Annonce • Apr 29
Biotalys Achieves First U.S. State Registration for Evoca in Florida Biotalys announced that its innovative biofungicide EVOCA has achieved state registration in Florida. This marks the first approval of an AGROBODY biocontrol by a U.S. state, underscoring a significant milestone for the company and the broader biocontrol sector. The Florida Department of Agriculture accepted EVOCA with the broad label previously approved by the U.S. Environmental Protection Agency (EPA). This state recognition confirms the product’s robust regulatory profile and its potential to support sustainable agriculture in the region, in particular in controlling the key fungal diseases Botrytis and powdery mildew in fruits and vegetables. In California, the Department of Pesticide Regulation (DPR) is progressing its review of EVOCA and its Human Health Assessment Branch has now accepted the EPA-approved label. The next administrative steps are in process, and approval is currently projected for the second half of 2026, further validating the safety and efficacy of Biotalys’ technology. Regulatory review of EVOCA in the European Union is also advancing with the two-month public consultation phase expected to be initiated this week. Both the European Food Safety Authority (EFSA) and the Dutch Board for the Authorisation of Plant Protection Products (CTGB) will then review comments after which the dossier is expected to proceed to the decision phase. EVOCA is a protein-based AGROBODY biocontrol that helps safely control the fungal diseases Botrytis (grey mold) and powdery mildew for fruit and vegetable growers. An approval of EVOCA paves the way for the regulatory submission of EVOCA NG, the product’s next generation version containing the same active ingredient. EVOCA NG is expected to be Biotalys’ first commercial biofungicide, with a planned launch in the U.S. in 2029 and in Europe in 2030, targeting a combined market of around USD 1,100 million. Annonce • Mar 25
Biotalys NV, Annual General Meeting, May 29, 2026 Biotalys NV, Annual General Meeting, May 29, 2026, at 10:00 Romance Standard Time. Location: at the company`s headquarters., Belgium Annonce • Jan 31
Biotalys NV to Report First Half, 2026 Results on Aug 20, 2026 Biotalys NV announced that they will report first half, 2026 results on Aug 20, 2026 Annonce • Jan 06
Biotalys NV to Report Fiscal Year 2025 Results on Mar 12, 2026 Biotalys NV announced that they will report fiscal year 2025 results at 12:00 PM, Central European Standard Time on Mar 12, 2026 Annonce • Nov 01
EPA Issues Proposes Registration Decision for Biotalys’ EVOCA Biofungicide Biotalys announced that the United States Environmental Protection Agency (EPA) has issued its proposed registration decision to approve the company’s first biofungicide, EVOCA. The agency will now initiate the final phase in its regulatory review, allowing stakeholders such as growers and industry associations 15 days to provide feedback before finalizing its regulatory decision. The EPA has also posted a final rule exempting EVOCA’s active ingredient residues on treated crops from tolerance requirements, indicating that no maximum residue limits will apply and highlighting the product candidate’s exemplary safety profile.EVOCA is a precision biocontrol solution that targets the fungal pathogens botrytis (grey mold) and powdery mildew in high-value fruits and vegetables without harming beneficial organisms or the environment. The product candidate offers growers a new mode of action to manage resistance to existing fungicides as was recognised by the Fungicide Resistance Action Committee (FRAC), a panel of renown industry experts. An approval of EVOCA paves the way for the regulatory submission of EVOCA NG, the next-generation version of the product candidate, and Biotalys’ anticipated first commercial launch. The company expects the review process for EVOCA NG to be significantly shorter as the product contains the same active ingredient as EVOCA and features enhanced formulation and production methods. Annonce • Sep 11
Biotalys NV to Report Fiscal Year 2025 Results on Mar 19, 2026 Biotalys NV announced that they will report fiscal year 2025 results on Mar 19, 2026 Annonce • Jun 30
Biotalys NV to Report First Half, 2025 Results on Sep 18, 2025 Biotalys NV announced that they will report first half, 2025 results on Sep 18, 2025 Annonce • Mar 25
