Dyadic International, Inc.

Good evening and welcome to the Dyadic International First Quarter 2025 Financial Results 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 call is being recorded today, May 14, 2025. I would now like to turn the call over to Ms. Ping Rawson, Dyadic's Chief Financial Officer. Please go ahead.

Thank you, good evening, and welcome everyone to Diatics International's Q1 2025 conference call. I hope you have had the opportunity to review Diatics' press release announcing financial results for the physical year-ended March 31, 2025. You may access our release and form 10-Q under the Investors section of the company's website, idiatics.com. On today's call, our President and CEO, Mark Emelfarb, And our Chief Operating Officer, Joe Hazelton, will give a review of our Q1 2025 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'll then hold a brief Q&A session. At this time, I would like to inform you that certain commentary made in this conference call may be considered forward-looking statements. which involve risks and uncertainties and other factors that could cause dietics as a result, performance, scientific or otherwise, or achievements to be materially different from those expressed or implied by these forward-looking statements. Diatics expressly disclaim any duty to provide updates to its forward-looking statements, whether because of new information, future events, or otherwise. Participants are directed to risk factors set forth in DIATIC's reports filed with the SEC. It is now my pleasure to pass the call to our CEO, Mark Emelfar. Mark?

Thank you, Ping. Welcome, everyone, and thank you for joining DIATIC's Q1 2025 conference call. In Q1 2025, DIATIC continued its transformation by focusing on commercializing high-value, high-demand recombinant enzymes and proteins using our proprietary C1 and epibis microbial expression platforms for the development of functional recombinant solutions and proprietary production strains to manufacture large quantities of precision-engineered proteins and enzymes for use in life science, nutrition, and industrial applications. We are leaning into our core strengths aimed at driving sustainable growth in non-pharmaceutical sectors with strong demand and clear market opportunities to target pressing market needs. While we maintain strategic partnerships in vaccine therapeutic developments, such as with the Coalition for Epidemic Preparedness, CEPI, the Gates Foundation, and Fondatione Biotech Napolo di Siena, FBS, the core of our growth strategy is now centered on products, in the high-value life sciences, bioactives, ingredients in industrial markets such as cell culture, media, nucleic, and other enzyme markets that can drive recurring revenue. As we move forward, DIAC 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 will now turn the call over to Joe Hazelton, our Chief Operating Officer, who will provide you with an update on our Q1 progress towards exploiting commercialization opportunities. Joe?

