Hosted by Heath Fletcher, The Healthy Enterprise explores how innovation, technology, and leadership are reshaping the life sciences industry—from discovery and development to commercialization and care delivery. Each episode features candid, heart-centered conversations with founders, scientists, executives, and investors, sharing real-world experiences and insights for building resilient, future-ready organizations.
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Heath Fletcher (00:01)
Hi there, I'm Heath Fletcher, host of The Healthy Enterprise. This episode is part of a limited series called Money Ball. It's in conjunction with the BLPN club. BLPN's Money Ball program helps founders step up to the plate and knock fundraising out of the park. You'll hear about the people, their ventures, and their pitch-making experiences. I hope you enjoy it.
Okay, Robert, thank you for joining me for this ⁓ special episode of the Money Ball series with the BLPN looking forward to hearing about your experience ⁓ in this journey ⁓ with them and ⁓ you can tell us all about Plakous Therapeutics.
Robert Boyce (00:38)
Thanks very much. I appreciate the opportunity. So Rob Boyce, CEO of Plakous Therapeutics, ⁓ a regenerative medicine company founded ⁓ in late 2016 with a mission to leverage placental tissue to drive ⁓ diseases of inflammation. Our initial focus is on a disease called necrotizing enterocolitis, or NEK.
And it's a devastating disease that affects severely premature babies. And then, either we're talking about babies that are born before 28 weeks of gestation, normal gestation being 40 weeks. So we're talking three or four months early, weighing less than two, two and a half pounds. And their GI tract is not developed and they get runaway inflammation, the tissue can die. And tragically, these babies.
About a third of the babies that are diagnosed with NAC ultimately will die from the disease. Yeah, it's a tough one.
Heath Fletcher (01:45)
⁓ And so how long has this disease been in existence? for a long time or?
Robert Boyce (01:52)
Yeah, interesting questions.
I was initially diagnosed probably in the 70s. ⁓ Babies that were born before 30 weeks, you know, many years back certainly wouldn't survive. ⁓ the opportunity for our product, you know, is bigger in Western or more advanced countries because you have to have an infrastructure where there's even an opportunity for a baby born this prematurely.
to have their lungs develop to a point where frankly they become at risk for neck. So it's been around again, 40, 50 years clear diagnosis of the disease. And it's interesting we operate in the neonatal intensive care unit. That's where we'll be treating the babies and our medicine will be used. And there's just not been a lot of effort.
put into this patient population and ⁓ developing medicines for these babies. Interestingly, Heath, the last time, a stab at how long it's been since the FDA approved a to specifically design for babies in the NICU.
Heath Fletcher (03:12)
Oh, yeah, are we talking like 30 years?
Robert Boyce (03:16)
We are talking 30 years. 1991 was the last time the FDA approved a medicine that was specifically designed for babies in the NICU. So that makes it a challenge because you're in this negative do-loom where, you know, we struggle with understanding a clear pathway. You know, we understand what our regulatory requirements will be, but there's not a lot of reason precedent for this.
you know, investors are a little leery because they say, well, you know, what's your regulatory path? Here's our regulatory path. What's, are there many companies that have done this? Well, not a long time. Now we're fortunate there are a couple of other companies now that are coming, developing products for other diseases of these, the same patient population. So we're hoping that a rising tide will in fact raise all boats here and we'll have an opportunity to bring our product to market and
that this patient population, the most vulnerable and frankly, those with the most opportunity for lifetime value will benefit.
Heath Fletcher (04:23)
Was there a particular moment where this idea was sparked for this denture? there.
