Biotalys NV Stock

Good day, and thank you for standing by. Welcome to the Biotalys Half Year 2026 Financial Figures and Business Highlights Conference Call and Webcast. [Operator Instructions] Please note that today's conference is being recorded.

I would now like to turn the conference over to your speaker, Toon Musschoot. Please go ahead.

Thank you very much, Razia, and welcome, ladies and gentlemen, to the Biotalys webcast following our press release detailing our results for the first half of 2026, which was issued earlier this morning. I'm joined today by our CEO, Carlo Boutton; and CFO, Luc Van Fraeyenhoven. At the end of our presentation, we will be happy to take your questions. You can ask them both through the webcast, through via the chat function and the conference call.

Let me remind you of our disclaimer on Slide 2, which is a standard part of our deck and which you can also consult in the tool of this webcast. Everything we say today is covered by these legal provisions.

As you may have seen in today's announcement, Carlo Boutton has been appointed CEO on a permanent basis following his interim appointment in March of this year. So please join me in congratulating Carlo. And Carlo, on behalf of the entire Biotalys team, we are very pleased that you will continue to lead the company and help driving the execution of our strategy.

And with this, Carlo, I leave the floor to you.

Thank you, Toon, and welcome to everyone joining us on the call today. So we will review our business highlights and financial results for the first half of 2026. We will discuss the progress achieved over the recent months and provide an update on our priorities and outlook.

But before we begin, I would like to sincerely thank the board of Biotalys for their confidence in appointing me as CEO of Biotalys. I am excited to take up the role because I'm still convinced about opportunities ahead, and I'm committed to execute our strategy to advance our mission and to create long-term value for all stakeholders involved, including, of course, our investors.

The first half of 2026 has been a very important period of focus and execution for us, for Biotalys. Following our strategic refocus announced earlier this year, we have concentrated our resources on our most valuable assets. We streamlined our organization, strengthened our financial position and continue to advance the regulatory and development milestones that are necessary to bring our innovative protein-based biocontrol products to the market. So our objectives are clear: to transform Biotalys into a commercial-stage company by bringing novel, effective and sustainable crop protection solutions to growers, and we'll do that by starting in key markets.

So let me begin with our product pipeline. And that, of course, starts with EVOCA and EVOCA NG. Our highest priority remains the advancement of EVOCA and its commercial success of EVOCA NG, which targets high-value fruit and vegetable crops affected by botrytis and powdery mildew. Following the EPA approval of EVOCA at the end of 2025, we achieved another important milestone in April this year with the first U.S. registration in Florida, which is marking the first state-level approval of an AGROBODY-based biocontrol product in the United States.

Further, in the U.S., we have also continued to make meaningful progress in California, which remains a key strategic market given its importance to high-value crops. At the end of June, California Department of Pesticide Regulation initiated the public commenting phase following a positive human health assessment. And this consultation phase has now been closed, and the next steps are under way. And so, we expect state registration in California later this year.

Switching to Europe, we also made significant advancements in our regulatory process in Europe. EFSA initiated its public consultation process in April. And following the completion of that consultation at the end of June, we submitted comprehensive responses to the comments received, and those responses are currently reviewed by EFSA and the Dutch Regulatory Authority CTGB. Biotalys now project a final regulatory decision in the course of 2027 for EVOCA.

Importantly, all of this work is creating a strong regulatory foundation for EVOCA NG, our next-generation product based on the same active ingredient as EVOCA. And leveraging this foundation, it should significantly reduce the time required for future regulatory approvals compared to completely new active substance.

EVOCA NG remains the product with which we intend to enter the market commercially, targeting large and attractive fungicide segments for control of botrytis and powdery mildew in fruit and vegetable crops. We continue to target a U.S. launch in 2029, and European launch in 2029 and 2030, addressing the combined market opportunity of more than USD 1 billion.

A key and very important next step that we took for EVOCA NG is that we started the 5-batch production campaign in early August. And we should not underestimate that. This is not only an important regulatory requirement to initiate a regulatory studies for EVOCA NG, it also demonstrates consistency and stability in the manufacturing process, and we currently expect results from this 5-batch production by early November of this year.

Finally, I'm pleased to share that EVOCA NG has been nominated for the prestigious Bernard Blum Award by the Association of Biocontrol Industry Manufacturers. The final award will be granted at the Annual ABIM Conference taking place in Basel, in Switzerland in the second half of October.

Switching to BioFun-6 and having a highlight on the BioFun-6 progress, which is a major second priority, our second biofungicide program that is targeting botrytis and powdery mildew in fruit and vegetables. We are very much encouraged by the data generated so far in field trials. So during the fall of 2025 and early '26 growing seasons, our second lead candidate from our BioFun-6 program was evaluated in more than 40 field trials across multiple geographies and crops, including grapes, strawberries, tomatoes, cucumbers, and the results demonstrated consistent and strong disease control.

Across many trial settings, the candidate outperformed existing biological alternatives available on the market today. In spray rotation programs, where a biological product replaces synthetic chemistry, BioFun-6 delivered disease suppression comparable to conventional solutions.

In addition to our internal trials, we also received the latest results from independent fungicide evaluations conducted by the University of Florida. And while we are awaiting the official publication of that report, we can today already share that among the relevant programs evaluated, a spray rotation program that included our BioFun-6 lead candidate in a rotation with a standard synthetic fungicide achieved the strongest overall performance in controlling botrytis on strawberries.

And both these internally commissioned and academic trials are very encouraging because they support one of the central premises of our AGROBODY platform, which is delivering biological crop protection products with efficacy levels that growers can depend upon in a real world farming conditions.

For BioFun-6, we are now continuing additional field trials focused on evaluating performance at lower dose rates. These studies are intended to further optimize the product positioning, the product profile and the product economics, and we expect additional results of these trials around the year-end.

In terms of manufacturing, another important development during the first half was a strategic partnership with 21st.BIO because commercial success requires not only effective products, it also requires scalable and cost-competitive manufacturing. And the partnership with 21st.BIO gives us access to advanced precision fermentation technology that can support both of these manufacturing objectives. So together with 21st.BIO, we are continuing to optimize our production process and manufacturing plans to ensure commercial competitiveness as we move towards market launch.

