The Biotech Pulse S1E3 - "Empowering Women's Health: A Conversation with Mary Kerr, CEO of NeRRe Therapeutics"

An edited transcript of the podcast follows below.

Geert-Jan Mulder:
Welcome today to the Biotech Pulse - A Forbion podcast. My name is Geert-Jan Mulder and I am a managing partner and founder of Forbion, which we founded almost 2 decades ago.

I have led many investments and exits over the years but one of the most recent ones was related to a success story called KaNDy Therapeutics. It is a company dedicated to non-hormone treatment for the frequent symptoms of menopause, and at Forbion, we have seen this as a great opportunity when we first invested in KaNDy back in the spring of 2017, and finally resulted into a successful exit when the company was sold in the summer of 2020 to Bayer.

Today we are speaking with a special guest, Mary Kerr, who co-founded KaNDy Therapeutics, and is now the CEO of NeRRe Therapeutics, from which KaNDy was spun out in 2017.

So welcome, Mary, and I am really happy that you could make the time available for us and join The Biotech Pulse, sharing your exceptional experience in the field of women who are leaders in the in the biotech arena as well as women's health.

Mary Kerr:
Hi, Gert-Jan it is always a pleasure to see you again, and great to be here. And on this international day of women and girls in science, to really talk about women leadership in biotech and also the unmet need in women's health. I am really looking forward to the conversation.

Geert-Jan Mulder:
So before we go into our discussion, I wanted to share with our audience your sterling career. For those who do not know, Mary is a true pioneer in the field of women's health. We are really delighted that you are joining the Biotech Pulse today, and maybe before we go into topic as you already mentioned, I want to take a moment to kick off our discussion because on February 11th it marks an important day, which is the International Day of Women and Girls in Science.

For all of our female scientists and entrepreneurs listening to this podcast, you have held several important leadership roles in both big pharma as well as in biotech and understand both worlds very well. So could you please tell us about your professional journey? What inspired you to choose this career and give a couple of examples of the challenges that you faced and how you address these challenges.

Mary Kerr:
I started like many women leaders in science. I did a PhD in pharmacology, and I decided at that time that while I love the content and the science, I was not really a vocational bench scientist, so I opted to move at the time to what academics believed was the dark side - to go to Pharma. So I started what became a very long and fulfilling career at GSK, and heritage companies. I spent over 20 years there. In short, the journey was, I started as a sales rep, and actually, by the way, that was very useful experience later on as a CEO, and moved through marketing, operational, global strategic roles. So you know, it was a great opportunity to learn about a lot of different parts of the pharma business. But probably the last two roles that I did at GSK, and at an associate company were the most important for my move into biotech. So I was on the start up executive team at ViiV Healthcare, which is a company dedicated to HIV.

My final role at GSK was the senior vice president and global franchise leader for the immuno-inflammation and infectious diseases business. So really, a long and very fulfilling and full career, I think, provided a super platform for me to move into biotech. And, as you know Geert-Jan, because we met then, when I was leaving GSK and starting as CEO of NeRRe. And since then I've been in biotech as you have described earlier.

Geert-Jan Mulder:
So it is very interesting to see that we see more and more women taking executive roles in biotech companies, being on boards of biotech companies, and specifically also in the in the Forbion portfolio, we have quite a number of real success stories. But there is room for improvement. So based upon your experience, could you elaborate in how in the VC world we should focus on, further support of, successful women in biotech?

Mary Kerr:
Well, that is a really great question. Honestly, Geert-Jan, I think it starts with the individual. It is very easy to point and look at other things and say that does not work for me because of X. For me, it was very much a personal mission that I personally wanted to be successful, and I was lucky enough to have a partner who supported me to do that. So I think VCs are really important in encouraging and opening the doors and providing the environment for women. But actually, it all starts with the individual. So there are a few things in there. It is the home life, the partner you have. It is if you are a parent managing your children, and then in the VC, I think having a very, as in any employer, having a flexible, open attitude to really women and diverse needs across the board. So really having the conversation about, how is this going to work for us together? And as long as the plan is reasonable, implementing it.

Geert-Jan Mulder:
Mary, that was great advice. That that made me think about you are a successful CEO of NeRRe Therapeutics, and in the past, KaNDy Therapeutics, and there will be many more companies to come as a serial entrepreneur going forward.

Could you give a little bit of perspective on what experience you actually took from Pharma into building a successful biotech company, and who were your examples or people that have made an impact on your career choices.

