Dyadic International, Inc. (NASDAQ:DYAI) Q4 2024 Earnings Call Transcript

Dyadic International, Inc. (NASDAQ:DYAI) Q4 2024 Earnings Call Transcript March 26, 2025

Dyadic International, Inc. misses on earnings expectations. Reported EPS is $-0.05 EPS, expectations were $-0.04.

Operator: Good evening. And welcome to Dyadic International’s year-end 2024 conference call. Currently, all participants are in a listen-only mode. Following management’s prepared remarks, there will be a brief question and answer session. As a reminder, this conference call is being recorded. As of today, March 26, 2025. I would now like to turn the call over to Miss Ping Rawson, Dyadic’s Chief Financial Officer. Please go ahead. Thank you. Good evening, and welcome everyone to Dyadic International’s full year 2024 conference call. I hope you have had a chance to review Dyadic’s press releases announcing financial results for the fiscal year ended December 31, 2024. You may access our press release and Form 10-K under the investor section of the company’s website at dyadic.com.

On today’s call, our President and CEO, Mark Emalfarb, and our Chief Operating Officer, Joseph Hazelton, will give a review of our 2024 business and corporate highlights and provide a commentary on the strategic direction of the business. I will follow with a review of our financial results in more detail. We will then hold a brief question and answer session. At this time, I would like to inform you that certain comments made in this conference call may be considered forward-looking statements, which involve risks and uncertainties and other factors that could cause Dyadic’s actual results, performance, scientific, or otherwise, or achievements to be materially different from those expressed or implied by these forward-looking statements. Dyadic expressly disclaims any duty to provide updates to its forward-looking statements, whether because of new information, future events, or otherwise.

Participants are directed to the risk factors set forth in Dyadic’s reports filed with the SEC. It is now my pleasure to pass the call to our CEO, Mark Emalfarb.

Mark Emalfarb: Thank you, Ping. Welcome, everyone, and thank you for joining Dyadic’s full year 2024 conference call. We are excited to share how our strategic focus on near-term product commercialization and technology licensing has positioned Dyadic to capitalize on the current and emerging opportunities. In 2024, we delivered strong revenue performance, including $1.9 million in milestone and license payments, driven by our emphasis on products that do not require human or animal clinical trials for commercialization. These results reflect our commitment to unlocking the full potential of our proprietary C1 and Dapavas microbial protein production platforms. These platforms are enabling us to generate immediate revenue through high-value alternative protein applications, including recombinant human albumin, transferrin, and DNase I alpha-lactalbumin.

At the same time, we are advancing mid- and long-term opportunities in human and animal health by applying our platforms to develop antigens, antibodies, enzymes, and other proteins that address critical needs in life sciences, food and nutrition, and bio-industrial markets. Our dual-track strategy, commercializing near-term non-pharmaceutical products while building a robust biopharmaceutical pipeline, continues to drive value. We are strengthening our global impact through partnerships with academia, industry, government, and leading nonprofit and public health organizations. We are proud to be working with the Coalition for Epidemic Preparedness Initiative (CEPI), Fondazione Biotecnopolo di Siena, and the Gates Foundation, and a growing number of other collaborators to accelerate the development and adoption of our C1 platform for vaccines and treatments, supporting global health preparedness and access to affordable biologics.

As we move forward, Dyadic remains deeply committed to delivering sustainable value to our shareholders and partners. With a growing pipeline, a strong network of collaborators, and platforms built for efficiency and scalability, we are well-positioned to lead in the global production of enzymes, alternative proteins, and biopharmaceuticals, meeting the demands of today and shaping the solutions of tomorrow. I would now like to turn the call over to our Chief Operating Officer, Joseph Hazelton, to provide an update on business results for 2024. Joe?

Joseph Hazelton: Thank you, Mark. 2024 was a transformative year for Dyadic International as we advanced our mission to improve global access to affordable, high-quality proteins through our C1 and Dapavas microbial protein production platforms. While Dyadic remains committed to human and animal health platform and product opportunities for mid- to long-term growth, today, I want to emphasize our progress in near-term revenue potential in the non-pharmaceutical and reagent product markets, which continue to show robust momentum in commercial readiness across our three areas of focus in alternative proteins, life science, food nutrition, and bio-industrials. We are making strong strides in commercializing several cell culture media components, each addressing growing industry demand for animal-free, cost-effective, and high-performing alternatives in the life science segment of alternative proteins.

Recombinant human serum albumin (RHSA), being developed through our partnership with ProLiant Health and Biologics, is on track for commercial launch in 2025. RHSA is a foundational product for diagnostics, bioproduction, and vaccine formulation. Our recombinant transferrin product is also progressing well, with active partner engagement and sample distribution underway. In initial cell proliferation studies, Dyadic’s recombinant transferrin protein demonstrated comparable performance to a recombinant reference standard, highlighting its potential as a high-quality, cost-effective, non-animal alternative for research and commercial processing applications, and we are currently exploring opportunities for scale-up and licensing. Furthermore, Dyadic is advancing the development of recombinant fibroblast growth factor (FGF) products for cell culture media and biopharmaceutical applications.

