Dyadic International, Inc. · NASDAQ:DYAI
Dyadic International — Investor Presentation (May 2019)
41 slides from Dyadic International's investor presentation, May 20, 2019
Slide 1: The C1 Technology Platform: Making Healthcare Accessible & Affordable
NASDAQ: DYAI The C1 Technology Platform Making Healthcare Accessible & Affordable Investor Presentation DYADIC INFORMATION
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 the federal securities laws. These forward-looking statements involve risks, uncertainties and other factors that could cause Dyadic’s actual result
Slide 3: Biologics Development and Manufacturing Need Change
Biologics Development and Manufacturing Need Change To further develop C1 into a safe and efficient gene expression system to help speed up the development, lower production costs and improve Dyadic’s the performance of biologic vaccines and drugs at flexible commercial Goal scales. CHO stopper? Bio
Slide 4: Dyadic Highlight
Dyadic Highlight Ticker: NASDAQ: DYAI Share Price: $4.35(1) 52 Weeks Range: $1.40-$4.87(1) Market Capitalization: ~$116.1 million(1) Shares Outstanding: ~26.7 million(1) Insider Ownership Percentage: 30.7% (2) Debt: Zero Warrants: Zero Cash and Investment Grade Securities: ~$40.1 m
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 PHARMA / FUNGAL GENE EXPRESSION PLATFORMS DYADIC INFORMATION DYADIC INFORMATION 5
Slide 6: 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 years Dr. Buckland worked at Merck for 29 years Mr. Tarnok (Dyadic chairman) spent the and held leadership roles within where he served in a number of senior R&D majority of
Slide 7: Why Invest in Dyadic? (DYAI)
Why Invest in Dyadic? (DYAI) Funded On-going Experienced Compelling Proven R&D Board Members Strong Cash Valuation and Technology for Collaborations and Position and NASDAQ Industrial Use with Top Tier Management Zero Debt Uplisted Pharm Team US$40.1M Sold Cash & Form 10 Effective Industrial Investm
Slide 8: 2018 Achievements and Milestones
2018 Achievements and Milestones Signed More Than 100 Confidentiality Agreements & MTA’s Entered Into Nine New Collaborations: Sanofi – Aventis Funded collaboration to use C1 technology to produce multiple types of biologic vaccines and drugs of interest for human health indications. Mitsubishi Tana
Slide 9: Q1-Q2 2019 Corporate Achievements and Milestones
Q1-Q2 2019 Corporate Achievements and Milestones Corporate Achievements • Uplisted to NASDAQ: Initiated trading on April 17, 2019 • Form 10 Effective on February 12, 2019 Two Sublicensing Agreements • Luina Bio/Novovet: with equity stake and royalties to use C1 to develop biologic vaccines and drugs
Slide 10: Dyadic and Serum Institute of India Collaboration
Dyadic and Serum Institute of India to Develop and Manufacture Globally Affordable and Accessible Antibody Products and Vaccines Serum Institute of India – the world's largest vaccine manufacturer by number of doses produced and sold globally - the number of doses account to more than 1.3 billion. S
Slide 11: Business Strategy to Sublicense C1 to Acquire Equity Interests
Business Strategy to Sublicense C1 to Acquire Equity Interests in Biotech Companies Future BDI 16.1% Ownership interest Sublicensee Animal & Human health Future Group www.bdibiotech.com Future Sublicensee Sublicensee Alphazyme Dyadic C1 VLP Bio 7.5% Ownership interest (2) Technology 16.3%
Slide 12: Biopharmaceutical Markets
DYADIC Biopharmaceutical Markets é- a pro ? “« 7 we
Slide 13: Global Biologic Drug Market To Be $479.8 Billion (2024)
Global Biologic Drug Market To Be $ 479.8 Billion (2024) “Market growth is primarily driven by the increasing demand for biosimilar drugs due to their cost-effectiveness, increasing incidences of chronic diseases, and strategic collaborations resulting in enhanced productivity and clinical trial act
Slide 14: Healthcare is an inalienable right; Society is failing patients