Thank you, Mark. We are increasingly focused on building a strong portfolio of commercial-ready, non-pharmaceutical products across the life sciences, bioactives, and ingredients in industrial sectors, areas where our expression platforms offer significant advantages in speed, scalability, and cost efficiency. In these segments, we're developing and advancing a diverse range of high-value, prominent proteins, enzymes, and bioactive ingredients that are well aligned with growing global demand for sustainable, animal-free solutions. Our top commercialization priority lies in the cell culture media space, a market valued at over $6.1 billion globally and growing at a robust 13% compound annual growth rate. Within this segment, through our collaboration with ProLiant Health and Biologics, we expect the launch of recombinant human serum albumin in Q3 2025. This product is designed to replace animal-derived components in key markets such as diagnostics, medical device coatings, gene therapy products, and chemically defined cell culture media. We also anticipate achieving a third milestone payment related to productivity improvements in Q2. In parallel, we're advancing a recombinant transfer, which has demonstrated comparable cell growth performance to reference standards in preliminary studies. Sampling programs are active and work. We are engaged in early-stage partnership discussions. Additionally, we are developing fibroblast growth factors, or FGFs, a critical class of proteins for regenerative medicine and cell-based manufacturing. Our recombinant FGF products have shown promising bioactivity in cell proliferation assays, and we plan to begin sampling in Q2 2025 to accelerate partner engagement. In the area of DNA and RNA manipulation tools, we are making notable strides to address growing market demand. Our recombinant DNase I RNA-free enzyme is a key reagent in gene therapy, biopharma production, and molecular diagnostics. To bring this product to market, we're working closely with the European Contract Development and Manufacturing Organization, CDMO, to validate our production process and initiate the manufacture of research-grade materials. Beyond DNA SWAN, we've developed and validated several additional enzyme prototypes, including RNase inhibitors and T7 RNA polymerase. These are part of our broader strategy to expand into the nucleic acid tools market, which is projected to exceed $4 billion globally by 2028. These products are undergoing continued development and optimization with performance results expected by year-end. Turning to nutrition, in the animal-free environment, dairy products market, valued at approximately $26.5 billion in 2023, our work in non-animal dairy proteins continues to gain momentum, offering both functional and nutritional advantages across multiple sectors. Alpha-lacta albumin, a key whey protein, is currently undergoing detailed characterization and is being sampled for applications in research, biochemical analysis, and ultimately food-grade nutritional products. We're seeing increased partner interest in this animal-free alternative as demand rises across the specialized nutrition markets like infant formula, medical nutrition, and wellness products. In parallel, we're advancing human lactoferrin, a multifunctional protein with potential applications in nutrition, research, and pharmaceutical markets, particularly as a functional, bioactive, antimicrobial, anti-inflammatory, or immune-supportive agent. We're currently advancing optimization to ensure high-yield, scalable production and accelerating characterization efforts to further refine the product. Looking ahead, we anticipate initiating sampling efforts with prospective partners and customers in late 2025. Also within the animal-free dairy space, scale-up is ongoing for the first recombinant dairy enzyme in partnership with our collaborator with a commercial launch expected by year-end. Additional dairy enzyme candidates are progressing under the 2023 license agreement we signed to develop and commercialize non-animal-derived enzyme solutions for dairy processing. In industrial applications, we've made significant progress with enzyme systems that enhance process efficiency. and Freeside, a product developed by using our Dapabas Expression platform under license to Firmbox Bio and launched in 2024 as a sustainable solution to convert pre-treated agricultural residues into fermentable sugars for more efficiently and cost-effectively. Building on that momentum, Firmbox received a large follow-on purchase order in Q1 2025, and production is now underway with deliveries expected in the coming months. This marks an important step forward in driving commercial traction in the bioindustrial market. In parallel, we've developed and are currently testing an enzyme cocktail targeting the approximately $400 million global enzyme market for pulp and paper applications, as well as a candidate cocktail for the biogas industry, where demand continues to grow for cost-effective, sustainable processing technologies. While our primary focus is on non-pharmaceutical product commercialization, we continue to strengthen and validate our C1 expression platform through a series of high-impact, fully-funded collaborative programs. We believe these initiatives can serve as important proof points for the scalability, speed, and cost-efficiency of our microbial production technologies. One such initiative is the $4.5 million grant from the Coalition for Epidemic Preparedness Innovations, or CEPI. awarded to Fundacion Biotechnopola de Siena, where Dyadic is a subcontractor eligible to receive up to $2.4 million. The grant supports the development of recombinant vaccines against emerging infectious diseases using the C1 platform, potentially enabling more rapid, cost-effective pandemic response. Also, we are executing a $3 million program funded by the Gates Foundation to produce low-cost monoclonal antibodies for malaria and respiratory succinct virus, or RSV. This disease continues to place a heavy burden on global health, particularly in low- and middle-income countries where effective antibody-based treatments have been cost prohibitive. In addition, Dianic has been selected to participate in the European Vaccines Hub for Pandemic Readiness, or EVH, a new 100 million euro initiative funded by the European Union. This collaborative initiative is designed to build centralized vaccine, R&D, and manufacturing capacity, and dyadic C1 technology will be evaluated among other cutting-edge solutions. This not only highlights the growing recognition of microbial expression systems, but also underscores the growing demand for scalable, non-mammalian production platforms in pandemic preparedness efforts. Our technology is also further explored through the CEPI-UVAX collaboration, which includes a $2.6 million grant to support the development of a MERS vaccine candidate. At the same time, this program is evaluating the C1 expression system's potential to reduce manufacturing costs and accelerate vaccine production timelines. Beyond human health, we're also demonstrating the flexibility of the C1 platform in growing the animal health sector. Our collaborations with Fibro Animal Health, VeroVax LLC, and others focus on further development of ferritin nanoparticle-based vaccines and other vaccines targeting infectious diseases such as avian influenza or bird flu and other livestock pathogens. The H5 ferritin nanoparticle vaccine candidate produced using our C1 platform in partnership with VeroVax LLC is being evaluated in poultry. Early trials show the generation of neutralizing antibody responses, supporting the potential for vaccine and diagnostic use. These programs expand how C1 can be used and highlight its strong potential to reduce bioproduction costs in a variety of veterinary applications. These advancements in our life science, bioactive ingredients, and industrial segments reinforce the versatility and scalability of our C1 adaptivist platforms across diverse market segments. As we continue to translate scientific innovation into commercial opportunities, it's equally important to maintain a strong financial foundation to support our growth. With that, I'll now turn the call over to our Chief Financial Officer, Ping Rawson, who will walk through our first quarter 2025 financial results.

