Dyadic International - Earnings Call - Q4 2024

Executive Summary

• Q4 2024 delivered modest revenue while FY 2024 improved YoY; total FY revenue rose to $3.50M (+20.6% YoY), driven by $1.0M Proliant license and ~$0.89M Inzymes success fees. Against Street, FY revenue missed consensus ($3.50M vs $4.30M*) and Q4 revenue missed ($0.82M vs $1.60M*); FY EPS was -$0.20 vs -$0.18* consensus, a slight miss.
• Liquidity strengthened: cash and investment-grade securities were $9.29M at year-end (vs $7.27M prior year), supported by convertible notes financing; balance sheet showed $7.46M total liabilities, including $4.98M in convertible notes (incl. related party).
• Strategic catalysts: CEPI funding (up to $4.5M, with Dyadic to receive up to $2.4M) and Gates Foundation $3.0M grant bolster platform validation and potential 2025 revenue opportunities. Near-term commercialization targets include Human Serum Albumin (expected Q2 2025) and DNase1 research-grade rollout.
• Management emphasized a dual-track strategy: monetize alternative proteins (albumin, transferrin, DNase1, dairy enzymes) while advancing human/animal health via C1 collaborations; tone constructive on adoption and non-dilutive funding.

What Went Well and What Went Wrong

What Went Well

• Alternative proteins monetization accelerated: $1.0M license from Proliant and ~$0.89M from Inzymes success fees; management: “$1.9 million in revenue from our cell culture media and non-animal dairy segments”.
• Non-dilutive validation and funding: CEPI awarded $4.5M to FBS (Dyadic to receive up to $2.4M) to speed C1 vaccine development; Gates Foundation granted $3.0M for mAbs in RSV/malaria.
• Quote: “We’re launching our first commercial products… recombinant albumin, non-animal dairy, DNase1… broadening the adoption of our microbial platforms” – CEO, closing remarks.

What Went Wrong

• Miss vs Street: Q4 revenue ~$0.82M vs $1.60M* consensus; FY revenue $3.50M vs $4.30M*; FY EPS -$0.20 vs -$0.18*, reflecting continued operating losses and lower-than-expected top line.
• Other income fell sharply YoY (to $0.09M from $1.43M) due to interest expense from convertible notes and absence of 2023 Alphazyme gain, pressuring net results.
• Continued net losses and operating loss FY 2024 (-$5.81M net, -$5.90M operating), underscoring scale-up and commercialization execution risk despite pipeline progress.

Transcript

Operator (participant)

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, 26 March 2025. I would now like to turn the call over to Ms. Ping Rawson, Dyadic's Chief Financial Officer. Please go ahead.

Ping Rawson (CFO)

Thank you. Good evening and welcome, everyone, to Dyadic International's Full-year 2024 Conference Call. I hope you have had the chance to review Dyadic's press releases announcing financial results for the fiscal year ended 31 December 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, Joe 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'll then hold a brief question-and-answer 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 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.

Mark Emalfarb (CEO)

Thank you, Ping. Welcome, everyone, and thank you for joining Dyadic's full-year 2024 conference call. We're 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 Dapibus microbial protein production platforms.

These platforms are enabling us to generate immediate revenue through high-value alternative protein applications, including recombinant human albumin, transferrin, DNase I, and alpha-lactalbumin.

At the same time, we're 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're proud to be working with the Coalition for Epidemic Preparedness Innovations, 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, Joe Hazelton, to provide an update on business results for 2024. Joe.

Joe Hazelton (COO)

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 Dapibus 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 and near-term revenue potential in the non-pharmaceutical and reagent product markets, which continue to show robust momentum and commercial readiness across our three areas of focus in alternative proteins: life science, food and nutrition, and bio-industrials.

We're making strong strides toward 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, bio-production, 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 bioprocessing 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. Initially 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, sampling initiatives are expected to begin in Q2 2025. These cell culture media components position Dyadic to capitalize on growing bio-production needs with high-quality, non-animal, cost-advantaged 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 platforms.

