DYAI Adds TurtleTree To Its Stable

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By John Vandermosten, CFA

NASDAQ:DYAI

What’s New

Since it reported third quarter 2020 results in a November 12th, Dyadic International, Inc. (NASDAQ:DYAI) has provided several updates to investors. This includes a televised interview, the appointment of a new member to the Board, announcement of a collaboration with TurtleTree Scientific and a presentation at the ZAPI Stakeholders Virtual Meeting.

Presentation at ZAPI Stakeholders Virtual Meeting

On February 4, 2021, Dyadic presented at the ZAPI Stakeholder Virtual Meeting. Dyadic’s Chief Scientific Officer Ronen Tchelet, presented Dyadic’s experience as a participant in the ZAPI project, including a demonstration of Dyadic’s fungal expression platform’s performance in producing high yield at scale. Dyadic had already demonstrated C1’s abilities in Schmallenberg virus (SBV) and Rift Valley Fever (RVFV), comparing favorably to baculovirus cell expression for the two antigens. Participation in the ZAPI project showed C1’s impressive ability to produce high yield requiring minimal fermenter volume and has led to several fully funded animal health collaborations outside of the project.

ZAPI

ZAPI, the Zoonotic Anticipation Preparedness Initiative, was launched in January 2015 by the Innovative Medicine Initiative (IMI), a €19 million program to test cutting edge technologies and their ability to swiftly address the emergence or reemergence of zoonotic viruses. The technologies considered include vaccines and monoclonal antibodies. While there are many zoonotic viruses, the most recently emerged include MERS-CoV, Schmallenberg virus and RVFV. These viruses have functioned as models in the ZAPI project to develop and test preparedness.

Zoonotic viruses originate from animals. There have been 25 documented zoonotic diseases that have emerged over the past 20 years and the frequency is expected to increase with changes in the environment and demographics. The SARS-CoV-2 pandemic has been a recent reminder of how vaccine response is difficult, especially due to the unpredictability of zoonotic outbreaks. ZAPI has brought together leading experts from organizations, agencies, academic groups and industry to develop more rapid response to these infectious diseases. Milestones for the ZAPI project include confirming the generation of viral vaccines based on small subunits expressed via non-mammalian or avian cell lines.

Collaboration with TurtleTree Scientific

On February 2, 2021, Dyadic announced it had entered into a collaboration with TurtleTree Scientific to develop recombinant growth factors. The collaboration is fully funded and aims to develop a number of recombinant protein growth factors that can be manufactured in bioreactors, leveraging C1’s high yield and low cost. Growth factors have applications in tissue development and healing, key to regenerative therapies. Leveraging the C1 platform with its productivity and flexibility should help TurtleTree’s commercialization endeavors, enabling them to provide therapeutics at competitive value in an emerging field. Growth factors have applications in cell agriculture, cosmetics and pharmaceuticals among others. TurtleTree Scientific is a subsidiary of TurtleTree Labs, a biotechnology company that was founded to explore the sustainable production of milk using a cell-based platform.

The addition of TurtleTree brings the total number of collaborations announced over the last year to 16. We summarize these collaborations in the following Dyadic collaboration chart.

Exhibit I – Summary of Dyadic Collaborations (1)

New Board Member

Dyadic appointed Patrick Lucy as the seventh member of the Board of Directors, announced January 11, 2021. The appointment went into effect on January 8. In addition to his role as an independent director, Mr. Lucy will also serve on the Board’s Science and Technology Committee. As a member of the Board, Mr. Lucy will leverage his near 30 years’ experience in the biotechnology industry and invest in Dyadic’s relationship with collaborators to facilitate the adoption and commercialization of Dyadic’s C1 platform. Mr. Lucy’s career features extensive experience in development, adoption and commercialization of cell lines in biopharma applications. Mr. Lucy currently serves as the President and Chief Operating Officer of Lykan Bioscience, a private contract manufacturing company. Prior to his role at Lykan, Mr. Lucy co-founded Pfenex Inc., which went public in 2014, after being launched in 2005 and subsequently spun out from Dow in 2009. Mr. Lucy joined Dow when Dow acquired Collaborative BioAlliance.

Televised Network Interview

Dyadic President and Chief Executive Officer, Mark Emalfarb, was interviewed by Liz Claman in a segment that aired December 9, 2020. A replay is available here. During the exchange Mr. Emalfarb described Dyadic’s background, specifically the development of C1. The expression system was developed over the past 25 years and more recently has been focused on biologic pharmaceutical applications, including the production of antibodies. Mr. Emalfarb shared achievements in the ZAPI project, where C1 was able to express over 300x more product than baculovirus-infected insect cells and reiterated the importance of efficiency in successful production of vaccines and antibodies. Due to the investment in development of the platform, C1 is now able to produce substantial amounts of the intended protein, at low cost, rapidly, easily and in vessels (fermenters) that are ubiquitous worldwide. Claman ended the interview enquiring about vaccination targets set forth by the White House. Mr. Emalfarb responded by reiterating C1’s ability to produce vaccine proteins in large quantities, rapidly, and cost effectively which are critical features necessary to meet vaccination targets.

Summary

Key reasons to own Dyadic shares:

‣ High cost of biologics production demands lower cost alternative

‣ C1 technology provides faster cell line development and production cycle

◦ Technology addresses high cost component of drug manufacture

◦ Favorable characteristics of productivity and purity

◦ Less stringent operating conditions required

◦ Low-cost synthetic growth media used

◦ Avoids mammalian cell related viruses, reducing purification steps

◦ Particularly beneficial for expensive, difficult to produce recombinant proteins

‣ Natural alignment between C1 and biosimilars/biobetters due to cost focus

‣ Development fully funded with cash on the balance sheet and partner contributions

‣ CEO holds dominant share of business and has history of cost conscious development

Dyadic continues to forge collaborations with a number of partners which will eventually yield deeper relationships. The latest collaboration with TurtleTree expands into growth factors that are used in a variety of regenerative medicine applications and builds on other relationships with animal health, top tier global pharma companies, COVID vaccine developers and government agencies. C1 may provide a potentially faster, safer and less expensive platform for generating a broad variety of proteins for use in research and commercial products.

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1. Source: Zacks Research and Dyadic corporate filings. Green highlight indicates animal health collaboration. Blue highlight indicates academic collaborator, orange indicates a follow-on project with a previous partner.

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