May 2012 DYADIC MANAGEMENT PRESENTATION THE C1 EXPRESSION SYSTEM REINVENTING BIOLOGIC VACCINE AND DRUG PRODUCTION May 2016 (OTCQX: DYAI)
Safe Harbor Statement Certain statements contained in this presentation are forward-looking statements. These forward- looking statements involve risks and uncertainties 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. Except as required by law, Dyadic expressly disclaims any intent or obligation to update any forward-looking statements. 2
Investment Highlights The Company The Technology The Opportunity Dyadic engineers hyper The C1 platform is recognized by Sale of Industrial Biotech productive C1 fungal cells to the industrials sector as a leading business to DuPont ($75M) in produce biologic vaccines and expression system December 2015 allows Dyadic to drugs using its proprietary C1 focus on developing C1 for High scalability and expression system biopharmaceuticals programmability Dyadic is a publicly-traded global Seeking strategic alliances to High purity and production levels biotechnology company leverage C1 technology in biopharmaceutical applications Proven technology refined by Market capitalization as of May 2, industry-leading partners including 2016: $63.4 million C1 technology may help bring DuPont, BASF, Abengoa, and biologic vaccines and drugs to Cash as of December 31, 2015: Codexis market faster, in greater volumes $68.6 million (1) and at lower cost to drug Owns co-exclusive rights with developers and manufacturers Initiating preparation for an DuPont, Dyadic has exclusive sub- and, hopefully, improve access anticipated up-listing to the license rights and cost to patients and the NASDAQ Excellent safety profile healthcare system Initiated a share repurchase High purity and production of program in Q1 2016 biologics, such as antibodies, Leadership team with a resulting in significant CapEx and successful track record OpEx savings (1) Excludes ~ $ 7.4 million held in escrow from DuPont Transaction, expected release of escrow funds July, 2017 3
Dyadic Target Markets The C1 technology will be further developed to enable its use in the development and manufacturing of biologic vaccines and drugs Recombinant Vaccine market Vaccines Biosimilars / Global insulin market to approximately (Human and Biobetters (non-Gly) be $42B by 2019 $35B in 2014 Veterinary) Global biological drug Biosimilars / Biosimilar market to be New Products market to be $287B by $26B by 2020 Biobetters (Gly) 2020 4
Dyadic Leadership Mark Emalfarb, President and Chief Executive Officer Michael Tarnok, Chairman of the Board ‒ President and Chief Executive Officer from 1979 to ‒ Chairman of Dyadic since 2015 2007, 2008 to present ‒ Former Chairman of Keryx Biopharmaceuticals from ‒ Founder of Dyadic and member of Dyadic’s board of 2009 to 2016 directors since 1979 ‒ Senior Vice President at Pfizer from 1989 to 2007 ‒ Chairman from 1979 to 2007, 2008 to 2015 ‒ M.B.A. from New York University ‒ B.A. degree from the University of Iowa Thomas Dubinski, CFO Ronen Tchelet, VP of Research and Business Development ‒ Vice President and Chief Financial Officer since 2014 ‒ Vice President of Research and Business Development ‒ Management Consultant at CFO Solutions from 2012 to since 2014 2014 ‒ Vice President at Codexis. Founder and Managing ‒ Finance Officer at Walgreens Infusion Services from Director of Codexis Laboratories Hungary from 2008 to 2007 to 2011 2014 ‒ ‒ Director of Finance at Novartis from 2003 to 2004 Chief Technology Officer of API at Teva ‒ Pharmaceuticals from 2000 to 2007 Finance Director Abbot Laboratories from1984 to 2002 ‒ Ph.D. in Molecular Microbiology and Biotechnology ‒ B.S. in Accounting from the University of Illinois, from Tel Aviv University Champaign-Urbana 5
Scientific Collaboration Dyadic has a history of strong scientific collaborations Moscow State University 6