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're actively partnering with a European contract development and manufacturing organization, or 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 sector. Dyadic is also advancing its presence in the bio-industrial sector of our alternative proteins segment, where our Dapibus protein production platform is being leveraged to support sustainable, large-scale enzyme solutions across multiple industries.

In 2023, we entered into a development and commercialization agreement Fermbox Bio, a synthetic biology research and manufacturing company. This collaboration led to a significant milestone in May of 2024 with the launch of EN3ZYME, an enzyme cocktail produced using Dyadic's Dapibus platform.

EN3ZYME 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 bio-based 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 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, or CEPI, awarded to Fondazione Biotecnopolo di Siena, or 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, or 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 23rd, CEPI announced the award of a $2.6 million grant to Uvax Bio. 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're developing a C1-produced self-assembling ferritin nanoparticle antigen 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 validation to support potential strategic partnerships and licensing opportunities. Additionally, our Mpox 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 A/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 Phibro Animal Health, or Abic 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 a 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 financials. Ping?

Ping Rawson (CFO)

Thank you, Joe. Thank you, everyone, for joining our call today. I will now go over our key financial results for the year ended 31 December 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 31 December 2024, we have cash, cash equivalent, and investment-grade securities of approximately $9.3 million compared to $7.3 million as of 31 December 2023.

Revenue for the year ended 31 December 2024, increased to approximately $3.495 million compared to $2.899 million for the year before. The increase is driven by the licensed revenue of $1 million from Proliant and approximately $890,000 from enzymes, including success fees in 2024. Cost of research and development revenue for the year ended 31 December 2024, decreased to approximately $1.195 million compared to $1.976 million for 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 31 December 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 I clinical trial of DYAI-100 COVID-19 vaccine candidates. G&A expenses for the year ended 31 December 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 relations 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 31 December 2024, was approximately $5.901 milion compared to $8.230 million for the year before. Net loss for the year ended 31 December 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 the two awards from CEPI to support C1 antigen development and accelerate the advancements of the C1 platform, from which we expected to receive additional funding.

These initiatives are expected to create additional revenue growth opportunity in 2025. Now, I will ask the operator to begin our Q&A session, after which Mark Emalfarb will provide closing remarks. Operator?

Operator (participant)

Thank you. 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. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. One moment while we poll for questions. Okay. Looks like our first question comes from John Vandermosten with Zacks Small Cap Research. Please proceed with your question.

John Vandermosten (Senior Analyst)

Great. Thank you. And how 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. I heard you mention that there were some other grant applications that you had made. Maybe you can reconcile, I guess, how the 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 (CEO)

Yeah. Thanks, John. To address your first question, yes, we have a number of additional grants either that we've applied and/or collaborators have applied for C1s embedded in those programs. That's both for Gates and CEPI, as well as other nonprofit organizations, government grants, in different countries.

Of course, you can tell by the Gates giving us the $3 million grant, they have a significant interest. We've been having calls with them already. I think they're excited about how fast they've seen on the work we're doing compared to the dispersal that traditionally used to seeing with the monoclonal antibodies. In fact, they mentioned how surprised they were, how fast we were already getting transformants. 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 Fondazione Biotecnopolo di Siena, the grant announced yesterday by CEPI with Uvax Bio, these are driving forward the innovation and the advancement of our platform, not only to make it quicker, faster, better, and cheaper, because quite frankly, it already produces things at remarkable levels fast and quick, but it's bringing adoption and use to potential products that are going to be put into human beings at some point down the road, as we hope will turn into lifesaving medicines that we can make profits on from our shareholders, but bring global health to the humanity.

On the animal health side, you know, Phibro as Joe mentioned, is advancing towards commercialization on one or two of the animal health vaccines.