And I'm very pleased to say that the first tangible result of this collaboration is our 5-batch production of EVOCA NG, which started a couple of weeks ago. At the same time, we are also engaging with potential manufacturing and distribution partners globally as part of our commercialization strategy.

If we then move beyond EVOCA NG and BioFun-6 and the rest of the portfolio, our BioIns-2 collaborations with Syngenta achieved a research milestone, and we are currently evaluating the outcome of the research phase together with our partner and expect to provide an update about this collaboration during the second half of 2026. Our BioFun-7 collaboration with the Gates Foundation remains ongoing to the end of this year. Biotalys and the Foundation will jointly assess if there's a sufficient basis to continue this collaboration beyond 2026. And finally about BioFun-4 and BioFun-8 programs, respectively against oomycetes in potato and grapes, and BioFun-8, Alternaria in fruit and vegetables. We remain open here for potential collaboration with third parties. And in this context, we can mention that the third party is currently testing an AGROBODY bioactive against oomycetes in Belgium and the Netherlands.

Then beyond the individual programs and more shifting towards the AGROBODY platform, a platform for us remains crucial in our strategy because it enables us to generate a highly specific protein-based bioactives against important diseases and it provides a basis for building further on a differentiated pipeline of sustainable crop protection products.

Of course, we are also continuously building and strengthening our intellectual property, and have now also received a patent for EVOCA in Japan, building on our previous patents in key regions like Europe, U.S., Brazil and China. Also, the wordmarks EVOCA and AGROBODY are now registered as trademarks, protecting these as valuable assets for the company.

With that, I will now hand over the call to Luc to discuss our financial performance. Luc?

Thank you, Carlo. Let me briefly review the financial results for the first half of 2026. Before going through the figures, I would like to emphasize that we continue to manage our financial position with discipline. We are closely monitoring our cash position and expenses and the cost-saving measures implemented earlier this year are progressing in line with our plans.

Other operating income amounted to EUR 1.6 million, mainly reflecting R&D tax incentive and grant income supporting our innovation activities. Research and development expenses were EUR 6.2 million compared to EUR 6.5 million in the first half of 2025. This reduction reflects lower operating expenses following the organizational changes implemented earlier this year, partly offset by continued investment in our key pipeline programs. General and administrative expenses decreased to EUR 2.7 million from EUR 3 million last year, again, reflecting the impact of our cost-saving initiatives and streamlined organization.

We also recorded EUR 1.9 million in restructuring costs related primarily to termination benefits associated with the strategic refocus. As a result, normalized net loss, representing the loss for the first half of 2026 adjusted for restructuring costs improved by EUR 0.9 million compared with the same period last year and amounted EUR 7.2 million. So the loss for the period was EUR 9.1 million compared to EUR 8.1 million for the same period last year.

Importantly, during May, we successfully completed a EUR 12.05 million private placement supported by our key investor and shareholders. The financing strengthens our balance sheet and demonstrates the continued support for our investor base for our strategy and pipeline.

At the end of June 2026, cash and cash equivalents amounted to EUR 11.9 million. Based on our current operating plans, we project our financial runway to extend through the end of first quarter of 2027. We are considering various options, both dilutive and non-dilutive to continue to fund the company to allow to become commercially active. The cost reduction measures implemented this year will continue to flow through the organization, and we expect these actions to contribute to a lower cash burn profile going forward, starting this year already and in full effect as from 2027 onwards.

Overall, we remain on track with our current operating plan while continuing to carefully monitor our financial position and manage expenses with discipline. With that, I hand over the call back to Carlo for closing remarks.

Thank you, Luc. To conclude, the first half of 2026 has been all about creating focus, building momentum and advancing our key milestones that matter most for the future of Biotalys. We have strengthened the company through a strategic refocus, we secured additional financing, we advanced a regulatory process for EVOCA in both the U.S. and Europe, initiated critical regulatory activities for EVOCA NG, demonstrated encouraging field performance for BioFun-6 and made a lot of progress in our manufacturing strategy through the partnership with 21st.BIO. So we are on track.

Before we start with questions, I would like to sincerely thank all the Biotalys colleagues for their commitment and resilience because this has not been an easy period, particularly following the restructuring earlier this year. The team, however, and all colleagues remain focused on our mission, and they continue to drive the progress that is needed to bring our innovative crop protection solutions closer to the growers.

Looking ahead, our priorities remain unchanged. We will continue to advance EVOCA NG and BioFun-6, we will continue pursuing key regulatory milestones, we will further optimize manufacturing and commercial readiness, and we will continue operating with disciplined capital allocation. We believe that the fundamental opportunity for effective, safe and sustainable protein-based crop protection remains highly compelling, and we are committed to realizing the full potential of our AGROBODY platform for growers, for partners and for shareholders.

So thank you again for joining and for your interest in Biotalys. I will now turn the call back over to Toon to begin our Q&A session.

Thank you, Carlo, and Luc. So Razia, we are now ready to take questions from the audience.

[Operator Instructions] We are now going to proceed with our first question. And the question come from the line of Guy Sips from KBC Securities.

Yes. I want to come back to the 5-batch production of EVOCA NG. The main question is, can you elaborate a little bit more on this? And especially, is this a binary process? Or is it yes or no? Or is the answer a potential yes, but answer? And what is the -- yes, so what is the expected news flow on this one? And the second question is on the general news flow, what news flow can we expect from now until, let's say, end of Q1 2027?

So thank you, Guy, for the question because we should not underestimate the value of the start of this 5-batch production. What it really means, and I try to be non-technical, is that we are finalizing the production process of EVOCA NG. It means that we come to a production process, which is robust, consistent and to a production process that will reflect the final material. And this is a necessary step to do regulatory trials, but also towards further commercialization. So it's not a binary process, it's a more complex process, but we are confident that the steps we have taken, it's a major hurdle and it's a major derisking factor that we took in the next step in commercial manufacturing.