Markus Heldt to Retire from the Board of Biotalys Biotalys announced the proposal to appoint Toni Bucci as independent director to its Board of Directors. Ms. Bucci’s appointment will become effective immediately upon election at the upcoming Biotalys shareholders’ meeting on 22 April 2025. She will succeed Markus Heldt, who will retire from the Board. Dr. Bucci has more than 30 years of experience, including leading and scaling agricultural and biotechnology companies, guiding their strategic growth and helping them navigate the route to commercialisation. Prior to her current focus leading start-ups, she spent 23 years at BASF where she was responsible for the research, development and commercialisation of new fungicides and insecticides as well as business development. She currently serves as an independent board director and advisor to several emerging biotech companies, with a strong focus on driving innovation and advancing sustainable agricultural solutions. Dr. Bucci earned a PhD in Entomology from North Carolina State University, a Master’s degree also in Entomology from the University of Georgia and a Bachelor of Science in Biology and Chemistry from Augusta State University. Annonce • Jan 20
Biotalys NV to Report First Half, 2025 Results on Aug 20, 2025 Biotalys NV announced that they will report first half, 2025 results on Aug 20, 2025 Annonce • Jan 15
Biotalys Provides Regulatory Review Update on EVOCA Biotalys provided an update on the regulatory review process of its first biofungicide, EVOCA, in Europe and the United States. European Union announced that the Dutch regulatory authority, CTGB (College voor de Toelating van Gewasbeschermiddelen en Biociden), provided the company with its initial Draft Assessment Report, recommending the approval of EVOCA's active ingredient throughout the European Union. The CTGB will now send its draft report to the Dutch Institute for Health and Environment (RIVM) for potential input regarding classification, labelling and packaging requirements, resulting in the closure of the first phase of the regulatory review of EVOCA in Europe. In the next phase, the European Food Safety Authority (EFSA) and EU member states perform in-depth reviews of the dossier and provide feedback to the CTGB, while allowing Biotalys to deliver certain data requested by CTGB. In parallel with the EPA, the California Department of Pesticide Regulation (CDPR) has been reviewing the regulatory dossier for EVOCA submitted by Biotalys. As announced previously, the company understands that the CDPR has finalized its own in-depth review, opening a path to a swift approval at state level pending EPA approval of the product at the federal level. EVOCA: Pending regulatory review. This product is not currently registered for sale or use in the European Union, the United States, or elsewhere and is not being offered for sale and no assurance can be given if and when registration will be obtained. EVOCA is a novel protein-based biofungicide that helps control the fungal diseases botrytis (grey mold) and powdery mildew in fruits and vegetables. EVOCA has demonstrated strong performance in trials across various regions, climates, soil types, production types, pathogen pressure and crops. If approved, EVOCA will pave the way for EVOCA NG which is expected to be the first commercial product out of the Biotalys' pipeline. Annonce • Dec 20
Biotalys NV to Report Fiscal Year 2024 Final Results on Mar 21, 2025 Biotalys NV announced that they will report fiscal year 2024 final results on Mar 21, 2025 New Risk • Oct 17
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 17% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 16% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-€17m). Shareholders have been diluted in the past year (17% increase in shares outstanding). Annonce • Oct 17
Biotalys Appoints Kamal El Mernissi as Chief Business Development Officer Biotalys announced the appointment of Kamal El Mernissi as Chief Business Development Officer (CBDO). Most recently serving as the Vice President, Sales and Marketing North America at biocontrol solutions leader Marrone Bio Innovations (currently Pro Farm Group), Kamal El Mernissi has been involved in the latest technological developments and trends in the industry and partnered with key players in the field. Reporting to Biotalys’ CEO Kevin Helash, Mr. El Mernissi will lead the company’s efforts to secure partnerships with major agricultural players that can benefit from the AGROBODY Foundry™ technology platform to develop biofungicides and bio-insecticides with new modes of action. Prior to his role at Marrone, Mr. El Mernissi held various commercial leadership roles at Syngenta, where he was Portfolio Manager North America and LATAM, Commercial Unit head and Director of Sales for Morocco, and Asset Manager EMEA responsible for the launch a major active ingredient. Prior to that, he took up various roles in sales and marketing in leading companies such as DELL and SIKA. He obtained his Engineering Diploma in Agriculture from the Hassan II Agronomic and Veterinary Institute (Morocco) and his MBA at the University of California, Berkeley (United States). The appointment of Kamal El Mernissi is effective as of 17 October 2024. Together with various colleagues from the Biotalys management, he will represent the company at the upcoming Annual Biocontrol Industry Meeting, taking place in Basel from 21 to 23 October. New Risk • Oct 14
