Innovation, Execution, and Equity in RNA-Based Women’s Health

Hello, hello everyone. This episode is about something I care very deeply about — the science behind the innovation, and the impact it can have on women's health. Doing some research on this topic, Klaas, you may be able to correct me, but I found that between eight and 45% of women will deal with urinary incontinence at some point in their lives, and those rates climb in middle age and beyond — so I'm definitely there. This topic is also very relevant for myself. Versameb is currently focused on stress urinary incontinence, which impacts between 15% and 50% of women worldwide, so I'm really excited about this conversation.

Klaas and I have had so many great conversations over the years, and now he's finally here on the podcast, so I'm really happy about that. I can't wait to talk about the work you're doing on this really important topic — and who knows where this conversation will go, but it's going to be interesting. So thanks so much for being here with me today, Klaas.

Thank you so much.

Yeah. So we've been talking about doing this for years, actually — it's funny how this topic keeps coming up and we end up chatting and going off into these big places with it. But I'm really interested to get into the detail about what you're doing. You've been in the industry a long time — you've worked in Big Pharma, in biotech, and now you're in RNA. What I'd love to hear is a brief introduction about yourself — what pulled you into this space, into this therapy area, and why does women's health even matter to you?

That's a good question. I've worked in pharma and biotech for a good 25 years now. After years working in oncology and rare diseases, I noticed there are a number of important health issues that get overlooked — like women's health. At some point I wanted to make a difference in an area with big unmet medical needs, and women's health fits that mission. It's really two things coming together. At our core, we're an RNA company, and the opportunity came around in 2019/2020 to work for a company building RNA technology. At that point — right at the start of COVID — it really captured me. It felt like RNA therapeutics could be a next-generation modality, a tool to help the body heal itself, to produce endogenous proteins in a way traditional drugs couldn't.

That's also what Versameb is trying to do — with one or two mRNA injections, we're trying to help the body regenerate the urinary sphincter itself. That regenerative power is very exciting. At the time, the company didn't have a clear indication yet, but there was a lot of excitement about applying that regenerative power to women's health. So that played a big role — cutting-edge technology on one hand, pressing need on the other. At the time we spoke with many clinicians — gynecologists, plastic surgeons, urologists — and that's how we started honing in on stress urinary incontinence, which, as you said, affects many women. The estimates in the literature vary — people often cite one in five — but on a worldwide basis it's hundreds of millions of women, and there's really no solution. In the US or Asia there's no approved therapy; people either use pelvic floor exercises, surgery, or other invasive methods. That's where we think the mRNA platform can really make a difference and help women with this condition.

Yeah, I think it's interesting you say that, because I see it in my own friends — you can't believe how many women talk about this. It's not always stress-induced, it's just a challenge a lot of women have. And you're right, in sports and exercise everyone's always talking about building your pelvic floor, or needing an external product to help. The need is 150% there.

Yeah, and that's part of the issue. It often starts after natural childbirth — many women experience some incontinence after that. More recently, the literature suggests this is associated with women who are lower in certain growth factors. It's particularly these women who end up coping with it for very long periods, whereas others recover after a number of weeks or months. Then, as women go through menopause, hormone levels change, receptors change, tissue changes — and that's when those growth factors decline further, and the body's intrinsic ability to heal itself declines massively. That's where we're trying to intersect.

Roughly speaking, stress incontinence and urge incontinence are the two components — pure urge is a bit smaller, while mixed incontinence, combining the muscle and stress components, is probably the largest group. Exactly as you said — when you're running, laughing, exercising, sneezing, that's when you risk losing urine involuntarily. It's a massive indication that really affects many, many women at different stages of their lives.

It's really interesting to hear, too, because what you're doing is quite novel. Given how many women it impacts, I'm always surprised by where research focus goes — the population is there, but there's not nearly enough research done around this. Was that part of what drove you in this direction?

Absolutely. Stress incontinence is an interesting area in itself, and this comes back to a larger issue we've talked about many times over the years — women's health research and funding is massively underfunded, which creates a huge gap. A lot of the early research on incontinence focused on trying to stimulate the nerve tissue. We now know, from the last eight to ten years, that it's mainly a muscle-weakness component, so the science has evolved fairly recently. In fact, we'll hopefully soon be publishing some novel tissue we've discovered in women — there's still a lot to be gained and discovered here. That makes it a very interesting area, because it has been neglected.