Mary Kerr:
I have really drawn on the pharma experience. When I am mentoring young women, I always say to them, going to big Pharma is a really fabulous place to start your career. For all the reasons that I experienced. In Big Pharma there are resources to support people through their career as they build: the insights, the maturity, the expertise, the skill base. Their exposure to different territories, to different countries, and it is a unique place to get that experience. So I definitely encourage people to spend some time in Big Pharma. For me, really I had a fantastic vantage point in the last few jobs that I did at GSK. There were senior leadership jobs, as an Executive Head of Europe on the ViiV healthcare team. As the global franchise leader, I had a real vantage point across an entire organization. Not necessarily an expert in all of it, but I really could see what was happening all the way from early discovery, right the way through to medicine into the hands of patients, and when you get that experience, you understand what is required across the board to make things happen. When I came to biotech as a CEO, I was very much thinking about the end game. How do we get this medicine through the clinic, through the regulator, through the payer, into the hands of the patient? Which is quite frankly why it was clear to me with KaNDy that we needed to have a big pharma buyer. Big Pharma has the resources to do what has to be done with a medicine like KaNDy, which needs to get the KaNDy compound which needs to get to many patients.

I mean, obviously, I am very supported in the work I do in NeRRe and historically in KaNDy, because I have got a terrific team. We work together very closely with you [Forbion] and the other investors, and each of them individually is an expert. And so, in the space that they are in, whether it is clinical, manufacturing and discovery and preclinical. When we all come together as a holistic set of leaders, we have a very diverse knowledge, base and experience base. Together, we can piece together a jigsaw that increases the probability of success of a medicine getting to market.

You are asking me who inspires me? Many, many people throughout my career. It is really interesting, I never worked for a woman in my whole life which says something about the historic state of women in leadership. Obviously, that has changed a lot now. So the people who inspired me, who mentored me, who gave me my career breaks were all men, and I do not want to name them here, but you know there are a lot of them to thank. Equally, the team I work with, they are all fantastic experts in their own right, and they are inspiring. And without them I could not have achieved what I and we have collectively achieved together. So it has been a very humbling experience, but definitely one where I have drawn very heavily on the Pharma base.

Geert-Jan Mulder:
I could not agree more. Having worked with you for several years now, the dedication of you and your team has always been a great example for how to run a very well organized tight ship and be successful in biotech. It has really been impressive. What you have been able to pull off with a limited team running late-stage clinical development. It also makes me think back on my own career, and what you mentioned our background that we both have in big pharma is a framework, it provides a perspective. You always focus on the end game. Where do we prove this product is differentiating from others? How does that translate in true value for patients and serving, true unmet medical needs?

That gets me close to discussing what you already brought up KaNDy Therapeutics, a great example of the first biotech companies pioneering in the field of women's health. There are very little companies active in this field. It is slightly increasing, but when I started in venture there was hardly any activity in women's health and not in big pharma, not in in biotech, but I would like to take a little bit of time of speaking about the areas and women's health that continue to be underserved, and specifically focus a little bit on indications like endometriosis that affects about 10% of all women worldwide. If you add that up, that is about 180 million women in the globe. Indications, like PCOS that affect about 6% to 12% of all women at reproductive age, reducing their chances of pregnancy substantially, and then the other part, which is also not to be underestimated and closer to the age that by the age of the relative to the menopause is fibroids where a large percent of the women over 50 would actually, have symptoms related to fibroids at any point in time in their life. So those are still areas where there is an enormous lack of interest by the large pharmaceutical industries. So could you elaborate a little bit on where do you think the biggest opportunities are? Bringing new treatments forward, and to make a difference in women's health, of course, also taking into consideration this is the Forbion Biotech Pulse so driving success on a commercial basis is an important consideration.

