IP, and customers within the clinical diagnostic market 5
T HE RAPID-B S YSTEM 6 Sample RAPID-B Instrument 1-Minute Analysis Flow Cytometer 2 Laser plus six Photo Multipliers Real-time Software Processing Sized-based Detection Viability Screen of the Target Specific Target Detection Sheath Fluid Flow -> Finding bacteria in a sample is akin to finding a needle in a haystack. The RAPID-B technology analyzes every ‘needle’ superfast - to find the bacteria of interest.
RAPID-B: S YSTEM H IGHLIGHTS PROPRIETARY: Joint patents filed with the FDA, exclusive licenses with the FDA SPEED: Generates results in substantially less time than competing technologies – 15 min to 8 hrs (RAPID-B) vs. 24 hrs to 28 days (Competitors) ACCURATE: Capable of counting the exact number of bacteria cells – providing greater accuracy and sensitivity. Can detect both live and dead cells - minimizing false results RUGGED: Durable and easily operated by lab personnel in the field COST EFFECTIVE: Saves customers money through improved efficiencies, reduced chemical costs, and longer-lasting equipment 7 RAPID-B System Hardware Software + Wetware RAPID-B’s Flow Cytometric system produces faster, more precise, and more cost-effective diagnostic results
RAPID-B: T ARGET M ARKETS 1.Clinical Market Applications – commercialization in 2015 2.Oil & Gas - commercialized in 2014 3. Food Processing and Distribution - commercialized in 2014 Future applications may be developed for the agricultural, water testing, pharmaceutical, and medical device markets. 8 The RAPID-B system provides rapid bacteria detection in multiple markets
Market Opportunity: Clinical Diagnostics Addressable Market: $12billion global microbiology market (approx $6BB U.S. market) $3BB global sepsis market Target Customers: Hospitals and clinics Large commercial Labs Product opportunities: More than 20 million blood cultures ordered in U.S. annually Average number of blood/urine tests performed per ICU: 100 per day (3,000 per month) RAPID-B Benefits: Able to detect bacteria in blood and urine within hours (vs. days) - providing the physician with the information necessary to prescribe the proper antibiotic, and potentially saving lives and reducing patient’s stay in the hospital Cost-effective screening method to determine which antibiotic is most effective Trillium’s patent on CD64 allows physicians to diagnose the probability of a patient becoming septic faster than the current Procalcytonin test. Successful completion of UTI pilot study at Cleveland Clinic (100% sensitivity/85% specificity at 15 minutes vs 48hrs) Certification: FDA Certifications required (Trillium acquisition will provide CE mark) 9
C LINICAL C OMPETITIVE A DVANTAGES 10 Current MethodTime to ResultsVivioneAdvantage Blood Culture Screen CO2 detection (BioMérieux, BD, Trek) 18-72 hours Flow- cytometric Speed to result (3-5 hours) - Quantification Urine Culture Screen Gram stain, Culture plate, Sysmex 24-72 hours Flow- cytometric Speed to result (3-6 hours) - Quantification Pneumonia Etiology Gram stain, Culture plate 48-72 hours Flow- cytometric Speed to result (2-4 hours) - Sensitivity & Specificity Sepsis Etiology Molecular methods (Roche, BD, Cepheid) Culture methods 20-72 hours Flow- cytometric Speed to result (3-5 hours) - Quantification
D RUG S USCEPTIBILITY 11 Direct Analysis Drug Susceptibility Analysis Current MethodsTime to Results Parameters Assessed Vivione Time to Results Vivione Parameters Assessed Broth Dilution12-18 hoursTurbidity 1.5 to 2 hours Both Growth and Morphology eTest BioMérieux12-18 hours Plate Inhibition Disk Diffusion16-24 hours Plate Inhibition Automated, BioMérieux, BD, Siemens 3.5-24 hours Growth Density
A CQUISITION : T RILLIUM D IAGNOSTICS 12 Trillium is a diagnostic development company focused on discovering and commercializing novel cellular biomarkers to be used in flow cytometric analysis. Trillium’s lab is located in Bangor, ME and the company currently has 5 employees. Trillium’s approach has several advantages over traditional blood biomarkers: 1.What cells are expressing the biomarker which can add a high level of sensitivity to the disease diagnosis. 2.How much of the biomarker is expressed. Trillium's core products are: 1.Leuko64 (sepsis and therapeutic response in septic patients) 2.CD163 (inflammation) 3.Fetaltrol (reagent used to assess maternal-fetal hemorrhage) Vivione has presented Definitive Documents and has exclusivity through December 31, 2014, with the ability to extend for an additional 30 days. Completion of acquisition is contingent upon signing of Definitive Documents and Funding.
