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August 2016 (OTCQX: DYAI) DYADIC MANAGEMENT PRESENTATION

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Page 1: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

August 2016(OTCQX: DYAI)

DYADIC MANAGEMENT PRESENTATION

Page 2: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

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.

Safe Harbor Statement

2

Page 3: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

Strategic Opportunity

Dyadic (OTC: DYAI) is a global biotechnology company producing enzymes and proteins using a proprietary expression system based on the Myceliopthora thermophila fungus (“C1”)

Commercial use of the C1 platform technology in industrial biotechnology culminated in DuPont’s acquisition of Dyadic’s Industrial Biotech business (12/31/2015) for $75 million

Market capitalization: $50.9 million(1)

Net cash: $62.6 million(2)

– No debt

Leadership team with a successful track record

The Company

3

(1) As of August 11, 2016. Share count represents 36.1 million common shares outstanding.(2) As of June 30, 2016. Reflects $0 debt balance. (i) includes investment grade bonds, but (ii) excludes ~$7.4 million held in escrow from DuPont

Transaction with expected release in July 2017

The C1 platform technology is a hyper-productive fungal expression system used to develop & manufacture large quantities of desired proteins at industrial scale more affordably

The C1 platform technology is proven and has been applied in the industrials sector by multiple market leaders: – DuPont

– BASF

– Abengoa

– Codexis/Shell

Active biopharmaceutical partnerships with Sanofi Pasteur and ZAPI Excellent safety profile Dyadic retains exclusive sub-license rights to the C1 platform technology in biopharmaceutical indications

The Technology

Potential to remove a critical bottleneck in protein development and manufacturing processes– Allows for rapid scaling

– Significantly lower CapEx and OpEx

Potential to improve therapeutic vaccine and drug performance Dyadic is seeking partnerships to sub-license, or partner its C1 platform technology in the vaccine, antibody

and biosimilar industries

The Opportunity

Page 4: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

Dyadic Target MarketsThe C1 platform technology has the potential speed the development, decrease the CapEx & OpEx, improve therapeutic vaccine and drug performance, and lower the cost of manufacturing biologic vaccines and drugs

Global biological drug market to be $287B by

2020(3)

Global vaccine market to be $100B by 2025(1)

Biosimilar market to be $26B by 2020(4)

Global insulin market to be $42B by 2019(2)

Recombinant Vaccines

(Human and Veterinary)

Biosimilars / Biobetters (non-Gly)

Biosimilars / Biobetters (Gly)Novel Biologic

Products

(1) World Health Organization.(2) Human Insulin Market - Drugs Type, Brands, Delivery Devices, Applications - Forecasts to 2020.(3) Global Market Study on Biological Drugs: North America to Witness Highest Growth By 2020.(4) World Biosimilars Market (follow-on-biologics) Opportunities, and Forecast, 2014-2020. 4

Page 5: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

C1 Platform Technology - Commercially Proven C1 platform technology used by industry giants in areas such as ethanol and industrial enzyme production and vaccine development

5Note: Refer to pages 37 and 38 for additional details on commercial applications of C1.

Acquired by

Page 6: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

Vaccine Applications

6

Page 7: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

$1.6B

$2.2B

$0.0

$0.5

$1.0

$1.5

$2.0

$2.5

$3.0

2011 2018

The Vaccines Market Opportunity

The vaccine market has increased from $5B in 2000 to

almost $32B in 2014– Influenza vaccine market: estimated to grow from $2.9B

in 2011 to $3.8B by 2018– Need for better patient immunization and lower cost– US: $1.6B in 2011 to $2.2B in 2018

Global market projected to rise to $100B by 2025

There are more than 120 new products in the

development pipeline

60 products are of importance for developing countries– Vaccines are becoming an engine for both the human

and animal pharmaceutical industry– Changing status of vaccines within the pharmaceutical

industry

7

U.S. Vaccine Market

Global Vaccine Market

$32B

$100B

$0

$20

$40

$60

$80

$100

$120

2014 2025

Source: World Health Organization.

