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244. Bull, Bear & Beyond – BioVersys: executive interview
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In this interview, we speak with Dr Marc Gitzinger, founder and CEO of BioVersys, about the strong momentum across the company’s antibiotics pipeline and the milestones shaping its next phase of growth. Marc discusses the advancement of lead candidate BV100 into the global Phase III RIV-TARGET trial for carbapenem-resistant Acinetobacter baumannii (CRAB) infections, the strategic significance of the China bridging study and how the parallel Phase IIb RIV-CARE study could provide important early clinical insights. He also shares the latest progress on alpibectir, the company’s GSK-partnered tuberculosis asset, and explains how BioVersys is leveraging strategic partnerships to maximise the value of its portfolio. Finally, Marc discusses the evolving competitive landscape in antimicrobial resistance, the company’s commercialisation strategy and the key clinical, regulatory and business development catalysts investors should watch as BioVersys continues to execute on its growth strategy.
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About ‘Bull, Bear & Beyond’
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 and Guest Welcome
00:00:07
Speaker
Welcome to Edison TV. We're joined today by Bioversus, a Swiss-based biopharmaceutical company focused on the development of novel antibiotics. We're going to be speaking with the company's founder and chief executive, Dr. Mark Gipsinger.
00:00:20
Speaker
Mark, thanks for joining today. Hi, welcome.
BV100 Phase 3 FDA Approval
00:00:24
Speaker
So Mark, you've had some strong news flow recently. Before we get into it, could you maybe cover off some of the most recent progress? Yeah, thank you, Aaron. Yeah, we had a really great start 2026, advancing the entire pipeline actually, but the the big news flow was certainly that our lead asset, BV100, which we developed for very severe hospital infections, got the FDA green light for its phase three trial.
00:00:47
Speaker
And um based on that and since that, we are obviously reported already a first patient, first visit. So we're super excited to get the trial really off the ground with patients. And um that's huge progress.
Phase 2 Alpibacteria Trial Results
00:01:01
Speaker
Besides that, also our second asset in the clinical stage development, Alpibacteria. We developed that and together with GSK and also here we could report that the first part of the phase two trial has finished.
00:01:15
Speaker
That was the first time that we tested that molecule in combination with the first line drug regimen. And here we could report that, you know, the trial is progressing into its next phase. Opibacter proves to your proofs to continually continuously be safe and well tolerated and really behaves as we would hope and expect.
00:01:33
Speaker
So all of that was really strong news flow. um And we could also get some of that science published really nicely in the New England Journal of Medicine. So 2026 can continue on
Global Phase 3 RIFTARGET Trial Design
00:01:45
Speaker
that track.
00:01:45
Speaker
Fantastic. and So diving in now to some of the clinical programs in more detail, um the phase three BV100 trial is now up and running. Could you just recap for us maybe the the trial design, the key endpoints, and then what the expected timelines are?
00:02:01
Speaker
Yes. So basically the phase three trial is called RIFTARGET and we develop our drug BV100 for very severe hospital-acquired pneumonia and ventilator-associated pneumonia caused by a gram-negative bacterium called Acinetobacter. The trial design um is really ah for regulatory approval. It's a global phase three trial aligned with the US FDA, with the European Medicines Agency and also the Chinese NMPA.
00:02:30
Speaker
um It's a pretty large trial. We have overall 100 sites roughly in approximately 15 countries. And obviously, randomized controlled trial blinded for us. um And it's randomized to today's standard of care as bye-bye treatment guidelines.
00:02:48
Speaker
Excellent. So the China Bridging Study as well has also recently been completed. could Could you recap for us why that was so important for the company and then maybe touch upon the commercial opportunity in
Bridging Study for BV100 in China
00:02:59
Speaker
China?
00:02:59
Speaker
Yeah. So overall, we developed BV100, of course, already in multiple phase one trials to really characterize the drug that it's suitable for these ICU patients. And China was important to have that small bridging study as it is required for the ah human PK exposure in ah in the Chinese population.
00:03:18
Speaker
So we just finalized that. And this allows us now to onboard later this year China into the phase three. So it was a very important milestone. and um China is important in in, I would say, any global development strategy, but particularly in anti-infectives.
00:03:35
Speaker
um It's a very large population. Drug-resistant infections are generally at a very high level in all of Southeast Asia, including China. So, um in in our line of business, it's a market that we cannot ignore.
00:03:49
Speaker
And it's also really the patients that I need for these new drugs. I see. So, 2026 is set to be a really important year for for the lead
Phase 2B RiftCare Trial and DSMB Reviews
00:03:58
Speaker
candidates. Beyond the phase three program, there's the phase 2B and some DSMB reviews expected throughout the year as well. So, could you just recapture for us what the investor focus should be there and what would constitute meaningful outcome from from those events? yeah Yeah, my first comment on this phase 2B that you mentioned, that trial is called RiftCare. And it's maybe a little bit unusual that the company does that in parallel to the phase 3 because we already had a phase 2 with very good outcome. So you wonder why we do this again. um We're not repeating exactly the same, but we're going into countries of very high unmet medical need, again, Southeast Asia focused.
00:04:35
Speaker
um And we run this trial ah with a different control arm, meaning best available therapy, allowing doctors more flexibility. And that's what they often like to see um when they are in the adoption phase later in commercial stage on how to decide which new antibiotics they should take.
00:04:50
Speaker
So we thought that rather than waiting until full approval and doing that as so-called phase four trials, we we actually put that forward. Sure. Now, the beauty for investors is there's really a couple of things here besides that we really anticipate it will drive commercial uptake.