New major risk - Revenue and earnings growth Earnings have declined by 16% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 16% per year over the past 5 years. Revenue is less than US$1m. Minor Risk Less than 1 year of cash runway based on current free cash flow (-€17m). Annonce • Oct 01
Biotalys Expands R&D Pipeline with New Biofungicide Program Biotalys announced the addition of a new biofungicide program, BioFun-8, to its research and development pipeline. Building on its expertise in biofungicide development for global fruit and vegetable markets, Biotalys will leverage its proprietary AGROBODY 2.0 technology platform to accelerate the development of a novel protein-based biocontrol targeting the leaf spot fungal disease Alternaria. As existing products for Alternaria treatments face rising chemical resistance and regional regulatory roadblocks, the global market size for a novel crop protection solution against this fungal disease is estimated to be in the range of USD 1.1 billion at grower level. In addition, as Alternaria causes significant contamination and rotting of food products in the storage period, applications of a new and effective product have potential in the post-harvest segment as well. BioFun-8 is the latest addition to the growing pipeline of protein-based biocontrols of Biotalys. The company has already finalized the development of its first biofungicide EVOCA, targeting botrytis and powdery mildew, which is currently under regulatory review by the authorities in the US and EU. If approved, EVOCA will pave the way for its next generation version EVOCA NG which is expected to be the first commercial product out of the Biotalys’ pipeline. Other ongoing R&D programs are BioFun-6, targeting botrytis, powdery mildew and anthracnose; BioFun-7, a program sponsored by the Gates Foundation to fight leaf spot disease on cowpea; BioFun-4, a project aimed at tackling oomycetes (water mould); and BioIns-2, a partnership with Syngenta to develop a new bioinsecticide against key pests. Annonce • Sep 20
Biotalys NV to Report Fiscal Year 2024 Results on Mar 21, 2025 Biotalys NV announced that they will report fiscal year 2024 results on Mar 21, 2025 Annonce • Sep 17
European Patent Office and the United States Patent and Trademark Office Grants Biotalys Patents for EVOCA in Both Europe and the United States Biotalys announced that it obtained patents for its first biofungicide, EVOCA™*, from both the European Patent Office and the United States Patent and Trademark Office (USPTO). In addition, Biotalys has requested patent protection for the product’s active ingredient in countries around the globe, such as Argentina, Brazil, and South Africa, which are compelling markets for crop protection. The company already obtained various patents worldwide on different elements of its technology and is continuously building its intellectual property protection for its products, formulations and processes. EVOCA is a novel protein-based biofungicide that earned an entirely new resistance classification by the Fungicide Resistance Action Committee (FRAC). The product helps control fungal disease in fruits and vegetables. Demonstrating strong performance in trials across multiple regions, climates, soil types, production types, pathogen pressure and crops to date, EVOCA is currently under review by the U.S. Environmental Protection Agency (EPA) and the Dutch College voor Toelating van Gewasbeschermingsmiddelen en Biociden (CTGB) in the European Union for regulatory approval. EVOCA will pave the way for EVOCA NG, which is expected to be Biotalys’ first commercial fungicide from its AGROBODY™ technology platform. EVOCA and EVOCA NG have the same active ingredient which is now protected by the patent grants in Europe and the U.S. Annonce • Sep 02
