Ghent, Belgium
August 23, 2023

• Strategic partnership with Syngenta to collaborate on the research and development and commercialisation of a new bio-insecticide
• Field trials with Evoca™* continue to demonstrate competitive performance in fruits and vegetables; trials now ongoing for additional crops such as blueberries and hemp
• Update on regulatory approval process for Evoca
• Successful CFO succession with Douglas Minder in function since July 1st
• Private placement of new shares for €7 million at market value
• Cash and cash equivalents amounted to €32 million end of June 2023
• Management to host a conference call and live webcast today at 15:00 CEST / 14:00 BST / 09:00 EDT, details below
   

Biotalys (Euronext - BTLS), an Agricultural Technology (AgTech) company developing protein-based biocontrol solutions for crop and food protection, today announces its key business achievements and consolidated financial results for the first half of 2023, prepared in accordance with International Accounting Standard 34 ‘Interim Financial Reporting’ as adopted by the European Union. The full half year report including the interim financial results is available here on the Biotalys website.

Patrice Sellès, Chief Executive Officer of Biotalys, noted: “Throughout the first half of 2023, Biotalys made significant progress in the buildup of its pipeline, technology and platform validation with industry leaders. We are continuing to work with the EPA to obtain regulatory approval in the U.S. for Evoca, the company’s first biocontrol solution, to help address the needs of growers seeking safer tools to make their crop protection strategies more sustainable. At the same time, we are working with partners on the future market positioning of Evoca, as well as on continuing to improve cost of goods for this important first product.”

H1 2023 operational highlights

In the first half of this year, Biotalys continued to seal partnerships, prepare for the launch of Evoca, and strengthen its patent portfolio.

• In April 2023, Biotalys entered into a strategic partnership with Syngenta to collaborate on the research, development and commercialization of a new bio-insecticide to counter the threat of pest resistance and advance sustainable agriculture.
• Evoca, Biotalys’ first protein-based biocontrol, further demonstrated its efficacy in recent global field trials in preparation for its U.S. market introduction. Announcing the results of over 160 field trials in partnership with industry leaders Biobest and Beck Ag across various high-value crops in May 2023, Evoca outperformed leading chemical and biological solutions in several trials.
• Earlier this year, Biotalys announced a major advance in manufacturing efficiency for Evoca, strengthening the production and distribution path for the product. The scientific breakthrough, based on the development of multiple proprietary yeast strains, increased the production efficiency of Evoca’s bioactive ingredient by 50 to 70%.
   
• Following the successful outcome of the feasibility study with Novozymes at the end of last year, Biotalys and Novozymes have been further exploring manufacturing possibilities for a next generation of Evoca based on Novozymes’ production hosts to create significant cost of goods and scaling advantages. The companies are also exploring collaborations beyond Evoca to address the need for effective and more sustainable protein-based biocontrols in new markets and indications.  
   
• In March 2023, Biotalys announced a succession plan for its Chief Financial Officer. The transition was successfully completed as planned with the promotion of Douglas Minder to CFO, effective 1 July 2023.
   
• Biotalys continued to strengthen its patent portfolio to protect its science and products. In H1 2023, two additional patents were granted to the company in India and Australia, both patents providing further IP protection relating to antibodies binding to fungal plant pests.
   
• Early in 2023, Biotalys earned Top 100 status in Forward Fooding’s FoodTech 500 list, climbing to #65. Biotalys was also honored in its inaugural FoodTech 500 $100 Million Club. A highly competitive event with thousands of nominations from 50+ countries, the FoodTech 500 ranks global entrepreneurial talent at the intersection of food, technology and sustainability.
   