The second question, if I may, was on the further outlook of 2026. And part is, of course, that we, first of all, for the EVOCA, approval of EVOCA in California. Second, more news on the finalization of the 5-batch, which you expect around November. And then hopefully, by the end of the year, also some other results of the BioFun-6 trials. I think that's the main key factors. Luc, Toon, if I forget something, let me know. BioFun-6, I think, I mentioned BioFun-6 results of trials end of the year, 5-batch production and EVOCA in California.

Guy, is that clear? Did you have any other questions?

No, no. Thank you from my side and all the best.

We are now going to proceed with our next question. The questions come from the line of Christian Faitz from Kepler Cheuvreux.

And Carlo, congrats again on your now permanent CEO position. Two questions, if I may. First one is, would you expect any more restructuring expenses to come in the second half of this year or into '27? And second question is just a quick check on BioIns-2, you mentioned in your release, this morning's release that you and your partner, Syngenta are, "currently evaluating" their collaboration in view of the outcome of the first research phase of BioIns-2. Is there something in terms of earlier results you could already share, or do we have to wait until you are prepared to say something in the course of the second half of this year?

Thank you, Christian, and thank you on the wishes, very much appreciated. On the restructuring expenses, Luc, I'll hand over to you.

Yes. So the question was, if I understood well, there's more restructuring to be expected, I think, on the expenses in the second half of the year. So the answer on that is no. So we have taken all restructuring expenses according to the IFRS accounting guidelines in the first half of the year when the people had to leave the company, unfortunately. So all expenses for point -- to the amount of EUR 1.9 million as we have laid out in the numbers have been taken into consideration in the first half of the year, Christian.

Thank you, Luc. If it's okay, Luc, I will take the second question on the BioIns-2 and collaboration with Syngenta. So again, reiterating, we achieved the first research milestone earlier this year, based on that research success, we continue, still in the research phase on next steps, which are currently ongoing. Depending on the outcome of these results, together with Syngenta, we will evaluate if these results are good enough to proceed into the development program, if they are good enough to proceed into a further research phase, or if it's not enough to proceed, and that's actually what we are alluding to.

We are now going to proceed our next question. And the questions come from the line of Frank Claassen from Degroof Petercam.

Two questions, please. First of all, now that you have implemented your refocus, could you elaborate how much lower the cost base will be in the second half versus the first half and also going into 2027? And secondly, on EVOCA NG, well, the 5-batch production, you expect the results in November. My question is, what are the next steps after that? What are the next hurdles you have to overcome before you can file for approval in the U.S. and Europe?

Yes. Thank you, Frank. Perhaps the first question, Luc, you can address that.

Yes. So in fact, when we have laid out the restructuring or the rightsizing program, Frank, we have announced also in the press that, that compared to the original structure that, that would lead to a saving compared to the original structure till the end of '28, a total saving of in total EUR 20 million. So that's what we have announced. And in fact, it consists of internal expense saving, which is based on, of course, the related salary expenses, overheads and so on and so on, but also partly related to external program expenses, which are the number of programs that we have put on hold. So it's a combination of both, but that's in fact, a total of EUR 20 million savings compared to the original plan till the end of 2028.

Thank you, Luc. On the second question on EVOCA NG and then what's happening after successful 5 batches. And so, to reiterate, the 5 batches are a requirement for regulatory studies. So that the material of this 5 batches, we will do a number of regulatory studies, not all of them because after all, we use the same active ingredient, so a limited number of regulatory studies, which are required for next submission. We'll also do bridging trials with EVOCA NG to demonstrate that the efficacy of EVOCA and EVOCA NG are similar. And then we also -- we are in discussions with commercial manufacturers to upscale the commercial manufacturing of EVOCA NG. Submission of EVOCA NG is planned for mid-2027, both U.S. and Europe.

There are no further questions on the phone. So I'll now hand back to you for the webcast questions.

Thank you, Razia. So we have a question here in the tool, in the chat function of the webcast. I will read it out on loud. Can you shed more color on the third party currently testing an AGROBODY bioactive against oomycetes in Belgium and the Netherlands?

Sure, it's a very relevant question. So thank you for the question. Of course, we cannot name the third party, we have the confidentiality there. But indeed, it is related to BioFun-4. As mentioned before, BioFun-4 program is a bit on hold. We had some early lead candidates. We had several discussions with a couple of parties about this early lead candidates, and now there is one third-party who is interesting in testing the performance of this BioFun-4 lead candidates, both in phytophthora, which is heavily devastating disease in potato in Western Europe and then plasmopara in grapes.

Thank you, Carlo. I don't see any other questions in the tool. Razia, I don't know whether there are other questions on the conference call?

No, there are no questions on the conference call currently.

Well, I think we're happy to close if everything is clear then. And with that, of course, I would like to thank everybody for joining the call. Thank you, Carlo and Luc, for the clarity. Everybody can reach out to us through e-mail via [email protected] or you will also be able to find us on our direct e-mail addresses. Thank you very much for joining us today and speak to you later.

This concludes today's conference call. Thank you all for participating. You may now disconnect your lines. Thank you.

Good day, and thank you for standing by. Welcome to the Biotalys Full Year 2025 Financial Figures and Business Highlights Webcast and Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your first speaker today, Toon Musschoot, Head of Investor Relations and Communications. Please go ahead.

Thank you very much, Sharon, and welcome, ladies and gentlemen, to the Biotalys webcast following our press release detailing our results for the full year of 2025, which was issued earlier this morning. I'm joined today by our Interim CEO, Carlo Boutton; and CFO, Luc Van Fraeyenhoven.

At the end of our presentation, we will be happy to take your questions. You can ask them both through the webcast tool via the chat function or the conference call.

Let me just remind you of our disclaimer on Slide 2, which is a standard part of our presentation and which you can also consult in the tool of the webcast. Everything, of course, we say today is covered by these legal provisions.

I will now turn the call over to our CEO, Carlo Boutton.

Thank you, Toon. And on my part, I want to welcome everyone joining us on this call today. I will start by providing an overview of our key business achievements in 2025, followed by our strategic priorities and outlook for 2026. Luc, our CFO, will then take you through the financials, our cash position and the discussions we are having around financing. And at the end, we will conclude with a Q&A session.

