Dyadic International, Inc. · NASDAQ:DYAI
Dyadic International — Investor Presentation (December 2019)
32 slides from Dyadic International's investor presentation, December 2019
Slide 1: The C1 Technology Platform
The C1 Technology Platform Making Healthcare Accessible & Affordable NASDAQ: DYAI Investor Presentation – December 2019
Slide 2: Safe Harbor Regarding Forward-Looking Statements
Safe Harbor Regarding Forward-Looking Statements Certain statements contained in this presentation are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including those regarding Dyadic’s expectations, i
Slide 3: Dyadic Highlight
Dyadic Highlight ▪ Ticker: NASDAQ: DYAI ▪ Share Price: $6.241 ▪ 52 Weeks Range: $1.73-$7.301 ▪ Market Capitalization: ~$169.7 million1 ▪ Shares Outstanding: ~27.2 million1 ▪ Insider Ownership Percentage: 30.3%2 ▪ Debt: None ▪ Warrants: None ▪ Cash and Investment Grade Securities: ~$37.2 million3 1As
Slide 4: Dyadic Overview
Dyadic Overview R&D: Helsinki BD&L: London R&D Management: Budapest R&D: Valladolid HQ: Jupiter, FL 20+ YEARS EXPERIENCE IN BIOPHARMA BD&L AND FUNGAL GENE EXPRESSION PLATFORM R&D DYADIC INFORMATION 4
Slide 5: Dyadic Investment Thesis
Dyadic Investment Thesis Recent Nasdaq Funded On-going Experienced Board Strong Balance Proven Technology Listing; Compelling R&D Collaborations Members and Sheet for Industrial Use Valuation with Top Tier Pharm Management Team April 17, 2019 ▪ US$37.2M cash & ▪ Success in Industrial Use Up-listed o
Slide 6: Dyadic Leadership Team
Dyadic Leadership Team M. Emalfarb P. Rawson R. Tchelet M. Jones Founder, CEO Chief Financial Officer Chief Scientific Officer Chief Commercial Officer More than 20 years life science and Inventor of 25+ U.S. and foreign More than 18 years’ finance and More than 15 years of experience in research Bi
Slide 7: Dyadic Board – Decades of Big Pharma Experience
Dyadic Board – Decades of Big Pharma Experience Arindam Bose Barry Buckland Michael P. Tarnok Dr. Bose worked at Pfizer for 34 Dr. Buckland worked at Merck for 29 years where Mr. Tarnok (Dyadic chairman) spent the years and held leadership roles he served in a number of senior R&D leadership majorit
Slide 8: Q1-Q3 2019 Corporate Achievements and Milestones
Q1-Q3 2019 Corporate Achievements and Milestones Three Additional Proof-of- Concept Collaborations with Top Serum Institute of India 25 Pharma Companies Collaboration Announced May ▪ Centered on various classes of 7, 2019 proteins, mAbs, and vaccine ▪ Collaboration to express and antigens manufactur
Slide 9: Biopharmaceutical Market Overview - The Opportunities
Biopharmaceutical Market Overview - The Opportunities ZAPI, NOVOVET, BDi and others Serum, IIBR and others Recombinant Vaccines for Animal health Recombinant vaccines & drugs Market size – for Human health $ 8.7 Billion by 20221 Market size – $ 66.54 Billion by 2027 Sanofi, and others Alphazyme New
Slide 10: C1 Gene Expression Platform
C1 Gene Expression Platform DYADIC INFORMATION 10
Slide 11: C1 – Myceliophthora thermophila
C1 – Myceliophthora thermophila C1 is a thermophilic fungus, Myceliophthora thermophila, originally isolated from alkaline soil in Russia C1 has a unique morphology, Engineered initially to produce allowing growth under a broad enzymes for biofuels, pulp & range of conditions paper, etc. Natural pro
Slide 12: C1 – Myceliophthora thermophila
C1 – Myceliophthora thermophila Dyadic & its licensees invested several hundred million dollars to turn C1 into a industrially proven gene expression platform Proprietary & patented genetic elements (tool box) for use in engineering C1 strains Low cost, high yield, Clear demonstration scalable, robu
Slide 13: C1 – Myceliophthora thermophila
C1 – Myceliophthora thermophila Dyadic built an industrial enzyme business, and licensed the C1 technology platform for industrial uses to Abengoa, BASF, Codexis/Shell and others: • Generated >$100 mm in enzyme product revenues from customers in 35 countries • Received > $30 mm in cash payments for
Slide 14: C1 – The Science
C1 – The Science CHO Unique Morphology Translates into better growth conditions High Purity of target protein secreted ▪ Higher yields of secreted protein ✓ Greater retention of target ▪ Lower viscosity secreted protein through downstream processing ✓ Requires only low cost synthetic C1 White media
Slide 15: C1 Can Operate Successfully in Single Use Bioreactor
C1 Can Operate Successfully in Single Use Bioreactor C1, a filamentous fungi, produces The productivity of 9.2 g/l is virtually Results between batches Certolizumab in Single Use bioreactors identical to the productivity achieved in are consistent, showing with the same performances as Stainless the
Slide 16: C1 Applied to Production of Therapeutic Proteins
C1 Applied to Production of Therapeutic Proteins DYADIC INFORMATION 16
Slide 17: C1 Gene Expression System is a Versatile “Workhorse”
C1 Gene Expression System is a Versatile “Workhorse” Impressive Yield and Purity Demonstrated for Therapeutic Proteins Fc-Fusion mAbs Fab (Certolizumab) Bispecific 12.2 g/l 22 g/l 14.5 g/l 1.04 g/l 144 Hours 168 Hours 164 Hours 144 Hours 1.74 g/l/day 3.1 g/l/day 2.1 g/l/day 0.17 g/l/day Proof of Pri
