NASDAQ:DYAI
READ THE FULL DYAI RESEARCH REPORT
Dyadic International Inc. (NASDAQ:DYAI) enters 2025 on the cusp of generating product revenues from its relationship with Proliant. Initially, commercialization efforts and sales will be focused on recombinant serum albumin. Further down the road, additional proteins may be added including bovine albumin, bovine transferrin and bovine alpha-lactalbumin. Dyadic’s partner is expected to first focus on research grade product, but will be able to expand into the excipient grade and current good manufacturing practices (cGMP) grade product as the market matures.
Consumers of these proteins prefer recombinant proteins because they are more consistent, avoid the impurities of animal-derived product and are more sustainable; however, the hurdle to using them has been cost. With C1’s efficient production ability, Dyadic asserts that recombinant bovine serum albumin can be manufactured at expense levels competitive with animal-based product. This has the potential of attracting market share from traditional sources as customers of these products recognize its value. In addition to the proteins that Dyadic has licensed to Proliant, there are other proteins[1] that have received a certificate of analysis[2] and are exposed to attractive markets.
Deoxyribonuclease I (DNAse1) is a critical and expensive input into manufacturing messenger RNA, producing proteins and enzymes, removing genomic DNA contamination and cell isolation procedures. In mRNA manufacturing, it helps ensure the purity and quality of the final mRNA product. Dyadic’s C1 produced DNAse1 holds a certificate of analysis and the product is ready for non-GMP production and cGMP process development. Dyadic is seeking a partner to manufacture and commercialize this product or may employ the services of a contract development and manufacturing organization (CDMO) to produce it and sell into small markets itself. This is estimated to be a $300 to $500 million total addressable market. Other raw material inputs to the mRNA enzyme market include another $825 million in total addressable market such as TdT terminal transferase, T4 DNA ligase, RNase Inhibitor and T7 RNA polymerase. These markets are now served by high-cost e. coli expression systems or natural sources, each of which has purity and cost considerations that are largely solved using the C1 expression system.
Dyadic has enumerated many of the key products in human health where it can contribute significant benefits. We include the list below.
$3 Million Gates Foundation Grant
Dyadic’s other work, especially that related to the $3 million grant from the Bill and Melinda Gates Foundation, provides other pathways to revenue. The Gates Foundation funding will allow Dyadic to validate its expression platform to manufacture monoclonal antibodies to address malaria and respiratory syncytial virus (RSV). The grant, announced last November, is seeking a way to make traditionally expensive biologics more cost effective so that they can be produced in developing countries such as Africa. If Dyadic successfully completes early-stage clinical trials, it may partner with South Africa’s Rubic One Health or Fondazione Biotecnopolo di Siena to advance it towards commercialization in developing regions where cost constraints demand novel solutions.
SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR.Â
DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.
________________________
[1] As of the latest update, Dyadic has received a certificate of analysis for DNAse-1, bovine albumin, bovine transferrin and bovine alpha-lactalbumin
[2] A Certificate of Analysis is a document that verifies that a product meets specified quality and consistency standards. When ensuring that expressed proteins are equivalent to another product (such as a reference protein or biosimilar), the CoA typically includes analytical test results and key quality attributes.