As you know, with the USDA just announced recently a billion dollars in funding for potential human health or animal health, and $100 million of that is partly going to be assigned potentially for vaccines. We actually got notice yesterday from them of a potential opportunity to apply for that grant, which we intend on evaluating and potentially doing in our own and/or in collaboration with academics and industry and nonprofit organizations. So hopefully that gives you a flavor for the fact that, 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 (Senior Analyst)

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? It seems like you know maybe in the next weeks or month or so, yeah, that milestone may happen of getting that dollar through the door. Can you update us?

Joe Hazelton (COO)

Yeah, absolutely, John. First of all, thanks 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's validated, the QC testing is done, and it's produced according to the right specifications in order to have a successful launch. In addition, starting to sample, that's going to be the first key, which we do hope, and it will be happening very soon. But again, we remain committed to pushing and hopefully commercializing in early 2025. We are still pushing. It's still about scale-up and making sure the product is qualified, and that just takes time.

There's really no shortcut you can take. It's kind of like, I don't want to say developing a drug, but in 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.

You want to make sure everything is basically all set and all systems point to go before you put a product on the market and then realize something is wrong. So we're just making extra sure and doing all the qualifications and QC to make sure these products are high quality, high purity, and that they'll meet our customers' needs. Again, hopefully, we still continue to push and have that commercialized as quickly as possible.

John Vandermosten (Senior Analyst)

Okay. Great. Thanks, Joe. I'll hop back in line.

Mark Emalfarb (CEO)

[crosstalk]

All right. Go ahead.

Operator (participant)

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

Vernon Bernardino (Managing Director and Senior Biotechnology Analyst)

Hi, everyone. Thanks for taking my question and congratulations on the great quarter and getting the 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 (CEO)

I think the important part is 80% of the research and development expenses are covered by somebody else with some profit margin built in for us. The CEPI grant for the $4.5 million, of which we're going to 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. We've demonstrated that we can create stable cell lines already within 21 days. That is very fast, and they're very productive, and they're mass-producible at very low cost without the need for cold, extreme cold chain storage.

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, governmental agencies, academia, it all starts by putting the gene into a cell line. Like Uvax Bio in the CEPI grant that was announced yesterday, where they're getting $2.6 million from CEPI to advance their MERS program, we're going to produce the antigen that goes in there that's going to be ultimately the vaccine, the active component of the vaccine. The more of these opportunities we get, the more demonstration of safety, efficacy, speed, yield, cost, the momentum is building and it's accelerating.

As we mentioned in the past, Rino Rappuoli is 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 governmental organizations, pharmaceutical companies, academia, etc. We expect more things to come from that collaboration in the not-too-distant future.

Vernon Bernardino (Managing Director and Senior Biotechnology Analyst)

Great. Follow up on the CEPI grant. The grant is to FBS, right? The press release said that the C1-produced protein engines can be compared to traditional mammalian approaches. Just wondering, what is FBS's experience with that, and when can we see results from their work?

Mark Emalfarb (CEO)

FBS experience is probably 30 years with Rino Rappuoli as a former GSK Chief Scientific Officer, at Novartis before that, at Chiron before that. As I mentioned, he's like one of the godfathers of vaccinology. He's probably taken 10 or 12 drugs through the clinic into commercialization over time.

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 hexo protein. We're expecting very good results on that program very soon.

Vernon Bernardino (Managing Director and Senior Biotechnology Analyst)

Will the comparison be in vitro or some kind of yield number?

No, it'll be in animal models, which is what we've already done. You'll see when the publication comes out that we can virtually make same thing, same quality, same efficacy, just faster, quicker, and cheaper without the need to do viral clearance. On the downstream, we can speed it up with less cost.

On the upstream, we can blow it away in terms of speed and cost.

We have already seen, at least in the mice trials that have been compared head-to-head, at least with a microneedle approach, that we were equal to the HEK cell, which is actually a human cell, which is actually better than the CHO cell.

Great. Thanks for taking my question and congrats again. I'll get back in the queue.

