Dyadic International, Inc. · NASDAQ:DYAI
Dyadic International — Investor Presentation (March 2020)
45 slides from Dyadic International's investor presentation, Mar 18, 2020
Slide 1: The C1 Technology Platform Making Healthcare Accessible & Affordable
The C1 Technology Platform Making Healthcare Accessible & Affordable NASDAQ: DYAI Investor Presentation – March 2020
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 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 4: Dyadic Highlight
Dyadic Highlight ▪ Ticker: NASDAQ: DYAI ▪ Share Price: $3.311 ▪ 52 Weeks Range: $3.31-$8.001 ▪ Market Capitalization: ~$90 million1 ▪ Shares Outstanding: ~27.7 million2 ▪ Insider Ownership Percentage: 30.3%2 ▪ Debt/Warrants: None ▪ Cash and Investment Grade Securities: ~$37.2 million3 1As of 3/17/20
Slide 5: 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 5
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 More than 20 years’ finance and More than 15 years of experience in research Inventor of 25+ U.S. and foreign 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: 2019 Corporate Achievements and Milestones
2019 Corporate Achievements and Milestones Four Additional Proof-of-Concept Serum Institute of India Collaborations with Top Pharma Collaboration Announced May Companies 7, 2019 ▪ Centered on various classes of ▪ Collaboration to express and proteins, mAbs, and vaccine manufacture in C1 up to 12 ant
Slide 9: Biopharmaceutical Market Overview - The Opportunities
Biopharmaceutical Market Overview - The Opportunities TWO OF TOP FOUR ANIMAL HEALTH CO’s ZAPI, IIBR and Coronavirus ZAPI, BDI, NOVOVET and others Vaccines and drugs for Recombinant vaccines for animal health Pandemic and Epidemic zoonotic Market size – diseases and biologic threats $8.7 Billion by 2
Slide 10: C1 Gene Expression Platform
C1 Gene Expression Platform 10
Slide 11: C1 – Myceliophthora thermophila
C1 – Myceliophthora thermophila C1 is a thermophilic fungus, Myceliophthora thermophila, originally isolated from alkaline soil in Russia Dyadic and its licensees invested several hundred million dollars to turn C1 into an industrially proven gene expression platform Proprietary & patented genetic e
Slide 12: 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 13: 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 14: How Dyadic Leverages C1 Advantages for Biologics
How Dyadic Leverages C1 Advantages for Biologics - High productivity - - Advanced genetic tools (Efficient transformation) - - Efficient secretory system - - Low viscosity - - Wide range of fermentation conditions - - Fast growing - - Grow on simple defined media - - Can tolerant high glucose concen
Slide 15: Generic Process Flow Chart for C1 (12 days)
Generic Process Flow Chart for C1 (12 – 14 days) (*) Pre-inoculum: Passage 1 Mycelium activation plate 1,5 1,5 days – Passage 2 1 1 Seed train: inoculum flask expansion in flask N-3 ~1.6L scale 2,5 2,5 days - Inoculum expansion - bioreactors N-2 ~40L scale 0,75 0,75 N-1 ~1000L scale 5 days 5 Product
Slide 16: Generic Process Flow Chart for CHO (41 days)
Generic Process Flow Chart for CHO (41 – 54 days) Passage 1 28 28 d Passage 2 - 18 Seed train: inoculum Passage 3 expansion Passage 4 Passage 5 Passage 6 N-3 ~80L scale 12 12 days - Inoculum expansion - bioreactors N-2 ~400L scale 9 N-1 ~2,000L scale 14 14 days Production bioreactor N ~12,000L scale
Slide 17: 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 18: C1 Applied to Production of Therapeutic Proteins
C1 Applied to Production of Therapeutic Proteins 18
Slide 19: 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 13.2 g/l 24.5 g/l 14.5 g/l 1.04 g/l 168 Hours 168 Hours 164 Hours 144 Hours 1.89 g/l/day 3.5 g/l/day 2.1 g/l/day 0.17 g/l/day Proof of P
Slide 20: 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 21: Neutralizing activity of mAb produced in fungus or CHO cells
Neutralizing activity of mAb produced in fungus or CHO cells Hemolytic assay in rabbit RBC with alpha toxin of Staphylococcus aureus Graph#1 0.2 Hemolytic assay The neutralizing activity assay 0.18 demonstrated great similarity 0.16 between C1 produced mAb and 0.14 CHO produced mAb 0.12 0.1 0.08 0.0
Slide 22: 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 23: Glycoengineering - Advantage of C1 over Yeast and CHO
Glycoengineering - Advantage of C1 over Yeast and CHO ▪ The native 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 ▪ We have successfully completed initial glycoengineering of C1 cells ▪
Slide 24: Applying C1 Technology in Collaborations and on Our Own Account
Applying C1 Technology in Collaborations and on Our Own Account… 24
Slide 25: 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 26: Zoonotic Anticipation and Preparedness Initiative ZAPI Project