But let me begin with a brief overview of 2025. 2025 was a pivotal year for Biotalys, marked by major regulatory, strategic and operational milestones, that significantly strengthened the foundations of the platform and the company. First and foremost, we reached a historic regulatory milestone with the approval of EVOCA by the U.S. Environmental Protection Agency.

EVOCA, our first protein-based biofungicide, and this approval of EVOCA is a major value inflection point for our company and validates both the robustness of our AGROBODY platform and our ability to navigate complex regulatory processes in one of the world's most demanding crop protection markets.

I'm also very pleased with the exemption on maximum tolerance residue levels that we received from EPA because this confirms the safety of our products and increases their value as safe and environmentally friendly alternatives for synthetic pesticides.

In parallel, EVOCA received strong regulatory support in Europe. The Dutch CTGB issued a positive recommendation for EU-wide approval of EVOCA's active ingredients, supported by the confirmation from RIVM, which is the National Institute for Public Health and the Environment in the Netherlands. And they claim or they support that there are no critical areas of concern and that our product qualifies for low-risk classification. And together, these achievements position EVOCA as a credible, differentiated, safe biological alternative for growth, facing increasing regulatory pressure on conventional chemistry.

I'm also very happy to share that EFSA, the European Food Safety Authority, has initiated yesterday the public consultation procedure in Europe, which is another important step forward in our regulatory efforts in the EU. And this consultation, which has now started, will run for 2 months, after which both EFSA and CTGB are expected to review comments and proceed to the decision phase.

Beyond regulation, 2025 was also a year in which we continue to advance and refine our pipeline. We generated encouraging data across several programs while taking a disciplined approach to prioritization, and I will come back to prioritization when discussing our strategic refocus.

And finally, we strengthened our external ecosystem through strategic partnerships, most notably our collaboration with AgroFresh in the Post-Harvest segment, which is expanding the potential application of our technology beyond the pre-harvest field. And taken together, these achievements reflect meaningful progress towards our ambition of bringing safe, effective, scalable and sustainable crop protection solutions to the market.

If I now turn to our product pipeline and how it has evolved, we see at the center of our pipeline EVOCA, which targets high-value fruit and vegetable crops affected by Botrytis and powdery mildew. With the U.S. EPA approval now in hand, EVOCA serves as the regulatory and scientific foundation for EVOCA NG, which is our second-generation product. EVOCA NG contains the same active ingredient as EVOCA and hence is expected to benefit from a shorter regulatory review process.

Importantly, EVOCA NG is designed to be our first commercial biofungicide with a planned launch in the United States in 2029 and in Europe in 2030, addressing a combined market opportunity of more than USD 1.1 billion.

In addition to EVOCA NG, we made strong progress with BioFun-6, our second biofungicide candidate. In 2025, initial field trials in Europe and the U.S. demonstrated that BioFun-6 can achieve a similar performance to EVOCA at significantly lower dosage rates, which is a very attractive feature from both a cost and sustainability perspective. And these results were further supported by successful independent academic trials conducted at the University of California Davis.

Alongside these lead assets, we continued work on partner programs, including BioIns-2 with Syngenta Crop Protection and BioFun-7 with the Gates Foundation. However, as announced in early February 2026, we also made the deliberate decision to strategically refocus our pipeline. This means prioritizing our most advanced biofungicides assets and spending early-stage programs, specifically BioFun-4 and BioFun-8, while opening this up for R&D collaboration with third-parties.

And this decision reflects our commitment to focus capital and resources where we see the highest near-term value creation. And this brings me to our strategic refocus, which is a critical element of our plan going forward. The objective of this refocus is clear. We will concentrate and focus our resources on the highest priority programs, streamline operations and materially reduce our cost base while safeguarding the long-term value of our technology platform.

Concretely, it involves adapting our organizational structure, including the leadership team, suspending selected early-stage activities and sharpening our commercial and regulatory focus. As a result, we expect an estimated reduction in total cash burn of approximately EUR 20 million through the end of 2028 compared to our previous operating structure. Our Board has now confirmed its decision to proceed with the implementation of the new structure, and we plan to execute this in the coming weeks. At the same time, we are not standing still operationally.

In early 2026, we entered into a strategic partnership with 21st.BIO, which will support the scaling of our protein-based biocontrols through precision fermentation at commercially competitive costs. And this partnership is a key enabler as we prepare for future commercialization. Importantly, these measures are designed not only to extend our financial runway, but also to ensure that Biotalys remains well positioned to deliver differentiated products that meet both grower needs and also regulatory expectations.

Looking ahead now to 2026, our priorities are well defined. First, we will continue to advance EVOCA NG and BioFun-6 as our lead biofungicide programs. On the regulatory front, we will work closely with the authorities in both U.S. and Europe. In the United States, we just received state registration for EVOCA in Florida, and we expect the same in California later this year. And for this year, we will prepare the regulatory submission dossier for EVOCA NG in the U.S. and for Europe.

In Brazil, we have initiated the registration dossier, and we are exploring options to work with a local partner for local registration. With regard to the BioFun-6 trials, field trials in the second lead candidate are ongoing, and we are also planning additional field trials to strengthen the scientific foundation of this program.

Second, we will continue to optimize the production and manufacturing plans, supported by our collaboration with 21st.BIO with a clear objective of achieving commercially viable cost structures. And third, we will maintain support for our pilot programs, notably BioFun-7 and BioIns-2, which allow us to progress innovation while sharing risk and investments. For BioIns-2, we have achieved the first research milestone early this year, reflecting continued progress in the collaboration, while not materially impacting Biotalys current financial runway.

With regard to the BioFun-4 and BioFun-8 programs, we are opening this up for R&D collaborations with third-parties. And finally, we remain focused on executing our strategic focus responsibly, very responsibly, including engaging constructively with all stakeholders during this transition.

And with that, I will now hand over to Luc, our CFO, to take you through the financial review and our current financing position. Luc?

