Dyadic International, Inc. (NASDAQ:DYAI) Q4 2022 Earnings Call Transcript

Joe Hazelton: We will have — I’m sorry, Vernon, this is Joe. And first of all, thanks again for the question. But — so great question, we will have some initial preliminary safety data from a data safety monitoring board analysis that will be done hopefully in May. We’ll be able to report on some of that. The immunogenicity data, the lab values, those will not be available until the end of the study on database lock because it is a blinded study, so we’re not going to have access to be able to report on that data.

Vernon Bernardino: Great. That makes sense. And I suppose you will need the full data to enter further discussions regarding C1 technology.

Joe Hazelton: Not — from the standpoint of safety, not necessarily. Obviously, from DYAI-100 for moving that forward, you want the immunogenicity results to have further discussions on that and what that would look like to potential partners moving forward and even with Rubic One Health. But when you’re looking at just the safety of the platform, that type of information, obviously, will be available a little bit sooner.

Mark Emalfarb: I think, Vernon, to also answer, I think part of your question is the pharmaceutical companies are already waking up and recognizing when there’s been no adverse events, and the study is going very well so far that they’re looking at this just like we are is this is a platform technology, and this is establishing and putting a flag in the ground that’s basically saying this is a first step in a human being that we’ve ever put a protein. And this is demonstrating as we would expect. And we won’t know until, obviously, we get the final results. But that we will have safety and that this platform can then be used for dozens, if not hundreds or thousands of potential things going down the road. And particularly, as Joe has pointed out, it’s ready now for commercialization use for recombinant protein antigens.

I don’t like to produce more of something, potentially to produce better vaccines with broader durability, our global reach into academia, industry. And government is expanding. We’re getting multiple inputs, not only from pharmaceutical and biotech companies, but from academic groups, that are looking to get the NIH or the European Union or other governments to fund Zika or Dengue or West Nile or Ebola, I can go on and on, the list of potential vaccines that these guys are applying for that they intend on using C1 now instead of baculovirus or other systems. So they seem to have starting to get buy-in and expansion and adoption certainly in the academic world of the people from these epi scientists that we’ve been working with for seven years.

They have been involved in this. Now that the safety data, not only in preliminary from South Africa, but they’ve also spent the money with the European Union to go into a non-human primate study on a monoclonal antibody that showed not only equal performance to the CHO cell but with no safety issues at all. So I think all of this momentum is building, and I think it’s just going to grow. And over time, our expectations are just like water sea at the lowest level that C1 is going to become a standard in many, many, let’s say, academic, government and industry labs that that’s where it starts. Putting the gene into the cell line, they can produce more for less, treats more patients, more affordably, and that’s the way the world needs to go. And we’re seeing this pressure is finally mounting on the cost of goods.