Biotalys NV Receives Approval for Large-Scale Demonstration Trials of EVOCA in the Netherlands Biotalys NV announced it received approval by the Dutch regulator CTGB (College voor de Toelating van Gewasbeschermingsmiddelen en Biociden) for large-scale demonstration trials in greenhouses of its first biofungicide candidate, EVOCA™. Importantly, the harvested fruits and vegetables can be sold for human consumption. The CTGB granted Biotalys the approval to test EVOCA against powdery mildew in 40 hectares of tomatoes, 20 hectares of cucumbers and 10 hectares of strawberries. Produce from these greenhouse trials is allowed to be sold for human consumption, an exemption to standard practices requiring crop destruction when a crop protection product is used that has not yet received regulatory approval. EVOCA is a novel protein-based biofungicide which earned an entirely new resistance classification by the Fungicide Resistance Action Committee (FRAC). The product helps control the fungal diseases botrytis and powdery mildew in fruits and vegetables. Demonstrating strong performance in trials across multiple regions, climates, soil types, production types, pathogen pressure and crops to date, EVOCA is currently under review by the U.S. Environmental Protection Agency (EPA) and the Dutch College voor Toelating van Gewasbeschermingsmiddelen en Biociden (CTGB) in the European Union for regulatory approval. EVOCA will pave the way for EVOCA NG, which is expected to be Biotalys’ first commercial fungicide from its AGROBODY technology platform. New Risk • Aug 23
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -€17m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (€134k revenue, or US$149k). Minor Risks Less than 1 year of cash runway based on current free cash flow (-€17m). Currently unprofitable and not forecast to become profitable over next 2 years (€13m net loss in 2 years). Annonce • May 03
Biotalys Starts Field Trials for Second Biofungicide Biotalys announced the initiation of field trials for BioFun-6, the company's second biofungicide program under development on its AGROBODY technology platform. BioFun-6 is a biofungicide targeting botrytis, powdery mildew and anthracnose in high-value fruits and vegetables. Biotalys has developed several candidate bioactive ingredients for BioFun-6 on its AGROBODYtechnology platform, and the company will now test one of the lead molecules in field trials starting in May 2024. The company will collaborate with selected third parties such as contract research organizations to perform these trials. The first round of field trials will focus on grapes and tomatoes in Europe, with initial results expected by the end of this year. Annonce • Apr 30
Biotalys Announces Board and Committee Changes Biotalys announced that it has appointed Laura J. Meyer to its Board of Directors and head of the Audit Committee, effective September 25, 2024. Ms. Meyer will replace Ms. Catherine Moukheibir who has decided to step down from the board. Ms. Meyer is Vice President, Investor Relations at Bayer, with responsibility for the Crop Science division, joining the company after leading Investor Relations for Monsanto since 2014. She initially joined Monsanto (now Bayer) in 1996 and served in pivotal financial roles in technology, commercial and product management organizations during the company’s transformation to the leading agricultural input company. Her more than 28 years of experience has spanned markets worldwide, including as the divisional Chief Financial Officer for the company’s global vegetable seeds and Asia row crops businesses. Ms. Meyer holds a Bachelor of Science degree in Accounting from the University of Missouri-Columbia. A native of St. Charles, Missouri, she began her career as a CPA with Deloitte. Ms. Meyer meets the requirements of an independent director, and the Board of Directors expressly confirms that it has no indication of any element that could call into question the independence of Ms. Meyer. Her appointment as independent director will be proposed for confirmation at the next shareholders meeting in accordance with article 7:88 of the Belgian Code of Companies and Associations. Annonce • Dec 19
