Transcript:

Isabelle Abdou:

Hi, and welcome to the Optimum Perspectives podcast. I’m Isabelle Abdou, and in this latest episode, we’ll be exploring women’s health, what’s really changing in the science, the capital behind it, and what still needs to shift. To explore it, I’m joined by three leading biotech executives and a seasoned healthcare investor. Colleen Acosta, CEO of Freya Biosciences, Agnès Arbat, CEO of Oriva Therapeutics, Jean Duvall, CEO of ReproNovo, and Hakan Goker, Managing Director at M Ventures. Thank you all for joining me. Let’s get straight into it. Women’s health is routinely called underfunded relative to its disease burden. What’s genuinely changing right now and what’s still just rhetoric? Hakan, let’s kick off with you.

 

Hakan Goker:

Isabelle, thank you. So what we are seeing is that there is more innovation coming through both academically and from a early company creation in the biotech space compared to the previous years. And that’s a reflection of more focus in the space, both through social media, through patient organizations and just general awareness is what we are seeing, plus a bit more activity in the investment space into this therapeutic area. And when we talk about women’s health, at least for M Ventures, we are more broadly around reproductive medicine rather than anything else.

 

Isabelle Abdou:

Thanks, Hakan. Colleen, anything to add?

 

Colleen Acosta:

Yeah, absolutely. Thanks so much, Isabelle and Optimum for having us around the table for this important conversation. So I do think that the tides are changing. I do think there’s more than just rhetoric as Hakan was describing, but I think there’s still so much to be done. If you look at just the allocation of healthcare investment dollars, only 6% of private healthcare investment goes to those companies that are tackling issues surrounding women and girls. When you look at those companies that are uniquely focused on indications affecting women, that number goes down to only 1%. This was laid out nicely by the World Economic Forum early this year. So I do think there’s still so much more to be done here. I think they laid out very nicely that if you tackle some of these indications that are uniquely but also differently and disproportionately affecting women, such as cardiovascular disease, osteoporosis, menopause, endometriosis, for example, there’s a potential here to unlock more than 100 billion by 2030. So really a huge unmet need. So I think while the tides are changing, there’s tremendous opportunity for more growth in this space.

 

Isabelle Abdou:

Thanks, Colleen. Now, as you mentioned, many of these conditions affect women disproportionately rather than exclusively, and reproductive medicine stands both partners. So does the women’s health label actually help or hinder how the field gets funded and understood? Jean, why don’t you start us off?

 

Jean Duvall:

Thanks, Isabelle, and thanks for bringing this group together. We do need to be careful that women’s health is not too narrowly framed. A definition that includes impact on women and burden to women is important. As Colleen mentioned, cardiovascular. There are many instances where disease might have a bigger impact on women or a burden to women. And for example, if we take fertility care, that historically has placed a disproportionate burden on women, but male factor infertility contributes to around 50% of infertility cases. Despite this, men, they have very few therapeutic options and there’s a significant gap for fertility treatment and the burden is placed on the woman for undergoing treatment. And that’s why at ReproNovo, we’re developing therapeutic options across both male and female infertility. Our lead candidate is being developed for the treatment of male infertility associated with low testosterone or no or impaired sperm production. And then on the second compound, we’re looking to support embryo implantation for women by reducing uterine contractility and helping to maintain uterine quiescence with the potential to improve pregnancy and live birth rates in IVF. So again, going back to the most useful framing is not women versus men. It’s about recognizing the impact to and burden on women. And we need to address those areas where patients and clinicians have limited or no approved options.

 

Isabelle Abdou:

Great, thanks Jean. And Agnès, do you agree? What’s your perspective on this label?