Thank you, Carlo, and good afternoon, everyone. I will start with a brief overview of our full 2025 financial performance before turning to our cash position, the runway and financing discussions.

For 2025, our other operating income amounted to EUR 3 million, mainly driven by R&D tax incentives, grants supporting our research activities and recognized partner fees. Research and development expenses increased to EUR 13.3 million compared to EUR 11 million in 2024. This increase reflects higher external spending related to strain engineering and field trials. This is in line with the progress of our pipeline.

General and administrative expenses remained stable at EUR 5.6 million, which is demonstrating our continued cost discipline despite inflationary pressures. As a result, our operating loss -- operating loss for the year amounted to EUR 15.8 million compared to EUR 13.5 million in 2024. The net loss for the period was EUR 15.8 million.

Turning to cash and liquidity. At year-end 2025, cash and cash equivalents totaled EUR 8 million compared to [ 2020.6 million (sic) [ EUR 22.6 million ] at the end of 2024. The annual cash burn net of capital raised via private placements increased by approximately 8% to EUR 14.6 million. On the balance sheet, total assets amounted to EUR 19.7 million, while total equity stood at EUR 12.1 million. Our liabilities remained broadly stable, reflecting continued management of borrowings and working capital.

Based on our current cash position, the company's financial runway extends until end of May 2026, consistent with what we have communicated previously. Given this runway, financing is naturally a key focus. As disclosed, Biotalys does not currently have sufficient working capital to cover at least 12 months of operations. We are in well-advanced negotiations with a number of investors to support the execution of our strategic refocus.

Next to an equity injection, we are also exploring other alternative dilutive and non-dilutive financing options. In this respect, the measures Carlo outlined, notably the pipeline prioritization and cost reductions, are expected to significantly reduce the capital required to advance our lead assets and execute our strategy. We will continue to update the market transparently as these discussions finalize.

Thank you, Luc. And to conclude, 2025 was a year of significant progress for Biotalys, highlighted by a major regulatory success, pipeline advancement and strategic partnerships. As we move into 2026, we are executing a focused strategy aimed at prioritization, efficiency and value creation. We remain committed to transparency and disciplined execution as we work towards bringing precision biocontrol solutions to the market.

I want to thank everyone on the call. And I'll now turn the call over to Toon to begin our Q&A session.

Thank you, Carlo and Luc. So Sharon, we are now ready to take questions from the participants.

[Operator Instructions] Our first question today comes from the line of Christian Faitz from Kepler Cheuvreux.

Two questions. First of all, can you give us any update on the European registration process for EVOCA in terms of time line? And the second question, I'm aware that the milestone achieved for BioIns-2 involves positive in vitro results. Yet, could I ask you to be a bit more specific about the BioIns profile and by when you would see this product achieving registration in key markets?

All right. Thank you for the question. I think the first question, if I remember well, was the question on the progress of EVOCA in EU. So first of all, let me say that we are super happy with the progress that has been made in EU. As we know, EU is a lengthy process. So we are excited that we see progress by the opening of the public consultation yesterday. This will take, I think, 2 months starting from yesterday. After these 2 months and depending on the questions, there will be a review by EFSA and CTGB and then after, it may take a couple of months to come to the final decision. What exact time will be a bit unpredictable, but that's the process and clear progress in place. But again, I want to stress that we are super excited by the progress that has been made.

Second question was on BioIns-2. As correctly stated by the -- by you, Mr. Faitz, we have indeed made a very important research milestone. So that means progress. Of course, and I have to be very careful here in collaboration with Syngenta. I cannot make any further statements about further progress. But as a scientist, I -- we all know that the next steps are moving this into in vivo stage, but I cannot really highlight on further time lines or on expectations when such a product could be in the market.

And on confidentiality...

Yes. So I have to [indiscernible] -- I have to respect confidentiality with...

And the next question comes from Andrew Sab from Degroof Petercam.

This is Andrew Sab from Degroof Petercam asking a question for David. First question on EVOCA NG and the collaboration with 21st.BIO. In the press release, you indicated that important progress on production process and manufacturing will be made in Q4, allowing you to initiate the required regulatory studies for EVOCA NG. Can you comment a bit more on these studies, more specifically the design and the time lines and the outcome expected thereof? And how soon after completion of these studies, do you expect to submit the supplementary dossier to the EPA?

And the second question on BioFun-6. How confident are you that trial results of the second lead candidate will exceed those of your first candidate? And how soon after would you launch later-stage trials? And when can you expect the market [indiscernible]?

Okay. Thank you for the questions. I think the first one is related to the EVOCA NG time lines and the production costs or production time lines. So thanks to our collaboration with 21st.BIO, we are making significant progress in terms of production process of EVOCA NG production. So we're aiming to start regulatory experiments towards the end of the year, so in Q4. And therefore, we need material that is quality that is representing the final material. And so that's -- I don't think I can go any -- much further than that, but that's what we need to have. So in a way, we need to have a process that is able to generate material that is representative for the end material. And that will allow us to start regulatory experiments in the fall of this year or Q4 this year. In terms of time lines, these time lines will take -- or these [indiscernible] will take a couple of months. So we aim to submit EVOCA NG both in U.S. and EU somewhere mid next year and hopefully to have it approved in 2029 U.S., 2030 EU.

And then the second question was about BioFun-6. So you correctly understood that we have a second lead candidate that we have -- that we are starting field trials now. As you may remember, we have published very encouraging field results for first lead candidate. As you know, in our business, we typically have one program, typical candidates in the [indiscernible] For us, the comparison mainly is EVOCA. So the ambition is to have the same efficacy of the BioFun-6 program at a lower dose. So we compare towards efficacy.

The question that you raised was comparison versus the first lead candidate, so we believe or we aim to have like a similar efficacy as the first lead candidate. What I want to say is in terms of selecting candidate, it's a [ multiparametric ] process or multiparameter decision. Efficacy is one thing and a couple of other things like cost of goods, et cetera. So it's a [ multiparameter ] decision.

Okay. Andrew, does that cover all your questions?

[Operator Instructions] And the next question comes from the line of Guy Sips from KBC Securities.