As a critical driver of cell growth and proliferation, recombinant FGF plays an essential role in biomanufacturing, regenerative medicine, and cell-based therapies, particularly in serum-free and chemically defined cell culture media. Initial cell proliferation studies have demonstrated that Dyadic’s recombinant FGF products exhibit comparable performance to reference standard recombinant FGF. In addition to further characterization and validation efforts, sample initiatives are expected to begin in Q2 2025. These cell culture media components position Dyadic to capitalize on growing bioproduction needs with high-quality, non-animal, cost-advantage solutions. In the alternative protein food and nutrition space, Dyadic is unlocking new opportunities across non-animal dairy, nutritional science, and research applications.

We are actively developing high-value recombinant whey and other proteins, including alpha-lactalbumin, caseins, and human lactoferrin, all of which are in high demand for use in infant nutrition, functional foods, wellness products, and pharmaceutical applications. Sampling and optimization efforts are ongoing, with increased interest from both potential collaborators across the R&D and non-animal dairy sectors. These proteins offer a sustainable, animal-free alternative to traditional dairy-based ingredients, addressing a growing consumer and industry shift towards ethically sourced and health-promoting proteins. In parallel, our dairy enzyme portfolio is progressing rapidly through our partnership with an EU-based commercialization partner.

In 2024, we achieved a productivity milestone of $425,000 for one of our recombinant dairy enzymes, with a commercial launch anticipated in late 2025. Additional enzymes are in development under our licensing agreement signed in 2023, expanding our reach into dairy processing and functional ingredient applications. Together, these programs provide Dyadic with a strong foothold in the expanding animal-free dairy and specialty nutrition markets, where the demand for scalable, functional, and animal-free protein solutions continues to accelerate. Dyadic is also making significant progress in the life sciences segment of our alternative proteins business with the development of a suite of DNA and RNA-related reagent enzymes, which are a natural and strategic fit for our proprietary platform.

One of the leading candidates in this vertical is our RNase-free DNase I enzyme, which is now in the final stages of process validation. We are actively partnering with a European Contract Development and Manufacturing Organization (CDMO) to initiate research-grade production. This enzyme serves a broad range of applications, including molecular diagnostics, gene therapy, and biologics manufacturing, where high purity and consistency are essential. In addition to DNase I, Dyadic is expanding its enzyme portfolio with the development of four additional reagents, including RNase inhibitors and T7 RNA polymerase. These are foundational tools in DNA and RNA manipulation, in vitro transcription, and next-generation sequencing workflows, which are key technologies that support genomic research, therapeutic development, and synthetic biology.

Early development and optimization efforts are progressing, with initial data and validation results expected by the end of 2025. This reagent enzyme market offers Dyadic a scalable, recurring revenue opportunity with relatively low regulatory hurdles and a shorter path to market compared to traditional biopharmaceutical products, enabling faster commercialization and greater near-term impact across our life sciences segment. Dyadic is also advancing its presence in the bio-industrial sector of our alternative proteins segment, where our Dapavas protein production platform is being leveraged to support large-scale enzyme solutions across multiple industries. In 2023, we entered into a development and commercialization agreement with Pharma Bio, a synthetic biology research and manufacturing company.

This collaboration led to a significant milestone in May of 2024 with the launch of ENDSRIZYG, an enzyme cocktail produced using Dyadic’s Dapavas platform. ENDSRIZYG is specifically designed to enhance the efficiency and cost-effectiveness of converting pretreated agricultural residues into fermentable cellulosic sugars, which is a key part of the critical process in the production of renewable chemicals, biofuels, and other biobased products. Beyond this partnership, Dyadic has continued to develop a broader portfolio of enzymes with potential applications across a wide range of bio-industrial markets, including nutrition, biogas production, biofuels, and biorefining. These enzymes are currently being sampled and evaluated by interested commercial partners as we work to identify optimal fits for industry-specific use cases.

This segment represents a promising area of growth where we believe our platforms can contribute to reducing reliance on fossil fuels and improving the economics of sustainable industrial processing. While the alternative protein segment drives near-term focus and revenue, our longer-term value in human and animal health is supported by our ability to partner with leading global institutions. As part of our ongoing strategy to expand the reach and impact of Dyadic’s platforms, we continue to strengthen our position through strategic grants and non-dilutive funding partnerships that support long-term innovation. Last week, we announced a significant milestone with the receipt of a $4.5 million grant from the Coalition for Epidemic Preparedness Innovations (CEPI), awarded to Fondazione Biotecnopolo di Siena (FBS) to accelerate the development and manufacturing of recombinant protein vaccines using Dyadic’s C1 platform.

With the project already underway, this funding will support key steps, including antigen design, cell line development, process optimization, product characterization, and scale-up to cGMP manufacturing. As a subcontractor on this initiative, Dyadic is expected to receive $2.4 million of the total grant amount. In November of 2024, Dyadic was awarded a $3 million grant from the Gates Foundation to support cell line development for monoclonal antibodies targeting respiratory syncytial virus (RSV) and malaria. These programs, powered by our C1 protein production platform, are focused on delivering affordable, scalable solutions for treating infectious diseases in underserved populations, further aligning our work with global health priorities.

