BioVersys AG ($BIOV)

Welcome, ladies and gentlemen, and thank you for joining our full year 2025 financial results and earnings call for BioVersys. So during this call, you can put questions to us via the chat function in Zoom, and we will try to answer those questions after the presentation, or you can raise your hand during the Q&A, and we're going to pass you the microphone for questions. These were the housekeeping topics done, and we can get right into it. So I want to remind our audience today of the forward-looking statements made during the call and that the call will be recorded and made available on our web page afterwards. So first, it is my pleasure to introduce our speakers for today's call. We have with me Glenn Dale, our Chief Development Officer, who will talk to you about our planned and ongoing clinical trials for BV100 and alpibectir. We also have Daniel Ritz, who joined us as CSO in November 2025, who will talk to our collaboration with Shionogi for our preclinical asset BV500; and Hernan Levett, our CFO, who will update you on our financial results. My name is Marc Gitzinger, I'm CEO of BioVersys. So I'm happy to start the presentation with a look at our pipeline and BV100 is our lead asset, which is being developed for severe hospital infections caused by carbapenem-resistant Acinetobacter baumannii, a bacterium that causes today mortality rates of up to 50%, which is unacceptably high. As you see, we are on track towards first patient first visit for the Phase III as early as April 2026. This is our RIV-TARGET trial. And for the Phase IIb, the trial we call RIV-CARE, first patient first visit is expected also in the first half of 2026. As a reminder, commercial rights for this program are with BioVersys, and we expect peak sales of around USD 800 million. BV100 has the QIDP label from the FDA, which stands for Qualified Infectious Disease Product designation, and it allows for fast track and 5 years additional U.S. market exclusivity. Alpibectir is our second clinical stage pipeline asset. The program is directed against tuberculosis, and we develop it in collaboration with our partner, GSK. The program benefits from significant support from non-dilutive funding sources, has also FDA qualified infectious disease product designation and orphan drug status from the FDA and EMA. And it also qualifies for the FDA priority review voucher. We are currently conducting a pulmonary tuberculosis Phase 2b/c trial and are in the process of starting a Phase II in TB meningitis. And our preclinical pipeline consists of BV200, a small molecule that prevents staph aureus from producing toxins, and we focus this program first on a topical application in atopic dermatitis. BV500 directed at non-tuberculosis mycobacterial infections in chronic lung diseases such as cystic fibrosis and COPD, which is now partnered with Shionogi. This leads me directly to our highlights of 2025. We have been able to execute on our strategy and progress our pipeline and entered new partnerships. We have made a lot of progress on our clinical stage assets. The highlights for BV100 are that we initiated the global Phase III trial called RIV-TARGET and received first country-specific approvals, including the FDA IND Green Light, and we remain on track for an end of 2027 readout. We initiated a Phase I trial in China, enabling us to include Chinese patients into RIV-TARGET in the second half of 2026. Our planned Phase IIb clinical differentiation trial, RIV-CARE, will be conducted in partnership with ADVANCE-ID and is largely co-funded by Wellcome. We presented the Phase II data presentation at the symposium at ESCMID Global in Vienna earlier in 2025. And we also hosted a corporate event with two key opinion leaders discussing the Phase II data. This webcast can still be accessed via our web page. Recently, we had a successful end of Phase II meeting held with the U.S. FDA on our study design and are now ready to move forward. Alpibectir Phase II -- sorry, on alpibectir, we have the Phase II combination trial in pulmonary tuberculosis started by our partner, GSK, with interim results warranting initiation of Phase 2b/c that recruited first patient in March of this year. EMA granted us orphan designation for alpibectir and ethionamide to treat tuberculosis in mid-2025, and we recently published our Phase IIa early bactericidal activity data in the prestigious New England Journal of Medicine. On the corporate side, we are able to generate -- we were able to generate new partnerships like the one with ADVANCE-ID and Wellcome and of course, also our landmark deal with Shionogi. All of this came on the back of our IPO on the SIX Swiss Exchange in February 2025. On the IP side, one key event was that an important patent for BV100 was also granted in China, thus making this patent now granted in over 25 jurisdictions. Besides our internal progress, 2025 also turned out to be an important year for policy around antibiotic reimbursement. We have seen the U.K. established as first country in the world, a novel subscription model to pay for new priority antibiotics. And in the meantime, the European Union decided to establish a new rewards system via so-called transferable exclusivity vouchers. These are part of the new pharma legislation, and these TEVs could come into action as early as this year. Other countries run procurement and subscription model pilots, as you see here on the flags. So for instance, Italy, Japan and Canada. And in the U.S., we have seen an updated version of the PASTEUR Act that has been prepared. Overall, we are very pleased to see this much needed progress on policies that assign an adequate value to critical novel antibiotics, addressing priority health threats and incentivizing innovative AMR companies like ourselves. With this, I'm happy to hand the presentation to our CDO, Glenn, who will provide some more details on the progress of our clinical assets. Glenn?