Page 8: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

Winding Up Of Sanofi Vaccine Collaboration

Sanofi Pasteur is one of the largest vaccine companies in the world

Entered into a Proof of Concept, Exclusive Option & Technology Transfer Agreement (March, 2011) to

evaluate Dyadic’s C1 technology to speed up the development & production of vaccines at a lower cost.– Research conducted on and off over 5 ½ years, partially funded by Sanofi

Project Results – Successfully demonstrated that the C1 technology is capable of producing vaccines at high levels, with the

potential to improve therapeutic vaccine performance. – Initial C1 produced antigen showed an equal or better immune response in mice trials than the existing antigen

Expected Project Benefits– We believe that the experience and knowledge obtained from the research is invaluable and expect it will

generate a greater interest in the C1 technology for developing and manufacturing biologic vaccines

Sanofi’s prior option rights to the C1 technology previously covered by the Agreement revert back to Dyadic.

Upon such reversion, Dyadic expects to leverage the knowledge gained, and the progress made from the

meaningful improvements to the C1 expression system across all biologic vaccine and drug indications.

R&D collaboration terminated by Sanofi, expected to end October 5, 2016

8

Page 9: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

ZAPI – New €22 Million Vaccine R&D Program

Program sponsored by the EU to develop a platform suitable for the rapid development and production of vaccines

and protocols to fast-track registration of developed products to combat epidemic zoonotic diseases that have the

potential to effect the human population

Dyadic Nederland’s, B.V. is using C1 to express vaccines and neutralizing agents which if such research is

successful we anticipate the C1 platform technology may be chosen as a preferred platform within the ZAPI

research project– Two of the objectives we hope to attain through the ZAPI funded research project are as follows:

• Additional examples of vaccines and neutralizing reagents against emerging pathogens expressed from C1• C1 produced proteins regulatory pathway identified, and carried out at least in part, through collaborative

partnerships between human and veterinary medical institutions, governmental regulatory agencies, expert academic groups and industrial partners

ZAPI is a multi year project which full results may not be known for 3-4 years

9

Page 10: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

Additional Proof of Concept: Animal & Human Vaccines

• Leveraging the knowledge gained, and the progress made from the meaningful improvements to the C1 expression system from the Sanofi collaboration across a variety of biologic vaccine indications.

• Further demonstrate high level productivity, with the potential to improve therapeutic vaccine performance for both animal & human vaccines.• In discussions with leading Animal Health companies interested in evaluating C1• Seek additional funding from industry and government • Potentially initiate internally funded research & development programs

– Initiated small animal vaccine research program

10

Page 11: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

Biologics Applications

11

Page 12: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

Biologics Market Summary

In 2014, biologics accounted for 21% of total global

spending on medicines– Biologic spending are expected to grow at 10.1%

CAGR until 2020 to $287B

The global biosimilar market is growing due to the

need for lower cost biologics– $1.9B market in 2014 is expected to reach $25.5B by

2020, growing at an impressive CAGR of 54.4% – Increasingly greater drug pricing pressures along with

competition for biosimilars is expected to reduce drug pricing by 45% or more

Biologics are the fastest growing drug segment

Source: Global Biosimilar Market Outlook 2020. 12

New technologies like C1 provide the pharmaceutical industry with a way to insure patient access and affordability

to biologic drugs while helping the industry maintain profitability

C1 has the potential to:– Lower the costs of biologics– Help bring new and improved biologics to market– Help to overcome protein expression challenges of potential biologics stuck in R&D

Expect to begin research project with a big pharma company, beginning Q4 to express antibodies

In various stages of discussions with other biotech & pharma companies

Global pharmaceutical sales (US$ billion, list price, ex. rebates and discounts)

20142004

930

519

21%

79%13%

87%

8%

Page 13: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

Case Study: Generic HumiraDyadic produced biologically-active monoclonal antibodies in C1

Heavy chain

Light chain

Source: Peter Punt, TNO.

Expression was achieved of both heavy and light chains

Heterodimeric antibody molecules were formed efficiently, allowing simple purification of the protein from the

culture fluid using Protein A

Cell-based bio-assays performed revealed almost complete bioactivity

Production levels of 2 g/L reached after 4 days in fermenter

13

Page 14: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

Case Study: Generic Humira (Cont.)

Protease deficient strains were developed to improve

the stability of expressed heterologous proteins

State of the art molecular engineering methods based

on computational biology will enable us to eliminate

specific proteases to stabilize biologic proteins

Low Cellulase with Low Protease Activity

Protease

C1(wt)

0

10

20

30

40

0 20 40 60 80 100

time (h)

pept

ide b

onds

(mm

ol)

C1 WT UV18-25#100f

0

10

20

30

40

0 20 40 60 80 100

time (h)

pept

ide b

onds

(mm

ol)

C1 Δ proteases

14

Page 15: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

Case Study: Generic Humira (Cont.)

