November 29, 2021

C1 Technology Platform

Rapid response to Pandemic and other

biological threats

Support the global combat against SARS-CoV-2 Variants of Concern

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, intentions, strategies and beliefs pertaining to future events or future financial performance. Actual events or results may differ materially from those in the forward-looking statements as a result of various important factors, including those described in Dyadic's most recent filings with the SEC. Undue reliance should not be placed on the forward-looking statements in this presentation, which are based on information available to us on the date hereof. Dyadic assumes no obligation to update publicly any such forward-looking statements, whether as a result of new information, future events or otherwise. For a more complete description of the risks that could cause our actual results to differ from our current expectations, please see the section entitled "Risk Factors" in Dyadic's annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, as such factors may be updated from time to time in Dyadic's periodic filings with the SEC, which are accessible on the SEC's website and at www.dyadic.com

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Our Mission, Transforming Biomanufacturing

"Improving how we feed1, fuel1, and heal the

world by utilizing modern biotechnology to revolutionize science, medicine, agriculture1."

"Providing a cost-effective solution that increases outputs and to meet the growing

demand for protein production."

"Ultimately fulfilling the unmet need of affordable biologic drugs, vaccines and biologic products and processes."

-Mark Emalfarb, CEO Dyadic

1 Dyadic has achieved certain ports of the above "Mission" through its twenty plus years of experience in industrial biotech. Currently, we are primarily focused on

animal and human health applications while opportunistically exploring if and how we may enter/re-enter certain industrial biotechnology applications.

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Broad Applications for the C1 Platform with 20 Years of Experience

1992

2005

2016

Today

C1 wildtype strain produces commercially valuable catalytic enzymes

C1 mutation leads to commercial launch of

C1 enzymes for industrial textile manufacturing

C1 molecular toolkit optimized for development in other industries including human therapeutics

Genome sequenced and cell line refined for high purity in industrial manufacturing

Enzyme library developed

Generally Recognized as Safe (GRAS) designation by FDA

C1 launched in biofuels industry

Launch of human development for vaccines and biosimilars

ZAPI project initiated

Acceleration of Proof-of-Concept collaborations with pharma industry

Covid-19 vaccine Collaborations

  • Africa - Rubic Consortium
  • S. Korea / SE Asia - Medytox
  • India - Syngene
    • Epygen (1)
  • Americas, Europe, Others
    • Sorrento (2)

Funded R& D, pre-clinical trials with top global pharma and leading animal health companies

C1 Platform first in human trials

"C1-cells" are an exceptional strain of genetically engineered fungus (Thermothelomyces heterothallica) whose usages have expanded through 20 years of commercial engineering

  1. Epygen - Awaiting investment funding to initiate pre-clinical and phase 1 & phase 2 clinical trials in India (BIRAC approved Co-funding)
  2. Sorrento - the parties are continuing to negotiate the License Agreement, the terms of which may be materially different than the terms set

forth in the binding term sheet announced on August 11, 2021; we can give no guidance if or when the License Agreement will be executed,

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but in the interim, technology transfer to Sorrento for DYAI-100 and the C1 platform has been initiated.

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C1-Cell Technology / Proven Rapid, Efficient Antigen Manufacturing Platform

Robust, versatile and scalable platform for production of Covid-19 variant of concern and other antigens

  • Status of C1-basedDYAI-100COVID-19 vaccine development
    • Stable C1-cell expressed RBD-CTag antigen Stable C1-cell expressed was developed by Dyadic in less than three months.
    • A C1 cell line (single gene copy) expresses the RBD at a level of .75 g/L in 4 days under GMP with high purity.
    • Since the gene is inserted into a single site and it is being expressed by promiscuous strong promoter there is no need for induction.
    • The single-copy integrated gene is very stable - No need for transient stage.
    • Pre-clinicalstudies in mice confirmed that the DYAI-100 vaccine candidate induced high level of neutralizing antibodies and generated protection in two (2) Human ACE2 mice challenge studies.
    • Phase I clinical study is planning to start first half of 2022.
    • Current production development is aiming to increase the titer to 2-3g/Lat production scale as already achieved in several lab scale fermentations.
  • Toxicology study demonstrated complete safety by using C1-RBD antigen & Alhydrogel
    • The Toxicology study involved 2 groups of n=20 rabbits each (n=10 males and n=10 females per Test Group). One group was subjected to ×4 injections of the Test Item and the second group served as Control Administrations will take place at an interval of 1 week between each injection during the study.
    • Toxicology study will support two or three doses of the DYAI-100 vaccine candidate
    • "In view of the reported findings and under the conditions of this study, it can be concluded that the Test Item C1-RBD Vaccine (Batch: 21Q-DY-02) Vaccine was not associated with major systemic adverse effects and the Test Item is considered safe".
  • Rapid generation of stable C1-cell lines for different variants
    • We can rapidly insert RBD variant's genes into the same cell line (same genotype).
    • In addition to the Wuhan RBD, the following variants: Alpha (UK), Beta (SA) Gamma (BR) and Delta
      (Ind) RBD's have been successfully expressed in C1 cell line (e.g., RBD-delta-CTag: 1.36 g/L in 5 days fermentation before fermentation optimization)
  • Rapid generation of stable C1-cell lines to produce Omicron (SA) being initiated
    • Anticipate stable C1-cell producing Omicron antigen in two months after gene synthesis

Rapid Development Timeline

1 week

3 weeks

1 week

2 weeks

Strain

MTP ferm., DSP

1-30 l scale

Gene synthesis

Plasmid

construction and

and analytics

fermentation

construction

re-isolation for

& RCB

from RCB, DSP

monoclonality

generation

and analytics

Sending samples

cGMP grade strain

and process

for evaluation,

characterization,

animal studies

MCB,

ACE2 - ELISA Assay

Alpha

Beta

Gama

3

3,5

3

(average,450nmAbs.n=3)

2,5

3

BTGref_4

(average,450nmAbs.n=3)

2,5

(average,450nmAbs.n=3)

2,5

SA_B4

2

2

2

1,5

1,5

1,5

1

BTGref

1

1

0,5

UK_RBD-C-tag

BTGref B2

0,5

0,5

0

0

SA_B2

0

200

400

600

800

1

10

100

1000

0

Conc. ng/ml

Conc. ng/ml log

0

200

400

600

800

1000

Conc. ng/ml

Delta

Alpha, Beta,Gama-Co-expressed

3

RBD-Delta-Ctag, BTG Elisa

3

n=2)

2,5

2.5

(average,450nmAbs.

n=2)(average,Absorbance

2

2

WhCtag ref

1,5

1.5

Delta-Ctag b1

1

1

BTGref

0.5

0,5

UK-SA-BR_RBD-Ctag mix

0

0

0

100

200

300

400

500

600

700

800

5

Conc (ng/ml)

0

200

400

600

800

Conc. ng/ml

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Dyadic International Inc. published this content on 29 November 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 29 November 2021 21:50:03 UTC.