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How NEXT Life Sciences Is Redefining Contraception for Men with Plan A™ · StartUp Health NOW Podcast

• 0:00
  [chimes] My name is Unity Stoakes, co-founder at Startup Health. Today we are speaking with longtime health transformer, Dr.
• 0:11
  Darlene Walley, who is the CEO of NextLife Sciences, which has a really novel, interesting solution called Plan A.
• 0:23
  This is the first male birth control solution that is non-hormonal, long-lasting, and reversible on demand.
• 0:33
  For men looking for a safe, simple, and reversible contraceptive, NextLife Sciences has been working really hard on this, and I think it's something really important for people all over the world for family planning and impacts a lot of other health iss- issues.
• 0:48
  So we're gonna be talking about the recent successes with clinical trials, new patents, and all sorts of updates. So stick around for a conversation about Plan A and NextLife Sciences. [upbeat music] Hi Darlene, welcome.
• 1:04
  How are you? Very good, thank you, Unity. So happy to be here with you. I am so excited to get a full update on NextLife Sciences and Plan A and everything that you've been doing.
• 1:16
  It's been a lot of momentum on, on your end, a lot of exciting developments. But why don't we start at the beginning? Let's...
• 1:25
  If you could share a little bit about NextLife Sciences and what Plan A is, that'll start framing the conversation, I think, in a very important way, because the mission that you're on, I think, is really extraordinary and very, very meaningful.
• 1:41
  How do you describe the vision and mission that you all are on? Yeah. The simple answer is NextLife Sciences is a reproductive health platform.
• 1:50
  It's very surprising that reproductive health has had very little innovation, very little investment in the last 50 years.
• 1:58
  Plan A is our flagship product that we're very proud of and looking forward to getting it in the market as soon as possible. So Plan A is a long-lasting, non-hormonal, reversible on-demand male contraceptive.
• 2:14
  Right there. I, I... just the world really has been demanding new options for, for birth control and for male birth control. So let's dig into that.
• 2:25
  I think this has global implications, certainly big implications here in, in the United States, but I could see this making a global impact. Talk a little bit about the origin story.
• 2:38
  How long has this been in development, and take us back to the beginning. Yeah. And just a few statistics to build on what you said, Unity. First of all, 50% of pregnancies in our advanced country are unplanned.
• 2:53
  That is just a phenomenal number, and that's, that is also true globally. So we have such a high rate of unplanned pregnancy, and that number was published by the WHO. It's used frequently.
• 3:09
  And a, a more important number is a recent Gates Foundation survey of men 18 to 49. Over 80% of those men are looking for a male contraceptive other than the current options, which are condoms and vasectomies.
• 3:25
  Two pretty poor solutions. So that's, that's the premise of why NextLife Sciences is so excited and focused on getting Plan A into the marketplace.
• 3:39
  There was some research in India, to answer your question, over 30 years ago. Professor Guha started studying different materials that could block sperm in a vas deferens of a man.
• 3:53
  Unfortunately, he did not understand the mechanism correctly, and that product was never commercialized. The Parsemus Foundation from the Bay Area took over that research around 2001.
• 4:06
  So they did a lot of pre-clinical work, a lot of foundational work, and then we licensed the technology about three years ago from the Parsemus Foundation. So we have a worldwide global license for the technology.
• 4:19
  We've since been granted patents on our delivery device.
• 4:23
  The one thing that's important about any product that's in our category, it's called a vasocclusive, vas being vas deferens, which carries sperm in the man's body, and occlusive, we're forming an occlusion.
• 4:36
  And that's the mechanism of how our product works. We- So is this considered a medical device then? Absolutely. It is a medical device. It...
• 4:45
  our proprietary polymer solution gets inserted into the man's vas deferens and forms a filter. So that filter blocks sperm, but it allows fluid to go through. So it operates by size exclusion. Sperm are just too large.
• 5:00
  Anything below one micron, fluid, cell debris, et cetera, can go through it. So that's an important aspect. The vas deferens is extremely small. The inside of it is even smaller.
• 5:13
  It-- we're talking millimeters, one to two millimeters.
• 5:16
  And we have a device that's been patented that we've developed that allows a doctor to confidently and safely place our hydrogel precursor into the vas deferens without damaging the vas deferens.
