Product pipeline

Our team’s R&D e orts and our AGROBODY™ technology have created a pipeline of multiple product candidates. These can address critical market segments in the food and crop protection market where existing products are scarce or threatened by an evolving regulatory landscape.

Biofungicides

Our development program is first focusing on fungicides, especially on providing innovative solutions for the high-value fruits and vegetables market. This is one of the most valuable segments, representing more than $6 billion in value of the global fungicide market worth some $16 billion. It is also the most a ected by food loss and waste and involves serious consumer and regulatory concerns about the presence of chemical residues.

These first programs are designed to o er novel biocontrol tools to address Botrytis and powdery mildew, devastating fungal diseases that a ect high-value crops like strawberries, tomatoes, cucurbits and grapes. We seek to achieve validation and credibility from the market calibration of Evoca™, our first biofungicide submi ed for regulatory approval, and to fully expand the technology in a growing range of crops.

In view of the breakthrough in protein expression in 2022, Biotalys has decided to adapt its pipeline to consolidate its e orts in biofungicides on capturing market share as rapidly as possible with the next generation of Evoca. Therefore, the next generation of Evoca (containing the same protein bioactive, with optimized manufacturing and formulation) is expected to enter both the US and the EU markets by 2026, subject to regulatory approval.

BioFun-6 will expand the market size of Evoca. The program is progressing according to plan with encouraging results in the lab over the past year. The Company expects to move this candidate product into the development stage by end of 2023, on track to bring a di erentiating o er to fruit and vegetables growers by 2028.

Our BioFun-2 and BioFun-4 programs address major diseases in row crops and specialty crops such as cereals (leaf spots) and potatoes and vines

(oomycetes). Leaf spots, common fungal crop diseases causing sizable yield loss, are mostly treated with conventional chemical fungicide classes. Over the last decade, increasing resistance has been observed in multiple crops, and regulatory scrutiny of conventional chemical solutions has risen. While Biotalys is exploring early-stage partnerships for these programs, the Company has recently initiated BioFun-4 by developing the project plan and target product profile, in collaboration with key opinion leaders including members of the newly established SAC.

In 2022, we initiated our research into novel biofungicides to control Cercospora canescens, the causative agent of leaf spot disease. This is a devastating disease of cowpea and other legumes that can slash smallholder growers’ output by up to 40%. Our Company received a 4-year grant of $5.98 million (€5.14 million) in total from the Bill & Melinda Gates Foundation to sponsor this research. The goal is to achieve, by the end of 2025, a proof-of-concept of e ective protection of the cowpea crop from leaf spot by an AGROBODY bioactive with potential cross-e icacy against other leaf spot diseases for broader commercial application across di erent crops. This program is labeled BioFun-7 in our pipeline.

Bio-insecticides and biobactericides

Our R&D team is also continuing its work on insecticides (BioIns-1 – targeting Lepidoptera for diverse field crops and vegetables), and on bactericides (BioBac-1 –targeting multiple key bacteria in fruits and vegetables).

These programs are expected to further demonstrate the broad technology potential of our AGROBODY FoundryTM platform and to address unmet needs in both the insecticide market and the “orphan” bactericide space.

EvocaTM

Innovative pipeline of protein-based biocontrols

Late Research Product Development Regulatory and Product Placement Early Research Target

Botrytis, Powdery mildew

BioFun-6

BioIns-1

BioBac-1

BioFun-7

BioFun-4

BioFun-2

Other programs

Botrytis, Powdery mildew, Antharacnose

Lepidoptera

Key bacteria

Cercospora

Oomycetes

Leafspots

Various pests and diseases in a variety of crops

Ongoing partnership explorations

Fungicides Insecticides Bactericides

Crops