 

Agnès Arbat:

Yeah, thank you Isabelle for having us and thank you all to share this moment. Having worked in both pharmaceutical and biotech, I’ve seen that women’s health label. often means less investment, fewer therapeutic options, weak understanding underlying biology, and fewer companies and investors willing to engage. But this isn’t just history. Even a year or two ago, I was told that women’s health was an inch. But when conditions affect up to 10% of more than half of the world, Niche is just the wrong word, right? Still, I do think that label matters. It gives context, visibility, and shared language for the field. And I think that we don’t need to create any market. The market is already created. We just need to recognize the signs. and the urgency of one that has been overlooked for too long. And as Colleen said, the numbers are already there. The World Economic Forum and the McKinsey Health Institute report estimates that closing the woman’s health gap unlocks $1 trillion in global economic value annually by 2040.

 

Isabelle Abdou:

Thanks, Agnès, it certainly can be a divisive issue. Now moving on, many women’s health conditions have been managed symptomatically for decades. Why is that and what does it take to start treating the underlying biology? I’ll come to you first, Colleen.

 

Colleen Acosta:

Yeah, thanks for that question. I think it is true that in many common health indications in women’s health, particularly related to reproductive and maternal health, and as this group was just mentioning, this is really where the focus of the field has been, specifically in recent decades. Estrogen and progesterone clearly influence symptoms. So that’s really where the market has focused. But we have a better understanding now of the underlying disease pathology that’s underpinning many of these indications. We know now that, for example, chronic inflammation, immune dysregulation, vascular remodeling, altered tissue repair, et cetera, is really at play. So what does it take to change this? I think treating the underlying biology requires moving from symptom suppression to mechanism-based intervention. Obviously, there needs to be a lot more scientific work to be done, but we do have a better understanding now. So I think also finding the right patients will be hugely important given the history of this space. I think a lot of diagnoses have been given as an umbrella. And as we understand more about the biology, we’ll start to become more specific in that. So I think advances in biomarker patient stratification, is going to be really key here to moving to mechanism-based intervention. We’ve incorporated that at Freya with every trial that we’ve run to really get to the bottom of which patient groups are responding better to our treatments. And this is going to be a critical element moving forward.

 

Isabelle Abdou:

Fantastic. Thanks, Colleen. And Agnès, what’s your view on this?

 

Agnès Arbat:

Yeah, I agree with Colleen. I mean, it’s exciting now that we can understand better the underlying drivers of the disease. And that with the advances in omics, in imaging and also the longitudinal patient data and increasing AI, we can integrate all this complex biology information in ways that weren’t possible before. And it’s an important moment because science, clinical understanding and investment are finally coming together. So we have the knowledge and the analytical tools to translate that science into better treatment. And it also creates, as Colleen was saying, the opportunity to evolve in clinical development in women’s health with better design or more sophisticated design of the clinical trials and endpoints that better reflect meaningful patient outcomes, maintaining, of course, rigorous safety standards. So ultimately, better science and smarter development can bring innovation to one faster.

 

Isabelle Abdou:

Brilliant. So switching gears slightly to the investment landscape, Hakan, it’s no secret that there’s a narrative that women’s health is having a bit of a moment with investors right now. Is this a permanent shift?

 

Hakan Goker:

I think it’s worth to note that Here we have three companies that are well known in the venture ecosystem, which is already a win on its own. So five years ago, this podcast would probably not have been possible, or you guys would have to hunt down through various platforms to identify these companies. So We see investors becoming more aware of the space and opportunities for, let’s say, growing these companies and the investor outlook exiting them at the right value is increasing. Looking at the public markets behavior, which kind of goes up and down, but nonetheless, there are adequate programs in appropriate stages of development that enables that path as well. So this attracts investors. Acquirers are still limited in number, which is a main concern for many, which is a fair concern. But nonetheless, this kind of alternative path on the public market being open helps investors rethink this. Additionally, there has been noises in industry over the last year that multiple traditionally non, let’s say, women’s health fertility focused companies now kind of having another look in this space. which increases the excitement both for entrepreneurs and investors. If others were to enter this space, there will be a plethora of others that could potentially be homes for these programs for getting into the market. So we believe it is a permanent shift. It is the fact that fertility is dropping in many geographies. around the world. And this is no hearsay anymore. There is significant amounts of recent research that points at that, validating also the market in inverted commas, if we can say. And what also has changed. changing is that you can see the self-pay system, which was a boogeyman for many biotechs and commercial people and pharma, has actually eased out a little, as has been demonstrated through the GLP-1s for obesity. So this is also adding to the excitement from the investor space. So cutting it short, we believe it’s a permanent shift.