Ping?

Thank you, Joe. I will now go over our key financial results for the quarter ended March 31, 2025 in more detail. You can find additional information in our earnings press lease and form 10-Q, which we filed earlier today. Total revenue for the quarter ended March 31, 2025 increased to approximately $394,000 compared to $335,000 for the same period one year ago. The increase is driven by the increase in grant revenue of approximately $210,000 for the gifts from the Gates Foundation and SAPI in 2025. There was no grant revenue for the three months ended March 31, 2024. Cost of research and development revenue for the quarter ended March 31, 2025 decreased to approximately $126,000 compared to $144,000 for the same period a year ago. The decrease in cost of research and development revenue was due to the decreasing number of collaborations in 2025. Cost of grant revenue for quarter-ended March 31, 2025 was approximately $171,000 compared to zero for the same period a year ago. Research and development expenses for the quarter-ended March 31, 2025 decreased to $495,000 compared to $523,000 for the same period a year ago. The decrease reflected a decrease in the amount of ongoing internal research projects. E&A expenses for the quarter ended March 31st, 2025 decreased by 10.8% to $1,596,000 compared to $1,789,000 for the same period a year ago. The decrease reflected decreases in business development and investor relations expenses of $97,000, management incentives of $78,000, accounting and legal expenses of $41,000, partially offset by other increases of $34,000. Loss from operations for the quarter ended March 31, 2025, decreased to $2,002,000 compared to $2,126,000 for the same period a year ago. Net loss for the quarter ended March 31st, 2025 was $2,028,000 or 7 cents per share compared to $2,010,000 or 7 cents per share for the same period a year ago. As of March 31st, 2025, we have cash, and investing-based securities of $7.4 million, compared to $9.4 million as of December 31, 2024. We continue to strengthen our balance sheets to support our near-term revenue growth and accelerate our strategic objectives of commercialization opportunities for pharmaceutical and non-pharmaceutical applications. With that, I will now ask the operator to begin our Q&A session. Each caller will be allowed one question and one follow-up question to provide all callers with an opportunity to participate. If time permits, the operator will allow additional questions from those who have already spoken. I will now ask the operator to begin our Q&A session, after which Mark Emesard, our CEO, will provide closing remarks. Operators,

Thank you. We'll now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. The confirmation tone will indicate your line is in the question queue. You may press star 2 to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. One moment, please, while we poll for questions. Our first question is from John Vandermosten with Vax.

Great. Thank you, and good afternoon, Mark, Joe, and Ping. So congratulations on the firm box deal there. That's nice to see that. Can you tell me how the royalty arrangement works with them and how you might recognize some benefit from that contract that they got?

Joe, do you want to go ahead and answer that?

Go ahead, Mark, and then I can fill in.

Yeah, so basically we have a joint venture collaboration with Firmbox, a multitude of different product opportunities, including this one that we're talking about here today. And the profit split is going to be split between the two companies, and we're not getting into the exact details here, but it's a fairly large profit split for both of us. So as he ramps up and lowers his cost of goods and starts delivering these enzymes for this application. We expect that to be quite a large application, and we'll fill you in on future quarters on that. I know, Joel, is there anything you want to add to that?

Yeah, I think the only thing I would add to that is that the revenue sharing is immediate. It's not going to be, you know, I guess delayed. So, you know, as the sales start to roll in, we'll start to see some revenue coming in from those.

Okay. Okay. I also want to follow up on the albumin arrangement and see if you could comment on the progress here, and then also if there had been any advanced orders placed by customers for that product through ProLiant.

No advanced orders at the current time. They're not actually taking them until the samples have gone out. That's expected within the second quarter here that sampling will begin. so that the orders can start being fulfilled and taken in the third quarter. So hopefully in the second quarter we'll start to see some of those, but we're still getting the final phases of scaling up and fill and finish. But everything right now is looking positive, and we're keeping our fingers crossed and keeping the foot on the gas to make sure that this gets to market as quickly as possible.

Okay.

Thanks, Joe.

Our next question is from Dick Williams with Williams Resource Group.

Hi, guys. John asked the same question about what I was asking on Fernbox, but maybe there's one part you didn't cover, Joe. This is for Joe. They have one, what I understand, they won a bid that they put in, I don't know with whom. I think it was the government, but I'm not sure. And that's what we're talking about, that is some revenue generation for us once they start delivering these things. But is there any opportunity for them to bid other contracts with the government or others where we also are a 50% participant?