In vitro stability of heavy chain against C1 fermentation culture filtrates

15

0 4 8 24Single deletion

0 4 8 24Triple deletion

Hrs:

ΔproA ΔproA, ΔproB, ΔproC

Page 16: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

2016 - Develop C1 platform

technology as an expression host for:

‒ Vaccines‒ Biosimilars‒ New products

The 20-year Evolution of C1 Platform Technology

1992 Discovered C1

wild type strain which naturally produced neutral cellulaseenzymes

Wild type

1995 - 1996 Mutation led to

development of high cellulase C1 strain with unique morphology

Commercial launch of C1 enzymes for textile industry

1st

breakthrough1997 - 2007 Developed molecular

toolkit for optimizing C1-based recombinant protein production for commercialization

Produced variety of commercial products using the C1 strains

Successfully expressed human therapeutic proteins in C1

High throughput robotic screening developed and patented

Development

2005 - 2015 Sequenced and

annotated the C1 genome

Developed low cellulase C1 strain, enabling the commercial production of “purer enzymes

Hyper productivity reached 100 g/l with ~ 80% purity

2nd

breakthrough2009 - 2015 Developed

comprehensive enzyme library

Produced first commercial product using low cellulase C1

GRAS status acknowledged by FDA

Developed HC strains for biofuel enzyme production

Hyper productivity reached 100 g/l with ~ 80% purity

C1 for bio-industrial

2016 - 2018 Develop robust high C1

host strain for biopharmaceutical applications

Develop versatile easy to use construct library based on system biology

Develop glyco-engineered C1 strain to resemble human protein-glycosylation structure

Future development

C1 for biologic drugs and vaccines

16

1992 1995 1997 2005 2009 2016

Page 17: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

C1 Platform Technology

17

Page 18: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

C1 Platform Technology Overview

18

Mature system for production of heterologous proteins

Excellent safety profile

Fully programmable, patented technology

C1 genome annotated

Platform

Low cost, commercially scalable fermentation at up to 500,000 liter scale

High purity and yield, 100+ grams per liter

No animal-derived ingredients used in media

Short development and fermentation times

Serves as both a research and production host

Production

Potential to generate improved immune response in vaccines

Favorable glycoprofile can be modified to become ‘human neutral’ to lessen immunogenicity

Potential to improve therapeutic vaccine and drug performance

Product

Page 19: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

World Class Productivity and Purity

Synthetic biology start-ups – large and small –

struggle with the reality of scaling up microscopic

cellular factories into profitable business models

Dyadic’s patented and proprietary C1 platform

technology is being used to produce biological

products at very high yields, low cost and in large

commercial fermenters

Two serendipitous mutations led to the creation of the world class C1 platform technology

High yields, high purity, low cost at industry leading scale

Over 100 grams per liter protein

Up to 80% of target protein has been achieved

Commercially produced enzymes in a single 500,000 liter fermenter

100 g/L

80%purity

500,000 liter scale

19

Page 20: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

C1 Platform Technology Advantages

Grows and expresses proteins over a wide range of pH levels and temperatures– Allows gene expression under conditions optimal for the activity and stability of a wide range of targets

Integrated gene expression system increases the likelihood of successful expression

C1 platform technology offers many advantages over current expression systems

Bacterial Fungal Mammalian E.coli Saccharomyces Pichia C1 CHO

Cost low low low low high

Growth rate high high high high low

Culture media and conditions simple simple simple simple complex

Post-translational modifications no some some some yes

20

In the same amount of time, Dyadic’s C1 platform technology is expected to produce up to 20 times the g/L compared to CHO cells(1)

~CHO Cell Yield 2-10 g/L(2)

C1 Industrial Yield (Actual)

C1 Biopharmaceutical Yield (Expected in 2-3 years)

12-15 days

10-20 g/L 20-40 g/L

80 g/L 160 g/L

5-7 days

5-7 days

(1) C1 has a single cycle fermentation time of approximately 5-7 days compared to CHO single cycle fermentation time of 12-15 days.(2) Range based on approximate yield of Lonza and ThermoFisher CHO cell line expression systems.

5-7 days

5-7 days

Page 21: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

Indicative Savings for Biosimilars with C1C1 productivity provides the potential to dramatically lower CapEx

21

C1CHO

(1) Represents lower range of yield. Refer to page 15 for additional details.