In collaboration with FBS and other partners, Dyadic has also submitted multiple new grant applications aimed at expanding the development and adoption of the C1 platform across additional vaccine and antibody programs. As a very recent example, on March 23, CEPI announced the award of a $2.6 million grant to UVAXBIO. This funding will support the development of a MERS vaccine and research to assess the capability of the C1 platform to speed vaccine production and lower manufacturing costs, improving access to vaccine doses in the future. These ongoing efforts not only bring in meaningful financial resources to advance research and development but also enhance our global visibility and validate the competitive advantages of our platform in addressing urgent health challenges worldwide.

Dyadic continues to advance its pipeline of innovations in both animal and human health, demonstrating the versatility and rapid development capabilities of C1. In collaboration with Virovax, we are developing C1-produced self-assembling ferritin nanoparticle antigens targeting H5 avian influenza or bird flu for potential use in diagnostics and vaccines across poultry, cattle, humans, and companion animals. With the ongoing bird flu outbreak posing significant risks to both agriculture and public health, we are actively conducting pre-commercial research and validations to support potential strategic partnerships and licensing opportunities. Additionally, our M-pox vaccine or monkeypox vaccine candidate, also developed in partnership with Virovax, is in early-stage preclinical development.

This project not only expands our infectious disease portfolio but also provides further validation of the C1 platform’s ability to rapidly produce cost-effective non-mRNA vaccine candidates. In diagnostics and vaccines research, our C1-produced adjuvanted ferritin nanoparticle H5 2.3.4.4b Astrakhan vaccine has shown cross-protection against multiple H5 virus strains in early studies. In poultry, early trials demonstrate the generation of neutralizing antibodies, supporting the potential for commercial viability in both vaccine and diagnostic applications. In cattle, preliminary diagnostic and vaccine data have shown similar cross-protective potential, opening the door to a broader addressable market in the livestock health segment. We have also expanded our collaboration with Fibro Animal Health or ADIC Biological Laboratories to develop vaccines for diseases affecting livestock animals.

This partnership strengthens our strategic position in animal health and further supports the application of C1 as a cost-effective and scalable solution. Beyond these programs, Dyadic has also successfully expressed high-yield, high-purity RSV F trimer antigen along with several other antigens and monoclonal antibodies. These developments further validate the flexibility and efficiency of the C1 platform in addressing a wide range of human and animal health challenges while continuing to support our longer-term biopharmaceutical pipeline. With that, I will turn the call over to our CFO, Ping Rawson, to cover our financial results. Ping?

Ping Rawson: Thank you, Joe. Thank you, everyone, for joining our call today. I will now go over our key financial results for the year ended December 31, 2024, in more detail. You can find additional information in our earnings press release and Form 10-K, which we filed earlier today. As of December 31, 2024, we have cash, cash equivalents, and investment-grade securities of approximately $9.3 million compared to $7.3 million as of December 31, 2023. Revenue for the year ended December 31, 2024, increased to approximately $3.495 million compared to $2.899 million for the year before. The increase is driven by the license revenue of $1 million from ProLiant, approximately $890,000 from enzymes, including success fees in 2024.

Cost of research and development revenue for the year ended December 31, 2024, decreased to approximately $1.195 million compared to $1.976 million the year before. The decrease in cost of revenue was due to higher individual contract amounts on certain research funding and related work performed during 2023. R&D expenses for the year ended December 31, 2024, decreased to approximately $2.044 million compared to $3.297 million for the year before. The decrease was due to the completion of the company’s phase one clinical trial of DYA100 COVID-19 vaccine candidate. G&A expenses for the year ended December 31, 2024, increased to approximately $6.135 million compared to $5.817 million for the year before. The increase reflected increases in business development and investor relation expenses of approximately $294,000, share-based compensation expenses of $109,000, professional service expenses of $82,000, and other increases, partially offset by decreases in management incentive expenses of $124,000, legal expenses, and insurance expenses.

Loss from operations for the year ended December 31, 2024, was approximately $5.901 million compared to $8.230 million for the year before. Net loss for the year ended December 31, 2024, was approximately $5.809 million or $0.20 per share compared to a net loss of $6.795 million or $0.24 per share for the year before. As previously disclosed, the company was awarded a $3 million grant from the Gates Foundation in November 2024. Additionally, in March 2025, our partners received two awards from CEPI to support C1 antigen development and accelerate advancements of the C1 platform, from which we expected to receive additional funding. These initiatives are expected to create additional revenue growth opportunities in 2025. Now I will ask the operator to begin our Q&A session, after which Mark Emalfarb will provide closing remarks.

Operator, thank you.

Q&A Session

Operator: We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove yourself from the queue. One moment while we poll for questions. Okay. Looks like our first question comes from John Vandermosten with Zacks SmallCap Capital Research. Please proceed with your question.

John Vandermosten: Great. Thank you. And how are you doing, Mark, Ping, and Joe? Thought I’d start out with a question on the Gates Foundation and CEPI grants. It seems like there’s a lot of interest in them, and you and I’m I I heard you mention that there are some other other grant applications that you had made. Maybe you can reconcile, I guess, you know, how Gates Foundation fits in and if some of those grants are in that area and also their interest in C1. Because it seems like they’ve done a number of things that recognize its value.

