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About Dyadic
Dyadic International, Inc. is a global biotechnology company focused on
improving and applying its proprietary C1 gene expression platform, based
on a patented and proprietary genetically modified strain of the fungus
Myceliophthora thermophila, to address opportunities in the human and
animal health markets. C1 is a potentially game-changing biopharmaceutical
gene expression platform that may help bring biologic drugs to market faster
than existing expression platforms, such as Chinese hamster ovary (CHO)
cells, E. coli and others, in greater volumes, at lower cost and with new properties that can improve access and cost to patients
and the healthcare system.
Dyadic’s C1 Gene Expression Platform: Faster, Viable, More Efficient, Cost-Effective
Research data generated in our third-party collaborations and our own internal research programs indicate that C1 is capable
of expressing a variety of vaccines and therapeutic proteins, such as human and animal recombinant antigens, vaccines, Virus
Like Particles (VLPs), monoclonal antibodies (mAbs), bi-specific antibodies, Fc-Fusions, Fabs and certain difficult-to-express
antibodies, at a higher productivity level than other gene expression platforms. Dyadic pursues R&D collaborations, licensing
arrangements and other commercial opportunities with its partners and collaborators in the development and manufacture of
biopharmaceuticals.
Industrially Proven Platform Technology: DuPont Transaction and Licensing Agreements
C1 technology has been used for producing commercial quantities of enzymes and other proteins for decades and it has
previously been licensed to leading industrial companies, including Abengoa, BASF, Codexis, Shell and DuPont to produce
numerous industrial products and applications at low cost and large volumes. In 2015, Dyadic sold its C1 technology for industrial
use to DuPont for $75 million while retaining co-exclusive rights to use the C1 technology in human and animal pharmaceutical
applications, with the exclusive ability to enter into sub-license agreements. DuPont retained certain rights to use the C1
technology in pharmaceutical applications, for which Dyadic will receive royalty payments upon commercialization.
Biopharmaceutical R&D Collaborations
• ZAPI Vaccination Program: Results suggest the C1 expressed antigen tested in a small mice study generated the desired
immune response and no negative effects on the health of the mice observed.
• Biotechnology Development for Industry (BDI): Evaluating a range of therapeutic proteins and a Virus Like Particle that are
used in the animal and human health markets, including glycosylated or non-glycosylated proteins (mAbs, Fabs and bi-
specific mAbs, etc.) to determine which, if any, of these proteins might be potential candidates for future commercialization.
• Mitsubishi Tanabe Pharma Corp.: Funded proof-of-concept research collaboration to explore the potential of C1 technology
to produce two difficult-to-express vital therapeutic proteins for human health indications.
• Israel Institute for Biological Research (IIBR): Evaluating C1
platform for the development and manufacture of recombinant
vaccines and neutralizing agents comprising targeted antigens
and monoclonal antibodies.
• Sanofi-Pasteur: Prior collaboration indicated C1-produced
influenza antigen generated an equal or better immune response
in mice than the industry-standard antigen used in the mice trial
and no negative effects on the health of the mice observed.
Dyadic International, Inc.
140 Intracoastal Pointe Drive
Jupiter, FL 33477
(561) 743-8333
www.dyadic.com
OTCQX: DYAI
Large and Growing Biologics and Vaccines Market
The global biological drug market is expected to be
$399.5 billion by 20251 and the global vaccines market is
expected to reach $49.3 billion by 2022.2
1 Grand View Research, May 2017
2
MarketsandMarkets, August 11, 2017
Shares Outstanding (as of 6/30/2018): ~28.1M
Stock Price (as of 8/15/2018): $1.47
Market Capitalization (as of 8/15/2018): ~$41.3M
Cash & Liquid Investments (as of 6/30/18): ~$45.8M
Two US National Academy of Engineer Board of Directors and Experienced Management Team
Dr. Arindam Bose: 34 years at Pfizer, where for his last six years, served as Vice President of Bio Therapeutics Pharmaceutical
Sciences External Affairs and Biosimilars Strategy.
