Ghent, Belgium, Sept. 18, 2025 (GLOBE NEWSWIRE) —
- Substantial progress in both the U.S. and Europe in the regulatory review of Biotalys’ first candidate biofungicide EVOCA™*
- Patent protection for EVOCA in Brazil and China, and for a BioFun-6 lead candidate in the U.S.
- Strategic partnership with AgroFresh to expand into post-harvest segment
- Leadership team expanded with proven industry executives
- Cash and cash equivalents amounted to €15.7 million as of the end of June 2025, offering a financial runway into May 2026
- Management to host a conference call and live webcast at 15:00 CEST / 14:00 GMT / 09:00 AM ET today, details below
Biotalys (Euronext – BTLS) today announces its key business achievements and consolidated financial results for the first half of 2025, prepared in accordance with IFRS as adopted by the European Union. The complete half-year report including the interim financial results is available here.
Kevin Helash, Chief Executive Officer of Biotalys, stated: “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.
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 (including post-period information)
Biotalys has continued to work closely with the EPA (Environmental Protection Agency) in the United States and the CTGB (the Dutch Board for the Authorisation of Plant Protection Products and Biocides) in Europe to move the regulatory review process for EVOCA forward.
- In the United States, Biotalys received further guidance from EPA end of August, in which the agency confirmed that the scientific review of the dossier is progressing, and that all the previous requests for additional information have been addressed. While the agency continues to work on the review, the company now expects the final steps of the registration procedure to be taken in Q4.
- In Europe, both the CTGB and the Dutch Institute for Health and Environment (RIVM) paved the way for the peer review phase at the European level by providing positive evaluations of EVOCA’s regulatory dossier in June. As no critical areas of concern were identified and it was proposed to classify EVOCA’s active ingredient as low risk, the Netherlands, as rapporteur Member State, proposed its approval in Europe, subject to the provision of certain additional data during the peer review phase.
H1 2025 R&D update (including post-period information)
- In May, Biotalys announced a strategic partnership with AgroFresh Solutions, Inc. to develop and commercialize biological solutions for post-harvest use to protect fresh produce. As fungal decay remains one of the most persistent and complex challenges in the post-harvest supply chain, sustainable freshness solutions are especially critical for high-value and highly perishable crops. Demonstrating the versatility of its protein-based AGROBODY™ platform to help preserve food quality without chemical residues, Biotalys will work with AgroFresh to provide sustainable solutions that keep food fresher for longer and reduce global food waste.
- In March, Biotalys announced that one of the lead candidates for BioFun-6 – the company’s second biofungicide program targeting botrytis, powdery mildew – demonstrated strong efficacy at lower dosage rates than EVOCA in trials in both Europe and the United States. The same candidate also performed well in independent academic trials by UC Davis in California (see here for the full results). Biotalys plans to test a second lead candidate in its field trial program this coming season to allow the company to select the best candidate for further development on its platform.
- Biotalys continued its work on its other pipeline programs in the discovery phase:
- BioFun-4, targeting Phytophthora infestans, an Oomycete (water mould) that causes late blight/potato blight, where the company has an ongoing collaboration with the University of Aberdeen;
- BioFun-7, the R&D program in partnership with the Gates Foundation targeting leafspot disease, where Biotalys has entered into a collaboration with the International Institute of Tropical Agriculture (IITA) in Nigeria, next to its existing collaboration with the University of California-Davis;
- BioFun-8, its most recent pipeline product against Alternaria; and
- BioIns-2, its bioinsecticide program in collaboration with Syngenta Crop Protection.
H1 2025 corporate highlights (including post-period information)
- Biotalys appointed Luc Van fraeyenhoven as Chief Financial Officer in May. With a strong background leading finance operations and strategy in the biotechnology and medtech industries, he provides seasoned financial guidance on both long-term strategies and day-to-day finance operations.
- In March, Biotalys appointed seasoned agriculture and biotech executive Toni Bucci to its Board of Directors. Her passion for innovation, extensive experience in agriculture and strategic leadership helps the company navigate critical next steps in its path to commercialization and accelerate its impact in sustainable agriculture.
- Biotalys strengthened its patent position and obtained patent protection for EVOCA in Brazil and China. In Brazil, the …