500

100

0

50

100

150

200

250

300

350

400

450

500

2-10 G/L 20-40 G/L

DE

VE

LOP

ME

NT

CO

STS

($ M

ILLI

ON

S)

YIELD (1)

10,000L fermenter reduced to a 1,000L fermenter

Capital investment required to build launch capacity

Factory with launch capacity must be built 24 months before FDA approval,

or very costly CMO

FDA license easier for small factory

Additional costs beyond factory investment related to

clinical trials ($300mm), regulatory ($10mm), and initial

marketing ($20mm) would still be required to complete

the full product development

Page 22: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

C1 strain non-toxic

Pathogenicity and toxigenicity data: strain is non-

infectious and no known toxins are produced

Peer-reviewed scientific literature have confirmed

— No known pathogencity

No mycotoxins found

C1 enzyme testing

In vivo feeding trials:– 14 day dose study in rats– 13 week subchronic rat study

Genotoxicity testing:– AMES bacterial mutagenesis– Chromosomal aberration test– Genetic mutation test

No adverse effects observed

No foreign DNA

Safety confirmed

C1 Has an Excellent Safety Profile

C1-cellulase accepted by FDA on September 29,

2009

GRAS notification letter is a public statement by

FDA acknowledging Dyadic’s safety

determination for the intended uses of C1

GRAS notification letters are broadly recognized

in the food and consumer products industries as

the safety standard

Generally Recognized as Safe (GRAS) status acknowledged by the FDA

22

Page 23: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

First Breakthrough: Morphology Change

Development lineage of low viscosity hyper-producing protein C1 strains

Propagules instead of hyphae results in hyper productivity and low viscosity

NG7C-19 HC

Viscosity Proteinyield

Visc

osity

(cP

)100

200

300

400

500

Pro

tein

(g/L

)

20

40

60

80

100

23

C1

UV13-6

HC

NG7C-19

UV mutagenesis

UV mutagenesis

NTG* mutagenesis

Wild-type

Cellulase over producer

De-repressed cellulase production

High cellulase, low viscosity mycelial fragmentation

Page 24: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

The Low Cellulase Strain for Protein ProductionDevelopment high productivity low protease activity of host strains for specific proteins productions

low cellulase prt- with specific protease disruption

Protease deficient strain

De-repressed cellulase production

24

Page 25: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

C1 White Strain 2.0

Expression of high levels of purer proteins

Second Breakthrough: High Purity

Dyadic’s C1 White Strain 2.0

successfully used in production of

single and multiple proteins derived

from fungal, bacteria, bacterial-

directed evolution, mammalian,

human and viral strains

Reduction of background proteins

that are not needed– Obtain purer protein– Higher levels of targeted protein

The C1 White Strain 2.0 is fermented

at large commercial scale

WT

LC

HC

C1 strain types

C1 “White Strain” 2.0 has a very different protein background than the C1 Wild Type Strains

25

C1HC

Page 26: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

C1 Engineering Next Steps

26

Page 27: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

C1 Genetics ToolsDyadic’s advanced genetic toolkit allows for sophisticated manipulation of C1 strain

27

Dyadic Toolbox

Precise Gene Targeting

Marker Recycling

Genome Sequencing

Gene Replacement

Promoter Replacement

Gene Deletion

Screening

Page 28: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

Gene 1

Optimizing codon usageLibraries of efficient

strong promoter

Libraries of TF and signal peptides and / or carrier

proteins

Protease activity reduction Low Cellulase

StrainAdjustment of post-

translational modification

Computational biology for

Low Cellulase Expression TechnologyAdvanced genetic manipulation methodologies enable rapid and efficient cloning of heterologous genes

28

Page 29: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

Rapid ScreeningMicrotiter plate-based C1 fermentation utilizes the same protein in the development process as is used to commercialize the product, saving time by eliminating the necessity to convert the development protein

Chromosome NotI NotI

NotI NotIC

BamHI BamHI

hTEL Pcbh TcbhpyrG insert AmpR pyrE hTEL

NotI NotIB

A

BamHI

pPinsT pyrE tel pyrG

Not I

pyrE

hTEL

I-CeuIhTEL

pyrGPcbh

insert DNA

Tcbh

AmpR

BamHI

Not I

Chromosome NotI NotI

NotI NotIC

BamHI BamHI

hTEL Pcbh TcbhpyrG insert AmpR pyrE hTEL

NotI NotIB

A

BamHI

pPinsT pyrE tel pyrG

Not I

pyrE

hTEL

I-CeuIhTEL

pyrGPcbh

insert DNA

Tcbh

AmpR

BamHI

Not I

2 months 4 months 6 months

Screening

29

Library construction TransformationIdentification of

high protein producers

Rescreening

8 months

FermentationHit verification

Page 30: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

C1 GlycansC1 glycans resemble human structure which results in less time and effort required to re-engineer cells compared to yeast