Dr. Barry Buckland: 29 years at Merck, where his last senior R&D leadership position was Vice President Bioprocess R&D,
focusing on fermentation and bioprocess development and the commercial manufacturing of biologics.
Mark Emalfarb, Founder, President & CEO: Inventor of 25+
U.S. and foreign biotechnology patents related to Dyadic’s
proprietary C1 fungus. Formation of several strategic research and development, manufacturing and marketing
relationships with U.S. and international partners since founding the company in 1979.
Dr. Ronen Tchelet, VP of Research: More than 15 years of experience in research and pharmaceutical industry incl. CTO of
Biotech at the API Division of TEVA Pharmaceuticals and founder and Managing Director of Codexis Laboratories Hungary.
Ph.D. in Molecular Microbiology and Biotechnology from Tel Aviv University in 1993 and Postdoctoral as an EERO fellow at
the Institute of Environmental Science and Technology (EAWAG) in Switzerland.
Matthew Jones, Chief Commercial Officer: More than 20 years’ life science and BioPharma industry leadership as well as
Private Equity deal making advisory experience incl. Concept Life Sciences, Lonza, Bain, Ricerca BioSciences, MDS Pharma
Services, Alkermes and GlaxoSmithKline.
Ping Rawson, Chief Accounting Officer: More than 15 years’ finance and accounting experience, incl. 7 years at Deloitte.
MBA and MS in Accounting from SUNY Buffalo and CPA in New York State.
Scientific and Business Development Milestones/Corporate Events
Expression time: Proved C1 can express gene in 3 mos., faster than CHO Q1 2018 ✔
O-Glyco: Analytics to date show no O-Glycosylation on proteins tested Q1 2018 ✔
Media optimization: Developed low-cost defined media without yeast extract Q1 2018 ✔
Higher productivity/yield level than CHO: mAbs 2.4 g/l/d, Fc-Fusion 1.3 g/l/d and Fab 1.9 g/l/d Q2 2018 ✔
Expression type: Proved C1 can express a variety of types of gene and difficult-to-express antibodies Q2 2018 ✔
Protease knock-outs: Validated protease expression library in Pichia Q2 2018 ✔
Host cell improvement: Generated a C1 host production organism with 8 protease genes deleted Q2 2018 ✔
Achieved C1 yield level of 9.12 g/l (1.9 g/l/d) w/ Certolizumab (biological drug component of Cimzia® Pegol) Q2 2018 ✔
Announced 3 new research collaborations including Mitsubishi Tanabe and IIBR Q1 2018 ✔
Announced 1 new research collaboration Q2 2018 ✔
Shareholders approved a reverse stock split proposal June 2018 ✔
Intend to file Form 10 and become a fully reporting SEC company Q1 2019
Safe Harbor Regarding Forward-Looking Statements: This fact sheet contains forward-looking statements. All statements other than statements of historical fact are
forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,”
“may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements are based on management’s beliefs and
assumptions and on information available to management only as of the date of this press release. 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. Investors are urged to consider these factors carefully in evaluating the forward-looking statements and are
cautioned not to place undue reliance on such forward-looking statements. 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 include, but are not limited
to: (1) general economic, political and market conditions; (2) our ability to generate the required productivity, stability, purity, performance, cost, safety and other data
necessary to carry out and implement our biopharmaceutical research and business plans and strategic initiatives; (3) our ability to retain and attract employees,
consultants, directors and advisors; (4) our ability to implement and successfully carry out Dyadic’s and third parties research and development efforts; (5) our ability
to obtain new license and research agreements; (6) our ability to maintain our existing access to, and/or expand access to third party contract research organizations
in order to carry out our research projects for ourselves and third parties; (7) competitive pressures and reliance on key customers and collaborators; (8) the
pharmaceutical and biotech industry, governmental regulatory and other agencies' willingness to adopt, utilize and approve the use of the C1 gene expression platform;
and (9) other factors discussed in Dyadic’s publicly available filings, including information set forth under the caption “Risk Factors” in our December 31, 2017 Annual
Report filed with the OTC Markets on March 27, 2018, and our March 31, 2018 Quarterly Report filed with the OTC Markets on May 10, 2018. 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.