Two questions from my side. First question is on the production yield. Can you give us some indication of this evolving? And what are your targets for the next, let's say, 12 and 24 months for that? And my second question is on the expected news flow. What news flow can we expect during 2026 from Biotalys? What is in the plans from that side?

So thank you, Guy. Your first question in terms of production yields. As a target, I wish, but I can't go into much detail. Where we are now is, since we started with our host generation and engineering, we have made a progress of more than 10 times, more than 15 times improvement in terms of yields. I cannot give you a concrete number. And actually, the concrete number is also super important because the yield you're achieving also depends on the host. So the type of the yield is one parameter, then you have the [ hosting ] plant [indiscernible], which is the second -- or which are other parameters. But we have made significant progress, more than a tenfold increase in yields compared to where we were a couple of years ago.

In terms of news flow for this year, of course, we have -- I want to stress that we have approval in Florida which we are very happy with. Later this year, we're also expecting approval in California, which is also a very big market. We will, of course, also announce progress on BioFun-6 for lead candidates for the field trials, which -- for which we should receive results towards the middle of the year somewhere. That's also a second important milestone to help me now a couple of my head.

Update on the production process by the end of the year?

Thank you for that. I was sitting out of mind. That was actually a previous question as well. So update towards the third or fourth quarter of this year, update on the production process of EVOCA NG. And I think that's going to be the 2 major one at least from a technical point of view.

I will now hand the call back to Toon for the webcast questions.

Thank you, Sharon. We have one question currently in the webcast from Mr. [indiscernible] . What is the potential of bioinsecticides in comparison to biofungicides?

Well, I think both are important. As you know, if you look at our pipeline, we are working on both. The majority of our focus is on biofungicides, which was a source of focus. The reason for that is that we're most advanced in EVOCA NG and BioFun-6, deliberate option to focus a bit more on biofungicides. Bioinsecticides is also an important market. And then we were a bit opportunistic and have a nice collaboration with Syngenta, which we cherish very much. But I think I would say, from a market perspective, both are equally important, so to speak. But as a company, we have to focus. And that's why we made the decision to focus a bit more on biofungicide, but we're not excluding bioinsecticides.

Thank you, Carlo. We currently have no further questions through the webcast tool. Sharon, do you have any other questions?

There are currently no further phone questions.

Well, I think that everything was clear then. I don't see any new questions coming in. So if that's the case, I want to thank you all for joining our webcast today. And of course, please keep in touch through our e-mail address, [email protected], our website and, of course, also our LinkedIn accounts. And we look forward to speaking with you next time. Thank you very much.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

Good day, and thank you for standing by. Welcome to the Biotalys Half Year 2025 Financial Figures and Business Highlights Webcast and Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Toon Musschoot, Head of Investor Relations and Communications. Please go ahead, sir.

Thank you very much, Sharon, and welcome, ladies and gentlemen, to the Biotalys webcast following our press release detailing our results for the first half of '25, which was issued earlier this morning. I'm joined today by our CEO, Kevin Helash; and CFO, Luc Van Fraeyenhoven. At the end of the presentation, we will be, of course, happy to take your questions. You can ask them both through the webcast tool via the chat function and the conference call.

Let me just remind you of our disclaimer on Slide 2, which is a standard part of our deck and which you can also consult in the tool of this webcast. Everything we say today is covered by these legal provisions.

And with that, I will now turn the call over to our CEO, Kevin Helash.

Thank you, Toon, and to everyone joining us on the call today. This year has been shaped by 2 powerful narratives. First, the critical pursuit of securing final regulatory approvals for Evoca in both the United States and Europe; and second, the equally transformative, though less visible groundwork underway to prepare us for the commercial phase in our evolution as a company.

Today, I will share updates on both the visible progress and the momentum building behind the scenes. The market dynamics for our technology remain compelling. The $40 billion global fungicide and insecticide market continues to expand, yet growers face increasing challenges. Resistance to existing active ingredients is rising, while regulatory and consumer pressures are restricting the use of traditional chemical solutions. As a result, growers are actively seeking innovative, effective alternatives that can be integrated into their pest management program to protect both their crops and their livelihoods.

Biotalys is uniquely positioned to fill this gap. As a pioneer in the precision biocontrols category, we're developing a new class of protein-based solutions that are designed to combine the performance of chemicals with the safety and sustainability of biologicals. Our platform is scalable across crops, geographies and markets, positioning us as a clear leader in this emerging segment.

Turning to Evoca's registration progress. The rationale for precision biocontrols remains compelling. As with any breakthrough innovation, however, the regulatory process takes time. While we had anticipated final EPA approval in the United States by the end of the third quarter, recent discussions with the agency indicate additional time will be required to complete the review.

That said, we remain confident the process is in its final stages. In Europe, progress remains on track. The Dutch authorities have recommended Evoca for approval as a low-risk fungicide to the European Commission, a milestone that clears a path for market entry into the world's largest fruit and vegetables crop protection market. In addition, we are preparing to submit a regulatory dossier for Evoca in Brazil to support the entry of our pipeline of products into this important agricultural market.

As we await regulatory approvals, we're making significant progress to ensure we successfully execute on our commercialization objectives and fully capitalize on our technology platform. I will touch upon both in more detail in just a few minutes. Growers urgently need novel solutions to continue to protect their crops, but they cannot risk inconsistency or underperformance. Efficacy and reliability are nonnegotiable when their livelihoods are at stake.

Our technology eliminates the long-standing trade-off between performance and profitability on one hand and sustainability and safety on the other. Only a select few companies are exploring comparable approaches, and Biotalys stands at the forefront with protein-based solutions that have the potential to bring novel modes of actions to crop protection. Supported by the depth of our R&D expertise, a solid intellectual property portfolio and meaningful regulatory progress in both the United States and Europe, we are well positioned to help shape this emerging category and contribute to the next evolution of the global crop protection market.