T RILLIUM A CQUISITION : B ENEFITS 13 Benefits of the Trillium Diagnostics acquisition include: Adds revenue immediately $1mm in 2014 $3.1mm in 2015 (est.) Adds intellectual property CD64 test has already received CE Mark (Europe’s equivalent to FDA approval), which provides immediate access to the European clinical market FDA De Novo application in process Over 20+ white papers showing CD64 is more sensitive/accurate than current market leader – Procalcytonin ($100MM +/Year Revenue) Adds deep experience Trillium’s staff has over 30 years extensive experience in both research and clinical practice with laboratory hematology and diagnostic flow cytometry Dr. Bruce Davis is an industry expert in flow cytometry and will assume CSO role at Vivione
Vivione will acquire 100% of Trillium debt-free through cash and stock purchase Approximately 60% of consideration is based on milestone achievement Cash portion: $1,500,000 cash at Closing $500,000 cash earnout if Trillium achieves $1mm in revenue in 2014 $1,000,000 cash earnout if Trillium obtains FDA approval for CD64 by June 30, 2015 Stock portion: $4,000,000 in stock at Closing (minimum of $.35 per share) $8,000,000 in stock as earnout based on achieving certain FDA approvals (At market or $.35 minimum) 14 T RILLIUM A CQUISITION : T ERMS
Market Opportunity: Oil & Gas Addressable Market: $2.9 billion worldwide ($1.3 billion U.S. only) Target Customers: Oilfield Services companies (i.e. Hydraulic Fracturing, Water Treatment) Oil & Gas producers Current Customers: Apache Energy purchased RAPID B Unit Trican, Green Energy purchased WCT and BET services Product opportunities: Fracing uses large volumes of water supplied from numerous sources, which must be tested repeatedly for the presence of bacteria Biocides are often used to treat contamination of water, fluids, and wells and require repeated testing in order to confirm the elimination of bacteria Typical frac company performs 240-400 bacteria tests per month (4 frac jobs per month, 60-100 tests per job) Custom-Developed Reagents to identify sulphur-reducing bacteria (SRB) and acid-producing bacteria (APB) RAPID-B Benefits: Quickly and accurately identifies bacterial contamination that can cause scale formation, pitting of steel, stress cracks – which ultimately reduce the production capability of wells Enables companies to test fluid samples on location - providing valuable results in minutes (vs. days) and allowing for immediate fluid remediation Optimizes biocide utilization 15
Vivione Management Team 17 Chester J. Jachimiec, serves as the Chief Financial Officer (CFO) of the Company. Mr. Jachimiec has over 30 years of experience in law, public accounting, finance, corporate development and product commercialization in the technology and energy industries. He has been a founder, and involved in the capitalization and growth of several public and private companies in the facilities services, fuels and lubricants distribution, oilfield services, software and bio-diagnostics industries. Mr. Jachimiec was an initial founding shareholder and director of PACEpartners Inc., the predecessor by merger of the Company. Mr. Jachimiec holds a Bachelors of Business Administration in Accounting from Loyola University of Chicago and a Juris Doctorate from Northwestern University School of Law. Dr. Gombrich serves as Chief Medical Officer (CMO) has approximately 20 years of development experience in the In Vitro diagnostic sector, namely around infectious disease and cancer testing. Dr. Gombrich was instrumental in market development of several rapid diagnostic assays for pneumonia-related pathogens, including the Binax (Alere) Rapid Legionella Assay and Pneumococcal Urinary Antigen tests. This included post- market clinical study design and the creation of sales and marketing educational content. Dr. Gombrich also has been involved in product development of a point-of-care cervical cancer screening test aimed at the developing world. Dr. Gombrich received his Medical Degree and Masters degree in Experimental Pathology from Case Western Reserve University in Cleveland in 2005. Kevin Kuykendall - Chairman and Chief Executive Office Mr. Kuykendall has more than 20+ years in senior management positions for Fortune 100 to early stage companies and has