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Building the Infrastructure for the Protein Economy

Dyadic Applied BioSolutions, Inc. (NASDAQ: DYAI) is no longer simply developing technology. After years spent refining its proprietary fungal gene expression platforms, the company has evolved into a commercial solutions provider focused on bringing non-animal recombinant proteins to market across Life Sciences, Food & Nutrition, and Bio-industrial applications.

The transition represents a significant shift from a platform-validation story to one increasingly centered around products, partnerships, licensing opportunities, and recurring revenue potential.

The market opportunity is substantial. From cell culture media and molecular biology reagents to non-animal dairy proteins, medical nutrition, industrial enzymes, vaccines, monoclonal antibodies, and other biologics, demand for high-quality proteins continues to grow across multiple industries.

Rather than building a large commercial infrastructure from scratch, Dyadic is leveraging strategic partnerships with established industry leaders while simultaneously expanding its own portfolio of recombinant proteins and technologies.

As demand for proteins continues to accelerate across biotechnology, pharmaceuticals, food, nutrition, diagnostics, and industrial markets, the need for scalable manufacturing infrastructure is becoming increasingly important. Dyadic’s goal is to help provide that infrastructure by making protein production faster, more scalable, and more cost-efficient.

At the same time, one of the potentially most significant long-term opportunities remains the continued advancement of Dyadic’s C1 biopharmaceutical platform through funded collaborations involving leading academic institutions, government agencies, biotechnology companies, and global health organizations, such as the Gates Foundation.

To better understand the Company’s evolution, commercialization strategy, and long-term vision, we sat down with Dyadic President and COO, Joe Hazelton.

Let's dive in…

Joe Hazelton, President and COO

Joseph P. Hazelton is President and Chief Operating Officer of Dyadic Applied BioSolutions, Inc., where he leads corporate strategy, operations, and global commercialization of the company’s proprietary gene expression platforms for biologics and alternative proteins. He has been instrumental in scaling Dyadic’s scientific and commercial initiatives, advancing partnerships across biopharma, food, and industrial biotechnology sectors, and positioning the company for long-term growth. Mr. Hazelton brings over two decades of experience in life sciences, including leadership roles spanning commercial strategy, market access, and operations. Prior to Dyadic, he served as Chief Operating and Chief Commercial Officer at Charleston Laboratories, where he led global commercialization and portfolio strategy. Earlier in his career, he held multiple leadership roles at Novartis, driving managed markets strategy, payer engagement, and market access across major therapeutic areas. He is actively engaged in advancing next-generation biomanufacturing and enabling technologies that improve the cost, scalability, and accessibility of biologics. Mr. Hazelton holds a degree in English and Biology from the College of the Holy Cross.

Thank you for taking the time to sit down and talk with us about Dyadic Applied BioSolutions. Can you take us through Dyadic’s story and how it has evolved into the company it is today?

Dyadic was founded in 1979 and initially focused on providing materials to the textile industry. As the industry adopted enzymes for applications such as stonewashing denim and fabric softening, the company shifted its focus in the early 1990s to industrial enzyme production.

That led to the discovery of our C1 filamentous fungal gene expression platform that enables the large-scale production of non-animal proteins and enzymes using simple, low-cost inputs like sugar and water.

The company built a global bio-industrial business around the C1 platform, supplying products to the textile, pulp and paper, and animal nutrition industries while licensing its technology to major companies. By 2015, Dyadic was selling its enzyme products in 35 countries before selling its bio-industrial business to DuPont for $75 million.

Following that transaction, Dyadic shifted its attention to higher-value applications, spending several years re-engineering the platform to produce complex human and animal proteins, including non-mRNA vaccines and monoclonal antibodies.

When I joined in 2022, the focus became commercializing the technology and transitioning Dyadic from an R&D-stage company into a commercial products company. That effort led us to focus on Life Sciences, Food & Nutrition, and Bio-industrial markets where we could bring products to market while continuing to advance the underlying platform technologies.

