• Continued to work closely with European and U.S. regulators on the regulatory review of its first candidate biofungicide EVOCA™*, earning recommendation for EU approval by the Dutch CTGB in January 2025 on the back of the approval of large-scale demonstration trials in the Netherlands
  • Progressed product pipeline with initial field trials for BioFun-6 showing strong results and highlighting the increased potency of the tested candidate
  • Closed €15 million private placement to continue strategic growth initiatives, with year-end cash and cash equivalents amounting to €22.6 million providing a financial runway into May 2026
  • Management to host a conference call and live webcast at 15:00 CET / 14:00 GMT / 09:00 AM ET today, details below

Ghent, Belgium (March 19, 2025) – Biotalys (Euronext - BTLS), an Agricultural Technology (AgTech) company developing protein-based biocontrols for sustainable crop protection, announced key business achievements and consolidated financial results for 2024, prepared in accordance with IFRS as adopted by the European Union, and an outlook for 2025. The annual report, including the full financial report, will be published on the company’s website on March 21.

Kevin Helash, Chief Executive Officer of Biotalys, stated: “Biotalys continued to lead the charge toward creating effective and sustainable crop protection products in 2024. While we worked closely with regulators to progress the potential approval for innovative protein-based biocontrols like EVOCA, we also strengthened our platform, pipeline, partnerships, and team. Additionally, we optimized capital resources last year, achieving a significant reduction in operating expenses while strengthening our balance sheet through a successful private placement. Looking ahead, we plan to further advance our product portfolio and develop novel modes of action, as well as expand options to scale and produce our biobased solutions.”

Highlights

In 2024, Biotalys continued to cement its role as a primary innovator in the biocontrol space by advancing its technology platform and product development pipeline.

Product Pipeline

  • Biotalys worked closely with the EPA (Environmental Protection Agency) in the United States and the Dutch CTGB (College voor de Toelating van Gewasbeschermingsmiddelen en Biociden) in Europe on EVOCA’s regulatory reviewthroughout the year.

ü While the regulatory landscape in the United States is evolving, Biotalys has recently received a request for additional information from the EPA. The company expects to provide the EPA with the requested data in Q2, positioning EVOCA for potential registration thereafter.

ü In Europe, the CTGB recently recommended the approval of EVOCA’s active ingredient throughout the European Union after previously granting approval to test EVOCA in large-scale demonstration trials in the Netherlands and offer the harvest for sale for human consumption. A registration in Europe would allow first access to this important market for Botrytis and powdery mildew fungicides estimated to be around USD 1 billion at the grower level. 

  • In addition, the company obtained patents for EVOCA from both the European Patent Office (EPO) and the United States Patent and Trademark Office (USPTO) in 2024, and from the Brazilian National Institute of Industrial Property (INPI) in February 2025. In Brazil, the patent examination process benefited from the Patentes Verdes (“Green Technology”) initiative to accelerate the examination of patent applications relating to technologies having a positive impact on the environment.
  • In March last year, Biotalys announced a partnership with Novonesis to advance EVOCA NG to the final stage of development. Pending success in this final development stage, the agreement secured Novonesis as the global manufacturing partner for EVOCA NG while granting it certain distribution rights. By year-end, substantial progress had been achieved in strain engineering for EVOCA NG, paving the way for the next phase of development
  • Biotalys also began field trials in both Europe and the United States for BioFun-6, a biofungicide candidate targeting Botrytis, powdery mildew and potentially other fungal diseases in high-value fruits and vegetables. Results published in March 2025, showed that the BioFun-6 AGROBODY biocontrol can achieve the same level of performance as EVOCA at significantly lower dosage rates, highlighting the increased potency of the new candidate.
  • In October, Biotalys introduced a new biofungicide program, BioFun-8, focusing on combatting Alternaria, a top leaf spot fungus, in fruits, vegetables and potato crops, and representing a global market opportunity of approximately USD 1.1 billion at grower level.
  • Early in the year, Biotalys also expanded its relationships with top academics, adding collaborations with leading plant science researchers for BioFun-4, targeting Phytophthora infestans, and for BioFun-7, a project in collaboration with the Gates Foundation and targeting leafspot disease. With these collaborations the company continues to build on the strong scientific foundation of its R&D programs and technology, creating synergies between the expertise and excellent research in academia and industry.
  • Biotalys also continued to advance its first bioinsecticide, BioIns-2, in collaboration with Syngenta Crop Protection.

Operations and Leadership

  • In October, Biotalys announced the close of a €15 million private placement with established shareholders, Ackermans & van Haaren NV and Agri Investment Fund BV, as well as a new investor, the Dutch asset management firm ASR Vermogensbeheer NV.
  • Kamal El Mernissi joined Biotalys as Chief Business Development Officer (CBDO) in October. A seasoned industry leader who has managed commercialization efforts for Marrone Bio Innovations (now Pro Farm Group) and Syngenta, he is now actively pursuing strategic partnerships with major agricultural organizations to support the commercialization path of Biotalys’s growing pipeline of novel biocontrols. 
  • The company also added Laura J. Meyer to its Board of Directors. With nearly three decades of financial experience in the agriculture industry, most recently as Vice President, Investor Relations for the Crop Science division at Bayer, she has been providing strategic and financial guidance for Biotalys since joining the Board in September.
  • The company was honored as the 2024 AgTech Breakthrough Sustainable Crop Protection Company of the Year and earned Top 100 status in Forward Fooding’s FoodTech 500 list.

Outlook for 2025

  • Biotalys continues to work with regulators in Europe and the U.S. on the next steps of the review process for EVOCA. The company expects to be able to provide the EPA with the required additional data in Q2.
  • Biotalys and Novonesis are discussing the optimal path forward for scaling of the commercial production and distribution of EVOCA NG – both potentially through third parties, depending on the assessment of commercial and financial parameters of such production and distribution.
  • The company expects to start working towards submitting a regulatory dossier for EVOCA NG, building on the EVOCA file as both product candidates have the same bioactive ingredient.
  • Biotalys will also continue to expand field trials for BioFun-6, while actively progressing its pipeline programs, such as its newest product candidate, BioFun-8.
  • Based on the cash and cash equivalents balance of €22.6 million at the end of 2024, the company expects the financial runway to reach into May 2026 without considering any additional financing through equity, newly awarded grants, partnerships or other sources of financing.

For more information, see the Biotalys report.

About Biotalys

Biotalys is an Agricultural Technology (AgTech) company developing protein-based biocontrol solutions for the protection of crops and aiming to provide alternatives to conventional chemical pesticides for a more sustainable and safer food supply. Based on its novel AGROBODY™ technology platform, Biotalys is developing a strong and diverse pipeline of effective product candidates with a favorable safety profile that aim to address key crop pests and diseases across the whole value chain, from soil to plate. Biotalys was founded in 2013 as a spin-off from the VIB (Flanders Institute for Biotechnology) and is listed on Euronext Brussels since July 2021. The company is based in the biotech cluster in Ghent, Belgium. More information can be found on www.biotalys.com.