Mark Emalfarb: Yeah. Thanks, John. To address your first question, yes, we have a number of additional grants here that we’ve applied and or collaborators applied for student loans embedded in those programs. And that’s both for Gates and CEPI as well as other nonprofit organizations, government grants, in different countries. So I of course, you can tell by Gates giving us a $3 million grant. They have a significant interest. We’ve been having calls with them already. I think they’re excited about how fast it has seen in the work we’re doing compared to the CHO cells that traditionally used to. Seeing with the monoclonal antibodies. In fact, they mentioned how surprised they were. How fast we were already getting transformers.

And, CEPI, we’re just getting started. But I think the key here that I think you pointed out is these are two of the largest nonprofit funding organizations on the planet related to vaccines and antibodies and global health. So I think that the money that we’re getting directly and through these Foundation Biotecnopolo di Siena, the grant announced yesterday by CEPI with UVAXBIO, these are driving forward the innovation and the advancement of our platform, not only to make it quicker, faster, better, and cheaper, but quite frankly, it’s already producing things at remarkable levels fast and quick. But bringing adoption and use to potential products that are gonna be put into human beings at some point. Down the road as we hope. They’ll turn into lifesaving medicines that we can make profits on from our shareholders.

That brings global health to humanity. And then on the animal health side, you know, Fibro, as Joe mentioned, is advancing towards commercialization. One or two of the animal health vaccines. And as you know, with the USDA just announced recently, a billion dollars in funding for potential human health or animal health and a hundred million of that is partly gonna be assigned potentially for vaccines, and we actually got notice yesterday from them of a potential opportunity to apply for that grant which we intend on evaluating and potentially doing on our own. And or in collaboration with academics and industry and nonprofit organizations. So, hopefully, that gives you a flavor for the fact and quite frankly, we’re seeing more interest in our platforms, our technology, and the products we’re producing than we’ve ever seen.

John Vandermosten: Okay. And, you know, we’re also excited about the albumin sales. And, Joe, I think last time we spoke a couple of months ago, you were walking through some of the steps that you needed to complete before getting that first product revenue dollar through the door. Can we revisit kind of how you’ve come along since then and it seems like, you know, maybe in the next weeks or month or so, yeah, that that that milestone may happen of getting that dollar through the door. Can can you update us?

Joseph Hazelton: Yeah. Absolutely, John. And then first of all, thank you again for the questions. Always appreciate your perspective on these things. And when you look at the albumin market, obviously, we’re excited to enter into commercialization. I think the key for us is continuing to rapidly accelerate scale-up and we’re doing that in conjunction with ProLiant Health Biologics. We have made progress, and obviously, we have to do it right. We have to make sure the product is validated, the QC testing is done, and it’s produced, you know, according to the right specifications in order to have a successful launch. In addition, you know, starting to sample, that’s gonna be the first few, which we do hope and then will be happening very soon.

But, again, we remain committed to pushing and hopefully commercializing in early 2025. So we’re still pushing. It’s still about scale-up and making sure the product is qualified. And that just takes time. There’s really no shortcuts you can take. It’s kinda like I don’t wanna say developing a drug, but in some, you know, some instances, you do have to make sure you meet the right product specifications, especially if you want your customers to be switching to a recombinant product versus, let’s say, an animal-derived. So you wanna make sure everything is basically all set and all systems go before you put a product on the market and then realize something, you know, something was wrong. So we’re just making, you know, extra sure and doing all the qualifications in QC to make sure these products are high quality, high purity, and then from me and our customers’ needs.

And, again, hopefully, we still continue to push and have that commercialized as quickly as possible.

John Vandermosten: Okay. Great. Thanks, Joe. I’ll hop back in line.

Operator: I’ll just say that our next question does come from Vernon Bernardino with H.C. Wainwright. Please proceed with your question.

Vernon Bernardino: Hi, everyone. Thanks for taking my question, and congratulations on a great quarter and getting this CEPI grant. I was just wondering if you can help us a little bit with determining the cost of research and development revenue. Just wondering if you could talk a little bit about the components that help us how to figure that out.

Mark Emalfarb: Well, I think the important part is 80% of the research and development expenses are covered by somebody else with some profit margins built in for us. So you the CEPI grant for the $4.5 million of which we’re gonna get $2.4 million directly. But the $4.5 million is all going towards developing C1 as Joe pointed out. Towards phase one launching capabilities. And increasing the speed to keep up with mRNA proteins and vaccines. And we believe actually that we can do that and we’ve demonstrated that we can create stable cell lines already within 21 days. Very fast. They’re very productive. And they’re mass-producible, very low cost. Without the need for cold extreme cold chain storage. But I think the point here is all that money is advancing this platform and innovation and driving it to the point where adoption and use in big pharma, government agencies, academia, it all starts by putting the gene into a cell line.