Operator (participant)

Thank you. As a reminder, if you'd like to ask a question, please press star one on your telephone keypad. That is star one. Our next question comes in from John D. Vandermosten with Zacks Small-Cap Research. Please proceed with your question.

John Vandermosten (Senior Analyst)

Great. Thank you. You had mentioned that by year-end that you may begin commercialization of the dairy enzyme.

Can you also walk me through the steps there, kind of like you did with the albumin, what needs to get done before, again, that first dollar can flow through the door?

Joe Hazelton (COO)

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 part of EMA that deals with food type or food proteins. In the US, it's GRAS. Essentially, the product has been filed for a self-affirmed GRAS application. That should hopefully be, I think it is submitted and once that is clear, they just do the final testing and production, and then they're able to put it on the market. It's similar in terms of the steps.

Obviously, you 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. That's essentially the main process.

John Vandermosten (Senior Analyst)

Okay. 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?

The human/animal albumin, the transferrin, and the growth factors. Kind of 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 (CEO)

Yeah, Joe, I think that some of that is proprietary information. So just leave it to be obviously, it's 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 those products, maybe one by one.

Joe Hazelton (COO)

Yeah. I think the key, John, as you look at it in terms of productivity, is that we are able to basically make better margins than traditional recombinant products in the market today due to our productivity. and Mark's right.

We can't get into the specifics, but suffice to say that the interest that we're receiving in our non-pharmaceutical applications, as Mark mentioned, whether it's transferrin and cell culture media, is due to the high productivity. These enzymes and cell culture, these proteins and cell culture media like albumin, like transferrin, they are thousands of dollars per gram or even, in some cases, per microgram. It is very important that we're able to use the productivity of the system to help not only bring the cost down, enables commercialization.

Cell culture media can be used in pharmaceutical development and manufactured at CGMP levels, but it's way too expensive for markets like cultured meat.

And the nice thing about the cell culture 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. Essentially, we're able to use these portfolios and cell culture media in two different directions, basically expanding and, in some cases, doubling and tripling our potential profit margins in these markets. We're making great progress in the testing, as Mark had mentioned, with transferrin and growth factors.

Being able to demonstrate that we can grow animal cells just like the products they're using today, except at much higher yields and potentially much lower prices, is very interesting. 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.

I think, again, we can't get into the specifics, but if you look across these products, they're all moving forward as quickly as possible. That is going to 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 a 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. 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 (Senior Analyst)

Okay. Great. Thank you.

Operator (participant)

Thank you. Our next question comes from Dick Williams with Williams Resource Group. Please proceed with your question.

Dick Williams (Research Analyst)

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 did not really materialize, it seems that ZAPI was one for five years. We were picked as the best technology for the future. It seemed it was unanimous. Of course, that whole group, including AstraZeneca, has really not done anything. It appears that the CEPI is something that will happen.

The one other factor with the CEPI release was they also had put out a release that got buried in their material with Uvax Bio, 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 did not get much attention, but it was buried. That was significant.

Now we 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 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 Proliant? I've checked out Proliant. It's a very large corporation. This isn't a Mom and Pop, guys.

They have a full worldwide sales force, several manufacturing facilities, and they're going to launch a product that we will get revenue from in a matter of months, I presume.

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. 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. 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 the 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 so truly deserve.

Mark Emalfarb (CEO)

Before Joe, John, [crosstalk}

Dick Williams (Research Analyst)

Can you kind of dissect that?

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 that market opportunities in them. I was around five, six years ago when this company did upwards of close to $100 million over, I forget what period of time, in the bioindustrial sector. Real revenue produced by Mark before Joe joined with this new area. That area, I understand, is blossoming again. One of the opportunities for us is to go back into and offer the products we now have for that industry.

So can you give some color of where we are and what type of an effort, Mark, you're going to put forth to go back to your old people and get some serious revenue from them?

Mark Emalfarb (CEO)

Yeah.

Let me answer the first question for the last. [crosstalk]

Dick Williams (Research Analyst)

I know it's a mouthful, but.