Yeah, definitely. Let's dive into the science a bit and talk about some of the key scientific and development challenges you've had bringing this therapeutic to life — and we can actually name it now: it's VMB-100, for this specific area of women's health.

VMB-100 is an mRNA molecule that gives instructions for the body to create a protein — an endogenous protein — to help repair itself. Essentially, we inject a tiny mRNA molecule into the weakened urinary sphincter muscle, which prompts it to regenerate and grow stronger — the basis for the body naturally healing itself. In preclinical and animal studies, we've shown that in a model where the urinary sphincter is damaged, a single injection can trigger regeneration within nine days and restore continence in the animal model. In humans it may take a little longer, but the expectation is that it will work the same way in women with stress incontinence.

That's incredible — nine days. And you've alluded to the bigger picture a little already, but there's much more behind this, right? This feels like the first step in the broader process — in the science at Versameb. Can you talk more about that? How do you see it?

Absolutely. At the core, the company started from a number of discoveries around enhancing the sequence code of the mRNA. Without getting too technical, this allows us to create an mRNA that's more potent, more stable, and potentially more efficacious — and we can combine different parts of the mRNA to target multiple targets. This is our lead indication, but we expect to develop many more drugs from this platform — in women's health and other regenerative indications like osteoporosis or cardiovascular conditions where we're able to regenerate tissue. Beyond that, there's also potential in oncology, though that's a bit further afield and more complex, with more competition in that space.

The power of mRNA to regenerate tissue is something I find very attractive, so that's the space we want to stay in. In the immediate future, with our current molecule, we're focused on regenerating the urinary sphincter within the urogenital space, but we could potentially address other things too — cesarean scar repair, or underactive bladder, which is sort of the nasty sibling of overactive bladder and a leading cause of urge incontinence. So there's a number of things we can do in this space. Incontinence was important to us as a starting point because it's such a large indication, and the approach is fairly straightforward — we inject a tiny amount into the urinary sphincter. That said, we still have a number of challenges to overcome over time.

What are some of those challenges?

mRNA is a very fragile molecule — stability and potency are one thing, so creating a more potent molecule lets us inject a smaller amount that can get to work before it's cleared or degraded. A major challenge was actually being able to inject into the urinary sphincter itself. Even though physicians, particularly urologists, are familiar with the anatomy, nobody had done this in a clinical trial setting before. So we had to work through it with regulatory authorities — what we could and couldn't do, whether it even made sense to test in healthy volunteers. One of the discussions we had with the FDA was that we should also go to a second, larger species to show we could safely perform the injection — so we ran studies in mini pigs, to demonstrate safety of the procedure itself, not just the drug. That's been a challenge, but also very interesting — together with the team, we discovered novel biology in women along the way, which, come 2025, is amazing —

It is amazing.

— novel anatomy. It's been a really interesting journey, and a rewarding one. With that, we also received IND clearance from the FDA, so we're now really looking to start our clinical studies in women with stress incontinence.

That is so exciting. Looking at that next step, what are some of the hurdles you'll face getting into the clinic?

Being a biotech startup, the major hurdle is of course financing — we're very actively raising funds to finance our clinical trial and show that the drug does what we believe it does. Beyond that, it's about deepening our understanding of the biology. We're starting in relatively young women who have incontinence after an initial childbirth, but we're also looking to expand into post-menopausal women, and potentially into mixed incontinence too, since that's a large population in terms of size. So those are some of the things ahead of us.

Funding is a big piece right now, and we've seen a real struggle over the last couple of years. We could push it aside and not talk about it, but let's do it anyway — I imagine you've had a lot of conversations with VCs, angels, and other investors. What kind of feedback are you getting, and do you see a positive future for funding in this space? And one more question in there: do you see a difference in the response because this is a women's health topic, compared to a different therapeutic area?

Yes — historically, women's health has been massively underfunded and under-researched, and I think that's part of a systemic bias. For decades, clinical research focused on men, or on mixed populations at best, and even within those mixed populations we didn't always adequately study the differences between men and women. There's also been a lack of women in leadership positions driving research agendas, which is an important factor too — that's part of why topics like endometriosis, menopause, and incontinence didn't get the spotlight, or the funding, they deserve. It's very different from, say, prostate cancer, which gets funding without question — I've sat in those meetings myself.