And like UVAXBIO, in the CEPI grant, it was announced yesterday, where they’re getting $2.6 million from CEPI to advance the MERS program. We’re gonna produce the antigen that goes in there. It’s gonna be ultimately a vaccine, you know, the active component of the vaccine. So the more of these opportunities we get, the more demonstration of safety, efficacy, speed, yield, cost, and momentum’s building. And it’s accelerating. And as we mentioned, in the past, Rino Rappuoli, one of the godfathers of the vaccine space. He’s the head of the Fondazione Biotecnopolo di Siena. That took us longer than we expected, to get embedded there, but he’s been out promoting our technology for over a year and a half. To a variety of different government organizations, pharmaceutical companies, academia, etcetera.

And we expect more things to come from that collaboration in the not too distant future.

Vernon Bernardino: Great. And follow-up on the CEPI grant. The grant is to FBS. Right? The press release said that the C1 produced protein antigens can be compared to traditional mammalian approaches. Just wondering what is FBS’ experience with that, and when can we see results from their work?

Mark Emalfarb: Well, FBS experience is probably 30 years with Rappuoli as a former GSK chief scientific officer, and Novartis before that, and Chiron before that. As I mentioned, he’s, like, one of the godfathers of vaccineology. He’s probably taken ten or twelve drugs through the clinic into commercialization over time. So the good news is that we’ve seen already in another funded program where we’ve actually worked with UC Davis and we’re working on that publication that the C1 produced full spike protein actually performed virtually identical to the CHO protein. So we’re expecting very good results on that program very soon.

Vernon Bernardino: So will the comparison be in vitro or some kind of yield number?

Mark Emalfarb: That would be an animal model, which is what we’ve already done. So you’ll see when the publication comes up. And we can virtually make the same thing, same quality, same efficacy, just faster, quicker, and cheaper. Without the need to do viral clearance. So in the downstream, we can speed it up with less cost. On the upstream, we can blow it away. In terms of speed and cost. And we’ve already seen at least in the mice trial that have been compared head to head, at least for the microneedle approach, and we were equal to the CHO which is actually human cell, which is actually better than the CHO cell.

Vernon Bernardino: We’re taking my question, and congrats again. I’ll get back in the queue.

Operator: Thank you. That is star one. Zacks Small Capital Research. Please proceed with your question.

John Vandermosten: Great. Thank you. So you had mentioned that by year-end, that you may begin commercialization of the dairy enzyme. You also walk me through the steps there kinda like you did with the albumin? What needs to get done before, again, that first dollar can flow through the door?

Joseph Hazelton: Sure, John. It’s Joe. And, again, thanks. This is similar I guess, a little bit to research grade in terms of it does require some level of regulatory oversight in cases of food proteins or enzymes, depending on the market you’re launching into. For Europe, it’s, you know, part of the EMA. That deals with food-type food proteins. In the US, it’s GRAS. So, essentially, the product has been filed for sulfur from GRAS application. That should hopefully be I think it is submitted, and once that is clear, then they just do the final testing and production, and then they’ll be able to put it on the market. So it did similar in terms of the steps. Obviously, we need to scale up, prove the quality, in some cases, like in the EU, you do need to do animal testing.

Of food proteins or food enzymes versus the US where it’s a little less stringent in some cases. But overall, it’s a slightly different less intrusive regulatory pathway, so they’re a little quicker, but you still do have to make sure that you follow the process for development and scale-up and then ensure the quality of the product and that it is food grade moving out the door. So right now, as it’s scaling up in a food-grade production facility, they’re parallel tracking the GRAS application. So that’s essentially the main process.

John Vandermosten: Okay. And one other question for you on productivity. Do you have the numbers in terms of grams per liter per day for the various applications that you have? You know, the human/animal albumin, the transferrin, and the growth factors. Kinda what’s the relative efficiency of those in terms of gram per liter per day or whatever, you know, time period you’re using.

Mark Emalfarb: Yeah. Joe, I think that someone has proprietary information. So just leave it to be obviously high enough that we’re getting commercial traction. And I’m glad you brought up transferrin and growth factors. DNase I, alpha-lactalbumin because, Joe, maybe you can expand on all the excitement and interest and progress we’ve made on all of the products maybe one by one.

Joseph Hazelton: Yeah. I mean, I think the key, John, is you look at it in terms of productivity, is that we are able to basically make better margins than traditional or common products in the market today due to our productivity in right, we can’t get into the specifics, but suffice to say that the interest that we’re receiving in our non-pharmaceutical applications, you know, as Mark mentioned, whether it’s transferrin cell culture media, is due to the high productivity. These enzymes and cell culture groups, proteins and cell culture media like albumin, like transferrin, they are thousands of dollars per gram or even in some cases per microgram. So it’s very important that we’re able to, you know, use the productivity of the system to help bring the costs down, enables commercialization like cell culture media can be used in pharmaceutical development, and manufacture, you know, at cGMP levels.

It’s way too expensive for markets like cultured meat and the nice thing about the cell cultured media market that we’re entering into is it does serve two different areas of the business, whether it be production of lab-grown meat or growing CHO cells to manufacture biologics. So that we have essentially, we’re able to use these portfolios and cell culture media in two different directions, basically, expanding in some cases, not doubling and tripling our potential profit margins in these markets. And we’re making great progress in the test transferring of growth factors, being able to demonstrate that we can grow animal cells, just like the products they’re using today. Except at much higher, you know, much higher yields and potentially much lower prices.