Thanks, Marc. We are progressing our Phase III development program for BV100, which we developed this for critically ill patients in the indication of hospital-acquired pneumonia or HAP and ventilator-associated bacterial pneumonia, or VAP. As a brief reminder, the progression of BV100 into Phase III comes on the back of our strong Phase II data in VAP in which we could show a relative reduction on all-cause mortality of over 40%, 50% versus best available therapy. It's important to point out that in this trial, we also saw Acinetobacter strains that were resistant to both Cefiderocol or Xacduro, which represent really the newest drugs reported with reported activity on Acinetobacter. In this trial, all 5 patients that were affected by these strains were cured by BV100 in the study arm. So coming now to our current work. We have initiated our first global pivotal Phase III trial for BV100 called RIV-TARGET. We received the FDA green light for IND and received -- we've also received additional country-specific trial approvals. So we're quite ready to go on this trial. RIV-TARGET aims to -- a second trial, RIV-TARGET aims to seek an initial regulatory approval with the main global regulatory bodies, the FDA, EMA and the China NMPA, which we will follow up by working swiftly towards a broad global access of BV100. The trial is designed as a non-inferiority trial, where we will test -- have a test for superiority. RIV-TARGET will be run in approximately 15 countries with approximately 100 sites. So besides the Phase III, which is designed for regulatory approval, we also run a trial that supports real-world evidence in regions where extensively drug-resistant patient populations, and this will also support the commercial uptake of BV100. This Phase IIb trial is called RIV-CARE and will assess additional background therapies and will be randomized to best available therapy, including the newest available drugs for CRAB. In the competitive process, RIV-CARE was selected by ADVANCE-ID to be conducted with their trial network, which is finally backed by the Wellcome. This allows BioVersys to offset a large portion of the budgeted trial cost. The study design of the Phase III RIV-TARGET trial is a randomized multicenter active controlled study and is shown in this slide. We will aim for 248 evaluable patients infected with carbapenem-resistant Acinetobacter baumannii. This will be randomized 1:1. The BV100 arm contains BV100 plus a low dose polymyxin B, benefiting from the strong synergy between those two drugs and uses meropenem as a background therapy to cover polymicrobial infections. This is the same setup during the Phase II trial using also the same BV100 dosing regimen. The control arm in this trial is fixed to the IDSA recommended treatment that is globally available, which is colistin plus a high-dose ampicillin-sulbactam. And again, with meropenem as a background therapy for polymicrobial infections. We will also have, again, a Part B of the study to capture those patients which suffer from colistin-resistant, carbapenem-resistant Acinetobacter baumannii in the form of [ rescue arm ] as these patients really have no treatment options. This arm is as important as it shows the effect of BV100 essentially in those patients which have no other treatment options. The primary endpoint of the trial is 28-day all-cause mortality. Several secondary efficacy and commercial relevant endpoints will be collected such as clinical cure, test of cure, time in the ICU and the ventilator-free days. The study is designed as non-inferiority and once that is met, we'll have a test for superiority. We estimate that the first patient in this trial will be in April 2026. And slide -- here, we show the design of our Phase IIb RIV-CARE trial, which is run for further clinical differentiation of BV100. The main differences are the randomization to best available therapy, allowing the clinicians to stay closer to the real-world settings in which multiple polypharmacy is used in these severely critically ill patients. We will also allow the use of the newest drugs available such as Xacduro to generate some head-to-head data. The second important difference is that we will combine BV100 plus low-dose Polymyxin B with a different background therapy that are deployed in the very high resistant settings, such as Ceftazidime/Avibactam and Cefiderocol. For Cefiderocol, we also see some synergistic effects with BV100, and this will be seen in this trial. The endpoints are the same as for Phase III, and we aim at overall 90 evaluable patients randomized 1:1:1 in the 3 arms. The geographical focus of this trial will be mainly Asia and eventually Europe, mainly focusing on countries with very high resistance levels to really work on the additional clinical differentiation of BV100. We expect the first patient in the first half of 2026. So for BV100, we are thus looking forward to a very exciting 2026. We will complete the Phase I bridging study in China and then get the first patients in our RIV-TARGET trial for which we will onboard China in the second half of '26, have a Drug Safety Monitoring Board update in the second half of '26. And our guidance remains the same for the last patient enrolled is anticipated for the second half of '27. For the Phase IIb RIV-CARE trial, first patient first visit is planned for the first half of 2026. The trial is an open label, thus allowing for interim update, which is anticipated for the second half of 2026. And again, our guidance remains for the last patient enrolled is also planned for the second half of '27. So this brings me to our second clinical asset, alpibectir, which we developed in partnership with GSK. The current Phase II trials are focusing around the identification of ideal regimens will lead to improving the outcome for patients with pulmonary tuberculosis. Based on the robust Phase IIa [ EBA ] data reported by alpibectir and ethionamide, or AlpE, we reported first patient first visit in the Phase II combination trial of pulmonary TB in the Q1 of 2025. This was led by ENABLE trial led by GSK. The top line data confirmed that alpibectir is generally safe and well tolerated, warranting its progression into [ step 2C ] trial in UNITE4TB. Originally reported -- we reported recently the first patient first visit, and this is slightly ahead of our original guidance. The last patient recruit is expected for the end of 2026 for this trial. For the Phase IIb tuberculosis meningitis trial, we have put together a consortium and the trial will be conducted in Zambia, Ivory Coast and Madagascar. We expect first patient first visit in this trial in the first half of 2026. We are also very happy with the EMA granting orphan designation for alpibectir, ethionamide combination to treat TB. This is an important recognition and support for the program. And as a reminder, the U.S. FDA granted orphan designation already in 2023. And also AlpE qualifies for the U.S. FDA tropical neglected disease priority review voucher. So here, I show briefly the ongoing Phase II combination trial for alpibectir and ethionamide in pulmonary tuberculosis. On the left side, you see the first 2 stages of the trial in which we tested additional doses for AlpE combination before moving the first time into isoniazid replacement settings within the current first-line TB treatment regimen. Patients were treated for 2 weeks in Stage 1 and Stage 2. The top line data showed a good safety profile and comparable efficacy to our Phase IIa EBA study, thus warranting progression into Stage 3 of the trial depicted on the right-hand side. We joined the UNITE4TB platform trial and the first patients have been dosed in March 2026. AlpE replaces isoniazid with the first-line treatment regimen, but this time in a 2-month treatment followed by 4 months of rifampicin and isoniazid as follow-up. The pulmonary TB Phase II part of the program is led by our partner, GSK, and we are excited to see the progress of AlpE. For the TB meningitis Phase II trial, we have fixed the trial design assessing different doses of ethionamide in combination with alpibectir on top of the current standard of care. The main aim of this study is to define the pharmacokinetics in the cerebral spinal fluid of patients and define the dose of AlpE in tuberculous meningitis. Potentially, we can also see the first signs of efficacy in this critically ill patient population. The trial consortium has been set up, and we anticipate the first patient first visit in the first half of 2026, pending regulatory approval processes in the trialing countries. This is now on for the clinical development programs, and I'm happy to hand the presentation again to Daniel.