Biotalys Announces Results of Independent Field Trials in the U.S Biotalys announced the continued strong performance of its first biofungicide candidate EVOCA in independent efficacy field trials conducted by highly reputed public institutes in the U.S.EVOCA performed as a true replacer for existing crop protection products to combat fungal diseases in grapevines and strawberries. The results confirm the previous findings by independent academics as published earlier on Biotalys' website. EVOCA aims to provide fruit and vegetable growers with a safe new crop protection product to help control the devastating fungal diseases Botrytis and powdery mildew. By offering a novel, biodegradable tool EVOCA can contribute to reducing dependency on chemical pesticides and development of pathogen resistance. The trials were conducted in 2022 and 2023 by the University of California Davis and the University of Florida and are industry gold-standard studies that provide growers and crop advisors with detailed information on the performance of crop protection products. In these grape and strawberry trials, EVOCA was tested among many other treatments and a non-treated control plot, enabling the comprehensive comparison of its performance with conventional chemical and biological fungicide products. The outcome of the academic studies in California is particularly relevant as California is the U.S. grape market. In that respect, the California Department of Pesticide Regulation (CDPR) has been reviewing the regulatory dossier for EVOCA submitted by Biotalys in April 2021. The company now understands that the CDPR has finalized its own in-depth review, opening a path to a swift approval at state level if the U.S. Environmental Protection Agency (EPA) approves the product at federal level. In 2023, EVOCA was further assessed in four rotation programs, substituting chemicals, across 22 different spraying schemes. While the disease pressure was overall low and therefore does not mandate firm conclusions, the combination of EVOCA with an adjuvant was a valid substitution for Captan in rotation with reference chemical Switch or Kenja. Powdery mildew - 2022/2023 - Plant Disease Management Reports (plantmanagementnetwork.org). EVOCA was assessed in two rotation programs at two dosages, substituting chemicals, across 24 different spraying schemes in both 2022 and 2023. The rotations of EVOCA with chemical products provided disease incidence levels equivalent to other chemical-only rotations. EVOCA: Pending Registration. This product is not currently registered for sale or use i n the United States, the European Union, or elsewhere and is not being offered for sale. In this study, EVOCA is identified as EXP14. Annonce • Nov 24
Biotalys NV to Report First Half, 2024 Results on Aug 22, 2024 Biotalys NV announced that they will report first half, 2024 results on Aug 22, 2024 New Risk • Nov 24
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 7.1% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 28% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (7.1% average weekly change). Shareholders have been diluted in the past year (3.7% increase in shares outstanding). Market cap is less than US$100m (€60.3m market cap, or US$65.8m). New Risk • Nov 17
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: €81.8m (US$88.8m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 28% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (3.7% increase in shares outstanding). Market cap is less than US$100m (€81.8m market cap, or US$88.8m). Board Change • Oct 25
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Member of Scientific Advisory Committee Ioannis Stergiopoulos was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. New Risk • Jul 25
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 3.9% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€40m net loss in 3 years). Shareholders have been diluted in the past year (3.9% increase in shares outstanding). Annonce • Jun 14
Biotalys NV has completed a Follow-on Equity Offering in the amount of €6.999995 million. Biotalys NV has completed a Follow-on Equity Offering in the amount of €6.999995 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 1,135,257
Price\Range: €6.166
Transaction Features: Subsequent Direct Listing Board Change • Nov 16
High number of new and inexperienced directors There are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. 2 experienced directors. 2 highly experienced directors. Non-Executive Director Johan Cardoen is the most experienced director on the board, commencing their role in 2013. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Board Change • Apr 27
Less than half of directors are independent There are 7 new directors who have joined the board in the last 3 years. Of these new board members, 3 were independent directors. The company's board is composed of: 7 new directors. 2 experienced directors. 2 highly experienced directors. 3 independent directors (4 non-independent directors). Non-Executive Director Johan Cardoen is the most experienced director on the board, commencing their role in 2013. Independent Director Markus Heldt was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors. 