Transformational Event for Dyadic The sale of Dyadic’s Industrial Biotech business to DuPont for $75 million is a transformational event for Dyadic The culmination of the development of C1 for industrial biotechnology applications was recognized by an industry leader in DuPont’s acquisition of Dyadic’s Industrial Biotech business C1’s unique growth and expression properties, coupled with its proven programmability, scalability high purity and yields, could be a game changer in developing and manufacturing biologic vaccines and drugs faster, in larger quantities with both less CapEx and OpEx, and potentially with even better performance Proceeds from the DuPont transaction, and other potential government and industry research funding, will enable Dyadic to accelerate further development and optimization of the C1 technology in the area of biopharmaceuticals Sanofi Pasteur and the EU-funded ZAPI program are examples of the types of industry and governmental funded research programs Dyadic will be pursuing There is a growing and critical need to bring affordable generic versions of biological vaccines and drugs to patients sooner and at lower costs – Biosimilars are helping to make healthcare more affordable and accessible to a growing and aging patient population – Experts predict savings to the U.S. healthcare system alone could range from $44B to $250B through 2025 (1) (1) Mulcahy AQ, Predmore Z, Mattke S. The Cost Savings Potential of Biosimilar Drugs in the United States. 7
C1 Technology 8
C1 Technology Overview Dyadic Mature system for Low cost, commercially High purity and yield, production of scalable fermentation at 100+ grams per liter heterologous proteins up to 500,000 liter scale Fully programmable, Excellent safety profile C1 Technology patented technology Refined by leading No animal-derived Flexible licensing model commercial partners ingredients used 9
C1 Has an Excellent Safety Profile C1 strain non-toxic Generally Recognized as Safe (GRAS) status acknowledged by the FDA Pathogenicity and toxigenicity data: strain is non-infectious and no known toxins are produced C1-cellulase accepted by FDA on Peer-reviewed scientific literature have September 29, 2009 confirmed — no known pathogencity No mycotoxins found GRAS notification letter is a public statement by FDA acknowledging Dyadic’s safety determination for the intended uses of C1 C1 enzyme testing In vivo feeding trials: GRAS notification letters are broadly – 14 day dose study in rats recognized in the food and consumer – 13 week subchronic rat study products industries as the safety standard Genotoxicity testing: – AMES bacterial mutagenesis – Chromosomal aberration test – Genetic mutation test No adverse effects observed No foreign DNA Safety confirmed 10
C1 Expression System Advantages C1 genome sequenced and annotated Extensive molecular toolbox with high efficiency, stable integration Advantageous growth conditions with low cost defined media Platform Track record of producing high purity and protein yields, under low viscosity, at technology varying scales up to 500,000 liters Excellent safety record and Generally Recognized as Safe (GRAS) status acknowledged by the FDA C1 White Strain 2.0 programmable to produce tailored “purer” proteins Cost Effective homologous and heterologous gene expression effective product Expressed proteins are typically secreted into the fermentation broth development Serves as both a research and production host Freedom to No royalty stacking (1) operate (1) If DuPont makes an improvement, and we choose to utilize it, there will be a royalty due DuPont, and vice a versa. DuPont will owe Dyadic a royalty upon commercialization 11 11
World Class Productivity and Purity Two serendipitous mutations led to the creation of the world class C1 expression system Synthetic biology start-ups – large and small – High yields, high purity, low cost struggle with the reality of scaling up at industry leading scale microscopic cellular factories into profitable business models Dyadic’s patented and proprietary C1 Over 100 grams expression system is being used to produce 100 g/L per liter protein biological products at very high yields, low cost and in large commercial fermenters Up to 80% of 80% target protein has purity been achieved Currently 500,000 produced in up to 500,000 liter liter scale scale 12
The Revolutionary C1 LC “White Strain” LC expression of specific proteins C1 strain types Dyadic’s C1, LC strains successfully LC-3 LC-1 LC-2 LC-4 used in production of single and multiple proteins derived from fungal, LC bacteria, bacterial-directed evolution, mammalian, human and viral strains WT The expression reaches high production levels of secreted proteins – > 100 g/l with ~ 80% purity of the HC targeted protein C1 LC “White Strains” The LC strain/s is fermented at large have very different commercial scale morphology than the C1 Wild Type Strains 13
C1 Platform - Commercially Proven C1 in use by industry giants Acquired by 14
Vaccine Applications 15
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