Thanks, Glenn, for this really exciting overview. I'm Daniel, and I joined the company in November 2025 as CSO. I'm thrilled to be part of BioVersys and to support the excellent pipeline going forward. Today, I would like to spend a few minutes to speak about our preclinical asset, BV500, which we developed for the treatment of NTM, non-tuberculous mycobacteria infections in cystic fibrosis patients and in patients with chronic obstructive pulmonary disease. We're really excited about this early-stage program as the data generated so far shows the potential for a best-in-class oral medicine to address this debilitating disease. We're equally enthusiastic about the research collaboration and license option with Shionogi, which was initiated in Q3 2025. Just to summarize the numbers, there are upfront and near-term payments of CHF 5 million and upon license option, regulatory development and sales milestones of up to CHF 479 million plus royalties on sales. Beyond the numbers, which, of course, are important, our excitement for the deal has more to it. We leverage the internal ansamycin platform and capabilities by maximizing and collaborating with Shionogi's discovery and development organization. This should maximize the speed to get our innovation to patients. Shionogi is a great company with a long history and extensive experience in infectious diseases. For a challenging clinical development of an asset for a chronic disease like NTM in CF and COPD, we're glad to have such a strong partner to collaborate. Further, the partnership allows us to accelerate the development of BV500 while preserving financial discipline on our rich development pipeline. The deal also shows the breadth of the BioVersys pipeline and the potential behind our technology platforms. Out of the 5 big pharma companies that are still active in antibiotic drug development, we now have two as partners within our pipeline. Talking about financial discipline, I'm happy to hand the presentation to Hernan to guide you through the financial highlights of 2025.