With investors, it's a bit different — they're ultimately dependent on pharma or public markets buying the company, so there's a lingering perception that women's health is a niche indication, which is obviously false; more than half the population is women, so it's certainly not a rare disease. Investors also tend to see reproductive health or pelvic floor health as a small market, and as a result only a tiny fraction of healthcare investment — I believe around 3% — goes into women's health solutions, which is a shockingly low rate. That's been a major challenge, and it's part of why startups and research projects in this space struggle to get off the ground — it creates a vicious circle: without funding there's less early research, without research there's less interest from acquirers, and without that there's less interest from investors.

There are also stigmas and taboos at play — topics like incontinence, menopause, and female sexual health aren't typically discussed very openly, and if a problem isn't talked about there's no public pressure or urgency to find treatments, which makes it easy for policymakers to overlook. We've seen the opposite with pediatric indications, where there's been real push and incentive for companies to study sub-populations — that hasn't really existed for women's health. And it comes back to what we said — a lot of the science on incontinence has only been discovered in the last ten years, which is fairly recent given the size of the indication. That said, I don't want to be all doom and gloom — I am optimistic. We're starting to close some of these gaps, especially over the last two or three years — there have been a number of big reports from consultancy firms drawing attention to this, people are starting to talk about it, and there are now investor conferences focused on women's health. They're still small, but it's a positive sign — I think the tide is turning.

Sure — yeah, you're right, we don't want to be all doom and gloom, and it is moving in the right direction. But it's such an interesting point, because thinking about what it's like to be a woman — or even a man — living with this: if you're a leader presenting at a board meeting, and it's in the back of your mind that you could release urine involuntarily, that has a real impact. It can affect whether you take on certain roles, because you feel completely uncomfortable, or because you have to wear protective garments. It's a bit like menopause — these are topics where you think, "I'll just deal with it," but there's much more behind it than just dealing with it. Because we haven't talked about it, what it actually does to us in those situations just gets overlooked and dismissed as insignificant.

Yeah, the quality-of-life aspect is really important here — actually "quality of life" is almost too mild a term. If you're presenting to your management team and you're afraid of losing urine, you're not going to be as focused as you should be. Being able to treat indications like incontinence, and maybe some menopausal symptoms too, can give women back freedom and independence they otherwise wouldn't have. That matters not just in terms of moving society forward as a whole, but in giving people the same chance to perform at their best as everybody else.

That shouldn't be overlooked. I really only started to notice this once we began talking to patients and working with urologists — we sat down with a number of patients to better understand how impactful this is, and it varies widely. Some women won't even tell their husbands or friends, because they're so uncomfortable talking about it.

Right — because it's so uncomfortable and embarrassing to talk about. And then once you do start talking about it, you realize how many other people are dealing with the same thing, and that there are solutions. That's why it's so important to keep pushing the conversation, and to push for research like what you're doing.

Exactly. Having real solutions in this space — knowing treatment can actually change that dynamic — changes everything. Without a solution, it's easier to hide and think, "I'm not going to get treatment anyway." On a bigger note, one of the things I hope Versameb can do is show that innovation can address these indications — which also validates them, and shows it's worth investing in innovative therapies for women's health. I think that's an important message too.

Definitely. Building on what you shared earlier — this is the first step in the innovative research you're doing, and the implications of investing here could have a huge impact on future therapies, and on other therapeutic areas you're focused on.

Yeah, definitely. I mentioned this before — something like cesarean scar repair. Many babies today are born by cesarean, but what few women know is the risk a cesarean poses for subsequent pregnancies, largely due to the scar tissue that forms in the uterus. It was fascinating talking to gynecologists about this — I think even people at pharmaceutical companies mostly have no idea. There's a lot unknown, and a lot of potential. That's one of the things that excites me about RNA therapies — something we all saw during COVID — how fast you can produce new, reliably safe drugs using mRNA as a modality. It's a really interesting space; it moves fast.

Yeah, it really is interesting, because speed is key, and this is a way to achieve that.

Absolutely. With new technologies things just keep evolving and getting faster, and I think mRNA is a technology that can keep up with that.

This is totally off the cuff — it just occurred to me from what you shared about scar tissue. What about something like endometriosis? Is that an area you're looking at too?

Yeah, definitely — endometriosis is a complex indication. For a long time treatment has mostly focused on managing symptoms, and it's a big indication too — about one in ten women. It really impacts women at a fairly young age, at the height of their careers, in terms of being able to work effectively. A lot of the current treatment focuses on pain relief, or hormonal approaches with significant side effects — far from ideal. But if you go earlier in the disease pathway, there are potentially things worth addressing — there's another company working on a preclinical RNA approach there, which I find very interesting. A lot of indications in women's health are somewhat muscle-related, which is part of why mRNA is well suited to regenerative therapies — it's a good fit for this space.