Regulatory update for Evoca

• The U.S. Environmental Protection Agency (EPA) has recently changed its review process and no longer sets dates for expected decisions to applicants. Biotalys continues to work with the EPA as it reviews the submitted regulatory dossier. Pending regulatory approval, Biotalys is preparing for the start of the market calibration with Evoca in 2024 and for the launch of the commercial version of the product in 2026.
• In Europe, the rapporteur Member State is The Netherlands where the CTGB (College voor de Toelating Gewasbeschermingsmiddelen en Biociden) is currently reviewing the regulatory dossier. Importantly, the authority has recently approved the sale of cucumbers treated with Evoca in greenhouse trials. While normally crops used in such trials have to be destroyed, as they are treated with products that are not yet authorized, the Dutch authority granted an exemption allowing sale of cucumbers treated with Evoca in greenhouse trials. This decision reinforces Biotalys’ confidence that the product is safe to use.

Private placement

• In June 2023, Biotalys successfully closed a private placement for €7 million. The company issued 1,135,257 new shares (approximately 3.67% of the company’s shares outstanding prior to the transaction) at €6.166 per share to deepen its relationship with existing shareholders, Agri Investment Fund BV (A.I.F.) and the Belgian Sovereign Wealth Fund (“Federale Participatie- en Investeringsmaatschappij NV” – SFPIM).
   

New board member (post-period)

• Connected to the private placement, Biotalys nominated Agri Investment Fund BV (A.I.F.), represented by Patrik Haesen, to the Board of Directors, which was approved by the Special Shareholders Meeting of 21 August 2023. Patrik Haesen is currently Chief Executive Officer of A.I.F. and General Manager Investments at M.R.B.B., the holding company of the Farmers Union in Belgium. He has in-depth expertise in audit, finance and investment. He also is a director in Arvesta, Acerta and Iscal Sugar and in several other innovative AgTech companies. Mr. Haesen holds a Master’s degree in commercial engineering (KU Leuven) and a European Master in public administration (KU Leuven and Corvinus University in Budapest), as well as a postgraduate degree in finance (EHSAL, Management School).
   

* Evoca™: Pending Registration. This product is not currently registered for sale or use in the United States, the European Union, or elsewhere and is not being offered for sale.

Select financial information

• Other operating income for the first half of 2023 amounted to €1.3 million and related to R&D tax incentives received and grants awarded to support R&D activities.
• Research and development expenses amounted to €8.7 million for the first half year, an increase of €1.1 million compared to the same period in 2022. These increases primarily related to higher costs for external consultants and wages (+€0.7 million), increased depreciations and maintenance costs for lab equipment, and additional IT costs.
• General and administrative expenses amounted to €2.8 million for the first half of 2023, compared to €2.6 million for the same period in 2022. The increase was mainly driven by higher wage costs related to the wage index increases and to a lesser extent the expansion of the team.
• Net cash used in operating activities decreased by €1.0 million, to €8.5 million for the six months ended 30 June 2023. This decrease was primarily caused by changes in working capital driven by advances received from various project grants.

Outlook

• Biotalys expects to initiate the market calibration of Evoca in 2024 with Biobest in selected U.S. states upon registration of the product. In the meantime, the company is focusing its field trial program with Evoca in a broader number of crops such as blueberries and hemp where demand for safe and sustainable solutions is high.
• In addition, Biotalys is now conducting field trials with the next generation of Evoca on a wide variety of fruits and vegetables to work towards market introduction of a commercial version of the product in 2026.
• The company expects to advance the product pipeline in H2 2023, with the planned promotion of the BioFun-6 program into development stage while progressing other current pipeline programs further in the discovery stage.
• Looking ahead, Biotalys plans to leverage the AGROBODY Foundry™ platform and pipeline to expand into new markets and crops, and will continue to explore strategic collaborations with the potential to create additional value.
• While maintaining the planned investment in the product pipeline and the technology platform, the company has decided to pause its sole bactericide program (BioBac-1) and focus its activities on the fungicide and insecticide programs where the commercial opportunity is higher.
• Excluding the funds raised in the private placement of June 2023, the company expects cash burn for FY 2023 to be slightly lower than in FY 2022 (2022: €22 million).
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Website: https://www.biotalys.com

Published: August 24, 2023