Mark Emalfarb (CEO)

Hi, Dick. Look, Dick, we're going to run out of time here. I love you. We appreciate your thoughts. You're a great supporter. We love all our shareholders and partners and employees. But we didn't just twirl our thumbs the last five years. We developed platforms, first from pharmaceuticals to revolutionize and transform speed, cost, and yield and release. You have to have a platform before you can make a product. You can't make a product in an inefficient platform where you're going to fall short or it's going to be people are going to die or suffer, which is what's happening in the world. We took the time and effort to do it right.

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 had the Israeli government. You had the EU ZAPI program. You had all kinds of things coming in that advanced it to make and wake up the Gates Foundation. They said, "I didn't just wake up yesterday. We've been talking to these people for years." It got to the point that they recognized that we actually have the keys to the kingdom to really improve speed, yield, cost, and release of not just pandemic purpose. We're talking about traditional oncology drugs, arthritis, dementia, Alzheimer's, you name it. We can probably make it in a more efficient way, at a lower cost, faster.

Once we get these things into the clinic and through the clinic, the doors are going to open up.

If you don't have a platform, you can't do any of this. We haven't just been twirling our thumbs for five years, and these guys didn't just show up. They showed up because we actually did what we said we were going to do, and we did it for a fraction of the cost that most other people would have done. On the industrial side, whether alternative protein and Joe's going to answer all those questions, we started with Dapibus to do the same thing at an accelerated pace, taking the learnings and education that we have and our CDMOs and research partners have.

We brought this out very rapidly, very quickly, as you point out, to go after an industry that's even more valuable than the one we did before when we generated $30 million-plus in non, let's say, diluted funding from Shell, Abengoa, BIOS, BASF, and then the $75 million from DuPont. 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 that too. I will let you go. Without these platforms, we would not be making anything, and our customers would not be making anything that would be commercialized.

Let's just leave it there. Joe, maybe you can jump in.

Joe Hazelton (COO)

Yeah. Dick, I think you hit the nail on the head there.

The markets that we're entering into are by design, and they're high-value markets where 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 it's growing at double digits per year. That's driven by a lot of the increase in the amount of vaccines being produced, not just in human health, but also in animal health. As we look to some of the other markets like DNase I and other RNA, DNA and RNA enzymes, that's a DNA or the endonuclease market, the DNase and ligase market is around $900 million. 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. That's where alpha-lactalbumin, lactoferrin, those things can play.

Each of these products also has a distinct, 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. It also potentially can play in pharmaceuticals, and it plays as a research-grade agent for nutritional and biochemical studies. Each one of these products has different markets. I think the key that I want to emphasize, though, 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. That's what we do. We take a DNA sequence, and we put it into our cell line.

While we're targeting multiple areas, we're targeting the right partners, as you mentioned, with Proliant Health & Biologicals. They're a major player in the albumin space. You look at even Uvax Bio.

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. I think that's the key. What we're doing remains the same. We're staying focused on that. 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 sector is what's driving the interest. You look across, 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.

That's really what we're trying to do right now. I think we're seeing unparalleled interest in all of our segments right now. It's due to the fact that we are starting to move closer to commercialization.

I think as soon as we get the first product on the market, that's going to be another driver for us or another inflection point that we can use to continue to expand the adoption. I think hopefully that gives you a flavor for the size of the markets that we're going into and the capability that are potentially that these products can have.

Operator (participant)

Thank you. Our next question comes from Tony Bowers with Intro-act. Please proceed with your question.

Tony Bowers (Director Of Corporate Sales)

Hi. I applaud Mark for his patience and persistence on the human side, but thankfully we've got 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?

Then a separate question is, where do we stand with all of the great work that was done in South Africa and the provenance 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 (CEO)

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 going to turn down $7.5 million with the financing, non-dilutive funding that we have some profit in to advance the platform. The learnings that we get from the pharmaceutical side of the development, we can apply also and are applying on the other side, okay? Our focus is currently driven by albumin, transferrin, DNase I, alpha-lactalbumin.