Thanks for the question. I can't get into exactly the specifics on the order itself, but you're absolutely correct. It's not a one and done from a bid standpoint. We're evaluating not only options from a government standpoint, but also in the private sector as well. So we're hoping that this continues to grow as we start to see this getting onto the market, but definitely not going to be limited to just government.

Okay, thanks. That's all for me.

Thanks.

Our next question is from Paul Rosenbaum with SWR.

Hi, Joe. I guess this is a question for you. You know, I've been around a long time. I own a hell of a lot of shares in this company. And what I heard on this call today was that you have a large commercial order and that you're going to concentrate on the non-pharmaceutical commercial area. When does the – either one, Mark or Joe, when do you start spending less money on the – $4.6 million in research and the $3 million in the Gates Foundation, which I've been around a long time. There's no revenue coming in there. It's exciting that there's going to be revenue in the protein area. When does the board decide that you're going to spend less money in one area and a lot more money in the area where revenue is coming in? This is not a criticism. It's just an observation on my part. And I think I'm allowed to say that considering how long I've been a friend of this company.

I think, Paul. Yeah, go ahead, Joe.

First of all, again, I appreciate the question. Absolutely, you have the right to voice your opinion, and we're glad to hear it. I think the key is now. Now we are starting to reprioritize all of our resources and all of our focus in the non-pharmaceutical sector for revenue generation through commercialization-ready products like albumin or the dairy space with the non-animal dairy enzymes. It isn't that we are putting a lot of effort and resources into the human health. It's kind of, I don't want to say on autopilot, but we've taken it as far as we can take it as a company, and now we need to rely on our partners and our collaborations to take it further. So in the coming weeks, months, years, it's going to be the focus on product development rather than platform development. Any platform development that we need to do will be focused on the products that are going through. And I think the toolbox that Mark and the team have created over the last 10 years has enabled us to do that. Now we just need to resource it and focus appropriately in those segments. But it's a valid question, and we absolutely are moving in that direction.

That's encouraging to hear, and I appreciate that. Thank you.

Thank you.

Our next question is from John Vandermosten with DAX.

Great. Thank you for the chance to ask a follow-up. Looking at your non-dairy applications portfolio, what product of those three appears to have the best margins? And then how does this compare with the reagent proteins in terms of attractive margins?

It's a great question.

Of all the current pipeline, lactoferrin probably has the highest margin potential simply because it's a much smaller portion of the protein concentration in milk products. That being said, alpha-lactal albumin, I think, overall has the largest market potential in terms of volume and margins for us because it's a lot larger. It's still a high-value segment, and it's not quite as easy to produce in some systems. We're very fortunate that our development is moving well. We have a very productive strain. And so far, the initial testing has demonstrated not only equivalent to current research-grade alpha-lactam products that are on the market, we also have some application testing in the food products. It's ongoing right now, and the initial results look good. positive. So I'm consciously optimistic that we don't have to do too much more work on that, that we can continue to progress towards commercialization more rapidly and just start to drive the So I definitely understand where you're coming from. Some of these segments are very thin, like the dairy enzyme segment. The margins are a lot tighter. But when you get into these specialized medical nutrition infant formula products, they're definitely higher value segments that we're going to be chasing. But I do think Alphalac represents probably the largest and quickest potential. Lactoferrin, there's been a couple of companies over the years that have tried it and haven't done quite so well. And, again, we're not trying to launch the product ourselves.

We're just trying to launch the product.

Sorry about that.

Okay. No, great detail on that. That's great information. Cool. Our next question is from Tony Bowers with IntroAct. Hi, Tony. Are you there? Tony, is your line on mute? Hi. Hi, Mark. Joe, is that better?

I'm off speaker.

Yeah, thanks.

That's good. A couple different questions. You give a statistic on the number of paid collaborators dropping nine to four. Is that partly because of the pivot? Is there any color on why folks have dropped out? What results there were when they satisfied with the collaboration, but just aren't going ahead. It's obviously a very weird environment right now in life sciences. That's the first question. The second is tariffs are pretty topical right now. Is there any quantifiable tariff problems for you guys with the initiatives you've got going?

You want to answer that first? You probably want me to do that.