As we think about our go-to-market strategy, we will be utilizing a model that is designed to maximize efficiency and profitability by focusing resources where we create the most value, discovery, research and development and regulatory advancements. Rather than building costly subscale infrastructure for manufacturing, marketing and distribution, we are partnering with established industry leaders to meet these needs. This model accelerates market entry drives early share capture and reduces risk while avoiding significant capital investment. To support this strategy, we are actively engaged with Novonesis and other leading players to secure the critical components required to bring our platform to the market.

From a production standpoint, we collaborate with world-class manufacturers, including Olon, as announced in early 2022 and are in discussions with additional potential manufacturing partners to ensure optimal flexibility. Regarding product distribution to growers, we are leveraging the market presence and global reach of established industry leaders.

Key collaborations are already in place with Biobest covering specialty markets, AgroFresh focused on post-harvest applications and with Syngenta with whom we are developing a novel bioinsecticide. We are also advancing discussions with other top-tier organizations to extend our reach into the broader pre-harvest markets. By the time we launch Evoca NG, we are confident that all critical elements of our commercialization strategy will be firmly in place, ensuring comprehensive market coverage and a strong foundation for long-term success.

Looking ahead, we believe our platform has the potential to deliver products with improved performance and lower cost of goods, critical success factors in our ambition to capture market share across the industry. This belief is reinforced by field trial results from our first BioFun-6 candidate, a next-generation fungicide targeting botrytis and powdery mildew. This candidate demonstrated strong efficacy in the United States and European trials this year, not only against current commercial standards, but also when applied at significantly lower dosage rates than Evoca.

A key strength of our AGROBODY platform is its ability to generate multiple lead candidates for a given pathogen, giving us to borrow a sports analogy, multiple shots on goal. In the case of BioFun-6, a second lead candidate will be tested this fall in the Southern Hemisphere, enabling us to select the best candidate for further development based on manufacturability, field performance and other critical parameters as we move into the 2026 Northern Hemisphere field trial season.

Before I turn the call over to Luc, our new CFO, I want to express how pleased I am to welcome someone of his caliber to the team. In just a short time, he has already made a meaningful impact, not only in finance, but also as a strategic partner across the company. I'm fully confident that Luc will help us maintain our disciplined approach to financial management and support the successful execution of our commitments as we move forward.

Luc, over to you.

Thank you, Kevin, and thank you to everyone on the call. I'm excited to be part of the Biotalys team and look forward to meeting our investors and analysts in person. Allow me to quickly introduce myself here. I consider myself a team player and will work together with the management team and all the colleagues here to deliver on Biotalys ambitions. I do not see finance as an isolated function, but rather as an integrated part of the organization.

I like financial discipline and the distinction must be made clearly between must-haves and nice to haves. Priority setting is key. Transparency towards all stakeholders is also key in my way of working. It's imperative to drive success and commit to deliverables. As Kevin mentioned, it was clear to me upon joining that the company has been by selective about where it deploys capital, focusing on R&D and regulatory milestones that advance the platform and accelerate the path to commercialization.

Our first half year results reflect this focus as we continue to invest in our unique technology platform and product pipeline, leading to an increase in R&D expenses, partially offset by lower spending for Evoca as it moved out of the development phase. General and administrative expenses were largely in line with the same period last year, only showing a small increase reflecting amongst others the indexation of salaries.

We also have been able to keep a tighter ring of our uses of cash. Our net cash used in this period of EUR 6.9 million was in line with the first 6 months of last year, resulting in a cash position of EUR 15.7 million at the end of June. This is EUR 1 million higher than the end of June last year, providing us with the runway into May 2026. Next to the key financial numbers from our first half year, I would like to take this opportunity to provide clarity on our financial strategy during this critical phase of growth.

Beyond product innovation, we continue to execute with operational discipline. Over the past 2 years, we have restructured operations, tightened costs and improved efficiency reducing cash burn by approximately 40% compared to uses of cash in 2022.

From the revenue side, we will continue to investigate opportunities to generate income from partnerships, whether through milestone payments, cost compensations or royalties on our products. From the spending side, we plan to further fine-tune our targeted R&D approach and develop our pipeline of candidate products in collaboration with key academic and industry partners. In addition, we will focus on earning regulatory approvals from Evoca in the U.S. and Europe and on the submission of a regulatory dossier in Brazil and the preparation of regulatory dossiers for its commercial version Evoca NG.

As we move into the next phase for the company, we will consider additional funding options to increase our cash runway. This will allow us to complete key regulatory approvals, advance multiple pipeline candidates, fine-tune our technology platform and prepare for Evoca NG's commercial launch, all this with the aim to effectively execute our strategy and further exploit the potential of our unique technology platform to help farmers grow their crops more sustainably.

With the lean cost base, capital-efficient model and non-dilutive revenue from partnerships, we believe Biotalys stands out in our sector as a compelling combination of innovation and financial discipline. Again, it's my pleasure to join Biotalys at this exciting juncture in the company's history. I look forward to being a part of future growth.

Thank you, Luc. As you've heard today, Biotalys is rapidly advancing towards the next phase of our evolution, pioneering a novel technology that establishes a new and critical class of crop protection products. With precision biocontrols, our ambition is to set new standards for performance and sustainability, positioning this category as a global benchmark with Biotalys at the forefront. While final regulatory approvals for Evoca are still pending, the outlook remains positive.

In the background, we are preparing for market launch, expanding our pipeline and advancing a lean partnership-driven model built on strong science, disciplined execution and a clear vision. We believe this dual focus on regulatory progress and market readiness will enable us to deliver lasting value to all our stakeholders, including growers by supporting their efforts to produce safe, healthy and affordable food more sustainably.

Thank you, and I'll now turn the call over to Toon to begin our Q&A session.

Thank you, Kevin and Luc. So Sharon, we are now happy to take questions from the audience.

[Operator Instructions] And your first question comes from the line of Christian Faitz from Kepler Cheuvreux.

Just one question for the start. Can you please talk a bit about the efficacy of BioFun-6 versus Evoca in more detail, i.e., for example, how much lower is the dosage rate versus Evoca?

Christian, thank you for your question. So as I mentioned in my remarks, we have multiple candidates that we are looking at for BioFun-6. We took one lead candidate out to the marketplace this past year. And we were extremely pleased with the efficacy we witnessed in the field. And we're talking about rates approaching half the dosage rates of Evoca and seeing similar performance results.