Healthcare is an inalienable right; Society is failing patients FDA Commissioner Scott Gottlieb Slams Pharma, Launches Biosimilar Pathway, 7/19/2018 “Less than two percent of Americans use biologics, but they account for 40 percent of total spending on prescription drugs. They also represent 70 perc
Slide 15: Hepatitis B: an Endemic in China
Hepatitis B: an Endemic in China Of the 350 million individuals worldwide infected with the hepatitis B virus, one-third reside in China, with 130 million carriers and 30 million chronically infected. Every year, 300,000 people die from HBV-related diseases in China, including 180,000 patients with
Slide 16: C1 Gene Expression Platform
DYADIC Ci Gene Expression Platform e~ ys fro r “ 7 we
Slide 17: C1, Myceliophthora Thermophila
C1, Myceliophthora Thermophila C1 is a thermophilic fungus, Myceliophthora thermophila originally isolated from alkaline soil in Russia for its ability to produce neutral/alkaline cellulases for use in textiles, and later used to produce enzymes for biofuels, pulp & paper, biogas … C1 has a uniq
Slide 18: C1 – The Science
C1 – The Science Translates into better growth conditions Unique Morphology • Higher yields of secreted protein • Lower viscosity C1 White Greater retention of target secreted CHO Strain 2.0 High Purity - 80% of protein through downstream processing Requires only low cost synthetic media targe
Slide 19: C1 vs CHO
C1 (12 – 14 days) vs CHO (41-54 days) - FLOW C1 VS CHO • C1: Higher Protein Productivity • ½ the Cycle Time • C1: Easier – Advanced Genetic Tool Box • C1: Faster – Develop Initial Cell Line in c15 weeks • Shorten development time • Lower Development & Production Costs • Increased productivity • Smal
Slide 20: C1 Can Operate Successfully in Single Use Bioreactor
C1 Can Operate Successfully in Single Use Bioreactor C1, a filamentous fungi, produces Certolizumab at Single Use bioreactor with the same performances than at Stainless Steel bioreactors The productivity of 9.2 g/l is virtually identical to the productivity achieved in the Stainless Steel Biore
Slide 21: C1 Broad Applications of Therapeutic Proteins
C1 Broad Applications of Therapeutic Proteins C1 to Help Overcome Difficult-to-Expressed Proteins
Slide 22: C1’s Broad Applications and High Yield Level
C1’s Broad Applications and High Yield Level Fc-Fusion mAbs Fab (Certolizumab) Bispecific 12.2 g/l 9 g/l 14.5 g/l 1.04 g/l 144 Hours 90 Hours 164 Hours 144 Hours 1.74 g/l/day 2.4 g/l/day 2.1 g/l/day 0.17 g/l/day Therapeutic Proteins Vaccines/Antigens/Virus Like Particles (VLP) Hemagglutinin Antigen
Slide 23: ZAPI Antigen yield: 1,780 mg/l
Fermentation Results of ZAPI Antigen With C1 9xΔ Protease Strain Seventeen (17X) The Initially Stated Target Expression Level Affinity chromatography purification at small scale to determinate the production level Baculovirus (30 - 50 mg/l) Fermentation Purification analysis steps ZAPI Antigen
Slide 24: Success In Bispecific Expression
Success In Bispecific Expression In a few months work we have been able to express a bispecific antibody using C1 to a level of 1.04 g/L and provide sufficient quantities of this antibody to our collaborator which they were not able to do previously using other expression systems after two years of
Slide 25: 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 o C1-produced purified using only single chromatography step o CHO-produced fully purified Potency of C1-produced bispecific in the bioa
Slide 26: Monoclonal Antibodies
Monoclonal Antibodies • Antibody very stable • Best productivity so far at 30L scale: o mAb titer of 9 g/L at 90 h o 2.4 g/L/day DYADIC INFORMATION 26
Slide 27: 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 available was produced in CHO (control Mab) and C1 (C1-produed mAb) The binding properties of a pharma’s mAbs to the ligand were mAb compared in a Biacore T200 assay The
Slide 28: Dyadic C1 Biopharmaceutical Projects
Dyadic C1 Biopharmaceutical Projects