We're developing some cellulosic enzymes for biogas, biorefining, cellulosic sugars. Joe can jump into all of that, but I want you 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. Joe, you want to go into that?

Joe Hazelton (COO)

I mean, I think we've kind of really hit the markets pretty well. I think the key, Tony, that you've mentioned, what we're doing with Rubic and South Africa, where that stands. Right now, they've shifted their focus to animal health and animal health vaccines. Right now, they're developing, I believe, up to five animal health vaccines because they're a little, obviously, easier to commercialize than human vaccines at this point. The Phase I study that we completed with Rubic for DYAI-100 was a milestone event for Dyadic.

I think it's what's helping drive this increased interest from people like Gates and CEPI in the fact that we have been in humans with a protein-producing system. Unfortunately, we were a little bit late to the party in the COVID space. I think we'll continue to evaluate that with Rubic, but right now, their focus has shifted towards animal health. I know that they're looking to hopefully have some clinical studies at, I think, the tail end of this year. I think there's definitely an opportunity there. It's just we're probably going to do it in animal health before human health in that market.

Tony Bowers (Director Of Corporate Sales)

You expected that, yeah, will the animal health products have to be funded by a government program?

Joe Hazelton (COO)

I don't know if they 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. I don't know, Mark, if you have any greater insight there.

Mark Emalfarb (CEO)

Yeah. Actually, I'm heading there next month. I'm going to go down to Johannesburg, and I'm going to have a meeting with them for two days. I do have a little more insight than Joe does because I'm going there. They already have, I think they're working on a challenge study already. It's already funded for an animal health vaccine. They also have, from what I understand, they 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.

I do believe that they're also, as Joe pointed, 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. They're moving forward. 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. The whole issue I want to bring up, and I think it's important because it's the elephant in the room, what Trump and Elon Musk are doing in DOGE and gutting out all these different programs.

Guess what? We don't have any of those U.S. government programs, so we're not getting gutted. The thing is, there's a shift.

The shift is going to cost efficiency, lower cost, save government money. In some ways, what's going on in D.C., we believe is playing into our hands. It is going to help us accelerate the technology and the platform sooner because if you want to lower your cost of drugs, you better make them cheaper. If you want to make more of them, you better make them cheaper. You want to stretch the dollars you do not have or less dollars to live on, you better make more for less. That is the message. I think that is the message we have been resonating. That is common sense. I do not know what's going on in D.C., but I think you better find a more efficient way of doing things than doing.

We have had discussions. I was on the phone yesterday at 1:30 P.M. with a senior person at the FDA.

I have a call with [Unintelligible] last week. There are things going on. I do not know if they are going to turn in any money, but they are happening. I think everybody is realizing cost of goods matters because without that, we have an unsustainable model in America, let alone across the globe. This may actually be working out in Dyadic's favor. Also, the whole twist about mRNA vaccines, I am not saying whether it is safe or not, I am not going to get into that debate, but there is hesitancy that has been created for the mRNA vaccines.

If we take a step back, which is what I think that RFK and Trump are doing on mRNA, it may open up the door for the spotlight to be focused on the more durable, faster, lower cost. Sure.

Joe Hazelton (COO)

See how it all goes. Thanks.

Tony Bowers (Director Of Corporate Sales)

Yeah, I think we've got a really good outlook here. Keep up the good work.

Operator (participant)

Okay. Our final question comes from Stephen Raphael, private investor. Please proceed with your question. Hello? Stephen, you're on the line. Okay. 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 (CEO)

I almost feel like we're already done, but I'll close it anyway. 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 in 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 biomanufacturing platform development to revenue generation. At the same time, we plan to expand strategic partnerships across key sectors, including the alternative protein section, 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 Dapibus 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 Dapibus 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. 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 (participant)

Thank you. With that, this conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.