30

Page 31: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

G0

N-acetylglucosamine

Mannose

Fucose

Galactose

Sialic acid

G1

Important in ADCCdeleted forms have 10-100x higher potency

1 or 3 additional mannose may be added

G0: simplest structure that is human and yet still fully functional - “human neutral”

Terminal sialic acid not necessary

Glycoengineering C1 CellsC1 glycoengineering for biosimilars and biobetters applications

31

Page 32: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

Development Timeline

32

Vaccines Development

(in process)

Non-Glycosylated Biosimilars

(in process)

Glycosylated Biosimilars

Strain glycoengineering

mAbs development

New BiologicDrugs

NDP platform development

H1 H2 H3 H4 H5 H6 H7 H8

Vaccines development

Vaccines CMC & registrations

POC for NGPs

NGPs CMC & registrations

Other molecules expressions

NDP development

32

Page 33: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

Conclusion: Commercially Proven

33

Validated by industry giants

Excellent safety profile

Utilizing the same cell line saves time as well as

increases the probability of cultivating a successful

commercial process

Potential to produce up to 20 times the g/L per day

compared to CHO

Significant capital and operating expense savings

Potential to improve therapeutic vaccine and

drug performance

Toolkit already developed to allow for sophisticated genetic modifications to

C1 strains

Experienced management team

Dyadic’s C1 platform technology, a hyper productive cell line, programmable and

commercially scalable

Page 34: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

Appendix

34

Page 35: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

Vice President and Chief Financial Officer since 2014 Management Consultant 2012 to 2014 Finance Officer at Walgreens 2007 to 2011 Director of Finance at Novartis 2005 to 2006 Finance Director Abbott Laboratories 1984 to 2002 B.S. in Accounting, University of Illinois, CPA Illinois

Chairman of Dyadic since 2015 Former Chairman of Keryx Biopharmaceuticals from 2009 to 2016 Senior Vice President at Pfizer from 1989 to 2007 M.B.A. from New York University

Dyadic Leadership President and Chief Executive Officer from 1979 to 2007, 2008 to present Founder of Dyadic and member of Dyadic’s board of directors since 1979 Chairman from 1979 to 2007, 2008 to 2015 B.A. degree from the University of Iowa

Mark EmalfarbPresident and Chief

Executive Officer

Michael TarnokChairman of the Board

Thomas DubinskiChief Financial Officer

Ronen TcheletVP of Research and

Business Development

Vice President of Research and Business Development since 2014 Vice President at Codexis. Founder and Managing Director of Codexis

Laboratories Hungary from 2008 to 2014 Chief Technology Officer of API at Teva Pharmaceuticals from 2000 to 2007 Ph.D. in Molecular Microbiology and Biotechnology from Tel Aviv University

35

Arindam BoseBoard Member

Board Member at Dyadic since 2016 Vice President of Bio Therapeutics Pharmaceutical Sciences External Affairs

and Biosimilars Strategy at Pfizer 2010 to March, 2016 Executive Director of Human Biologics Strategy & Sourcing at Pfizer 2003 to

2009 Director of Human Biologicals at Pfizer 2000 to 2003 Senior Technical Advisor of Human Biologicals at Pfizer 1997 to 2000 Manager of Bioprocess Development at Pfizer 1991 to 1997 Ph. D. in chemical engineering from Purdue University and a M.S. in chemical

engineering from the University of Michigan, Ann Arbor

Page 36: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

Moscow State University

Scientific CollaborationDyadic has a history of strong scientific collaborations

36

Enzyme Development

Genome Annotation

C1 Strain Development, Optimization

Development programs for gene expression, gene knock outs and gene discovery (low protease C1 strains and C1 molecular toolkit)

Performed annotation of the C1 genome, allowing identification of key metabolic functions that influence expression and glycosylation

Isolation, discovery and characterization of the enzymes expressed by the wild type and mutants of the C1 fungus

Fermentation, Process Development,

Optimization

Development, scale up and commercial scale production of enzymes and other proteins utilizing the C1 platform technology

