Next Generation Proteins for World Health
C1 Protein Production Platform
6th Annual BFC Global Healthcare BD and Investment Conference from January 8, 2023, San Francisco, CA USA
Dyadic International, Inc.
(Nasdaq:DYAI)
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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Dyadic's Mission: Proteins for World Health
Transforming Biomanufacturing &
Closing the Technology Gap Across the Globe
Meeting the growing demand for proteins worldwide for human and animal health with highly productive scalable microbial biomanufacturing platforms.
To improve how we feed, fuel, and heal the world by utilizing modern biotechnology to revolutionize science, medicine, agriculture, nutrition and food.
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Over $100MM and 30 Years of commercial engineering invested in C1
"C1" (Thermothelomyces heterothallica) is an exceptional genetically engineered fungal strain
Broad application of C1 has expanded through decades of commercial engineering
1992 | 2005 | 2016 | Today | |
C1 strain discovered to produce commercially valuable enzymes
Commercial launch of C1 enzymes produced for industrial textile manufacturing
C1 molecular toolkit optimized for broad development across other industries including human therapeutic applications
Genome sequenced and cell line refined for high purity in industrial manufacturing
Enzyme library developed
C1 launched in biofuels industry
Generally Recognized as Safe (GRAS) designation by FDA
Launch of human biologics development for vaccines and biosimilars
Proof-of-Concept collaborations with pharma industry accelerate
Global partnerships and R&D projects with top pharma and leading animal health companies
Preparations for 1st in human trials: DYAI- 100 COVID Vaccine moving into in Phase 1 Clinical Trial in South Africa & India
C1 produced COVID-19 mAb shows safety and efficacy in hamsters and nonhuman primate studies
Strategic partnerships and collaborations:
- Janssen
- NIIMBL
- Rubic
- Epygen
- Syngene
• Phibro | |
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Dyadic investing in validation of C1 Platform for human clinical trials
Platform Evaluations
Regulatory
-DYAI-100 regulatory assessment performed by Parexel with no significant deficiencies identified
-DYAI-100 CMC technical package, pre-clinical animal and toxicology studies evaluated by Paul-Ehrlich-Institute (PEI) -PEIconclusion data package and studies supported submission of Clinical Trial Application (CTA)
-DYAI-100 IMPD and IB completed, CTA submitted with CMC requirements to South African Health Products Regulatory (SAHPRA) -HumanEthics Committee approved protocol, SAHPRA approval to proceed with Phase 1 trial (~ EARLY Q1 2023)
CMC
Toxicity/Safety
-Completed cGMP manufacturing of toxicology and clinical trial material
-Developed full regulatory CMC technical package for Drug Product & Drug Substance, Submitted CTA -DYAI-100 fill/finish completed, product on long term stability
-CMC technical package completed and approved by SAHPRA to proceed with Phase 1 trial
-Vaccines produced from C1 proteins tested for safety in animal trials with cattle, lambs, chicken, rabbits, hamsters and mice
-Demonstrated safety and efficacy in broad range of animal models for infectious diseases (influenza, COVID, RVFV, SBV)
-DYAI-100 safety studies in mice, hamster studies and rabbit toxicology study.
-DYAI-100 New Zealand White Rabbit Tox Study observed no adverse events
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Dyadic International Inc. published this content on 04 January 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 January 2023 23:17:06 UTC.