MaryKerr:
It is almost shocking the level of unmet need, and the years of chronic under investment over many, many decades has really taken its toll across all areas of women's health. It has been interesting to see that recent McKinsey publication that really shines a light on the impact of under funding and under investment, and the results, the impact that it has had. We all know, for example, you mentioned endometriosis, you mentioned polycystic ovary, and fibroids. There are large populations of young women in child bearing age and yes, fibroids tend to be associated with slightly older population. But these women are suffering for years - up to 8 years - before they get a diagnosis. They are misdiagnosed. They go from pillar to post, with no satisfaction. By the time they are finally diagnosed, often the only option they have is surgical. We always say if someone else would go in and say, because we misdiagnosed you we did not diagnose early, have to get it cut out. Well, it just would not be acceptable. The great thing is that there are a lot of voices now talking about this, and none more so than women themselves. It is great to see very high profile women who are publicly talking about things which are very personal and very embarrassing, potentially, but they have the courage to go public and really shine a light on the fact that something needs to be done. You and I have talked about this a lot. It would be absolutely fantastic to improve the treatment, the diagnosis, of conditions like endometriosis, fibroids, polycystic ovaries that are affecting huge proportions of young women in reducing the debilitating symptoms they get, and reducing the infertility that often arises. This is very very important work. But it is good to see that there is increasing focus on this. There are organizations and venture capital firms who are actually actively stating their interest in women's health, and for me, venture has always been a critical part of the funding cycle. Venture has driven a lot of the recent approvals in the last decade through the FDA. So venture capital coming back into women's health the way Forbion did when you stepped in 2017, seeing that happen is a really good signal, because they are going to feed the ecosystem that will eventually result in new medications for these treatments.

Geert-Jan Mulder:
Mary, you bring up several important points, and I think we also have an important kind of realization that we need to bring across to the regulators. Once we are going to further explore the opportunity to develop new medication in these indications, because also, from a regulatory point of view, the endpoints which are valid, for approval of these indications are rarely are often still related to old fashioned thinking about these diseases. They are more focused on, for instance, in the case of PCOS increasing the rates of pregnancy instead of truly understanding the burden of the disease in endometriosis. It is pretty much similar in fibroids. It is more straightforward because most of those are related to pain or other symptoms. I think there is also a path that we need to flatten in getting more acceptable regulatory endpoints for these indications.

MaryKerr:
Geert-Jan, you mention endpoints, and that is absolutely a critical topic, and I know we have had many hours discussing endpoints. But it is fundamental for all therapy areas to be able to define an endpoint that the regulators will accept, and that the payers will pay for. That proves that the medicine works in the patient population. That has been one of the issues with women's health. Because there has been so little development that in some conditions there is that paucity, or even you could say an absence of well defined endpoints. So we know in the menopause that was good because there is a defined, regulatory pathway, albeit rather old now, and probably requiring updating, but nonetheless it exists. Whereas in polycystic ovary there is no defined regulatory pathway to market. And that has got to be another reason that puts biotech companies off, pharma companies off, venture firms from funding. So you are right. Defining endpoints - the only way to do that is to do the studies is critical in women's health.

Geert-Jan Mulder:
We had very recent very good news from Bayer. Could you elaborate on that? That was a press release that was sent out on January the eighth. But I would love for you to share that with our listeners.

MaryKerr:
It was great.Geert-Jan, and I think rather unexpected. We were not anticipating that. Obviously, I can share what's already in the public domain. I know no more than that. So I can share what Bayer announced the first day of JP Morgan that both of the phase 2 pivotals had read out positively for all of the primary and the secondary endpoints. They did not provide any data, or any numbers, but they clearly made a statement that the pivotals were positive.

It is a momentous moment for biotech and for venture capital funding that we finally can come back with something that is of massive need, a non hormonal treatment for women. And Bayer also announced that they had launched, and our progress had started, and are progressing well with a study in women who have had breast cancer and are not candidates for hormone treatment.

So even extending the potential for that KaNDy drug to be used in women who otherwise would have no medical options. We were there in in San Francisco when Bayer announced the news. It was surprising for us - it was earlier than we thought, but I think we are all thrilled, and we just have our fingers crossed, that everything goes well for Bayer the company as they progress and make the filing, and that the FDA accept the file and approve it and then make it available to women. So we are all watching this space, but terrific. It is terrific news!

Geert-Jan Mulder:
That was a great start of the annual JP. Morgan Healthcare Conference week definitely, Mary. I think it is important to stress again that after decades really decades. This is the first time a novel non hormonal treatment will be hopefully soon introduced to the market for the treatment in in women's health, and I think that is a completely new class of drug that can have broader applications as well.

Back to the days when we started to look at your company. Can you share some thoughts on and perspective on those days. What it was to fundraise as a CEO for a specific company in the women's health space?

MaryKerr:
Oh, yes, it was painful and not very productive. So I think you recall Geert-Jan and when Mike Trowers the other co-founder, when we started raising money for the series B, for it was then NeRRe therapeutics actually had the drug. We spoke to maybe 40 VCs across Europe and the US, and there was very little interest. There were lots of excuses. There is no unmet need [Really?] There is no market. [Really?] The other really important thing for VCs at the time was they could not see where the exit would come from. So there were no acquirers. So basically, it was a very difficult raise. We went for months and months without really getting a bite, and it was only when we made the strategic decision to switch gears and actually lead on another drug lead on our chronic cough, NeRRe drug that we started to get bites. But of course, yourself, Fountain, Advent, and Orimed were in the pioneering group who really got the importance of the menopause drug.

