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184. Bull, Bear & Beyond – BioVersys: executive interview
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In this interview, we speak with Dr Marc Gitzinger, CEO, and Hernán Levett, CFO of BioVersys, about the company’s strategy to address the growing global challenge of antimicrobial resistance through its pipeline of novel antibacterial therapies. Management outlines BioVersys’s key value drivers, led by BV100, a late-stage asset targeting carbapenem-resistant infections, one of the most critical unmet needs in hospital settings. Marc discusses the programme’s differentiated mechanism, competitive positioning and the rationale behind the upcoming Phase III trial planned for early 2026, highlighting the clinical and commercial opportunity if successful. The discussion also covers alpibectir, BioVersys’s tuberculosis programme developed in partnership with GSK. Management explains the asset’s unique mechanism, its potential role in tackling drug-resistant tuberculosis and how the 50/50 collaboration structure reduces development risk while preserving long-term value. Hernán provides insight into BioVersys’ capital strategy following its 2025 Swiss listing, including funding runway, capital allocation priorities and how the company is positioning itself to support late-stage development. The conversation concludes with management outlining key catalysts over the next 12–18 months, centred on clinical progress, partnership execution and pipeline advancement.
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Bull, Bear & Beyond': features candid conversations with senior executives and from our own team of experts from across industries, exploring strategy, innovation, and the opportunities shaping their markets and 60-second pieces are a compressed summary of content designed to convey our message in a single, easily shareable hit.
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Transcript
Introduction to Bioversus
00:00:06
Speaker
Hello and welcome to Edison TV. I'm Jyoti Prakash, healthcare care analyst at Edison. I'm joined today by Dr. Mark Kidzinger, CEO and Hernan Leavitt, CFO of Bioversus.
00:00:18
Speaker
Bioversus is a Swiss specialty biotech developing novel antibacterial therapies for serious multi-drug resistant infections.
Swiss Stock Exchange Launch
00:00:27
Speaker
The company listed on the Swiss Stock Exchange in February 2025 and has a current market capitalization of over 140 million Swiss franc.
00:00:36
Speaker
Mark, Hernan, thank you for joining us today.
00:00:41
Speaker
Thank you for having us. Thank you for having us. Hi, Jyoti. Hello, Ammar. And just to kick off, antimicrobial resistance is a growing global challenge and a core focus for Bioversus.
00:00:54
Speaker
But before we get into the specifics of how Bioversus is positioned in this space, could you briefly introduce yourselves and your role at Bioversus?
Leadership Perspectives
00:01:05
Speaker
Yes, happy to. So my name is Marc Kitzinger and I'm the CEO and co-founder of Bioversus, which ah the company we started really directly from my PhD thesis at the Swiss Federal Institute of Technology.
00:01:20
Speaker
My name is Anand Levitt. I'm the chief financial officer. I've been doing finance for about 30 years now, most of those within the pharma industry, 10 years with Novartis. And I've been a group CFO of public listed companies, both on Nasdaq and on the Swiss exchange.
00:01:37
Speaker
Thank you both for the for that introduction.
Pipeline Overview
00:01:39
Speaker
And moving on to Bioversus, the company has a broad pipeline spanning late and early stage assets. What programs do you see as the key value drivers for Bioversus today?
00:01:54
Speaker
Yeah, so our pipeline has ah four programs overall, two in clinical development and two in preclinical development. ah We draw these programs actually from two different in-house technology
PV100 Phase III Trials
00:02:05
Speaker
platforms. um The key value driver is, of course, today the most advanced asset that we have. It's called PV100. We developed that for very severe hospital-acquired infections, mainly pneumonia, bloodstream infections caused by one of these very nasty gram-negative bacteria.
00:02:23
Speaker
um The indication has very high mortality rates um and we bring this program currently into a phase three clinical trials. So we're just starting up that phase three program actually.
00:02:34
Speaker
um For the rest of the pipeline, we have um something in tuberculosis partnered together with GSK. The program is called AlpiBectia. which is currently in several clinical phase two trials. And then on the earlier stage pipeline, we have a preclinical asset focusing on dermatological diseases.
00:02:57
Speaker
It's called BV200, an antivirulence acid um on the bacterial component and that Staph aureus plays in atopic dermatitis. And lastly, we have BV500, which is an acid for non-toclosus mycobacteria in cystic fibrosis and COPD patients, which we recently also partnered with Shionogi, the Japanese global pharma company.
00:03:21
Speaker
That's great.
BV100 and Market Potential
00:03:22
Speaker
And sort of diving deeper into your lead asset, BV100, it's targeting carbapenem-resistant infections, and it's one of the highest unmet needs in the hospital setting.