experience in fund raising and operations. Mr. Kuykendall is currently CEO of Vivione Biosciences, Inc. and was instrumental in taking the company public on the Toronto Stock Exchange, raising $6 million, and commercializing the Company’s products in 2013. He was also a Founding Member and CEO of White Energy (Ethanol Producer) and Health2O (Nutraceutical). Mr. Kuykendall raised over $490MM in equity/debt for White Energy and developed $750MM in Revenue within the first 36 months of operations. Kevin played major league baseball for the Cleveland Indians and has a Bachelor of Science degree in Business Administration from Western Oregon University.
Vivione Senior Management (Cont’d) 18 Mr. Springfield serves as the Senior Vice President of Sales and Marketing and has over 15 years of Marketing and Sales experience in the Clinical realm. Mr. Springfield’s leadership has been instrumental in the growth and success of early stage companies by penetrating and growing multimillion-dollar accounts and driving top line revenue and bottom line profit growth. He has responsibility for the company's Global Marketing and Sales groups. His organization is responsible for positioning Vivione's growth strategy, cultivating opportunities in new and existing customer markets and growing demand for Vivione's solutions globally, as Vivione establishes itself as the #1 Rapid Diagnostics company in the world. Ms. Bradford serves as Director of Sales and Marketing for Vivione and has over 15 years’ experience in Sales and Marketing, Product Development and Manufacturing in the Clinical and Nutraceutical sector. As a Certified Nutritionist, Pharmacy Technician and Health and Fitness writer she combines her knowledge of nutrition, pharmaceuticals and health conditions with her innate ability for strategic business planning to create and execute sales strategies for companies looking to expand their product offerings and portfolio. Ms. Bradford has received industry awards for Best Practices in developing sustaining business models that significantly and consistently drive revenue. Her strategic know-how blended with the right amount of thought leadership has enabled her to build a sales model that connects a variety of industries including clinical, nutraceutical, food safety and oil and gas. Dr Bruce H Davis will serve Chief Science Officer (CSO) upon closing of the Trillium transaction and is a recognized international leader in the fields of laboratory hematology and diagnostic flow cytometry. He has had over thirty-five years experience in academic medicine following receiving his M.D. and B.S. degrees from University of Connecticut and Cornell University (pathology faculty at SUNY Upstate Medical Center, Dartmouth-Hitchcock Medical Center and Wm Beaumont Medical Center). Dr Davis has been active in laboratory standardization (Past Chair CLSI Hematology Committee, CAP Hematology Resource committee for 10+ years, and past Treasurer and board member for International Council for Standardization of Haematology; lead author of several practice guidelines and consensus guidelines in clinical cytometry), leadership in diagnostic medicine (co-founder, Internal Society for Laboratory Hematology; recipient of Bernd Houwen Award from ISLH; past-President, charter board member and recipient Wallace Coulter Award, International Clinical Cytometry Society; Mentor of Year award, CLSI), and as an innovator within the in vitro diagnostic field (founder and president, Trillium Diagnostics, recipient of 2007 Innovator of the Year from Maine International Trade Center and 2009 Frost & Sullivan's European IVD Innovator of the Year Award). He has over 100 peer-reviewed publications is currently focused on the establishment in clinical practice of the patented innovative biomarkers (neutrophil CD64 expression, soluble CD163 levels, and cfDNA quantitation in blood) in the area of infection/sepsis detection and clinical monitoring, while continuing to improve maternal healthcare with superior IVD tools for monitoring fetomaternal hemorrhage. Dr Davis is currently working full time in the IVD diagnostic field through Trillium Diagnostics after over 25 years in medical practice as a board certified hematopathologist in both academia and large esoteric testing national laboratories.