Page 37: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

DuPont Sale is a Transformational Event for Dyadic

The market acceptance and commercial use of the C1 platform technology in industrial biotechnology applications

has been recognized by industry leading companies which culminated in DuPont’s acquisition of Dyadic’s Industrial

Biotech business for $75 million

Dyadic will leverage over two decades of experience in industrial biotechnology and technological advances in

synthetic biology, genomics and biotechnology to pursue opportunities for using the C1 platform technology for

biopharmaceutical applications– Vaccines– Biosimilars / biobetters– Novel biologic drugs

Sanofi Pasteur and the EU-funded ZAPI program are examples of industry and governmental funded research

programs utilizing Dyadic’s C1 platform technology in biopharmaceuticals– Sanofi R&D collaboration utilizes C1 platform technology to speed up the development and production of new vaccines

at a lower cost with potentially better immunogenicity• Five plus year collaboration winding up Oct 2016

– ZAPI program uses C1 platform technology to develop a platform suitable for the rapid development and production of vaccines and protocols to combat epidemic Zoonotic diseases

Dyadic has recently initiated internally-funded R&D programs to demonstrate the production of insulin and

ranibizumab

Dyadic will commence C1 glycoengineering to manufacture antibodies such as Enbrel and Humira

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Page 38: DYADIC MANAGEMENT PRESENTATION€¦ · The Vaccines Market Opportunity The vaccine market has increased from $5B in 2000 to almost $32B in 2014 – Influenza vaccine market: estimated

Collaborator

Dyadic licensed C1 to Abengoa on a non-exclusive basis Abengoa funded a research project at Dyadic in order to develop a C1 strain to convert biomass into

sugars for industrial applications in certain territories Dyadic granted Abengoa expanded rights to the original non-exclusive C1 license, granting ,among

other rights a worldwide territory

ADM acted as a toll manufacturer for Abengoa, producing enzymes at 500,000 liter scale for use in Abengoa’s 20 million gallon cellulosic ethanol plant in Hugoton, Kansas

Antibioticos acted as a toll manufacturer for Abengoa, producing enzymes at 50,000 liter scale for use in Abengoa’s cellulosic ethanol pilot plant in Salamanca, Spain

Dyadic granted a non-exclusive C1 license to BASF to develop, produce, distribute and sell industrial enzymes

BASF funded a research project at Dyadic Nederland's former R&D facility using the C1 platform technology

Dyadic granted a non-exclusive C1 license to Codexis to develop and manufacture cellulosic and hemicellulosic enzymes for bioethanol and bio-based chemical production

The Codexis C1 license allowed for a sub-license to Shell who funded ~$400 million to Codexis for further advancing & developing C1

Dyadic sold its Industrial Technology business, including the C1 platform technology to DuPont for $75 million in cash

DuPont has granted back to Dyadic co-exclusive rights to the C1 platform technology for use in pharmaceutical applications, with exclusive ability to enter into sub-license agreements in that field

DuPont will retain certain rights to utilize the C1 platform technology for development and production of pharmaceutical products, for which it will make royalty payments to Dyadic upon commercialization

C1 Platform Technology - Commercially Proven C1 in use by industry giants

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C1 Platform Technology - Commercially Proven (Cont.)

C1 used by industry giants

Acquired by

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Collaborator

Iogen in its collaboration with Shell through Codexis, developed a large commercial scale fermentation process and manufactured at 150,000 liter scale cellulosic and hemicellulosic enzymes to convert biomass into sugars for bioethanol production

Martek acted as a toll manufacturer for Dyadic’s industrial biotech business, producing a variety of different enzymes at 150,000 liter scale which Dyadic sold to over 35 countries for various industrial enzyme applications

Polfa Tarchomin acted as a toll manufacturer for Dyadic’s industrial biotech business, producing a variety of different enzymes at 50,000 liter scale which Dyadic sold to over 35 countries for various industrial enzyme applications

Sanofi Pasteur and Dyadic entered into a vaccine research collaboration where Sanofi Pasteur hasfunded collaborative activities at Dyadic Nederland's former R&D facility using the C1 platform technology

Data generated by Sanofi Pasteur indicates that the C1 produced antigen generated an equal, or better, immune response in mice than the industry standard antigen

Shell in conjunction with the Codexis’ non-exclusive C1 license funded Codexis with ~$400 million to develop and manufacture cellulosic and hemicellulosic enzymes based on and manufactured by C1 to convert biomass into sugars for bioethanol and biobased chemical production.