00:03:34
Speaker
How does BV100 work, and what differentiates it from competition? And just to move on from that, how large you see the commercial opportunity in this space? Yeah, so BV100 is really a great find in that sense. It's actually based on an active pharmaceutical ingredient that is already on the market since the mid-90s.
00:03:55
Speaker
But we identified that the product and this API actually has an activity on carbapenol-resistant acetylbacter. which is ah linked to a new mode of action. The molecule actually opens an outer membrane porin of the bacteria and promotes its own entry.
00:04:13
Speaker
um So that's a piece of the new mode of action. And then secondly, we also needed to um create a new formulation for the molecule because it currently only exists as an oral tablet and does not reach the concentrations and exposures that we need in patients to treat these very severe infections. So um we needed to create a human suitable intravenous formulation, which we did and have strong patent protection around it.
00:04:39
Speaker
um So, yeah, that's the product. It's really differentiated in the way from other um molecules that work on acinetobacter. Number one, because it overcomes all pre-existing resistance mechanisms for other classes, it is a really new class, which attacking the gram-negative bacteria at a new bacterial target, meaning that they're not expected to have pre-existing resistance, and also we haven't found it. So it really um comes with a very strong activity against these bacteria and offers physicians later on um a truly differentiated asset to treat the infection.
00:05:18
Speaker
Interesting mechanism of action. And we would like to talk a little bit more about the clinical journey of BV100. It is approaching a major inflection point with the registrational phase three trial plan to start imminently.
00:05:32
Speaker
What gives you confidence in the study design and what would be the most critical parameters for success? Yeah, again, I think we have already conducted quite a comprehensive clinical program, including um a Phase II clinical trial in ventilator-associated pneumonia. Did a large Phase one program overall with seven different clinical Phase I studies to characterize the drug also for its suitability in the ICU setting, meaning that we checked for drug-drug interactions for patients with special interests like renally impaired and hepatic impaired patients.
00:06:08
Speaker
And all of this de-risked the the molecule um quite significantly. So we know that we have a safe and well-tolerated molecule. And the efficacy that we have seen in the Phase II trials was really outstanding. We actually reduced all-cause mortality by 50%.
00:06:25
Speaker
And this combination now, moving into Phase III, we actually just expand the size ah for the Phase III. We don't change any doses, for instance, that we tested in the Phase II clinical trial.
00:06:37
Speaker
The indication is pretty much the same. We expand a little bit beyond ventilator-associated pneumonia to also hospital-acquired pneumonia and bloodstream infections. But um in general, the the trial is really a larger version of the phase two.
00:06:52
Speaker
And that gives us a lot of confidence that we hopefully don't expect any surprises during that um trial. Excellent. And we look forward to the initiation of the trial.
Alpivecter and TB Resistance
00:07:02
Speaker
And let's move on to your second clinical asset, Alpivector, which is targeting drug-resistant tuberculosis and has a unique mechanism of action.
00:07:11
Speaker
Can you briefly tell us about this asset and what role do you see it playing in the future treatment landscape of TB? Yeah, this is a small molecule that we discovered and it works with a new mode of action. We actually target ah bacterial transcriptional regulators.
00:07:29
Speaker
And in such, alpibectia is a co-drug combined with with an existing tuberculosis drug that helps actually to reduce the effective dose of the existing TB drug and overcome its pre-existing resistance. So alpibectia is in the end combined with a theonomide. The positioning of, ah in short, how we call it ALP-E is really interesting because it has one of the features that is that it is really highly bactericidal. So it kills the tuberculosis bacteria really fast. And that's a key feature in any TB drug regimen that you want to have. But ah due to drug resistance, the main drug that today does that, it's called isoniazide, is losing disability more and more.
00:08:15
Speaker
And in such, ALP is beautifully ah positioned to potentially replace isoniazide even in first-line ah TB regimens. It certainly can be added to some of the newer second-line regimens that address multi-drug-resistant TB as one of the components that is killing the bacteria really fast.
00:08:36
Speaker
And we also have a positioning in tuberculosis meningitis, which is an extremely high onmet medical need because most antibiotics do not penetrate the blood-brain barrier, but ALP-E actually does and can really make a difference for patients there as well. So there's really um quite a bit of different positioning possibilities going forward to make a lot of difference for for patients here. And Alpi Vecter is being developed under a 50-50 partnership with GSK.
00:09:05
Speaker
Could you touch on the economics of this agreement and how the collaboration de-risks the program? Yeah, GSK is already a long-term partner for us since 10 years, since the preclinical stages. We work with ser GSK very well together.
00:09:19
Speaker
Now, um as as probably expected in in a tuberculosis drug development program, we receive a lot of co-funding from non-dilutive sources. Generally, we speak about 70% to 80% funding from non-dilutive sources, meaning governmentance government government grants or NGO grants, e etc., um as an example.