Slide 18: MAbY Binding Assay by Biacore T200
MAbY Binding Assay by Biacore T200 Studying the interaction of mAbs in real time MAbY for which the ligand was commercially The binding properties of a pharma’s mAbs to available was produced in CHO (control Mab) the ligand were compared in a Biacore T200 and C1 (C1-produed mAb) assay The control mA
Slide 19: Bispecific Produced in C1 and CHO Have Identical/Similar Activity
Bispecific Produced in C1 and CHO Have Identical/Similar Activity ▪ The function of C1-produced bispecific was compared to the CHO-produced control in a bioassay • C1-produced purified using only single chromatography step • CHO-produced fully purified Blue – C1-produced bispecific ▪ Potency of C1-p
Slide 20: Applying C1 Technology in Collaborations and on Our Own Account
Applying C1 Technology in Collaborations and on Our Own Account… DYADIC INFORMATION 20
Slide 21: Our Approach to Business Development and to Selection of Internal Programs
Our Approach to Business Development and to Selection of Internal Programs We meet our business partners and research collaborators where they are, seeking to leverage our C1 technology at little or no cost to us: For big pharm companies focused For small biotechnology firms, we on specific therapeu
Slide 22: Our Approach to Business Development and to Selection of Internal Programs
Our Approach to Business Development and to Selection of Internal Programs We resource internal programs where our C1 gene expression technology can overcome barriers to gene expression in alternate systems and where C1 offers meaningful technological and commercial impact: Biosimilars and “Bio-bett
Slide 23: Dyadic and Serum to Develop and Manufacture Affordable and Accessible Antibody Products and Vaccines
Dyadic and Serum to Develop and Manufacture Affordable and Accessible Antibody Products and Vaccines Globally Serum Institute of India ▪ World’s largest vaccine manufacturer -- > 1.3 billion doses ▪ Serum supplies vaccines to more than 140 countries ▪ 65% of the children in the world receive at leas
Slide 24: Dyadic’s Certolizumab (Cimzia) Biosimilar Program
Dyadic’s Certolizumab (Cimzia) Biosimilar Program Certolizumab is a Cimzia 2018 C1 produces SSB Yield of 14.5 Results between pegylated Fab’ sales of € 1.44 certolizumab in g/l in 7 days batches are antibody fragment billion for UCB inexpensive single fermentation consistent, showing targeting TNFα;
Slide 25: Roadmap for Biosimilar Certolizumab Development
Roadmap for Biosimilar Certolizumab Development ▪ 1 year Phase I trial to determine PK USP&DSP Analytics to compare the equivalence (mainly safety) in AS patients development structural & (250) physicochemical ▪ 2 year Phase I pilot study for RA patients (19) In Bench scale C1 characteristics of pro
Slide 26: Dyadic’s Nivolumab (Opdivo®) Biosimilar Program
Dyadic’s Nivolumab (Opdivo®) Biosimilar Program The immunotherapy drug Opdivo (nivolumab), manufactured by Bristol We have created a glycoengineered Myers Squibb, is indicated for C1 cell line with ~95% G0 level metastatic cancers, including melanoma and lung cancer Opdivo is priced at $12,500 a mon
Slide 27: Glycoengineering - Advantage of C1 over Yeast and CHO
Glycoengineering - Advantage of C1 over Yeast and CHO ▪ Fundamentally, the C1 glycan structure is more mammalian-like than that of yeast • Native C1 glycans are mostly high mannose type (Man3-Man9) including low amount of hybrid glycans • Fewer engineering steps needed to modify C1 glycosylation pat
Slide 28: Sanofi Vaccine Trial and Model Vaccine
Sanofi Vaccine Trial and Model Vaccine Murine Immunogenicity Study of HA/NC Produced by C1 vs. baculovirus C1 can produce high amounts of HA (~1 g/L) and other antigens in 3 -7 days by using low cost fermentation Recombinant Hemagglutinin (HA) produced in C1 is well tolerated in mice ▪ No weight los
Slide 29: Potential Use of C1 to Produce Associated Virus (AAV) Vectors
Potential Use of C1 to Produce Associated Virus (AAV) Vectors New York Times, Nov 27, 2017: Recombinant Adeno-Associated Virus Global Opportunity Analysis and (AAV) Vectors Gene Therapy Hits a Peculiar • A widely used vehicle for delivering Industry Forecast, 2017-2023, Roadblock: A Virus Shortage g
Slide 30: Applying C1 to Produce Metabolites
Applying C1 to Produce Metabolites Our in silico metabolic model supports precise engineering of C1 for optimal primary and secondary metabolites Primary metabolite production: ▪ Dyadic collaborated with a third party to develop C1 strain for a high yield, low cost primary metabolite product ▪ Dyadi
Slide 31: Dyadic Investment Thesis
Dyadic Investment Thesis Recent Nasdaq Funded On-going Experienced Board Strong Balance Proven Technology Listing; Compelling R&D Collaborations Members and Sheet for Industrial Use Valuation with Top Tier Pharm Management Team April 17, 2019 ▪ US$37.2M cash & ▪ Success in Industrial Use Up-listed o
Slide 32: THANK YOU !
DYADIC THANK YOU !
Dyadic International — Investor Presentation (December 2019) on 6ix