C1, An Ultra-High Yielding, Game Changing Gene Expression Platform Dyadic (non-conf) BD Overview February, 2018
Safe Harbor Regarding Forward-Looking Statements Certain statements contained in this presentation are forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve risks, uncertainties and other factors that could cause Dyadic’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Any forward-looking statements speak only as of the date of this presentation and, except as required by law, Dyadic expressly disclaims any intent or obligation to update or revise any forward-looking statements to reflect actual results, any changes in expectations or any change in events. Factors that could cause results to differ materially are discussed in Dyadic’s publicly available filings, including information set forth under the caption “Risk Factors” in our December 31, 2016 Annual Report filed with OTC Markets on March 24, 2017. New risks and uncertainties arise from time to time, and it is impossible for us to predict these events or how they may affect us. DYADIC INFORMATION 2
Table of Contents Title and Safe Harbor Regarding Forward-Looking Statements 1 Table of Contents 3 Dyadic Overview 4 C1 Commercially Successful in Industrial Biotech 7 C1 Technology Platform - Where to Play and How to Win 8 Biopharma Industry and Society Challenges 11 C1 Production Host 15 C1 For Biologics 17 C1 Technology Combat Emerging Diseases and Threats 22 Advantages of using C1 for the Development & Production of Biologics and Vaccines 25 Summary 28 DYADIC INFORMATION 3
Dyadic Overview 1979 FOUNDED R&D: Finland BD&L: London BD&L: Budapest R&D: Spain HQ: Jupiter, FL 20+ YEARS EXPERIENCE IN PHARMA / FUNGAL GENE EXPRESSION PLATFORMS DYADIC INFORMATION 4
Platform Technology C1: Fungal Gene Expression Platform for use in the Development and Production of Biologics Novel engineered cell line (Myceliopthora thermophila) >20 Patents Value & Differentiation: Decreased Development Time Lower Production Costs Improved Biologic Performance SignificantCapEx Savings DYADIC INFORMATION 5
Industrially Proven >100 g/l Yield & ~80% Purity Hyper Productive Enzyme Expression GRAS FDA 500,000L Certified Scale Production Industrial Licensees: DYADIC INFORMATION 6
Dyadic Leadership Team M. Emalfarb T. Dubinski Founder, CEO Vice President, CFO R. Tchelet, PhD M. Jones Vice President, R&D Commercial Officer DYADIC INFORMATION 7
Financial Overview LIQUIDITY FINANCIALS >$110M $51M C1 Related License Cash & Investment Deals, Milestones & Grade Securities (1) Equity $0 $75M Debt Deal with DuPont for Dyadic’s Industrial Technology Business $44M Market Cap $19M Share Buyback OTC Markets Stock Exchange Completed 2/2017 (OTCQX: DYAI) $5M Add’l Share Buyback Initiated 8/2017 28.7M Fully Funded to Common Shares Execute Business Plan Outstanding (1) DYADIC INFORMATION 8
Dyadic Board – Decades of Big Pharma Experience Arindam Bose, PhD Barry Buckland, PhD Michael P. Tarnok Chairman EXPERIENCE EXPERIENCE EXPERIENCE Dr. Bose worked at Pfizer for 34 Dr. Buckland worked at Merck for 29 years Mr. Tarnok spent the majority of his years and held leadership roles where he served in a number of senior career at Pfizer and is a seasoned within bioprocess development R&D leadership roles focusing on finance and operational executive and clinical manufacturing and is fermentation and bioprocess with extensive experience in the widely recognized as a Key development and the commercial pharmaceutical industry. Currently Thought Leader in the manufacturing of biologics and is widely also serves on the Board of the biopharmaceutical industry. recognized as a Key Thought Leader in Global Health Council, and Ionetix, the biopharmaceutical industry. Currently, Inc. Prior Board service includes Dr. Buckland is the Executive Director, Keryx Biopharmaceuticals, Inc., NIIMBL (National Institute for Innovation in where he also served as Chairman Manufacturing Biopharmaceuticals) A of the Board. public-private consortium dedicated to advancing biopharmaceutical manufacturing innovation. LAST POSITION LAST POSITION LAST POSITION Vice President, Biotherapeutics Vice President, Bioprocess R&D, Merck Senior Vice President in Pfizer’s US Pharmaceutical Sciences, External Research Laboratories Pharmaceutical Division Affairs and Biosimilar Strategy DYADIC INFORMATION 9