• 5:30
  'Cause it's very important, first of all, for our product to be effective, to be in the right location, and secondly, that's a very, very tiny tube that we don't wanna damage because we're able to reverse that process very easily by adding a small amount of sodium bicarbonate solution, and the hydrogel just collapses into a water-like solution.
• 5:51
  So it's really important that the integrity of the vas deferens is maintained throughout the process.
• 5:57
  Because we think men are excited about birth control, they may choose a babyOne month after having Plan A, maybe three years later, maybe 10 years later or more, but we want them to be able to have the process reversed so they could become fertile and have children when they want to.
• 6:17
  Yeah. It seems like this has huge implications on family planning as well as just health in general.
• 6:25
  It could impact your partner's health, your wife's health, whatever situation you're in, in, I think, significant ways as well. What... So you mentioned you've gotten some patents.
• 6:35
  I know you've also had success with clinical trials as well. Yes. Can you share a little bit about that? Yes. We've run clinical trials so far in Australia and Canada, and that was on our delivery device.
• 6:46
  100% success in doctors, both relatively new doctors all the way through urologists who had maybe 40,000 vasectomies under their belt already.
• 6:57
  So our delivery device was proven to have the 100% accuracy, which we're looking for. We're now starting clinical trials with our occlusion device. Vasalgel is the name of it.
• 7:10
  So those will start this year, and then our next stage will be pivotal trial for FDA submission. So we've met with the FDA, they've approved our plan, and we're in constant communication with them.
• 7:22
  Do they give any indication at this stage in terms of timing? I'm sure lots of people are gonna listen to this, and they're gonna immediately wanna know, when can we get access to this?
• 7:33
  You know, is there a sense of timing? I know the process is usually long in these situations. What's your sense at this point? Yeah. No, great question.
• 7:42
  As, as you've rightly pointed out, we're a medical device, so our clinical trials are smaller. The length of time is smaller than developing a new drug, for example.
• 7:52
  So we are hopeful that in 2027 that we will have all the clinical trials completed to make our FDA submission. Oh, that's amazing. And you...
• 8:02
  I know one of the strengths you all have really focused on is you've built an extraordinary team of- Mm-hmm... experts, different leaders that are involved in this.
• 8:12
  Can you share a little bit about your philosophy there, some of the- Mm-hmm... people maybe you've organized around this mission? Yeah. No, we have an incredible management team. All of us have over 30 years experience.
• 8:25
  We have experience in commercialization, in men's health, in medical devices. So we have some of the leaders who have had very successful exits in companies, including myself. Then we have an advisory board.
• 8:39
  They are the key opinion leaders in men's health from Stanford, from Canada, from practitioners who are considered the godfathers of urology.
• 8:50
  We also have the founder of the Parsemus Foundation, who did all that groundbreak- breaking work back in the early 2000s. And then we have Peter Hutt, recently added.
• 9:00
  He was at the FDA during very productive years in the '70s and has really followed me to al- almost every company I've been a part of, so I'm really pleased to have him to give us the regulatory perspective.
• 9:13
  That really helps us. But as you said, Plan A is a global product, and unplanned pregnancies, as you mentioned, have physical consequences, mental consequences, and it's directly linked to poverty, generational poverty.
• 9:28
  So this is something that's really gonna make a huge difference on society.
• 9:32
  If you think back to the film clips we see in the '60s of the pill, women in the streets rejoicing, et cetera, I can't wait to see what men do when we release Plan A.
• 9:45
  Yeah, I mean, it's surprising really that it's taken this long, so just kudos to you all for focusing on this and this important topic. What, uh, do you think the demand will be like? What's your sense of...
• 9:58
  First of all, do you expect that it comes to market here in the US, then globally, or certain markets before others? What's kind of your strategy there?
• 10:07
  And what's your sense of the demand for this must, might, must be off the charts, people just already asking [laughs] for it. When's it gonna be on- Absolutely... on market? Yeah, absolutely.
• 10:20
  We have over 50,000 men who have come into our website already because they want to get Plan A as soon as it's available. They would like to be in clinical trials as well if possible.
• 10:30
  So there's great demand, and I think your point is well taken, that most medical innovations take a long time.
• 10:37
  The work on Ozempic, for example, Novo Nordisk started over 30 years ago and then finally came to fruition very recently.