Is very interesting. And that’s what’s driving really the unprecedented interest that we’re getting in the platform right now, not just in the alternative protein space, but also in the pharmaceutical space. So I think, you know, again, I can’t we can’t get into the specifics, but you know, if you look across these products, they’re all moving forward as quickly as possible, and that is gonna be our focus commercialization of products, either ourselves or through partners. As Mark mentioned, DNase I, we’re getting ready to partner with or we are partnering with the CDMO to scale up a research-grade production of DNase I that we can begin to commercialize ourselves or sell in bulk to others to sell. So I think we’re positioned correctly in the right high-value segments.

It’s just obviously making sure that we continue to develop these products as quickly and efficiently as possible.

John Vandermosten: K. Great. Thank you.

Operator: Thank you. And our next question comes from Dick Williams with Williams Resource Group. Please proceed with your question.

Dick Williams: Hi, gents. I wanted to touch on a couple of things. Having been a shareholder for a great number of years and gone through the projects that didn’t really materialize. It seems that Zappi, it was won for five years, which were picked as the best technology for the future. It seemed it was unanimous, and, of course, that the whole group, including has really not done anything. But it appears that the CEPI is something that will happen. The one other factor with the CEPI release was the also had put out a release that I got buried in their material. With UVAX where they mentioned that they had given them the $2.6 million, but also in the vaccine development, whatever it is for, that they would be using the C1 manufacturing system for whatever it was, which obviously gave us some good accolades.

It didn’t get much attention, but it was buried, but that was significant. Now we’ve finally have an opportunity with an organization that appears to be making product that will be sold and will start to get revenue because I think, Joe, in terms of your area, it’s it’s so significant. If we were to dissect it down to try to see where the revenue stream opportunity comes from from these various products and the margins. I mean, we’d probably be on the phone for four hours, but can you give us an idea as to the market size opportunity in some of the segments in your area that you mentioned as well as Proline I’ve checked out Proline. It’s a very large corporation. This isn’t an mama pop guys. They have a full worldwide sales force, several manufacturing facilities, and and they’re going to launch a product that we will get revenue from in a matter of months, I presume.

I we don’t have a date, but I believe it’s somewhat in a matter of months. And this is serious revenue that could flow to us and probably the most immediate revenue for us of size. So can you give some more color on where that is? I know you talked to John about the research aspects and the technical aspects. I like to hear about the money aspects, profit motives, and revenue streams that can come in from all of these projects and this will be the refreshing part of the new Dyadic. For five years, all we’ve heard was research projects with no revenue. We finally have arrived at point where now we can produce revenue for all of the stakeholders as well as for the people on Wall Street to give the recognition. We saw truly deserve.

Mark Emalfarb: Unfortunately, I’m not even gonna dissect that. And then the other thing, excuse me, is another factor that has kind of gone, I think, fallen by the board because we’re doing so many things, and we see the market opportunities of them. But I was around five, six years ago when this company did upwards of close to a hundred million dollars over, I forget what, period of time. In the bio-industrial sector. Real revenue produced by Mark before Joe joined with this new area. And that area I understand is blossoming again and one of the opportunities for us to go back into and offer the products we now have for that industry. So can you give some color on where we are and what type of an effort, Mark, you’re gonna put forth to go back to your old people and get some serious revenue from them?

Mark Emalfarb: Yeah. Well, let me answer the first question. For the last I know it’s a mouthful, but you I did. I did. We’re gonna run out of time here. So I love you. We appreciate your thoughts. You’re a great supporter. We love all our you know, all our shareholders. And partners and employees. But we didn’t just twiddle our thumbs in the last five years. We developed platforms first for pharmaceutical, to revolutionize and transform speed, cost, and yield, and release. And you have to have a platform before you can make a product. If you can’t make a product in an inefficient platform or you’re gonna fall short or it’s gonna be people are gonna die or suffer in the which is what’s happening in the world. And we took the time and effort to do it right.

And we got a ton of funding from pharmaceutical companies, we spent some of our own money on it. We got funding from governmental agencies. You know, you had the Israeli government. You had the EU Zappi program. Had all kinds of things coming in that advanced it to make and wake up the Gates Foundation. So let me just wake up yesterday. We’ve been talking to these people for years. It got to the point they recognized that we actually have the keys to the kingdom to really improve speed, yield, cost, and release of not just pandemic proof. We’re talking about traditional oncology drugs, arthritis, dementia, Alzheimer’s, you name it. We can probably make it in a more efficient way and lower cost, faster, and once we get these things into the clinic and through the clinic, the doors are gonna open up.