00:05:05
Speaker
um This trial is an open-label trial. So we are allowed to see the data and can actually report at interim levels, so, you know, at a recent or a decent amount of patients recruited. we can actually report how how the data looks there. And I think it's super important and very indicative ah of, you know, is the phase three going in the right direction? Because if anything, the patient groups that we will recruit in the RIV care trial in the phase two B are even more severe.
00:05:33
Speaker
um So if we see good effects there, I think it's fair to assume that it translates well into the phase three. The phase three is blinded. So you mentioned DSMB reviews, Drug Safety Monitoring Board reviews. We'll get these updates, of course, but you know as the name says, Drug Safety Monitoring Board, this is mainly related to um is the safety acceptable and good, and can the trial continue. And that's all we will really learn from from those. But it's updates and we we're happy to keep the market appraised of this progress as well.
CRAB Infections and Pharma Interest
00:06:06
Speaker
Sounds good. So taking a step back now, we've certainly seen that the sort of crab infection space has seen a renewed interest amongst pharma and biotechs. So it'd be really helpful to understand from you how you see the competitive landscape and then how your drug candidate might maintain that competitive edge.
00:06:23
Speaker
Yeah. So maybe we start to you know explain a little bit what CRAB is. That's carbapenem-resistant, they're seen into bacta infections. um This pathogen is categorized today by multiple organizations around the world, including the WHO, as the most highest unmet medical need because with today's available treatments, so all antibiotics that we have on the market, it's the least treatable actually. So that describes the unmet medical need. Logically, if you have such a high unmet medical need, I think there is interest for developing drugs against it.
00:06:54
Speaker
um And that's a good thing because we really need a few different options and answers to to treat these infections. um It's great to see companies like Roche, a large farmer, jumping into this again um and developing. We have another couple of smaller biotechs as well involved in that space.
00:07:13
Speaker
um We are at the moment, from the competitive landscape point of view, um the only company in phase three at this stage. And then we had one competitor um that got an approval already ah two years ago in the US and in the meantime, also in China. It's a good product.
00:07:31
Speaker
very happy, but it doesn't answer all of the resistance problems that we have, particularly in Southeast Asia, but also um in the US, the rising numbers of so-called metallolactamases. That's in a nutshell a bit the competitive landscape. um We feel extremely well positioned there, particularly um since you have to always consider that physicians by guidelines, are asked to ah use two different antibiotics to treat these severe infections. So coming really from different angles attacking the bacteria to prevent ideally new resistance development.
00:08:04
Speaker
Excellent.
Asset Partnering Strategies and Market Potential
00:08:05
Speaker
So Bioversus clearly has a great track record for partnering assets. It would be great to learn a little bit more about how the company chooses to prioritize those for partnering versus internal development. And then following on from that, if you could touch upon maybe the commercialization strategy for BV100.
00:08:22
Speaker
Yeah, that's a ah loaded question there. um Look, I mean, we we have a very long-term partnership. Maybe we start with that one first in our second pipeline asset called Alpibacter for tuberculosis. It's in global health. And here we work since a very long time with GSK and are super happy about this partnership. um It's working greatly and and it really you know shows the strengths of both partners going together after a disease that affects literally millions of people around the globe.
00:08:52
Speaker
BV100, so far we decided to progress alone because it's our lead asset. We wanted to move rather quickly. We partnered with you know support for development in terms of financing. Wellcome is financing this RiftCare trial, for instance.
00:09:07
Speaker
via clinical trial network of advanced ID. So this we did, but we wanted to capture so far the upside, mostly on our side. um We have made another deal in partnering in 2025, mid of the year, and that was on our very early stage pipeline asset called BV500 for mycobacteria.
00:09:28
Speaker
And one of the drivers for the decision there was that overall we're still a small team. Obviously our focus has to be on creating value in the phase three, but BB500 is an extremely promising and really very potentially very big asset actually.
00:09:45
Speaker
um So that drove us to see what we find and we we had already interest for this asset and then we we progressed you know by saying, look, wouldn't it be beneficial to keep the speed of development?
00:09:57
Speaker
by um onboarding a partner. And we then found with Shionogi, the Japanese pharma company, one company that we feel is really the right partner because they are very dedicated in the space anti-infectives. They understand development in those indications. And so far, I think we have proven right because the partnership is going very well.
00:10:19
Speaker
um You also asked about the commercialization. Yes. There's a lot of change happening in the antibiotic space for commercialization, um which is related to reimbursement.
00:10:30
Speaker
And these reimbursement reforms you know change a little bit the playing field and what small biotechs could do or could not do. And the example is that UK, for instance, has a so-called subscription model, meaning there's an annual base fee being paid ah for actually delivering the antibiotic to the country.
00:10:49
Speaker
where you have revenue without sales force and a lot of the marketing activities, etc. And Europe recently ah also um ah decided to give so-called transferable exclusivity vouchers.
00:11:02
Speaker
In a nutshell, these vouchers are anticipated to be worth around 150, 200 million. And that's a very good kickstart in your commercialization strategy in terms of capital to build capacities.
00:11:15
Speaker
And this changed also a little bit our thinking. We believe that certain geographies we could actually tackle ourselves. I think we have always been clear and outspoken that China, we would look for a partner, for instance.
Conclusion and Further Resources
00:11:27
Speaker
Fantastic. Mark, that's been highly insightful. Thanks very much for joining today. Thank you, Aaron. It was great discussion. If our audience would like to learn more, we refer them to the Edison website where our research on the company is freely accessible.
00:11:39
Speaker
Thanks.