Slide 29: Cimzia Information
Cimzia® Information Certolizumab pegol, the drug substance of Cimzia® is a recombinant, humanized Fab' antibody. It lowers inflammation in the body by blocking a protein called TNF (tumor necrosis factor). Certolizumab Cimzia® is manufactured by UCB and used to treat Crohn’s disease, arthritis
Slide 30: Success in Expressing Certolizumab (Fab) by C1
Success in Expressing Certolizumab (Fab) by C1 Successful expression of Certolizumab No N glycosylation has been identified to date in Certolizumab O-glycosylation has recently been identified in Certolizumab, it will need to be reduced or removed ELISA kit was used to measure and conform Ce
Slide 31: Roadmap for Biosimilar Certolizumab Development
Roadmap for Biosimilar Certolizumab Development CMC development and batches production (GMP for clinical assays) Optimization of process & product quality attributes profile, cell line characterization & stability, formulation & product stability testing. Year 1 Year 2 Year 3 – Year 6 Cell line CMC
Slide 32: Opdivo Information
Opdivo® Information The immunotherapy drug Opdivo ® (nivolumab) is manufactured by Bristol Myers Squibb. Opdivo is approved for several cancers that are metastatic (such as lung cancer, melanoma, and more), and has resulted in responses previously not seen with these advanced cancers. Opdivo,
Slide 33: Successful expression of Nivolumab (mAb) by C1
Model Glycosylated Monoclonal Antibody (mAb) Successful expression of Nivolumab (mAb) by C1 Glycoengineering of the C1 host production cell is ongoing Once we have the proper glycoengineered C1 cell line we will try and express nivolumab in that C1 cell. This will be a potential BioBetter, a
Slide 34: Sanofi Pasteur Mice Trial
Sanofi Pasteur Mice Trial Immunogenicity Study of HA/NC Produced by C1 HA/New Caledonia The Recombinant Hemagglutinin The HA/New Caledonia C1 can produce high levels of HA (~1 g/L) as well as (HA) produced in C1 did not produced in C1 showed other Antigens in 3 -7 days by using low cost induce
Slide 35: Model Vaccine – Based on Sanofi Pasteur HA Data
Model Vaccine – Based on Sanofi Pasteur HA Data Hemagglutinin (HA), (Develop C1 as a seasonal flu platform). • HI response after 2 IM immunizations in Mice: • Significant 2-fold difference in favor of HA derived from C1 Based on preliminary mice trial data C1 has the potential to produce HA at l
Slide 36: Exploring the use of C1 to produce AAV Vectors
Exploring the use of C1 to produce AAV Vectors Adeno – Associated Virus (AAV) Vectors New York Times, Nov 27, 2017: Gene Therapy Hits a Peculiar Roadblock: A Virus Shortage o Significant increase in gene therapy; Backlog for in the production of viruses o Manufacturing disabled viruses (usually a
Slide 37: Applying C1 to Produce Metabolites
Applying C1 to Produce Metabolites Metabolic model was developed to Primary metabolite support PRECISE ENGINEERING approach for Primary and Dyadic collaborated with a third party to develop C1 strain for a Secondary metabolites production high yield, low cost primary metabolite product Dyadic is
Slide 38: In Summary...
DYADIC In Summary...
Slide 39: Leveraging C1’s Industrial Biotech Commercial Success
Leveraging C1’s Industrial Biotech Commercial Success In 2 ½ Years Proprietary Technology C1: Fungal Gene • Signed More Than January 2019 Our Expression Platform 100 NDA’s & MTA’’s 40 Year Anniversary Success in Industrial Use 9 - Deals in 2018 HQ: Jupiter, FL 5 - Deals To Date 2019 Biopharmaceutica
Slide 40: C1 Business Benefits and Opportunities
C1 Business Benefits and Opportunities Shorter development & Higher protein yields Higher purity & greater production cycles Lower CapEx/OpEx protein recovered No negative clinical Low cost media / No signs in mice studies viral inactivation R&D Licensing Other Commercial Collaborations Arrangements
Slide 41: Thank You!
DYADIC" THANK YOU !
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