T HE O FFERING 19 Vivione Biosciences, Inc. (VBI) a TSX Venture Exchange listed company headquartered in Little Rock, AR is offering up to 28,571,429 shares of stock * in the company at a price of $0.35 per share Subject to TSX approval. Canadian residents shall receive Class A shares; non-Canadian residents shall receive Class B shares which are non-voting but are convertible into Class A shares on 75 days notice. Except for voting rights, Class B shares have the same rights and privileges of Class A shares prior to conversion. Said shares are NOT listed on the TS Venture Exchange. CAN $10,000,000
U SE OF F UNDS $10,000,000 Total Investment $ 750,000Closing Costs (Finders Fee, legal, accounting) $1,500,000Trillium Diagnostic Payment $ 350,000Stratedigm Equipment purchase $1,000,000Assay Development $2,000,000FDA 510k Clinical studies (CD64) $5,600,000Total Business Costs $4,400,000Working Capital Reserve $10,000,000Total Use of Funds 20
C AP T ABLE (P RE - AND P OST -F UNDING ) 21 Pre-Closing Capitalization Class A Voting Common Shares37,707,086 Class B Non-Voting Common Shares29,387,762 Options5,617,190 Warrants14,752,000 Post-Closing Capitalization (assumes max offering is reached) Class A Voting Common Shares51,992,800 Class B Non-Voting Common Shares43,673,476 Options5,617,190 Warrants Note: Assumes $10MM Investment is 50/50 split between Class A/Class B shares for US Investors 14,752,000
C OMPARABLE V ALUATIONS Table of comparable bioscience companies and EV/Rev multiples (US$) 22 Company Revenue Range Market Cap Multiple (EV/Rev) StatusRelevance Accuri †$20MM$205M10.25Sold - 09/2011 Diagnostics / Instrumentation Cepheid$446-461MM$3.73B8.09-8.36 NASDAQ (2/25/14) Microbiology Diagnostics Handylab ‡$8MM (est.)$275M34.38Sold - 11/2009Microbiology Diagnostics MTM ‡‡$15MM (est.)$180M+12.00Sold - 07/2011Diagnostics Neogen$235–250MM$1.59B6.36-6.77 NASDAQ (2/25/14) Microbiology Diagnostics Roka$3.4MM$215M62 NASDAQ (8/22/14) Microbiology Diagnostics BRAHMS $90MM$490M*5.45 Sold-2008 Biomarker Discovery (Procalcitronin) † BD Bioscience Acquisition ‡ BD Biosciences Acquisition ‡‡ Roche's-Ventana Medical Systems Acquisition * Acquired by Fisher 2008
Investment Summary Vivione Biosciences is a technology and life sciences company focused on rapid bacterial detection with an expanding IP portfolio The company’s RAPID-B platform is the fastest, most accurate, and most cost-effective diagnostic testing system currently available for detecting bacteria Vivione is in the process of commercializing the RAPID-B system for several multi-billion dollars markets, including oil & gas, food safety, and clinical in-vitro diagnostics Vivione has completed a clinical pilot studies at the Cleveland Clinic and preparing for a study at Northwestern University The Trillium acquisition will immediately add revenue, IP, experience management, and access to the clinical diagnostics market The company has been gaining traction within the Oil & Gas market – and is currently negotiating $5mm in purchase orders 23