Dyadic Launch's Biopharmaceutical Strategy for The C1 Gene Expression Platform DYADIC INFORMATION 10
Dyadic is Developing What the Industry Refers to As a “CHO stopper” CHO stopper? Biogen looks to alternative cell lines for future of bioproduction. BioPharma Reporter Bioprocessing survey report, The Chinese hamster ovary 11/03/2017 (CHO) cell line is not the future for biomanufacturing “Nearly half the respondents of says Biogen, MIT & Gates our second state of the global Foundation biomanufacturing survey believe we are too reliant on Chinese Hamster Ovary (CHO) expression systems.” Dyadic’s Goal To further develop C1 into a safe and efficient gene expression system to help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales. DYADIC INFORMATION 11
C1 Technology Platform– Where to Play & How to Win Biologic drugs make up the fastest growing segment of the pharma industry and are some of the most expensive treatments; therefore, they are placing an enormous financial burden on both patients and the healthcare systems globally. Total Addressable Market and Market Penetration 1 Global vaccines market projected to be $48.0 billion Biologics are the fastest by 2021 growing segment of the pharmaceutical industry $1.3 trillion projected to grow at a spent on drugs CGAR of 10.9% over the currently, 18% period 2016 – 2024 to or $235 billion $479.8 billion is for biologics Dyadic is well positioned to penetrate the very attractive biologics market for Drugs and Vaccines, both human and animal health, with its uniquely powerful and proven technology, the C1 Gene Expression Platform. 1 Data from market research published by MarketsandMarkets as of May 12, 2017 & Transparency Market Research published on Oct 6, 2016 DYADIC INFORMATION 12
Industry & Society Challenges Industry Problems Few advances in the protein Involves using enormous production process during the past quantities of expensive decade, particularly in the area of growth medium CHO cell improvement Therapeutic protein Requires costly Current productivity is not production is expensive manufacturing facilities adequate to meet future commercial manufacturing demand CHO Productivity Appears To Have Plateaued 1 4 g/l 0.1 g/l 1985 1995 2005 2015 Current Industry Solution: Build more expensive manufacturing plants & operate 1 Estimated Industry Average CHO Yield for a 12-14 day fermentation run, results vary by company. DYADIC INFORMATION 13
CHO Technology is Highly Capital Intensive and Costly Samsung Biologics plants in the Songdo district in Incheon, South Korea, Cost $740 million DYADIC INFORMATION 14
C1 Benefits: Lower Production Costs, Both CAPEX and OPEX Stainless Steel Multiuse Single Use Bioreactor 2 x12,000 liter 2,000 liter CHO C1 Annual Protein Demand in g 800,000 800,000 800,000 Tank size in Liters 12,000 2,000 2,000 Productivity g/l 4 10 15 % Yield 65% 75% 75% Batches per year 20 40 40 Tank Output in g 624,000 600,000 900,000 Tanks Needed 2.0 2.0 1.0 % Capacity Utilized 64% 67% 89% C1 can lower CAPEX: C1 can lower OPEX: Smaller facility footprint and related Low cost media • costs High Yield / Produce at smaller scale • DYADIC INFORMATION 15
C1 Production Host DYADIC INFORMATION 16
C1 – The Science Wide operating Shorter conditions for Development & High Purity - 80% of Unique target protein pH and Production Higher Morphology secreted temperature Cycle Productivity § Translates into better § Greater retention § At scales ranging § Develop g/l/d C1 § High Levels of expression growth conditions of target secreted from laboratory cell lines in 15 mAbs > 1.5 g/l/d • Higher yields of protein through shake flasks to weeks Fc-fusion > 1.3 g/l/d • • secreted protein downstream 20,000l tanks and § From seed flask to Lower viscosity processing above fermenter • § Requires only low § C1 has received Savings of • cost synthetic GRAS (Generally nearly 10 -14 media Recognized as days vs CHO § No Viruses which Safe) designation § Fermentation Cycle eliminates 2 from FDA and is time 4-7 days purification steps considered fit for 1/2 to 1/3rd • typical in CHO human the time of No Low pH consumption CHO • viral inactivation No Virus • nanofiltration DYADIC INFORMATION 17
C1 for Biologics DYADIC INFORMATION 18
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