Key Takeaways
- Biotalys continues advancing protein-based biocontrols for sustainable crop protection, focusing on regulatory progress and product development.
- Regulatory approval for EVOCA remains a key priority, with ongoing discussions with the EPA in the U.S. and CTGB in Europe.
- Pipeline expansion includes BioFun-6 and BioFun-8, targeting fungal diseases in fruits, vegetables, and potatoes.
- €15 million private placement completed in 2024, with a cash balance of €22.6 million at year-end.
- Net loss reduced to €13.2 million in 2024, down from €20.5 million in 2023, reflecting cost-saving measures.
Biotalys Advances Biocontrol Pipeline and Regulatory Efforts
Biotalys (Euronext: BTLS), an AgTech company developing protein-based biocontrols, has released its 2024 financial results and business highlights, with an outlook for 2025. The company continues to focus on sustainable crop protection solutions, progressing its regulatory approvals, product development, and partnerships.
“Biotalys continued to lead the charge toward creating effective and sustainable crop protection products in 2024,” said Kevin Helash, CEO of Biotalys. “Looking ahead, we plan to further advance our product portfolio and develop novel modes of action while expanding options to scale and produce our biobased solutions.”
The full financial report will be available on Biotalys’ website on 21 March 2025.
Biotalys Regulatory Progress and Product Development
EVOCA Biocontrol
- Biotalys continues working with the U.S. Environmental Protection Agency (EPA) and the Dutch CTGB on EVOCA’s regulatory approval.
- The EPA has requested additional data, which Biotalys expects to submit in Q2 2025.
- The CTGB has recommended EVOCA’s approval in Europe, supporting access to a market estimated at $1 billion for Botrytis and powdery mildew fungicides.
- EVOCA patents were granted by the European Patent Office, the U.S. Patent and Trademark Office, and Brazil’s INPI under the Patentes Verdes program for environmentally beneficial technologies.
Pipeline Expansion
- BioFun-6 field trials in Europe and the U.S. demonstrated comparable efficacy to EVOCA at lower dosage rates, increasing the biocontrol’s potency.
- BioFun-8, introduced in October 2024, targets Alternaria leaf spot in high-value crops such as fruits, vegetables, and potatoes.
- Collaborations with leading researchers and the Gates Foundation expanded Biotalys’ work on new biocontrol solutions for plant diseases.
- BioIns-2 insecticide development continues in collaboration with Syngenta Crop Protection.
Partnerships and Commercialization
- Novonesis partnership: Significant progress was made in strain engineering for EVOCA NG, preparing for commercial production and distribution.
- Discussions are ongoing for scaling up manufacturing and potential third-party distribution.
Financial Overview of Biotalys: Cost Optimization and Capital Management
Financial Performance in 2024
- Operating loss reduced to €13.5 million, compared to €20.9 million in 2023.
- R&D expenses decreased by €5.6 million, reflecting cost efficiencies in production and field trials.
- General and administrative expenses declined by €1.2 million, attributed to cost-saving initiatives.
- Cash and cash equivalents increased to €22.6 million, up from €21.6 million in 2023.
Private Placement and Shareholder Support
In October 2024, Biotalys closed a €15 million private placement with key shareholders, including Ackermans & van Haaren NV and Agri Investment Fund BV, along with new investor ASR Vermogensbeheer NV.
Financial Outlook for 2025
- Biotalys expects its cash runway to extend into May 2026, without additional financing.
- Regulatory submissions and field trials will continue as part of ongoing product development.
- The company remains focused on cost-efficient operations and strategic partnerships to advance its pipeline.
Looking Ahead: Key Priorities for 2025 for Biotalys
Biotalys plans to continue working towards:
- Submitting additional data to the EPA to advance EVOCA’s U.S. registration.
- Finalizing commercial production and distribution strategies for EVOCA NG with Novonesis.
- Expanding field trials for BioFun-6 and BioFun-8.
- Exploring additional financing options and partnerships to support commercialization efforts.
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