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Dyadic fact sheet august 2018

  • 1. About Dyadic Dyadic International, Inc. is a global biotechnology company focused on improving and applying its proprietary C1 gene expression platform, based on a patented and proprietary genetically modified strain of the fungus Myceliophthora thermophila, to address opportunities in the human and animal health markets. C1 is a potentially game-changing biopharmaceutical gene expression platform that may help bring biologic drugs to market faster than existing expression platforms, such as Chinese hamster ovary (CHO) cells, E. coli and others, in greater volumes, at lower cost and with new properties that can improve access and cost to patients and the healthcare system. Dyadic’s C1 Gene Expression Platform: Faster, Viable, More Efficient, Cost-Effective Research data generated in our third-party collaborations and our own internal research programs indicate that C1 is capable of expressing a variety of vaccines and therapeutic proteins, such as human and animal recombinant antigens, vaccines, Virus Like Particles (VLPs), monoclonal antibodies (mAbs), bi-specific antibodies, Fc-Fusions, Fabs and certain difficult-to-express antibodies, at a higher productivity level than other gene expression platforms. Dyadic pursues R&D collaborations, licensing arrangements and other commercial opportunities with its partners and collaborators in the development and manufacture of biopharmaceuticals. Industrially Proven Platform Technology: DuPont Transaction and Licensing Agreements C1 technology has been used for producing commercial quantities of enzymes and other proteins for decades and it has previously been licensed to leading industrial companies, including Abengoa, BASF, Codexis, Shell and DuPont to produce numerous industrial products and applications at low cost and large volumes. In 2015, Dyadic sold its C1 technology for industrial use to DuPont for $75 million while retaining co-exclusive rights to use the C1 technology in human and animal pharmaceutical applications, with the exclusive ability to enter into sub-license agreements. DuPont retained certain rights to use the C1 technology in pharmaceutical applications, for which Dyadic will receive royalty payments upon commercialization. Biopharmaceutical R&D Collaborations • ZAPI Vaccination Program: Results suggest the C1 expressed antigen tested in a small mice study generated the desired immune response and no negative effects on the health of the mice observed. • Biotechnology Development for Industry (BDI): Evaluating a range of therapeutic proteins and a Virus Like Particle that are used in the animal and human health markets, including glycosylated or non-glycosylated proteins (mAbs, Fabs and bi- specific mAbs, etc.) to determine which, if any, of these proteins might be potential candidates for future commercialization. • Mitsubishi Tanabe Pharma Corp.: Funded proof-of-concept research collaboration to explore the potential of C1 technology to produce two difficult-to-express vital therapeutic proteins for human health indications. • Israel Institute for Biological Research (IIBR): Evaluating C1 platform for the development and manufacture of recombinant vaccines and neutralizing agents comprising targeted antigens and monoclonal antibodies. • Sanofi-Pasteur: Prior collaboration indicated C1-produced influenza antigen generated an equal or better immune response in mice than the industry-standard antigen used in the mice trial and no negative effects on the health of the mice observed. Dyadic International, Inc. 140 Intracoastal Pointe Drive Jupiter, FL 33477 (561) 743-8333 www.dyadic.com OTCQX: DYAI Large and Growing Biologics and Vaccines Market The global biological drug market is expected to be $399.5 billion by 20251 and the global vaccines market is expected to reach $49.3 billion by 2022.2 1 Grand View Research, May 2017 2 MarketsandMarkets, August 11, 2017 Shares Outstanding (as of 6/30/2018): ~28.1M Stock Price (as of 8/15/2018): $1.47 Market Capitalization (as of 8/15/2018): ~$41.3M Cash & Liquid Investments (as of 6/30/18): ~$45.8M