Interesting, because it's such a huge impact — I love this, it's fascinating, you could go in so many directions with it. So thinking about the platform, and tissue regeneration on a broader scale — what are your big dreams? Where do you see this going, and what roadblocks do you see, or have you already run into?

At the core, the technology is very scalable — it's not limited to one protein or one disease. Herniated discs, osteoporosis — areas outside the urogenital space — are also very interesting, though the administration challenge is bigger there. Getting the drug to bone is much more difficult than getting it to muscle tissue. But as the mRNA space evolves, there's a tremendous amount of research happening around delivery technologies, so I think those challenges will get solved too, and we'll be able to push the field much further. Outside of regeneration, there's oncology, and potentially even rare diseases where mRNA could help. The big vision is to see the platform evolve — what we're doing now, and potentially well beyond that into other indications. As a company we made a very deliberate choice to start in women's health, because we saw a massive opportunity and the science made sense — but there's really no limit to what the platform could eventually do.

Amazing. So you've mentioned some of the potential roadblocks, and the speed we saw during COVID with approvals — are you seeing any regulatory roadblocks at all?

I wouldn't necessarily call them roadblocks. We submitted our IND to the FDA, and overall it was actually a very good experience — we got very good feedback. One thing was clear: the level of quality and safety regulators expect for RNA therapeutics is much higher than what was allowed for the COVID vaccines, which were pushed to market very fast — we could debate for a long time whether that was good or bad, but that level of speed certainly isn't going to happen for RNA therapeutics going forward.

One of the challenges we ran into was the production process — we worked a lot on using a novel starting material, a novel DNA, to produce our RNA, using a method called "doggybone DNA." I spent quite a bit of time with the FDA discussing whether we could use it safely, and they were actually very open to that discussion. There are also more release assays required nowadays, and — as I mentioned — the safety of the injection procedure itself is looked at very thoroughly. But with all of that, we've actually been allowed to move directly into patients for our first-in-human studies — essentially skipping phase one and moving straight into a phase two study, which creates real opportunities. Going directly to patients also means we can start to look at efficacy signals, which you typically can't do well in a phase one study, so that's very exciting.

Outside the US, the European and even Chinese regulatory authorities are evolving very fast — some of their requirements are now at the same level, or even higher, than where the US was a few years ago, which is a good thing. It's an area where we need to keep evolving. More recently in the US there's been a lot of public discussion — and misinformation — around mRNA. That's not coming from the regulatory authorities, it's more in the public domain, but as scientists we probably have some responsibility to help push back on that misinformation.

Chips inside of us, right? You're so right — just being transparent about it, and talking about what's being said and how we deal with it.

Yeah, absolutely — you need to be able to discuss these things openly and give clear information. With the FDA, since we're regenerating tissue, the first safety question that comes up is: what happens if things over-regenerate — is there an oncology risk? We ran a number of studies to show that isn't the case, but it's also something we actively monitor — we have a safety monitoring plan in place. Essentially, what we're doing is bringing the tissue back to normal, not into overgrowth. These are important questions, and we need to stay open about them. Beyond that, in this space of regenerating muscle tissue, we sometimes get asked about applications in other, less clearly medical areas — that's something we deliberately stay away from. We want to work on serious medical indications, not on enhancing performance.

Yeah — dodgy therapies. How have your potential investigators and key opinion leaders responded to this? What have those discussions been like?

One of our key investigators is now our Chief Medical Officer, Roger Dmochowski. He's great — he started out as an advisor. He's exceptionally experienced in this space, involved in more clinical trials than almost anyone I know, and he was genuinely excited about the potential — he'd also worked with the FDA over the years on regenerative approaches. Key opinion leaders more broadly have been very open to this too. The thing to understand, particularly with incontinence, is that for people who fail on physical therapy and pelvic floor exercises, there are very few options — for more severe cases it may mean surgery, which carries real risk. A lot of urologists and specialists spend a significant part of their time repairing damage from mesh procedures, and the statistics there are pretty poor. If you do go that route, you want a very experienced physician — done well, it can work really well. That's what we're trying to do: give women a real solution before they have to turn to more invasive options.