 

Isabelle Abdou:

Brilliant to hear. Thanks, Hakan. And Jean, When you’re first in disease, how do you think about the commercial pathway and convincing investors that the market is real?

 

Jean Duvall:

Good question. So first you have to make sure that the investors see that the therapeutic gap is visible. We’re developing a drug in adenomyosis, and that’s a good example of a woman’s health drug for first in disease. Adenomyosis is sometimes called the sister disease to endometriosis, where the lesions occur in the uterus itself rather than in the abdominal area like with endometriosis. And adenomyosis puts a significant burden on women’s everyday lives and fertility. but yet it has less visibility. So you can’t assume investors know the market or even know the disease. You have to build the case step by step. What the disease is? How are the patients impacted? How are they managed today? Why did the current options fall short? What would a meaningful clinical benefit look like? What type of pricing can you get? And ultimately, what’s your sales potential? When you have a first in disease, you have to create a compelling case because it’s nice because it’s a untapped space, it’s a white space, there’s no approved therapies, but you have to prove there’s a commercial opportunity. So with adenomyosis, we’re showing the pain, heavy bleeding, fertility and pregnancy challenges. So there’s a clear gap there, for example, between the burden of the disease and the therapeutic options available to women. So I guess just big picture, with investors, we can’t just rely on advocacy. It’s important advocacy, but we really have to have a clear development path and a credible commercial plan. And once investors then see there’s need, there’s lack of options, And as Agnès was saying, that it’s not a niche women’s health issue. You can make real money in it and there’s an opportunity for meaningful therapeutic innovation. Investors start to listen and we’re seeing that.

 

Isabelle Abdou:

Brilliant. And Hakan, anything to add here, given your experience?

 

Hakan Goker:

I mean, what Jean said is very valid, right? Because many investors, we all have been kind of quite focused on the, let’s say, at least perceptionally larger areas like oncology, immunology, neuro has been a darling of investors for a number of years. So it does take an added effort to kind of bring people up to the same level of understanding. So this is a, I wouldn’t say a challenge, but an interesting opportunity for entrepreneurs to really do that, to kind of, to go through the realities of what the market looks like, what the disease, how this really impacts people. Because many people hear the name of the, let’s call it the indication, but may not necessarily understand how the long-term impact is. And in quite a lot of these cases, it’s also quality of life. that can then be translated to working hours. So the whole socioeconomic impact can be translated into then dollar numbers for many governments and payers. So it is perhaps a little more handholding than it is for some of the other areas that investors have been used to. And adenomyosis is one example, even endometriosis, which is, you know, supposedly better known, We have had experiences, this was a while back, where it was tough to attract investment into the companies that we were building. And we have been kind of on the other side because of the, let’s say, the leading role of Merck’s fertility franchise. We have been more exposed to the field, with the mothership being one of the potentially main buyers in this space. It’s a little more of a long-winded way than it is perhaps for other indications, Isabelle.

 

Isabelle Abdou:

Great. Thank you for that, Hakan. So just before we come to our conclusion, tell us briefly what your company is working on right now and what’s next in your pipelines. Colleen, we’ll start with you.

 

Colleen Acosta:

Yeah, great. Thanks. So Freya is an I&I company focused on the underlying inflammation and immune dysregulation involved in women’s health indications. We have two main programs, one focused on IVF implantation failure and the other one on preterm births. FB301, which is for IVF, is in phase two, two phase two programs for preterm birth. That’s funded by the Gates Foundation that is going into phase two next year. So what’s next for Freya? We’ve always been interested in this underlying immune component. So we are obviously interested in indications that are more broadly affecting women. So in addition to advancing our core programs, we’ll be working on expanding the pipeline as well. So excited to say more about that in a short while.

 

Isabelle Abdou:

Brilliant. And Agnès?