• 10:45
  And I think it's a confluence of our technology today is much advanced over when it was first res- when Plan A was first researched in India.
• 10:56
  And socially, men want to be, as you said, they wanna be involved in family planning in a way that they weren't as interested in maybe 20, 30 years ago. People assume that women have birth control under control.
• 11:10
  There were no side effects. It was just very pleasant. We now know that over 20% of women can't tolerate hormonal birth control. We know that men are struggling looking at their partner and feeling helpless.
• 11:23
  They can't help this person they love, who is having mental issues, physical issues from birth control that they can't tolerate.
• 11:31
  So I think men are very much more interested in being a true partner and being a participant in family planning. And then there's a group of men who also want reproductive autonomy.
• 11:42
  They, as we know in this country, and I hear it in Europe and Asia, couples are waiting longer to have children, so Plan A fits that scenario perfectly.
• 11:52
  We allow couples not to have children when they're not ready, but to wait until they're ready, both financially, career-wise, et cetera.
• 12:01
  And I think the fact that it's reversible, you don't need to go in for surgery, I mean, these are, this is a pretty big transformation. Also, I imagine the cost...
• 12:12
  difference is sub- substantially different, which opens up access in an exciting way or very helpful way globally. Absolutely. Absolutely.
• 12:23
  And the thing that you touched on is that because it's so accessible, because it's such a simple procedure, literally it takes five minutes on each side because there are two vas deferens in, in men.
• 12:35
  The, the thing that really is exciting to me, I've spent a career with medical innovations, and the medical practice very appropriately is cautious.
• 12:45
  So I remember some of those medical innovations, we had to put a whole program together to convince doctors to try our product.
• 12:51
  When I talk to urologists or family practitioners who are s- treating men, they can't wait for this product. They literally are trying to get the product out of our hands as soon as they can.
• 13:03
  So that's gonna be another really important aspect because there's a consumer side. We will reach out and we'll advertise to men about Plan A and its availability.
• 13:13
  In fact, I was just a speaker last week in New York at Marketing to Men, which was very eye-opening on all the work that's going on to help communicate more effectively to men as society is changing.
• 13:25
  So we, we both will have a consumer element as well as a professional, medical professional, training, education, et cetera. So it's really- So that's really interesting.
• 13:34
  So there's an education component direct to consumer. Mm-hmm. And then is it through urologists or who's... what's the right pathway on the professional side or clinical side? Yeah.
• 13:45
  To start with it will be urologists because they're seeing men right now, but a family practitioner who is interested in being trained would be a perfect person.
• 13:54
  And the other thing to think about is men in our demographic, if you look at that 18 to 49-year-old segment, they're really not seeing a doctor routinely for preventative medicine.
• 14:06
  We're being told this by the medical profession, that they really are gonna enjoy having men in earlier so they could do other preventive testing for things that we see on the rise, like prostate issues, different forms of colon cancer, et cetera.
• 14:21
  So I think it's gonna have a major impact on men's health overall. It also helps the doctor. The doctor is gonna have more patients coming in.
• 14:29
  As women, we start going to a gynecologist in our teens and then go every year. Men don't really see a urologist until much later if they have an issue. They have a prostate, kidney stones, or they want a vasectomy.
• 14:41
  So we really... we're really, I think, expanding men's health in general as well as contraception. That's interesting.
• 14:48
  I could see now as a young man, you now go develop that relationship with the urologist at a much younger age. Mm-hmm.
• 14:57
  And then now that you've established, that might prevent other types of health issues for men down the line because you're catching those early because you're educated, you have that relationship.
• 15:07
  I didn't even think of that. That's interesting. No, it's very powerful. It's... as some people say, it's a movement. I'm curious about this conference you mentioned. What were your takeaways? What did you...
• 15:21
  anything surprising to you? Any big takeaways, things that in terms of communicating or educating to the male market around health that really stood out?
• 15:32
  There were so many incredible takeaways of hearing the other speakers talk about how men innately are compassionate, curious, caring, and somehow we have to get back to talking to them in that way to bring out them.
• 15:48
  And we... there were a lot of psychologists, there were a lot of people who have spent decades researching the best way to communicate with men for their health, for their wealth, et cetera.
• 15:59
  So I think it was a groundbreaking meeting, and I think there'll be many more. And you have such a track record yourself on building big, big things.