I think I still have that email that you sent to a colleague of yours when we were trying to bring a chair on, and you had written that our lead compound is in chronic cough, but actually, the jewel in the crown is the menopause drug. So high right you were! But of course, NeRRe hopes that the chronic cough is also going to be productive. It was very difficult. But to be fair to venture and to industry, I think they had been bitten and burned by the HRT story. The hormone replacement therapy story is, I think, those who are in the field know, that in 2002 there was a publication by the Women's Health Initiative that basically, said HRT was associated with increased risk of cancer and cardiovascular diseases. Overnight the HRT market plummeted, and it never recovered.

And I think what we are seeing now is a slow recovery from that scare that rippled the whole way through the industry in the medical community and through women. There is still a large mistrust of HRT which is not always merited. So there was a reason why venture was feeling the way they are. I mean one of the by products of the KaNDy deal, I hope will be that this is an example of how women's health. That we can find treatments that are really meeting unmet need that really fill a gap in the market that treat millions of women in the Western world, and globally and can be financially lucrative for the companies, for investors, and importantly, for women who can get their lives back. So I hope that the climate has changed, and I am hoping that the KaNDy deal plays some part in that, and I am sure in the next few years we will look back and say that it did in fact, do that. Things were bad, but they are getting a lot better.

Geert-Jan Mulder:
I think this combined with a big increase in the understanding about specific diseases. Women might have different symptoms. Clinical trials represent more the male part of specific diseases compared to the female part. So there is a lot of awareness in combination with the success that we have recently seen in our phase 3 studies on the old KaNDy compound. Do you think that the environment for women's health and new entrepreneurs or VCs, and in investing in this space has changed recently?

MaryKerr:
I definitely think it has. I am seeing announcements of new companies being funded. Some women health company going to IPO. We are seeing VCs announcing that they are hiring chairs for a startup and women's health. I personally get approached for a lot of things. We see the BII- the Bio Innovation Institute who have a specific focus on women's health as part of their fundraising. So I think there are firms like yourself who have always been and remain interested and in receiving all proposals in women's health. I definitely think there is a groundswell, and our recognition that this is an area where, because of that the unmet need, it is a space where venture should play, and Pharma also will play if the compound and the data really shows benefit for women. So I feel very encouraged by the momentum that we see for sure.

Geert-Jan Mulder:
Well, for all the listeners of the The Biotech Pulse, you will see Forbion remaining to have an interest in the women's health space and definitely will see us coming back in this field. We always have a final question for our guests, Mary, and it is related to a specific advice that you have received or a wish that you received. I want to tweak that question a little bit today, and make it more specific - could you share with specifically female leaders as you as they are thinking about building or starting their companies?

MaryKerr:
I definitely have one of those, and this is something that was said to me when I was training to be a sales rep and the sales trainer said, “no today does not mean no tomorrow”. So when you go out there as a sales rep or as a CEO raising, financing, you will get a lot of nos and actually the majority of the responses will be, no. But that does not mean it is going to be no tomorrow. And I think the point is that every time I get a “no” I want to know why are you saying “no?” What is about this proposition that you don't like?

Help me understand how I can make it better, and I will make it better, and I will come back to you with a better proposition. So I think it is just about that concept of being resilient. Not taking “no” for an answer, listening to what people really think and really believe, uncovering their concern and resolving it. So that has been a very useful mantra for me, one to keep going, and to really understand exactly why somebody is saying no when they say it. So that that has been a bit of a guiding saying for me.

Geert-Jan Mulder:
Okay, that was very insightful. Thank you very much, Mary, for joining us today on The Biotech Pulse. As always, it has been very insightful and inspiring to talk to you about what you have mentioned. For us at Forbion, being the CEO of two of our portfolio companies and part of our success, and a great inspiration to all of the employees at Forbion and an enlightening example of successful women in in our business.

So for all listeners, I have hoped that you enjoyed listening to “The Biotech Pulse” today specifically discussing women's health and women in science with my special guest, Mary Kerr, CEO, currently of NeRRe Therapeutics, and do not forget to follow “The Biotech Pulse” whenever you get your podcasts. We are available on all platforms, and remember that you can also access this podcast directly on the Forbion website. Thank you for listening. Goodbye.