Today, Dyadic is increasingly focused on delivering products, partnerships, licensing opportunities, and manufacturing solutions rather than simply proving the technology works.

Can you take us into some of your strategic partnerships? How do they support your commercial strategy?

One of the best examples is our partnership with Proliant Health and Biologics.

Dyadic developed a high-producing recombinant human albumin strain and licensed it to Proliant. In less than two years, we went from signing the agreement to launching a commercial product.

That demonstrates the speed at which we can help bring products to market and the value of partnering with established commercial organizations.

Proliant already serves customers globally and is one of the largest suppliers of albumin products. Through our collaboration, they can now offer recombinant non-animal albumin to customers who increasingly want sustainable, traceable, and consistent protein sources.

For Dyadic, the partnership generated upfront and milestone payments and provides the potential for long-term profit sharing as product adoption grows.

Our broader strategy is to leverage the commercial infrastructure, distribution networks, and customer relationships of established partners while focusing on what we do best: developing high-performing recombinant protein production solutions.

Can you describe the growing demand for protein across your target sectors?

Demand for protein continues to grow across virtually every market we serve.

In Life Sciences, proteins such as albumin, transferrin, growth factors, and enzymes are critical components used in vaccines, monoclonal antibodies, diagnostics, cell and gene therapies, and cell culture media.

In Food & Nutrition, demand is growing for medical nutrition, sports nutrition, healthy aging products, infant nutrition, and non-animal dairy proteins.

At the same time, customers increasingly want sustainable, traceable, animal-free solutions that can be produced consistently and at scale.

The common challenge across all of these industries is the need for better manufacturing solutions. That’s where we believe our dual C1 and Dapibus platforms can provide significant value.

You mentioned precision fermentation. How broadly can these platforms be applied?

If a protein can be encoded by DNA, it has the potential to be produced using recombinant expression technologies.

The difference between expression systems comes down to productivity, speed, scalability, manufacturing economics, and the ability to consistently produce proteins at commercial scale.

Every protein behaves differently, but when our platforms performs well, we believe they can offer significant advantages in speed, scale, productivity, and cost-efficiency.

That flexibility allows us to pursue opportunities across multiple industries rather than relying on a single product category.

What is the market opportunity for Dyadic?

We focus on markets where recombinant solutions can provide meaningful advantages over traditional sourcing methods.

The albumin market alone is estimated at approximately $7 billion.

Cell culture media and supplements represent an estimated $10 billion to $12 billion opportunity.

The broader molecular biology and nucleic acid reagent market is estimated at approximately $10 billion to $15 billion, with DNase I alone representing an estimated $2.5 billion opportunity.

Beyond those markets, there are opportunities in cultivated meat, non-animal dairy, medical nutrition, biologics manufacturing, industrial enzymes, synthetic biology, and advanced therapeutics.

These are large, established markets that already exist today and are projected to grow. Our objective is to participate through product sales, licensing agreements, manufacturing partnerships, distribution relationships, and strategic collaborations.

Can you take us through Dyadic’s products and long-term goals?

Today we are commercializing a growing portfolio that includes recombinant albumin, transferrin, DNase I, growth factors, chymosin, alpha-lactalbumin, and other recombinant proteins.

Some products are sold directly. Others are commercialized through partners. In some cases, customers may license strains and manufacture products themselves.

We view ourselves as a solutions provider rather than a competitor.

Our goal is to create multiple revenue streams through direct sales, OEM and white-label programs, distribution agreements, licensing, manufacturing partnerships, royalties, and profit-sharing arrangements.

That diversification is important because it allows us to participate in value creation through multiple business models.

Are there any other high-value targets Dyadic is pursuing?

Growth factors remain an important opportunity because they are critical components used in cell culture, regenerative medicine, and advanced biomanufacturing applications.