00:09:40
Speaker
um And then the rest of the cost is really split between GSK and us. We have together joint team working on this program, um ah you know addressing all the pieces from regulatory CMC to the clinical development. And then, um yeah, our aim is to bring this drug forward ah through a phase three in the end and get it to market. And then, as you mentioned, the partnership is also such that we share all revenue of this program in the end, including the ah priority review voucher for which tropical neglected diseases, meaning also tuberculosis, are eligible for.
00:10:19
Speaker
Excellent.
Financial Strategies
00:10:20
Speaker
And Bioverse is listed on the Swiss exchange in February 2025, raising 77 million Swiss franc. What were the key strategic drivers for going public at that stage?
00:10:34
Speaker
And how does this shape your capital allocation and partnering strategy? Yeah, ah we our strategy had um primarily two objectives. We wanted to raise sufficient capital to take our lead asset, BB100, to approval.
00:10:50
Speaker
ah ah Advanced ALP bacteria, our second clinical stage asset delivering Phase II data, and under this collaboration that Mark alluded to with GSK, both for pulmonary TB and TB meningitis.
00:11:04
Speaker
And advanced our preclinical candidates, BB200 and BB500, close as we can ah to be ready for the clinic by the end of 2027, right? So that's the capital and the way that we allocated our capital the capital raised to the programs.
00:11:21
Speaker
ah The second objective was, of course, to um expand the investment thesis to a broader number of investors. and gain broader access to capital markets. So that then when we continue to think about building the future for Bioversus, that is already attainable to the company, right? As you have seen, we have a large but pipeline that we can benefit from. and And of course, that will require additional capital later down the road.
00:11:49
Speaker
um With regards to partnership, ah of course, having this kind of pipeline is super exciting. And you've seen that after the IPO already in July, we we we did reach that agreement with Shionogi under a research collaboration agreement that then in turn, Shionogi will have the option to license the asset for a total consideration up to 479 million Swiss francs.
00:12:15
Speaker
um And that was an important achievement post-IPO for us. Naturally, um the other angle with regards to partnership that investors should be aware of is the commercial strategy for BB100. We mentioned that China is an important marketplace for us.
00:12:35
Speaker
There are a lot of patients in great need. Acina Tabacta happens to be the number one or the number two pathogen ah for hospital-acquired infections. So it's a true, um you know, need for patients in China. So we're in that process of exploring who could be the best partner for us ah to bring the drug as fast as we can to these patients in need in China.
Pharma Reforms and Benefits
00:12:58
Speaker
And you've guided for 2025 end-of-the-year cash position of around 80 million Swiss franc. What kind of operational runway does this provide given the upcoming advanced stage trials?
00:13:11
Speaker
And when does funding become a strategic consideration again for the company? So from from ah from a timing point of view, the company is well financed into 2028. But I think more importantly, like I said, we raised the capital to take BD100 to approval and to progress significantly LPVAC Deer. And just as a reminder to the investor community,
00:13:33
Speaker
Alpivectier, we allocate part of the capital raise, but not all of it. A lot of the money that we put behind Alpivectier comes from the form the in the form of non-diluted funding, which the company has a great track record of doing so. And we also announced recently you know support for the Phase 2B for BB100 from the Wellcome Trust, so that you know speaks to the company's capabilities around raising none and attracting non-diluted funding. right um When do we think strategically funding will be the next window of opportunity? um
00:14:09
Speaker
Naturally, for any biotech, raising capital is is mission critical, right? That said, in our particular case, I think that that will revolve around how we build the future.
00:14:21
Speaker
post-approval of BB100, particularly when we talk when we think about how to build the organization for a commercial launch. um A lot of that will be determined. You might have read recently that there has been important developments in Europe with regards to the reimbursement reforms. These are incentives that are specifically targeted towards anti-infective companies, and that could do that reform may have significant incentives for companies like bioversus. So that will dictate a lot how we think about the next funding opportunity and how we tackle the commercial um buildup for the company. Great. And shifting gears a bit towards the more macro level picture, in December 2025, the long-awaited pharma legislation reforms package was announced for European Union.
00:15:16
Speaker
How do you think this will impact the broader anti-infective space in general and bioversus in particular? Yeah, Hernan has already a bit alluded to it in his last answer. um Look, ah basically, we have the situation as the market used to be for novel antibiotics. ah You launch and obviously, um you know, the more you sell ah volume, the better off you are.
00:15:43
Speaker
Look, for BV100, we think we we have identified a niche indication that is really, really important. And in the traditional market environment, we feel that we have a peak sale potential of roughly 800 million on a global level, which for an antibiotic is clearly a really good ah market in the end.