• 16:10
  What are your biggest lessons learned so far leading Next Life Sciences and the work you're doing with Plan A?
• 16:18
  You know, a lot of, as you said, my history in developing products and having successful exits, which, you know, is important for investors, and we truly appreciate investors.
• 16:29
  They're really the lifeblood of the work we do. We couldn't be... we couldn't do what we're doing without our wonderful investors. You are part of that.
• 16:37
  So I think probably the most compelling difference I've seen in this company, as I pointed out earlier, was the medical community adoption.
• 16:46
  That's something that, as I said, it typically is gonna take a period of time for adoption. Plan A is something that we... the door is open for us immediately.
• 16:58
  That's great, and we're so proud to be investors and supporters of, of what this... what you're bringing to market here. Are you currently fundraising? Are you always fundraising?
• 17:09
  Maybe a lot of investors are gonna hear this. I guess my larger question would be, wave a magic wand, who do you want to connect out with? Who do you want to be reaching out to you and learning more about Plan A?
• 17:24
  Who do you wanna be in touch with? No, thank you, Unity. That's... as you probably hear from other CEOs, we're always [laughs] fundraising. We're always building and fundraising. It's just part of our DNA.
• 17:35
  We've been very fortunate to have raised in our seed rounds over $15 million. We now have Series A, um, underway. That's a $20 million round, and that will get us through all the clinical trials for Plan A.
• 17:48
  As a medical device, we don't need thousands of people. We just need a couple hundred. So I would love to have anyone who's interested in investing in our Series A to contact me. We would love to have them on board.
• 18:02
  And the website is planaformen.com? Correct. I know there's your Next Life Sciences parent company- Right... but the product, Plan A, we're talking about. Is that the best place to send people? That's the best place,
• 18:17
  or feel free to reach out to me on LinkedIn.And excellent. Where do you think-- take us into the future. What do you think the impact is? There's now more options, Plan A is in, in the market. What's the vision?
• 18:32
  What do you see the impact being? Yeah.
• 18:36
  One of the things that our founder says, and it resonates with me, is in the future, people are gonna look back at us and say, "How could you let 50% of your pregnancies be unplanned?
• 18:48
  And your solution was just adding more hormones to women who already couldn't tolerate it? What was wrong with [laughs] you guys?" So I think that's really is very telling of the future is gonna be so different.
• 19:00
  I don't think we can imagine what it's gonna be like to have a male contraceptive, several of them in fact, 'cause there are others in development, on the market in the next five years. So 10 years from now,
• 19:13
  we may not even think that women should be involved in contraception. The tide may change, just like the other speaker on my panel last week was talking about men welcoming women into the wealth discussion.
• 19:27
  And I said, "That's really ironic because now women are welcoming men into the contraceptive conversation." So I think it's gonna be a very different world.
• 19:36
  I think as we pointed out, I think the health of men is gonna be greatly enhanced by what we're doing and getting men into doctor's offices earlier for more preventive testing.
• 19:50
  Yeah, and it's as the more we're talking here, it's you're part of the men's health moonshot, but it's really also part of a women's health moonshot- Mm-hmm... and the access to care moonshot, and all sorts of other...
• 20:03
  It really has, I think, far-reaching implications here. So we're really grateful to have you as a health transformer in our community and to support what you're doing, and we just cannot wait for this to come to market.
• 20:17
  So if you are looking to learn more, you should go definitely look into this, and I think investors that care about these types of things should definitely reach out to Darlene as well. Any last words?
• 20:29
  Any last biggest insights, things you wanna share? You know, we're just so excited about the journey we're on. I have a team that is so committed, and everyone wants to be part of this team as well.
• 20:41
  So it's an ever-growing team of investors, of participants. We're just really fortunate, and I think the world is ready. The world's ready for a really effective, easily reversed male contraceptive. Thank you, Darlene.
• 20:55
  Thank you, Enoch. [upbeat music] And finally, an invitation to all of the extraordinary health transformers.
• 21:04
  Whether you are a startup, someone building the future of health, or whether you are an investor, funder, or buyer of the solutions out there in the marketplace, this is an invitation to you to join the Startup Health member community.
• 21:19
  Learn more at startuphealth.com. Look forward to hopefully seeing you soon. [upbeat music]