We also have others, as I mentioned, that we're looking at. We're going to take a second candidate into the Southern Hemisphere, looking at botrytis control on grapes. And then as we move into the Northern Hemisphere, we'll make some further decisions in terms of which candidates we can move forward. So a couple of points I'd like to make here, Christian, is that we're extremely excited about the potential of our AGROBODY platform to develop multiple candidates that we can look at and screen.

And secondly, the first candidate that we took to the marketplace was a proof of concept and that we believe we can continue to bring products to the marketplace with increasing efficacy, lower dosage rate. And of course, that serves to lower our cost of goods and allow broader penetration into the marketplace. I hope that answers your question, Christian?

And our next question comes from the line of Guy Sips from KBC Securities.

My question is on the time line of the, let's say, of the news that will come in. What is -- how do you see the Evoca announcements, meaning will it be suddenly in the morning that there will be a press release that it's a yes or a no? Or is it -- is there a pre-announcement? Or how do you expect this to work?

Guy, it's Kevin. Good to hear from you. So in terms of the U.S., I would say that the next public piece of information will come out is when the EPA puts out the recommended registration for public comment. Of course, that will be out in the marketplace, and we anticipate we will also likewise make an announcement. So that will be what we see as the next milestone in terms of information we can provide to the market.

But now of course, if there's something we receive that is material and reliable information beforehand, we certainly will be very happy to share that as well.

And the second question is also on BioFun-6. So this is actually the second, let's say, step and second proof of concept. How important should we see this?

Well, we definitely see BioFun-6 as a next-generation product. I mean Evoca -- if you think back to our intention, Evoca really was meant to be our proof-of-concept product. We're super happy with how it has performed in all aspects, both in terms of the efficacy and an integrated pest management program for control of botrytis and powdery mildew, the ease of handling of the product from a farmer's perspective, storability, et cetera.

But that's not the end game, as Guy, you've heard us speak about. We have, I would say, a robust pipeline in the works now. And as we mentioned earlier, we anticipate adding new projects to our pipeline as we move forward. So yes, of course, we are eagerly looking forward to advancing BioFun-6 as well as the other candidates that we have and other pathogen control products that we have in our pipeline.

So it's kind of like asking which one of your children do you like the best, right? I mean we love them all, and we're excited for them all.

That's helpful. Yes. And the last question is on the production and the yield of the production of -- how is that evolving? Are they taking steps in the production yields?

Yes. So we've made significant progress in terms of moving towards final production of Evoca NG or what we anticipate to be Evoca NG through a contract manufacturer. I can say that from where we were 18 months ago to where we are today, there is an absolute step change. And then great -- I would say, great thanks to our work with Novonesis, who we continue to work with and discuss about options moving forward in terms of helping us ensure that we have the maximum production capability and producibility that is possible.

So yes, we're quite happy with the progress we've made. We still got some work to do there to nail down all the components, Guy, from a production standpoint, final production standpoint, but we're certainly happy with the progress we've made thus far.

There are currently no further phone questions. I will hand over to Toon for webcast questions.

Thank you very much, Sharon. We have a couple of questions in the tool. First of all, a question from [indiscernible]. A question for you, Kevin. Can you elaborate on the partnership with AgroFresh and in particular, what role they intend to play during R&D and marketing and for which pipeline candidates this collaboration will work?

No, thank you for the question. So we are very pleased to have announced a collaboration with AgroFresh. They are the leader in post-harvest control of food and produce, and they operate globally. So we couldn't have picked a better partner, I think, for that -- for access to that marketplace. In terms of the collaboration, you can think about it as truly a partnership all the way from formulation all the way through to final product application and market research.

So we have quite an open and broad relationship with AgroFresh. And in terms of which products we are going to work with them on. I would say our thinking is that the entire portfolio will be in discussion with them. And of course, we'll make decisions together in terms of which ones we move forward into post-harvest application.

Thanks very much, Kevin. That's loud and clear. We have a next question for Luc. What type of additional financing are you considering?

Okay. Thank you, Toon, for the question. Perhaps there in the context of that question, I would like to iterate a number of elements here. I think first of all, we reconfirm with this earnings call that the cash runway that we have already given 6 months ago that is still recommitted to May 2026. I think that's an important element. Secondly, what we also said during the earnings call that we -- for the remainder of the period, we will further carefully look at our expenses and be cost conscious. So that's very important also to mention.

Next, of course, we will further invest on our product pipeline and an important element there is also to work further, as Kevin also elaborated on the approval process of Evoca. And of course, the approval of Evoca will be an important milestone for the company. And yes, we will explore, we will consider different and all opportunities and possibilities in terms of funding. And that will be elaborated on in the next period. And so that we will come back to the market when the moment is right. to give more news on that. So all possibilities will be explored and considered.

Thank you very much, Luc. We do have a next question in the tool, Kevin, on Evoca, when do you expect to submit a regulatory dossier in Brazil?

Thank you, Toon. Yes. So we are quite excited to start our entry process into Brazil. We've been working on that already quite a bit this year. We -- let me just say that the time line and the cost to get into Brazil is substantially quicker and lower than going to the U.S. and into Europe. And we anticipate being able to launch Evoca NG about the same time as, let's say, U.S. and Europe, depending on how the regulatory process goes.

So it's ongoing work. We're making good progress there. And due to the fact that it has an anticipated much quicker time line, the ultimate launch date will be in the same time frame. Yes. So we're really looking forward to our first step into the Latin American market and certainly into one of the largest in the world being Brazil.

Absolutely. Thank you, Kevin. The last question was from [indiscernible].

Sharon, I don't have any other questions at this stage in the webcast. I don't know whether you have other questions in the conference call.

There are currently no further questions on the conference call, sir.

Well, I think we've addressed the questions from our audience. I think Kevin and Luc were clear. I would like to thank everybody on the call. Feel free to get in touch with us via e-mail, for instance, at [email protected]. And we, of course, hope to see you again at one of our next events.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.