  • 2. Two US National Academy of Engineer Board of Directors and Experienced Management Team Dr. Arindam Bose: 34 years at Pfizer, where for his last six years, served as Vice President of Bio Therapeutics Pharmaceutical Sciences External Affairs and Biosimilars Strategy. Dr. Barry Buckland: 29 years at Merck, where his last senior R&D leadership position was Vice President Bioprocess R&D, focusing on fermentation and bioprocess development and the commercial manufacturing of biologics. Mark Emalfarb, Founder, President & CEO: Inventor of 25+ U.S. and foreign biotechnology patents related to Dyadic’s proprietary C1 fungus. Formation of several strategic research and development, manufacturing and marketing relationships with U.S. and international partners since founding the company in 1979. Dr. Ronen Tchelet, VP of Research: More than 15 years of experience in research and pharmaceutical industry incl. CTO of Biotech at the API Division of TEVA Pharmaceuticals and founder and Managing Director of Codexis Laboratories Hungary. Ph.D. in Molecular Microbiology and Biotechnology from Tel Aviv University in 1993 and Postdoctoral as an EERO fellow at the Institute of Environmental Science and Technology (EAWAG) in Switzerland. Matthew Jones, Chief Commercial Officer: More than 20 years’ life science and BioPharma industry leadership as well as Private Equity deal making advisory experience incl. Concept Life Sciences, Lonza, Bain, Ricerca BioSciences, MDS Pharma Services, Alkermes and GlaxoSmithKline. Ping Rawson, Chief Accounting Officer: More than 15 years’ finance and accounting experience, incl. 7 years at Deloitte. MBA and MS in Accounting from SUNY Buffalo and CPA in New York State. Scientific and Business Development Milestones/Corporate Events Expression time: Proved C1 can express gene in 3 mos., faster than CHO Q1 2018 ✔ O-Glyco: Analytics to date show no O-Glycosylation on proteins tested Q1 2018 ✔ Media optimization: Developed low-cost defined media without yeast extract Q1 2018 ✔ Higher productivity/yield level than CHO: mAbs 2.4 g/l/d, Fc-Fusion 1.3 g/l/d and Fab 1.9 g/l/d Q2 2018 ✔ Expression type: Proved C1 can express a variety of types of gene and difficult-to-express antibodies Q2 2018 ✔ Protease knock-outs: Validated protease expression library in Pichia Q2 2018 ✔ Host cell improvement: Generated a C1 host production organism with 8 protease genes deleted Q2 2018 ✔ Achieved C1 yield level of 9.12 g/l (1.9 g/l/d) w/ Certolizumab (biological drug component of Cimzia® Pegol) Q2 2018 ✔ Announced 3 new research collaborations including Mitsubishi Tanabe and IIBR Q1 2018 ✔ Announced 1 new research collaboration Q2 2018 ✔ Shareholders approved a reverse stock split proposal June 2018 ✔ Intend to file Form 10 and become a fully reporting SEC company Q1 2019 Safe Harbor Regarding Forward-Looking Statements: This fact sheet contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. 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. Investors are urged to consider these factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on such forward-looking statements. 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 include, but are not limited to: (1) general economic, political and market conditions; (2) our ability to generate the required productivity, stability, purity, performance, cost, safety and other data necessary to carry out and implement our biopharmaceutical research and business plans and strategic initiatives; (3) our ability to retain and attract employees, consultants, directors and advisors; (4) our ability to implement and successfully carry out Dyadic’s and third parties research and development efforts; (5) our ability to obtain new license and research agreements; (6) our ability to maintain our existing access to, and/or expand access to third party contract research organizations in order to carry out our research projects for ourselves and third parties; (7) competitive pressures and reliance on key customers and collaborators; (8) the pharmaceutical and biotech industry, governmental regulatory and other agencies' willingness to adopt, utilize and approve the use of the C1 gene expression platform; and (9) other factors discussed in Dyadic’s publicly available filings, including information set forth under the caption “Risk Factors” in our December 31, 2017 Annual Report filed with the OTC Markets on March 27, 2018, and our March 31, 2018 Quarterly Report filed with the OTC Markets on May 10, 2018. 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.