Thank you, Daniel. 2025 was a transformational year for BioVersys. We successfully raised the capital we needed to advance our pipeline through key development milestones. We've added 2 very important partnerships that further strengthen our financial position, and the pipeline continues to move forward across all programs. As key takeaways from 2025, the cash position at year-end was CHF 82.5 million. We continue to run the business, ensuring financial discipline. And to that end, you can see here most of the capital was allocated to R&D, representing 71% of the total expenses. We did add key positions to our staff, primarily to support our development team, but still keeping a lean organization, finalizing the year with 33 FTEs. In terms of partnerships, Daniel just mentioned the research collaboration agreement with Shionogi. From a financial point of view, this is adding CHF 5 million of upfront payments, but it also relieves the cash runway as we had foreseen to -- as part of the use of proceeds from the IPO to allocate a similar amount for BV500, which is now going to be primarily absorbed by our partner, Shionogi. The other important partnership is with ADVANCE-ID, financially supported by Wellcome Trust. This provides us another way to advance BV100, primarily for our Phase IIb trial that Glenn alluded to. Again, this is an additional relief to our cash runway because we had foreseen that BioVersys with the use of proceeds from the IPO would pay for the Phase IIb trial, which is now supported by this partnership. Last but not least, we also drew down the third tranche of the loan facility we have with the European Investment Bank, adding another EUR 7.5 million to our cash runway. So all in all, the progress made in 2025 puts BioVersys on a unique path to deliver on its pipeline with significant catalysts ahead of us. Moving on to the financial statements for the period ended December 31, 2025. The net loss of the period amounted to CHF 21.8 million compared to CHF 18.7 million in 2024. This is broken down by operating income of CHF 3.3 million Research and development amounted to CHF 16.5 million, which is an increase of CHF 3.6 million compared to 2024. Of course, this is expected given that we have started our Phase III activities, as Glenn and Marc mentioned before. G&A amounted to CHF 6.7 million, broadly in line with 2024. Please keep in mind that the transaction cost of the IPO are reflected in this figure, and we expect G&A to be significantly lower in 2026. Financial results, that is the net of financial income and financial expense decreased by CHF 1.9 million compared to 2024, mainly driven by the amortized cost adjustment of the BKB loan, which had to be repaid and the obligation was triggered by the IPO, lower interest income from short-term deposits that we had in 2024 and the change in the fair value measurement of the warrants related to the BKB loan. Moving on to the statement of financial position for the same period ended December 31, 2025. The total shareholders' equity was CHF 59.8 million, which is a result of total assets of CHF 90.6 million, of which CHF 82.5 million is cash and cash equivalents. Total liabilities resulted in CHF 30.8 million, which is an increase of CHF 7.3 million compared to the same period of 2024, primarily driven by the drawdown of the third tranche under the EIB loan facility. In terms of cash and cash equivalents at the end of the year, we -- like I said before, we ended up with CHF 82.5 million. Of that, operating activities resulted in outflows of CHF 21.9 million, inflows from investing activities of CHF 5.8 million and financing activities net of CHF 72.6 million, primarily driven by the proceeds of the IPO, transaction cost paid proceeds from the tranche of the EIB loan and the repayment of the BKB loan. In 2026, we expect the operating loss to be in the range of CHF 40 million to CHF 45 million. The increase naturally comes from our BV100 Phase III program. Naturally, that is more capital intense, and that's what we raised the capital for during the IPO. And cash and cash equivalents is estimated to be in the order of CHF 43 million at year-end. Based on our current strategy and the programs that were detailed today here and during the call, we expect the company's operations to be financed into 2028. We continue to pursue non-dilutive funding opportunities across all of our pipeline. And of course, we'll keep you apprised of any new developments with regards to those efforts. In terms of business development, we will continue to explore partnership opportunities, and we will update you as we make progress. We will be hosting our Annual General Meeting, which is scheduled to take place on April 30, 2026, and we look forward to meeting our shareholders at that event. And we're also planning the first half 2026 financial results to be published in early September. And with that, I would like to hand over the presentation back to Marc for the closing remarks.