Yeah, sure. You're probably better equipped to handle the tariffs. Maybe address that first. Right now, we don't see a significant problem, but we actually see potential opportunity for When you look at onshoring, especially with biologics and manufacturing, that could potentially be an area of potential for us. Obviously, we're looking at expanding our capability for manufacturing here in the US. We do have a pretty good footprint abroad. As you look at some of the other markets or some of the other collaborators that have dropped off, it is due to the pivot. We are focusing on licensing deals and product partnerships. Rather than collaborations that require use of our resources and potential investment, we're actually trying to make sure that everything we're doing is focused on bringing products to market, whether that's by ourself or in conjunction with other partners. So we have a lot of ongoing work. The discussion is happening right now. A lot of term sheets that are being exchanged. So this is going to pick up rather quickly. I can't get into a lot of that, but it definitely is a much different focus for us. Rather than chasing collaborations that will take development and 12 years to produce a product, we want to be producing products like we do with ProLiant and partnering them within 12 to 18 months somewhere in that neighborhood.

And the Firmbox initiative, this is back to your old roots, Will, is that, if I think of it as ethanol, for example, is it something like that as an end product?

Yes, you're absolutely right. That is exactly how you would think of it.

Okay, so it fits into the... Like a renewable biofuel?

Yeah. And the thing with Firmbox, it's not just a one-off, as Joe pointed out earlier. We're in discussions with them and on their own for additional partners and collaborators that would like to build multiple plants based on the success of this first customer. So we've been testing different substrates with those enzymes to see how well they get digested and turn into glucose sugars for renewable chemicals and fuels. So it's not a one-off, but we think it's a reproducible, consistent growth area for us and for Fernbox. as well as other products, as Joe pointed out earlier, pulp and paper and biogas and other things that we're looking at developing. And your question about tariffs and how it would affect us, I think we want to make it clear, the albumin is being produced here in America, so it's not going to affect at all ProLiant. So that's a domestic production. Yep. And we have other things, the enzymes actually with our dairy enzyme company, It's going to be launching the dairy enzyme. It's produced here in America as well. So both of those are being scaled up here in the U.S. So that's a good thing. And then as Joe pointed out on biomanufacturing, you know, and as you saw I think the other day, you know, where there's an executive order to reduce the cost of drugs, which includes biologics, which is the most expensive, there's pressure on the pharmaceutical industry that hopefully will be looking for more efficient ways to produce their products so they can maintain their margins. as they're getting squeezed on the other side.

That's great. And if I missed it, sorry, did Ping forecast the burn rate going ahead?

No, she did not. Okay.

Any aspirations on that? I think we hope to, like we showed in the third quarter, when we got money in from ProLiant and we got money in from it, our dairy milestone that we will have license agreements of, we hope, significantly more money up front, milestones, and then, of course, launching these products, getting revenue in from both Carliant on the album sales and also from Firmbox and launching the transfer in a D&H one, either on our own or in collaboration with different parties that we're in discussions with now. I don't know, Joe, you want to add any color to that?

No, I think probably the decrease in the number of collaborators, too, is due to the fact that we need to take these products further in order to maximize the potential. You look at albumin, just taking albumetics as an example. The company sold for $500 million, but they worked on it for 20 years. Obviously, we don't want to have those types of products. It takes a little too long, but In the segment, we really do need to take these a little further, and if we're going to have more upfront monies and longer or shorter-term revenue projections, we'll need to have these products validated, have production methods at least somewhat up and running, and have the protein characterized and the correct assays done, because that's what drives the value. If we partner these too early, we're just kind of shooting ourselves in the foot. We're taking a little bit more time to make sure that we have all the necessary information to extract as much value in our partnerships or in our sales as possible.

Thank you.

There are no further questions at this time. I'd like to hand the floor back over to Mark Amelthorne for any closing remarks.

I'd love to thank all of you for joining us today and for your support over the years. In closing, Q1 2025 marked a pivotal step forward in dietetics evolution from a development stage biotech company to a product-driven revenue-generating enterprise. By focusing our efforts on the development of functional or common solutions and proprietary production streams to manufacture large quantities of precision-engineered proteins and enzymes for use in life science, nutrition, and industrial applications, we are positioning ourselves and our partners to meet the growing global demand for scalable and affordable, animal-free, precision-engineered proteins and enzymes. With commercial launches on the near horizon, a robust pipeline backed by non-dilutive funding, and a powerful technology platform, both for C1 and APOBIS, validated across multiple sectors, we believe DIAC is well on its way to unlocking meaningful long-term value for our shareholders.

We appreciate your continued support and look forward to updating you on our progress in the months ahead. This concludes today's conference. You may disconnect your lines at this time.

Thank you for your participation.