00:16:05
Speaker
However, the ah reimbursement reforms that are being discussed in many countries, particularly the G7 and EU27,
00:16:15
Speaker
are quite important. And the EU has made ah an interesting move now. and They decided for a new vehicle that they call transferable exclusivity vouchers in Europe.
00:16:27
Speaker
These vouchers are being handed to companies that um you know register very early on or ideally as first market a new antibiotic in Europe.
00:16:39
Speaker
And upon that registration, the company would get, um if eligible, with the priority pathogens that you address, etc., um a transferable exclusivity voucher.
00:16:51
Speaker
And this voucher we can either use ourselves in another pipeline program or sell onwards, very much like priority review vouchers. But here the transferable exclusivity, as the name says, would allow the buyer, so potentially a pharma company, to extend the data exclusivity of a given product by 12 months. So delay the generic entry on the European market.
00:17:15
Speaker
That also results in a higher value for those vouchers. Current estimates are that these vouchers could be valued around 350 to 450 million. um But it remains to be seen. a few of the details are now being put in legislation. We expect implementation not before 2027.
00:17:35
Speaker
ah which for Bioversus, we are still in time. We could be amongst the the very early potential beneficiaries of such a um new voucher.
00:17:45
Speaker
And I want to link this a little bit to the answer that Hernan gave beforehand. You understand that this drives a lot of the strategy on how we launch BV100, how do we you know see capital allocation and how much new capital would we potentially need? Because obviously, if such a voucher um can be sold onwards, it's a significant injection of capital that would allow us to potentially think very differently about ah potential self-commercialization, for instance.
00:18:16
Speaker
And um these are significant changes. They come on top of, and maybe I should mention that as well, additional changes that have already been made, like the UK system, where already the UK pays a so-called subscription model for new antibiotics, meaning volume independent and annual fixed fee for about 15 years for new ah priority antibiotics that are being registered in the UK.
00:18:40
Speaker
We have Germany and Italy that allowed for higher pricing of new antibiotics. I think the summary of this is that the global community has very much understood how important new antibiotics are for modern medicine and and yeah for our healthcare systems.
00:18:58
Speaker
And these changes in the reimbursement system are very important because they give a new value to novel drugs that now address highly drug-resistant infections, meaning less patients than, let's say, the genericized and very volume-driven older existing antibiotics. And this change is really important. It's about time, to be fair, as well. um But we see on a constant and consistent level these changes now being implemented. And we believe that this is for us as Bauer versus a great opportunity, but generally speaking also for the investor community um when looking into this very important space.
Upcoming Catalysts
00:19:38
Speaker
Very interesting indeed. and And we actually look forward to see how things pan out on this front. And just to wrap up, Mark, ah what are the key catalysts over the next 12 to 18 months that you believe would be of most interest to investors?
00:19:54
Speaker
Yeah, maybe ah you allow me to start with 2025. So a little view in the rear mirror mirror, because it was really an exciting year for us. Besides our IPO on the Swiss Stock Exchange, you know, we managed to onboard a new pharma partner in the form of Shionogi into our pipeline. We were able to ah get access to additional non-dilutive funding from the Wellcome Trust in quite a significant ah amount.
00:20:20
Speaker
to um you know help us support one piece of our phase three program ah for BV100, which is actually called a phase 2b to generate more real world evidence. um We also got patents granted that were very key ah now also in China, meaning that we expand that patent protection to over 25 jurisdictions um and many smaller milestones like getting orphan drug designation for Alpi Pacti in Europe. etc. So very busy year, a very great year that also led then towards the end to the official initiation of our phase three program by by the first submissions in in the individual countries and that is the transition to 26. 26 is now fully focused on clinical execution. ah We want to obviously conduct our phase three, um bring that up to speed.
00:21:12
Speaker
The real world evidence trial that we call phase 2b in the same program um We expect towards the end of the year ah then the first drug safety monitoring boards for the phase three. The phase 2b, which is an open label trial, might already be able to give first interim data. um And in our second clinical asset, Alpibacter, also a lot happening. We're going to have a small readout um for another phase 2a,b. that is currently still running and going seamless into recruitment of additional phase 2 BC trials and pulmonary TB and also initiate our tuberculosis meningitis trial. So you see lots of activity, lots of clinical work, which is key. In the end, we develop these medicines for patients. We access patients now in these trials and we want to see the results and the difference that we make. So very excited. um And then obviously there's always room for potential builds for um you know additional news flow around the early stage pipeline. This we'll have to see.
00:22:16
Speaker
Great. And lots to look forward to. Mark, Hanan, thank you for this insightful discussion. For our audience keen to learn more about Bioversus, please visit the company website and tune into edisongroup.com for our ongoing coverage of the company.
00:22:31
Speaker
Thank you again.