Thanks, Hernan, and thanks to the team. With this, I'm happy to summarize today's call. We really think that BioVersys had a very successful 2025, delivering on our key catalysts and advancing into clinical Phase III. The main achievements in '25 are summarized by the progress of BV100, on the one hand, receiving FDA IND green light and additional first country-specific approvals for the RIV-TARGET global Phase III trial, while the RIV-CARE trial has been submitted to first country-specific regulatory authorities. Besides that, as outlined beforehand, RIV-CARE, this trial entered the collaboration with ADVANCE-ID, which is supported by Wellcome and a landmark partnership that shows the evolution of future antibiotic drug development between public and private entities. We extended the geographies in which our key patents are granted and the dissemination of our Phase II data also progressed. Alpibectir, the Phase II combination trial in pulmonary TB Part 1 showed again good safety and progressed into the next phase. We received the EMA orphan designation for alpibectir/ethionamide to treat tuberculosis and published our Phase IIa EBA results in the New England Journal of Medicine. We also made a landmark global research and license option deal with Shionogi for BV500, and all of this followed our successful IPO, and we thus further strengthened after the IPO, as outlined by Hernan, our financial position via non-dilutive funding and the Shionogi deal. The company is fully financed into 2028, allowing us to execute on the company's strategy. Our near-term catalysts are all around clinical progress and data. BV100, the RIV-TARGET Phase III trial and RIV-CARE Phase IIb trial will see first patient first visits coming up. BV100 Phase I, the bridging study in China will come to completion. And alpibectir, the full Phase 2b/c trial will recruit the last patient at the end of 2026, while the TB meningitis trial will be initiated now. Of course, we always continue our efforts to attract further non-dilutive funding and also additional partnerships. And with this, I'm happy to move to the Q&A section.