So if you don’t have a platform, you can’t do any of this. So you know, we we haven’t just been twiddling our thumbs in five years. These guys didn’t just show up. They showed up because we actually did what we said we were gonna do. And we did it for a fraction of the cost. Than most other people would have done. On the industrial side or the alternative protein, and Joe’s gonna answer all those questions. We we started with Dapavas to do the same thing at an accelerated pace taking the learnings and education that we have our CDMOs and research partners have. And we brought this out very rapidly, very quickly, to do as you point out, to go after an industry that’s even more valuable than the one we did before, when we generated thirty plus million in non let’s say, diluted funding from Shell Amigua Bios.

BASF, and then there’s seventy five million from DuPont. But alternative proteins for alpha-lactalbumin, for transferrin for FGF, for DNase I, those margins are much higher than what we had in the industrial section. Albeit, we are going after some of those industrial products. And Joe will talk about too. So now I’ll let you go. But without these platforms, we wouldn’t be making anything and our customers wouldn’t be making anything. It would be commercialized. So let’s just leave it there. And Joe, maybe you can jump in.

Joseph Hazelton: Yep. And, Dick, you know, I think you hit the nail on the head there. The market that we’re entering into are by design and they’re high-value markets for our technology has a significant advantage in terms of its productivity. If you look at the human albumin market, that’s roughly a $5.6 billion market, and I believe that’s growing in double digits per year. And that’s driven by a lot of the increase in the amount of vaccines being produced, not just in human health, but also in the animal health. And as we look to some of the other markets like DNase I and other RNA, DNA and RNA enzymes, that’s a the DNase or the end of the gluase market, the DNA ligase market is around $900 million. And again, it’s growing at almost double digits, I believe, a year as well.

You look at things like non-animal dairy proteins, that’s a $26 billion market. And that’s where, like, alpha-lactalbumin, lactoferrin, those things can play. Each of these products also has a distinct well, not all of them, but some of them have a distinct market like alpha-lactalbumin, it doesn’t just play in the non-animal dairy space. Also potentially can play in pharmaceuticals, and it plays as a research-grade agent for nutritional and biochemical studies. So each one of these products has, you know, different markets. But I think the key that I wanna emphasize is even though we’re in all of these markets and we’re developing products for high-value segments, what we do remains the same. We develop cell lines, but that’s what we do. We take a DNA sequence, and we put it into our cell line.

So while we’re targeting multiple multiple set of, you know, areas, we’re targeting the right partners, as you mentioned, with, like, ProLiant Health and Biologics. They’re a major player in the albumin space. You know, you look at, you know, even UVAXBIO, you know, you look at CEPI and Gates. We’re targeting the right partnerships and the right potential partners for these products. Because we can’t do it as Dyadic. And I think that’s the key. What we’re doing remains the same, and we’re staying focused on that, and that is creating products in these non-pharmaceutical or reagent segments that we can quickly commercialize due to the fact that we have high productivity and obviously potentially lower cost for the sectors that’s driving the interest.

So you look across, there’s no there’s not a lack of available market to go after. It’s getting the product to the market and identifying the right partner to help us commercialize and that’s really what we’re trying to do right now. But I think you know, we’re seeing unparalleled interest in all of our segments right now, and it’s due to the fact that we are starting to move closer to commercialization. And I think as soon as we get the first product on the market, that’s gonna be another, you know, another driver for us or another inflection point that we can, you know, we can use to continue to expand the adoption. So I think, you know, hopefully, I give you a flavor for the size of the markets that we’re going into. And the capability that that are potentially that these products can have.

Operator: Thank you. And our next question comes from Tony Bowers with Introact. Please proceed with your question.

Tony Bowers: Hi. I applaud Mark for his patience and persistence on the human side, but, you know, thankfully, we’ve got, you know, what Joe’s been working on, particularly in this environment. Given the sort of international turbulence, the turbulence in Washington, is there anything that is kind of obstructive other than the uncertainty of grants? To your business plan. And then a separate question is where do we stand with all of the great work that was done in South Africa and the providence that you’ve developed there. How long will it be before we see all sorts of biologics with Dyadic inside the way we’ve seen Intel inside computers.

Mark Emalfarb: Tony, good questions. First and foremost, we are completely focused on the non-pharmaceutical side of the business to drive revenues. We’re developing multiple products there. But at the same point, we’re not gonna turn down $7.5 million with the financing non-dilutive funding that we have some profit in to advance the platform. And the learnings that we get from the pharmaceutical side of the development we can apply also and are applying on the other side. Okay? But our focus is currently driven by albumin, transferrin, DNase I, alpha-lactalbumin, developing some cellulose enzymes or biogas bio-refining, cellulosic sugars, so Joe can jump into all that, but I wanted to know that yes, we realize that the environment has changed, but long before the environment changed, we started targeting these other areas that bring in revenue and profit sooner. So Joe, you wanna go into that?

Joseph Hazelton: Pretty well. I think the key that Tony thought that he’s mentioned would be what we’re doing with, you know, Rubicon, South African, where that stands. But right now, they’ve shifted their focus to animal health and animal health vaccines, and right now, they’re developing I believe, up to five, you know, animal health vaccines because they’re a little, obviously, commercialized in the human vaccines at this point. The phase one study that we completed with Rubicon for DYA100 was a mild sort of event for Dyadic, and I think it’s what’s helping drive this increased interest from people like Gates and CEPI. And the fact that we have been in humans with a protein-producing system. Unfortunately, you know, we were a little bit late to the party in the COVID space.

