Our R&D process

Our AGROBODY Foundry™ technology platform is built to create a new generation of protein-based biocontrols that e ectively and selectively target pests and pathogens with novel modes of action.

Discovery

Our teams start the discovery phase, by selecting and analyzing the target of interest. Based on that assessment, science plans are outlined. A new project can be started internally or in collaboration with a relevant industry partner.

In the next stage, the Lead Generation phase, the teams prepare tools and reagents from the selected target to start immunization as identified in the project plan. This is followed by the generation of AGROBODYTM libraries and the selection and screening of a panel of AGROBODY proteins. The most promising hits are further characterized in the Lead Characterization phase at which we look at in vitro functionality.

The last phase is testing the top performers, in on planta bioactivity experiments. In parallel the AGROBODY lead candidates are assessed upon early development parameters and productivity at the research level to meet the requirements for viable commercial manufacturing.

Development

During the second phase of our R&D process, the biocontrol product candidates are developed into market-tuned products. The activity of the AGROBODY candidates is validated in field trials which are set up in di erent environments and on a variety of crops. The results of these field trials, which typically span multiple years, are crucial for the submission of registration dossiers in target countries.

Parallel product development work includes internal and external engagements to strengthen our IP position, preparing the regulatory filing (with regulators and third parties), planning the distribution/supply chain, and ensuring the timing of market introduction.

Strain engineering

Our teams apply a multi-expression system approach to develop the most robust and efficient microorganisms for the expression of our current and future product candidates. We are optimizing our Pichia pastoris expression platform, as well as developing

Automation

Our technology platform is highly automated to shorten the time required to identify potential candidates compared to manual methods and boost the platform’s reliability and e iciency. It also increases our capacity and allows to run multiple projects in parallel.

To bring our process activities to the next level, we have invested in the implementation of three state-of-theart, customized robotic systems. These systems are used throughout the research cycle of the Company, an expression platform with filamentous fungi strains (filamentous fungi are broadly used in the biotech industry for fermenting large quantities of proteins and enzymes). The strain engineering strategy and implementation are built on in-house expertise, validated and augmented by external resources for feasibility testing.

Manufacturing, biofermentation and formulation

Our product candidates are manufactured by microbial fermentation and formulation at an industrial scale, by leading contract development and manufacturing organizations which we have partnered with.

Our current manufacturing partner Olon Group has superior expertise in microbial fermentation. This process, an industry standard, is well-controlled and validated. It is one of the most eco-friendly and sustainable technologies.

from the early stage in the discovery of the AGROBODY protein towards the optimization of the AGROBODY protein production process. The implementation of these robotic systems not only increases the quality of generated data, but allows us to significantly increase the complexity and number of activities (so called “High-Throughput”) by providing a superior alternative for many labour intensive and error prone manual processes.

Further downstream, the fermentation media are processed by micro- and ultrafiltration into a technical intermediate. The active ingredient is then formulated into a crop protection product that fits growers’ practices and needs for convenience on the field. It forms the last step of a biocontrol’s production process before packaging and shipping to the customer. In 2022, we signed an agreement with Kwizda Agro, an established crop protection manufacturer and provider of tolling services for the agricultural industry, to act as the formulator of our biocontrol products. Kwizda Agro formulates the liquid active ingredient into watersoluble granules that form the customer’s end product. It also packages the products for distribution.

In 2022, we also initiated a new partnership with Novozymes, a world leader in biotech solutions, to explore additional routes for the scale-up and production of the bioactive protein of Evoca.

Field trials

All product development and product positioning trials are outsourced to third-party contract research organisations (CROs) accredited and authorized to conduct trials with products under development. They apply standard farming practices recognized by the industry and the regulators.

Field trials are conducted to drive product development and confirm e icacy in relevant commercial se ings, with the ultimate goal of providing growers with a return on investment in yield and/or commercial value of their final produces without compromising the environment and the overall biodiversity.

In later development stages, trials are equally set up to meet regulatory data requirements. This includes crop advisors, university extension specialists, crop reference institutes, and candidate commercial partners.

Scientific Advisory Commi ee to support global expansion

End of 2022, we established a Scientific Advisory Committee (SAC) to sustain company growth, accelerate product pipeline work, and deepen scientific partnerships. We also announced the appointments of Dr. Claude Bensoussan, Dr. Hans-Jürgen Rosslenbroich, and Dr. Ioannis Stergiopoulos to the SAC. Their expertise will supplement that of the four prominent industry leaders already advising Biotalys: Dr. Adrian Percy (appointed SAC Chairman), Dr. Jacqui Campbell, Dr. Daniel Joo, and Dr. Franz-Josef Placke.

While actively building toward global commercialization, we are tapping the industry’s best scientific minds to broaden our innovation and direct our product development. The SAC links up leading scientists with industry experts to pursue safer, more sustainable solutions to be er protect crops from field to plate.

Closely aligned with the Biotalys executive team and scientists, SAC members will guide scientific and industry-specific initiatives in their respective domains including R&D, fungicides, bactericides, and insecticides.

Dr. Hans-Jürgen Rosslenbroich on…

…the newly created Scientific Advisory Commi

ee:

“In my opinion, the new SAC will provide an excellent platform for the assigned experts from all areas to discuss new findings and their impact on the whole discovery and development process. Besides that, it will also support Biotalys’ R&D team in defining the best and most e icient ways to deliver marketable products that are a ractive to growers.”

…his role on the Commi ee:

“My expertise lies in field development of selected development candidates, and determining their strengths and weaknesses. I also have extensive experience in developing unique selling points, preparing registration dossiers, and providing evidence-based marketing arguments with the aim of positioning new products in spray programs and the market in general, as well as in the life cycle management of existing products.”

…his contribution to the future growth and success of Biotalys:

“From my professional expertise, I would like to work towards establishing a new segment in protein-based crop protection. An ambitious goal, indeed, but Evoca is an excellent starting point. It is extremely important for me to keep the growers’ perspective and needs in mind and develop products that deliver value for them, but also for all other stakeholders. This will ultimately be the key to success, and for this I am happy to work closely with the experts at Biotalys.”

Previously Head of Disease Management in Agronomic Development for Bayer Crop Science, Dr. Rosslenbroich has a long history of disease management product development, both biologicals and chemicals. On the SAC, his exceptional expertise in plant pathogens and disease-crop biology will drive the development and positioning of fungicides for disease control and safeguarding plant health. Dr. Rosslenbroich has in the past also been providing advice on Evoca, including its mode of action, field trial data analysis, and plant compatibility.