And I remind everyone, you can raise your hand or put the questions into the chat. Maybe I can open already because we see 2 questions in the chat, both from Ram from H.C. Wainwright. And the first one is, how do we see the competitive landscape around non-tuberculosis mycobacteria for our BV500 program? I'm happy to answer that. So currently, we see that one product that is pretty strong in the area is, of course, Insmed with ARIKAYCE, the inhaled amikacin. We also have Paratek that has the tetracycline derivative, NUZYRA that is often used in the indication, but off-label still. And then I think in clinical pipeline, there's not that much following anymore because we had 2 failures from AN2 Therapeutics and Spero in Phase II. And then mostly, we are at early-stage innovation. I should add to this that NTM is, again, one of those bacterial diseases, quite chronic that will not be treated by a single molecule. One always needs a safe and efficacious combination therapy of different molecules. So certainly, in our development also synergies between existing therapies will be tested. There was a second question from Ram, which relates to the percentage of carbapenem-resistant Acinetobacter infections that are already estimated to be resistant to both Cefiderocol and/or Xacduro, so the newer treatments. We shall say that the stand-alone data for Cefiderocol on Acinetobacter is still varying in its outcomes from the different clinical trials reported. However, the kind of average resistance rates that we see relate often to around 15% to 20%. It depends a little bit on the region. For Xacduro, the main preexisting resistance relates to so-called metallo-beta-lactamase, which Xacduro cannot overcome. And it depends again very much on the geography of the world. But we estimate in the U.S. at around 8% to 15%. And in some Asian countries, we already see up to 50% reported in recent clinical trials. So I think this is alarming already, particularly for the patients suffering from this. And it shows that this field remains highly important for showing further innovation that BioVersys, for instance, delivers or other companies also moving into that direction. Sorry, I need a little bit of time to read the new questions in the chat. Okay. One question comes from [indiscernible]. I hope that the name was pronounced correctly. The question relates to the changes in the Phase III trial design based on the FDA's agreed plan. And we previously estimated around 190 patients for Part A, now coming to approximately 300. Glenn, do you want to answer that one?

Yes. So we expect 248 evaluable patients in Part A. That's 124 patients per arm. In the earlier estimates, we were counting or predicting a 20% non-inferiority margin. But after various discussions with the FDA, we and other companies recently moved down to a 15% non-inferiority margin, and this slightly increased the number of patients needed for the study. The 300 patients includes -- are the ones that would be screened and included in the study, and we expect a 20% dropout rate due to not having a sufficient quantity of bacterial load that's carbapenem-resistant acinetobacter. So in fact, the 190 compares to the 248. And this has to do with the change in the non-inferiority margin.

Yes. And the previous estimates, I may add to this were actually based on the previous trial from that Entasis conducted for Xacduro. So yes, but that explains the change. We have an additional question from Jelena Milovic, which is around the timing of the Phase II TB meningitis trial, which we initially guided to be recruiting first patient in Q1 2026 and is now shifted to the first half. I think this slight delay is really to be explained around process-related work for the regulatory approvals. You see that in tuberculosis, you often have to go to countries that are maybe not as standardized for clinical trial conduct. We are in Zambia, Madagascar and Ivory Coast coming with certain additional sometimes somewhat unexpected difficulties in, for instance, informed consent documents, et cetera, that need to be translated to less common languages, et cetera. But this is really purely process related, and we are not too concerned by this delay. I move on through the Q&A section. We -- this one I pass to Hernan. It's from Jyoti Prakash that we have previously guided for around CHF 29 million, excuse me, operating loss for 2025 and now are closer to the CHF 20 million. Hernan?

Yes. Thanks for the question, Jyoti. I think here, there are a couple of things. When we prepared the guidance during this first half earnings call, there were a number of things that we were still working on. Those materialize in a positive way. And I think that explains part of the variance. I think the actual tally is CHF 29 million to CHF 22 million, almost CHF 21.8 million. So half of that already comes from the operating income. And then -- of course, there is some phasing effects that relate to how we ramp up the trial with [ PAREXEL ] and everything that goes with that agreement. So I hope that answers the question.