We are also focused on molecular biology reagents used in cell and gene therapy, synthetic biology, mRNA vaccines, monoclonal antibody manufacturing, and other nucleic-acid-based applications.

Our DNase I product is one example. We believe fungal expression systems may offer advantages in producing certain enzymes that can be challenging or expensive to manufacture in traditional systems.

We continue to evaluate additional opportunities involving RNA inhibitors, polymerases, and other high-value molecular biology products.

The opportunity in Food & Nutrition is significant. Can you take us through Dyadic’s focus in that sector?

Our primary focus is on high-value proteins and non-animal dairy ingredients.

Markets such as sports nutrition, medical nutrition, healthy aging, infant nutrition, and specialized nutritional products continue to grow.

Products such as alpha-lactalbumin, lactoferrin, and chymosin are examples where demand continues to increase and supply can be constrained.

We believe precision fermentation can play a significant role in helping address future protein supply challenges while providing high-quality alternatives to traditional production methods.

One of the potentially underappreciated parts of Dyadic’s story is the continued advancement of the C1 biopharmaceutical platform. Can you discuss that?

Absolutely.

While Dyadic is increasingly focused on commercial products and recurring revenue opportunities, one of the most significant potential upside opportunities remains the continued advancement of the C1 biopharmaceutical platform.

The commercial products business is designed to generate revenues through product sales, licensing, manufacturing partnerships, royalties, and profit-sharing arrangements. However, the C1 platform represents a separate and potentially significant long-term value creation opportunity.

C1 continues to be advanced and evaluated through funded collaborations involving leading academic institutions, biotechnology companies, governments, and global health organizations, including the Gates Foundation, the Coalition for Epidemic Preparedness Innovations (CEPI), the 170 million euro European Vaccine Hub initiative, NIAID/NIH, the Israel Institute for Biological Research, Oxford University, Scripps Research, Johns Hopkins University, and others.

These organizations are helping evaluate the platform in real-world applications involving vaccines, monoclonal antibodies, recombinant proteins, pandemic preparedness, and next-generation biomanufacturing.

Importantly, most of these programs are externally fully funded through grants, government support, and collaborative research initiatives. This allows Dyadic to continue advancing and validating the C1 platform while preserving capital.

The potential upside is that Dyadic may be building two value streams simultaneously.

The first is a commercial protein products business focused on generating recurring revenues across Life Sciences, Food & Nutrition, and Bioindustrial markets.

The second is a biopharmaceutical platform that could create substantial future value through grants, licensing opportunities, strategic partnerships, manufacturing collaborations, and broader adoption by pharmaceutical companies, governments, and global health organizations.

We believe this aspect of the story is often overlooked. While the commercial products business is creating value today, the C1 biopharmaceutical platform may represent significant additional upside if adoption continues to expand.

Looking ahead, how is Dyadic positioning itself for long-term growth?

Today, we have products being commercialized by partners and products being sold directly by Dyadic.

Our objective is to build multiple revenue streams over time.

We want recurring product revenue. We want licensing revenue. We want manufacturing partnerships. We want profit-sharing arrangements. We want royalties. We want strategic collaborations.

The goal is to build a diversified and sustainable business model capable of creating long-term value while continuing to expand into large and growing markets.

Is there anything else you want people to know about Dyadic?

The one thing I would emphasize is that this is a new Dyadic.

For many years, Dyadic was viewed primarily as a technology platform company. Today, we are increasingly becoming a commercial products company with products in the market, commercial partnerships, multiple revenue opportunities, and exposure to large addressable markets.

At the same time, the C1 biopharmaceutical platform continues to gain validation through collaborations with leading global organizations, academic institutions, governments, and industry partners.

Perhaps most importantly, we are pursuing both opportunities simultaneously: building a commercial products business today while continuing to advance a biopharmaceutical platform that may create significant additional value in the future.

That combination is what makes Dyadic unique.

Thank you for your time.

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