 

Agnès Arbat:

Oriva is a clinical-stage women’s health biotech company. We are focused on the development of first-in-class and best-in-class therapies for chronic prevalent and gynecological diseases with a high-end medical need. Our pipeline is built around two advanced programs in endometriosis and uterine fibroids. leveraging novel chemistry, targeting validated biological pathways and differentiated from the existing treatment options. Both are innovative and disease modifying approaches. With the endometriosis assets, we are in clinical phase one, preparing for the phase two, and in fibroids, preparing phase one that’s going to start next year.

 

Isabelle Abdou:

Great. Thanks, Agnès. And Jean, how about you?

 

Jean Duvall:

So most recently, during ESHRE last week, we announced the start of our phase two study for RPN-002. And this is focused on the implantation process after embryo transfer as a key factor in the success rate of IVF treatments. We know that for many women and couples undergoing IVF, each embryo transfer represents a significant emotional, medical, and financial investment. Studies have shown that by different research groups that you have lower pregnancy rates in women with an increased frequency of uterine contractions during embryo transfer, indicating that there’s interference with the implantation process. And with RPN-002, we hope to develop a therapy that will help improve some of those factors and impact successful embryo implantation in early pregnancy during IVF treatment programs. And we’re really excited to be on this journey. It’s the key KPI. Is the IVF successful? Is the cycle successful? So it marks an important milestone for us for ReproNovo in advancing our phase two pipeline. We have 4 indications going in phase two across fertility and women’s health. And right now we’re focused on executing across these programs and hope to have readouts.

 

Isabelle Abdou:

Brilliant. Well, sounds like great progress is being made on all fronts. And to close, in just a few words, what’s the single biggest unlock that would accelerate the whole field? Colleen, we’ll start with you.

 

Colleen Acosta:

Yeah, I think one of the biggest catalysts for the field would be a clear commercial and clinical success for a first in class non hormonal therapy and a large women’s health indication. I think that will fundamentally change how investors in pharma view and engage with the space. Being on this call, I’m super excited to see that happen in the near future. As Hakan was saying, I think, you know, five years ago, this might not have been possible, but there is a changing tide where we do see additional companies entering the therapeutic space. So yeah, excited to see the near term future for when this happens.

 

Isabelle Abdou:

Brilliant. Agnès, what’s your view?

 

Agnès Arbat:

Yeah, my one final thought is that we are at the right moment. We finally understand what drives the diseases, and we are increasingly aligned across science, development, and capital to turn insight into impact cluster.

 

Isabelle Abdou:

Great. And Jean?

 

Jean Duvall:

I think we see momentum building, and in fertility in particular, as Hakan mentioned, it’s a growing global crisis. its impact demographics across the world. Yet treatment innovation has really lagged and the field needs momentum with innovation and investment to bring new therapeutic options to patients. They need more choices.

 

Isabelle Abdou:

Great. And Hakan, we’d love to hear from you.

 

Hakan Goker:

So, I mean, Left to the last, I would love to borrow exactly what these three amazing entrepreneurs have brought up with these equally exciting companies on here. And I think it’s the realization that at least the infertility side is no longer a niche market. I think there is more understanding around that. You can see a number of buyers getting more excited on this. I mean, I had the opportunity to join Jean at ESHRE, the largest, let’s say, non-North American meeting around fertility and endocrinology that was in London. And you could see a number of known and not so known in the space pharma companies circling around in the crowd and that is positive. So of course, what will really provide that push and demonstrate that this space is active and addressing such large market will be a few acquisitions, let’s say, by pharma to really progress these innovative ideas onto the market as drugs that actually help patients deal with their daily lives. So that’s what I think is going to be the big push that really permanently reserves that position on the landscape of venture investing and patient benefit.

 

Isabelle Abdou:

Brilliant. Well, that’s all we have time for today. Thank you to all of our wonderful guests, Colleen Acosta, Agnès Arbat, Jean Duvall, and Hakan Goker for joining me to discuss such an important topic. Thanks again. Until next time.