So I think there's somewhat a follow-on from Jyoti as well regarding that with the EIB loan as well.

Yes. I'm just reading through the question, yes. Yes, I think it's a good question. We see the 2026 calendar year being the one that is going to do most of the heavy lifting from a financial point of view when it comes down to the Phase III trial. And as we continue to see that we're going to finish it by 2027, financially speaking, the year 2027 is going to be less of a burden than compared to 2026. Of course, this is all always subject to how we recruit patients and how that develops. By the same token, if we have any delays in the recruitment rates, then, of course, there will be also a positive phasing effect in 2026 that will migrate to 2027. That's the way the dynamic is going to play out, right? And yes, sorry, just to finalize on that question, yes, the cash runway outlook does include the repayment of the first tranche to the European Investment Bank.

Okay. Then I move forward to questions from [ Juris Zimmerman, ] who also noted that probably the Zoom function for raising their hand and speaking up doesn't work. So we apologize for that. But thank you for putting the questions in writing. First, related to the financials, maybe what I can say here, answering beyond what Hernan already answered, the Wellcome contribution of funds will not be directly flowing via BioVersys accounts. But actually, this is a contribution to the trial network and thus offsets costs that we had previously -- obviously, we forecasted.

We forecasted those costs, and that's going to be now borne by the partnership we have with ADVANCE-ID and the Wellcome Trust. Yes.

Then the second question from Juris is related to our progress on BV100 after we recently announced the IND clearance and also the initiation of the kind of official program. I think the detail between this and what has happened now is really that we obviously did all the country-specific INDs or clinical trial applications. And as you see in a global trial, this is not a centralized procedure, but you have to go through the different jurisdictions and geographies. And that's also what Glenn alluded to. We have first approvals already, very important that the FDA also agrees to the protocol, et cetera, so that we can really see that this global trial is moving forward. And that's literally what happens right now. It's all process related, going through the ethical committees, regulatory approvals in the countries, shipping drugs to sites, site initiation, et cetera. So we're in full swing of initiating that or working through the process.

We have a question from Xian on the -- she's raising her hand. I don't know if we can take the question live.

Could you hear me all right?

Yes, we can.

Perfect. Sorry, I actually don't have the function to type questions. So I saw in your press release, you mentioned for the BV100 Phase III trial. So there is a [ DSMB ] reviews planned in second half this year and first half next year. So just wondering -- sorry, if I missed it in your prepared remarks. So just wondering if you could give us some color on that. So are the interims or basically -- yes, any color on that, that would be great. Yes, that's the question.

Yes. So the study is sponsored blinded. So we will not see the data from this trial. And what the DSMB will do is we'll look for any safety signals. And if there's no safety signals, the trial will continue, and we'll just get that the trial can continue. It's safe and well tolerated. But we won't know anything about the efficacy or the effect of the BV100 in this trial.

Which is, of course, different, sorry, for the second trial, the Phase IIb, the RIV-CARE trial, where this is open label and will allow us to see the data and also after an appropriate amount of patients recruited in the trial to report on that data.

There is another question from Joris. Coming back to the -- Wellcome fund contribution. Is this relief by the contribution already reflected in your cash reach estimate into 2028? The answer is yes, Joris. That's already included. We updated the cash runway forecast with everything that we have, both the Wellcome and the Shionogi deal.

