Biotalys announces HY results and highlights

blueberries
Photo: Ri Butov/Pixabay

Biotalys, an agtech company developing protein-based biocontrol solutions for crop and food protection, has announced its key business achievements and consolidated financial results for the first half of 2023.

H1 2023 operational highlights

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

In April 2023, the company 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 US market introduction. Announcing the results of more than 160 field trials in partnership with industry leaders Biobest and Beck Ag across various high-value crops in May 2023, Biotalys said 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.

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.

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 is currently reviewing the regulatory dossier. 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.

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 SFPIM.

Other income

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 €2.6million 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 June 30, 2023. This decrease was primarily caused by changes in working capital driven by advances received from various project grants.

Patrice Sellès, chief executive officer of Biotalys, said: “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 US 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.”

Outlook

Biotalys said it expects to initiate the market calibration of Evoca in 2024 with Biobest in selected US 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 toward 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 said it 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 in June 2023, the company expects cash burn for FY 2023 to be slightly lower than in FY 2022 (€22 million).

Jim Cornall is editor of Future Food Today and publisher at Ayr Coastal Media. He is an award-winning writer, editor, photographer, broadcaster, designer and author. Contact Jim here.