And I think they will continue to evaluate that with Rubicon. But right now, their focus is shifting towards animal health. And I know that they’re looking to hopefully, you know, have something have some clinical studies at the, I think, the tail end of this year. So I think there’s definitely opportunity there. It’s just we’re probably gonna do it in animal health before human health in that market.

Tony Bowers: And it’s We’re expected that no. Yeah. Will the animal well, animal health products have to be funded by a government program?

Joseph Hazelton: I don’t know if you necessarily need to be funded by a government program, but they could be. I think they’re also looking at other sources of funding and revenue as well. So I don’t know if Mark has any greater insight there.

Mark Emalfarb: Yeah. Actually, I’m heading there. Next month. So I’m gonna go down to Johannesburg, and I’m gonna have a meeting with them for two days. I do have a little more insight than Joe does because I’m, well, not going there. And they already have I think they’re working on a challenge study already. It’s already funded. For an animal health vaccine. And they also have from what I understand, they have either have received a grant or will be receiving a grant for $1.8 million for equipment and things like that. Working towards getting ready to try to build a facility down there. And I do believe that they’re also as you pointed out, raising capital not from government, grants, but from equity to bring in several million dollars to accelerate those efforts.

I’ll have a lot more clarity when I get down there, but I’ve been in touch with them recently and on a constant basis, and that they’re moving forward. So they’re doing very well. They’re not going as fast as we’d like. But they also don’t have the wherewithal to do the funding that we can get in the United States. But the whole issue I wanna bring up and I think it’s important, because it’s the elephant in the room. You know, with Trump and Elon Musk doing in Doge and gutting out all these different programs, guess what? Don’t have any of those US government programs, so we’re not getting gutted. But the thing is is a shift. And the shift is going to plus efficiency, lower cost, save government money, in some ways, what’s going on in DC we believe is playing into our hands.

It’s gonna help us accelerate the technology and the platform sooner because you wanna lower your cost of drugs, you better make them cheaper. If you wanna make more of them, you better make them cheaper. I wanna stress the dollars you don’t have. Or less dollars to live on. You better make more for less. And that’s the message, and I think that’s the message we’ve been resonating. That’s common sense. So I don’t know what’s going on in DC, but I think that better find a more efficient way of doing things. And we’ve had discussions. Okay. The phone yesterday at one thirty with a senior person to the FDA. I have a call with you on Friday because so the thing is going on. I don’t know if they’re gonna turn in any money. But they’re happening.

And I think everybody’s realizing cost of goods matters because without that, we have an unsustainable model in America, let alone across the globe. So this may actually be working out in Dyadic’s favor and also the whole twist about mRNA vaccines, I’m not saying whether they’re safe or not. I’m not gonna get into that debate. But this hasn’t been created for the mRNA vaccines. So we take a step back, which is what I think the RFK and Trump are doing, an mRNA, it may open up the door for the spotlight to be focused on more durable, faster, lower cost goes.

Tony Bowers: Thanks. I think, yeah, I think it’s a we’ve got a really good outlook here. So up the good work.

Operator: K. And our final question comes from Steven Raphael, private investor. Please proceed with your question. Hello, Steven? You’re on the line? Okay. And we’ll look and with that, it doesn’t look like there are any more questions. I’d like to pass the call back to Mark Emalfarb for closing remarks.

Mark Emalfarb: I almost feel like we’re done, but I’ll close it anyway. Okay. Looking ahead to 2025, and beyond, our strategic priorities are clear and focused. We’re launching our first commercial products, we’re expanding strategic partnerships and alternative proteins. And industrial biomaterials. We’re broadening the adoption of our microbial platforms across numerous markets. We’re preparing to launch our first commercial product in recombinant albumin, non-animal dairy, DNase I, cellulosic enzymes making a major milestone in Dyadic’s evolution from bio-manufacturing platform development. To revenue generation. At the same time, we plan to expand strategic partnerships across key sectors, including alternative protein section, segment, diagnostics, research tools, leveraging the growing interest in sustainable animal-free and high-performance protein solutions, we will also continue to leverage our proprietary C1 and Dapavas platforms to meet the rising global demand for affordable and efficient biomanufacturing technologies across all the markets, with a strong IP portfolio and an expanding product pipeline.

And increasing global recognition, Dyadic is well-positioned to be a disruptor in the biomanufacturing space. And a revenue-generating engine delivering tangible near-term value for shareholders. Our C1 and Dapavas platforms are engineered to maximize efficiency. Ensuring that funding goes further to meet the needs for more efficient high-yield protein production in today’s rapidly evolving landscape. We’re excited about the opportunities that lie ahead and remain committed to driving innovation, accessibility, and growth across all areas of our business. Thank you for joining today’s call. And a special thank you to our investors, partners, employees, and board members who have made 2024 a standout year. We look forward to delivering continued growth and innovation in 2025 and beyond.

Operator: Thank you. And with that, this conference has now concluded. Thank you for attending today’s presentation. You may now disconnect your lines.