Okay. So we have then a further question on the chat from [ Robert Zimmerman. ] Here, the question is around the drug candidate from Roche, Zosurabalpin, if we consider that a direct competition and what our expected time advantages for market access and also to elaborate a little bit on the subscription and reimbursement strategy. So I will take that. Roche did actually anticipate or announce, I think, in mid last year that they wanted to start the Phase III around about this time. So far, we have not heard or seen any sign of them starting this trial, so we cannot really comment where they are. We certainly do believe that Roche is a strong, on the one hand, competitor, on the other hand, also potential future partner in the therapy for these patients. And I explained that a little bit. So the molecule from Roche is like BioVersys BV100, which are currently the only 2 molecules that truly come with a mode of action that is new to the bacteria, so to Acinetobacter, and that offers a tremendous advantage in pre-existing resistance and also offering treatment options to doctors. So in that sense, we really hope that Zosurabalpin will also have a successful development. And then I said potential partner. Again, these very severe infections are seldomly to never treated with a stand-alone molecule, but with more than one molecule to ensure that the bacteria are hit hard, fast and don't cause too fast new resistance. In that sense, we can also see Zosurabalpin as a potential future partner therapy. Regarding the market access and subscription models, et cetera. So we see currently that we are on track with our progression for the trials. We're super happy about this and focus on that. And we don't see in the trial sites where we are currently present any site competition from competitors. So that's all positive. In terms of the new subscription models and reimbursement systems, I think this is a very fast currently evolution of how this reimbursement is changing. And it is certainly offering new opportunities to companies like BioVersys because if you think about a subscription model where basically you deliver good quality drug product to a country without needing on-the-ground sales force, et cetera, or the European vouchers that provide a cash event once you sell that voucher of quite significant amount. The current estimates are probably around [ EUR ] 150 million, the most recent ones. That offers cash in a way that can be deployed for certain launches in other jurisdictions or geographies by ourselves. But we will evaluate carefully over the coming years, certainly how this evolves and also how we adjust our strategy for potentially building up capabilities in certain geographies ourselves or continuing our search for partners on the commercialization. I hope that answered those questions. We move on from Joris. Do you want to take that?

Sorry, actually, for the Phase IIb RIV-CARE study, could you elaborate on the study endpoints and what constitutes best available therapy in the control arm and how consistent that will be across different geographies? How do you see the study supporting regulatory approval?

Yes. So the RIV-CARE trial, the endpoints will be very similar to the Phase III trial. We'll have 28-day all-cause mortality, 14-day clinical cure tested cure. The best available therapy is the best therapy that the clinician at the country can use. And since we are looking at carbapenem-resistant Acinetobacter, there are very limited options. So we expect a very, let's say, focused therapy. Most of it will be colistin-based plus or minus second antibiotic, and we expect only 1 to 2 other antibiotics at this point. So we don't expect a large plethora of drugs used in the study, but rather just a limited number. And that has to do with the geographies that we chose strategically to be able to show the effect of our drug in that population.

And I think the one part of the question, how it's supporting the regulatory submission. I think for us on the regulatory side, that study is very important to collect additional safety data on dose and duration for the drug, which is always very supportive in regulatory. And at the same time, as mentioned before, it's more driven for educating physicians and kind of the market on how to use that drug best in commercial uptake. Joris had also the question around commercial strategy. So I think part of that was already answered, but I can reiterate that really these new incentives and initiatives that we have, particularly from Europe, which is quite a large potential cash event with the transfer exclusivity vouchers, it offers new possibilities for companies like us. And I think we have to carefully assess that. And that also relates to potential partnerships to be fair. So I think we try to see a very holistic view and 360-degree view here internally. We still have some time to prepare adequately, and 2026 will be certainly for us a year where we evaluate how some of these new initiatives play out, how fast they will be implemented, understand better detail around it and then also can hopefully make a better adjustment of what it -- how it influences our commercialization strategy. So at this moment in time, we're now nearly 50 minutes into the call. We do not have any additional questions currently on the Q&A panel in writing, and I also do not see actively raised hands at this stage. There is one more, sorry, for Joris. Excuse me, I didn't see that. Joris, can you talk?

Marc, yes, I can now. But I think most of my questions have already put through the chat or colleagues have raised the questions. So I really think there is nothing more on my list.

Thank you so much, Joris.

Thanks for joining.

Yes, with this, I would like to reiterate our thanks from the team for all of you to join this call and showing the interest. Thank you also for the thorough questions and attention to this. We remain at your disposal as management team and are looking forward very much to an exciting 2026, where our focus is certainly on clinical execution, and we're quite excited about it. So thank you very much.