Biotalys Reports H1 2025 Results and Advances Regulatory Progress for EVOCA

Key Takeaways

• Biotalys reported an operating loss of €8.1 million for the first half of 2025, compared to €6.6 million in H1 2024.
• Cash and cash equivalents stood at €15.7 million as of June 30, 2025.
• The company advanced regulatory review of its first biocontrol candidate, EVOCA, in both the U.S. and Europe.
• A strategic partnership was signed with AgroFresh to develop post-harvest biobased solutions.
• Pipeline progress included strong trial results for BioFun-6 and continued collaborations with Syngenta, UC Davis, and IITA.

Biotalys CEO Perspective

Kevin Helash, Chief Executive Officer of Biotalys, highlighted regulatory and strategic milestones: “In the first half of the year, we achieved meaningful milestones in our mission to bring sustainable precision biocontrols to market. Building on our close cooperation with regulators in the United States and Europe, we made significant advancements in the approval process of our first biocontrol candidate, EVOCA, and we remain optimistic that favourable decisions are within sight.”

Helash added: “We also advanced our pipeline and solidified a number of key elements of our commercialization strategy to support market entry of our portfolio, including the important new partnership for post-harvest biobased solutions with leading player AgroFresh. Looking ahead, we will continue to take a disciplined, cost-conscious approach and evaluate additional financing opportunities to effectively execute our strategy and further exploit the potential of our unique technology platform to develop precision biocontrols.”

Regulatory Update for EVOCA

• United States: Biotalys received further guidance from the Environmental Protection Agency (EPA) in August, confirming that the scientific review of the EVOCA dossier is progressing, with all previous information requests addressed. Final steps of the registration procedure are expected in Q4 2025.
• Europe: Positive evaluations from the Dutch Board for the Authorisation of Plant Protection Products and Biocides (CTGB) and the Dutch Institute for Health and Environment (RIVM) paved the way for European peer review. No critical areas of concern were identified, and EVOCA’s active ingredient was proposed as “low risk.”

Pipeline and R&D Progress

• AgroFresh partnership (May 2025): Focus on sustainable post-harvest biological solutions to reduce fungal decay and global food waste.
• BioFun-6 (March 2025): Lead candidate demonstrated strong efficacy at lower dosage rates than EVOCA in Europe and U.S. trials; also validated in UC Davis trials.
• Other programs:
  • BioFun-4 (late blight), in collaboration with University of Aberdeen.
  • BioFun-7 (leafspot), with the Gates Foundation and IITA in Nigeria.
  • BioFun-8 (Alternaria).
  • BioIns-2 (bioinsecticide), in collaboration with Syngenta.

Biotalys Corporate Developments

• Leadership: Luc Van Fraeyenhoven appointed CFO (May 2025); Toni Bucci joined the Board of Directors (March 2025).
• Patents: Granted protection for EVOCA in Brazil and China, with U.S. patent secured for BioFun-6 active ingredient.
• Recognition: Ranked #32 in the 2025 FoodTech 500 list by Forward Fooding.

Biotalys Financial Results (H1 2025 vs. H1 2024)

Outlook

Biotalys plans to:

• Secure regulatory approvals for EVOCA in the U.S. and Europe, and submit a dossier in Brazil.
• Prepare regulatory dossiers for EVOCA NG with shorter review timelines.
• Finalize commercial production and distribution agreements for EVOCA NG.
• Continue developing pipeline candidates in partnership with academic and industry collaborators.

The company emphasized its intention to remain cost-conscious while pursuing financing options to support long-term growth.

Read the complete financial results.