That's what it's about — having options, and being able to decide. I imagine there are so many women who aren't even aware of what you're doing. I know you're being asked more and more to speak at events — you've spoken at a few recently. What's the feedback been like? Are people surprised? What kind of reaction are you getting?

The reaction has been very positive, especially at scientific events — there are some very dedicated conferences, particularly in urogynecology, and it's very well received there. It's a bit harder talking to the public — maybe that's just me being a scientist. I don't want to overpromise, because it's still going to take a number of years before the drug reaches the market. I've been to dinner parties where people get really excited and ask if they can get it now — but there's a rigorous process to go through, and drug development takes a lot of time and a lot of money before it all comes together.

That said, very early in my career I worked on some of the erectile dysfunction drugs, and the companies working on ED at the time did a phenomenal job educating the market — but looking back, nobody ever really questioned whether we should be doing it.

Right — no one was asking how many studies we needed, they were asking how quickly it could get to market.

Exactly — men could just be told they'd be fine. Nobody ever questioned that. So I think it's partly a mindset. I remember presenting at a number of these conferences, and I do think the space needs to evolve a bit more — financing will definitely help. It needs to get pulled out of that niche stigma.

Yeah — how do you get people really interested, and get them to see the bigger picture? This is a huge area in itself, but also being part of what comes next is incredible.

Yeah — in particular, from the time a woman turns 18 to when she's 80, many of the health issues she'll encounter along the way are significant.

We're complex beings — it really is true, the science of what we go through is very complex. I gave a talk recently looking at the stages a woman goes through, from her teens into her 80s, and the impact when things aren't diagnosed and addressed early on. Endometriosis is one example — left unaddressed, it can have a huge impact on your entire life.

Absolutely — massively impactful. Men and women go through different stages, but there's a lot here that warrants research, and I think, as drug developers, there's a moral imperative to do this work. It's not just about the conditions that largely affect women, like endometriosis or incontinence — there's also things like cardiovascular and metabolic disease, where women simply respond differently to drugs than men do. Those are areas we need to focus on to do a better job in healthcare overall.

Definitely. I'm really glad you're taking this step — it's very exciting, and I'm thrilled we finally got to have this conversation, because we could talk for hours about it. The moral imperative you mentioned is also a key piece — something for VCs and investors to think about, in terms of the values a company holds. Obviously investors are very focused on financial return, but I can't imagine there wouldn't be a strong return on this kind of investment, given the population size and the future impact.

No, absolutely. Early on we specifically looked at the business case, and even with very moderate pricing assumptions — in the range of what women already pay for incontinence products like pads — it becomes a very attractive business case from a big-pharma perspective. From a reimbursement standpoint too, we've had some initial discussions in Asia and the US, and those have been fairly straightforward — authorities and healthcare systems seem ready to fund this. I do think there could be more incentives from a government perspective for women's health as a whole, similar to what's been done over the last 20 to 30 years for pediatric programs — we could do the same to push this area forward. There's a lot we can do, and as I said, it's not all doom and gloom — I'm genuinely positive and optimistic about the future.

This conversation makes me optimistic too, knowing what you're doing and that we get to share it with people. For anyone listening, Klaas — how can people get in touch with you if they're interested? Obviously funding would be great, but also just to learn more about your experience and what you're doing.

The first stop is probably our website, Versameb.com — we try to keep it updated, though I'll admit we could do a better job there. We post press releases and updates on it. We're always happy to talk to people who want to know more about the platform, or about women's health in general — we're fairly active on LinkedIn, which is probably the easiest place to reach me and Versameb. We post milestones there and respond to comments. We also attend conferences and try to stay active in the community, at women's health events where investors and startups gather. There are a lot of people genuinely passionate about this space, and I think it's growing — the more people who get involved, the faster women's health will advance.

Absolutely. I think it's important to expand the conversation around women's health beyond fertility and menopause — which we're already talking about more — because this is a very real issue too, alongside things like cardiac care. There are so many areas where we need to expand our thinking about women's health, and this is one we definitely need to keep talking about, and make comfortable to talk about.

Those are very important things — being able to talk about them creates awareness and raises the topic. Absolutely.

Thank you — thanks for being here today. As always, I really love our conversations, and thank you for what you and your team are doing. It's such an important topic — women's health is key, and we've covered a lot of ground today. So, thank you.

Thanks for the opportunity — and to everyone listening, please don't hesitate to reach out and connect. We love sharing what we do, and we're very open to any conversation. Thanks so much.

Fantastic. Thanks, Klaas.