Zoonotic Anticipation and Preparedness Initiative ZAPI Project ZAPI, is a research and development program sponsored by the EU with the goal of developing a platform suitable for the rapid development and production of vaccines and protocols to fast-track registration of developed products to combat
Slide 27: Potential advantage, commercial scale production SBV (ZAPI) antigen
Potential advantage, commercial scale production SBV (ZAPI) antigen ➢ The production volume that will be needed to produced 1 batch of 100K, 1,000K and 10,000K SBV doses with C1 (1.75 g/L) ➢ C1 fermentation is based on Fed-batch technology with glucose feeding and synthetic media Doses per batch (20
Slide 28: Collaboration with Sanofi-Aventis Deutschland GmbH
Collaboration with Sanofi-Aventis Deutschland GmbH C1 Expressed ALL seven (7) of the Sanofi therapeutic and vaccine proteins in the feasibility study • C1 expressed more than half of the seven proteins at or exceeded the production levels initially set by Sanofi. • We expect a decision by Sanofi som
Slide 29: 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 30: Dyadic and IIBR Expand Collaboration to Combat Emerging Diseases
Dyadic and The Israel Institute for Biological Research (IIBR) Expand Collaboration to Combat Emerging Diseases The Israel Institute for Biological Research “IIBR” is a governmental, applied research institute specializing in the fields of biology, medicinal chemistry and environmental sciences. IIB
Slide 31: Coronavirus Opportunities – C1 Gene Expression Platform
Coronavirus Opportunities – C1 Gene Expression Platform Working together we can “Keep The World Safe” by helping to address the immediate coronavirus outbreak, be better prepared for future infectious diseases, pandemic, and epidemic outbreaks, and leveraging this unfortunate situation to advance bi
Slide 32: Coronavirus spike receptor binding domain: key target for potent neutralizing Abs
Coronavirus spike receptor binding domain: key target for potent neutralizing Abs ACE2 receptor Antigen minimization Receptor Binding Domain (RBD) Receptor binding domain: • Single folded polypeptide chain • All potent neutr. Ab target the SARS-CoV-2 RBD spike structural model • Ag minimization -> f
Slide 33: UfoVax / Scripps Research Institute
UfoVax / (Scripps Research Institute) Ufovax, Inc. and Its 1c-SApNP® Technology Towards An Effective 2019-nCoV Vaccine • Single-component self-assembling protein nanoparticle (1c-SApNP®), streamlines vaccine development that targets: The picture on the left is one of the first electronic microscopy
Slide 34: The Rapidly Growing C1 Glycoform Cell Lines
The Rapidly Growing C1 Glycoform Cell Lines / Dialing up & Down Immunogenicity Achievements so far: The Glycoengineering of C1 has generated good results to date Four C1 Strains (Glyco structures on C1 native proteins) Native C1 Man3-9 Strain C1 M3 Strain C1 G0 Strain C1 G2 Strain Man3-9 with hybrid
Slide 35: Potential advantage, commercial scale production SBV (ZAPI) antigen
Potential advantage, commercial scale production SBV (ZAPI) antigen ➢ The production volume that will be needed to produced 1 batch of 100K, 1,000K and 10,000K SBV doses with C1 (1.75 g/L) ➢ C1 fermentation is based on Fed-batch technology with glucose feeding and synthetic media Doses per batch (20
Slide 36: Sanofi Vaccine Trial and Model Vaccine Murine Immunogenicity Study
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 Recombinant Hemagglutinin (HA) produced fermentation in C1 is well tolerated in mice ▪ No weight los
Slide 37: Seasonal Flu – C1 Gene Expression Platform
Seasonal Flu – C1 Gene Expression Platform C1, has potential to produce larger quantities of lower cost more potent recombinant seasonal flu vaccines Sanofi Pasteur Conclusions (1) : 1. The full length recombinant HA from the A/H1N1/New Caledonia/20/99 strain produced in Myceliophthora thermophila (
Slide 38: University of Oslo consortium feasibility study
University of Oslo consortium and Dyadic have agreed to enter into a feasibility study whereby University of Oslo can evaluate the C1 technology The purpose of the feasibility study is to demonstrate the potential viability of Dyadic’s C1 technology to express APC-targeted Influenza virus antigen pr
Slide 39: 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 40: 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 41: 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 42: Potential Use of C1 to Produce 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 43: Applying C1 to Produce Metabolites
Applying C1 to Produce Metabolites Our in silico metabolic model supports precise engineering Primary metabolite of C1 for optimal primary and secondary metabolites production: ▪ Dyadic collaborated with a third party to develop C1 strain for a high yield, low cost primary metabolite product ▪ Dyadi
Slide 44: 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 45: Thank You
DYADIC TT THANK YOU !
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