Robert Boyce (04:28)
Sure. So our founder, Scott Washburn, is a practicing obstetrician gynecologist. And years back, about 15, 18 years ago, he started a birth tissue, specific tissue bank. And that tissue bank was capturing donated tissue, umbilical cord, placental discs, embryotic membrane, amniotic, excuse me, membranes. And
using those products for primarily wound healing. And he thought, well, the placental disc, the actual organ itself is rich in proteins and has great immunomodulatory accepting factors within the body. So why don't we develop some products for that? And his partners weren't interested in doing that. And as a result, he said, you know what, I'm going to sell my piece of the business here at this ⁓
birth tissue tissue bank and start a company to develop products. And that was the genesis of Plaincoast back in 2016 with a focus ⁓ on regenerative medicine. we ultimately coalesced having looked at a number of different indications on necrotizing enteroclonus because of the medical need. know, currently, Keith, there are no ⁓ FDA approved products for this disease. And there are no diagnostic tests. So
There's a patient population in the U.S. of about 50,000 babies who are at risk for this disease. And there's only fortunately about 3,000 that are diagnosed. The challenge is we don't know which of those 50,000 are gonna get this disease. And so our plan at Plakous will be to treat those at risk babies prophylactically from the time they're born to prevent this disease from happening.
Heath Fletcher (06:24)
very interesting wow okay so how is how does play coast do this how do you do how do you do this what's the
Robert Boyce (06:32)
The product itself, essentially what we do is we pull all of the proteins out of the organ, the placental organ. So we, in a simplified fashion, what we do is we lyse or pop, if you will, the cells, extract the proteins, and then we ultimately will lyophilize or dehydrate the product after we've processed it. And what we're left with is a shelf stable powder that
represents all of the proteins, the growth factors, the cytokines that exist in amniotic fluid we've captured. And interestingly, our product mimics amniotic fluid at mid-pregnancy, and that's where our patients, you know, should be mid-pregnancy. instead, they've been born for whatever reason, severely prematurely. the notion of playcosis human placental extract is to
Rehydrate this product in breast milk, you know mom's milk if she's able to pump and or donated breast milk and and that's kind of the standard of care in the nicu is to Put our product back in here to use breast milk for these babies and there's been significant benefits shown in using breast milk, but By adding our product which mimics amniotic fluid to their feeds
What we're able to do is put an amniotic fluid like product back into that nascent gut and provide the signaling to help their GI tract develop and continue to develop as if it were still in uterus.
Heath Fletcher (08:17)
Very interesting, Yeah. Wow. So you must get very interesting feedback when you present this first time to ⁓ potential investors or other people.
Robert Boyce (08:29)
We do. And I mean, it's fair to say that we open our presentation with a case study, a little girl named Laurel who was born at Duke University Hospital here in North Carolina. When she was born, she eight a pound and a half. You could literally hold her in the palm of your hand. Within 10 days of life, she was diagnosed with necrotizing enterocholitis, had emergency surgery to save her life.
She spent the next five months in the neonatal intensive care unit, went home, had to come back into the hospital for infections and had two additional surgeries. So Laurel is today a thriving six-year-old, but she is not without challenges from the fact that she had to be opened up at 10 days of life, only 20.
six weeks of gestation in order for her life to be saved. So it's a challenging disease ⁓ and it's a very, presents a good story. mean, certainly you can appreciate and everyone can visualize Laurel, ⁓ which is great, but it's not without challenges. And certainly when you present, people appreciate that you're going after babies and it's noble, you people.
But they're also cautious for reasons I alluded to earlier around the regulatory pathway. We've got a very robust source. There are hundreds of thousands of donated tissue every year. So there's a huge abundance of the resource material that we need to make our product. It's fundamentally safe. It mimics amniotic fluid. So we feel very good about
the safety profile of the product, the abundance of the resources. But it's a tough time to raise money right now. that's the challenge we have is it's a good story, but it's rare, it's pediatric, and that's an area that people are cautious of.
Heath Fletcher (10:40)
If we can use Laurel as the example here as your case study, ⁓ maybe go back and if Laurel had had access to this product at the time of when it was discovered, how could that have shifted Laurel's outcome?
Robert Boyce (10:57)
So, believe that, so necrotizing enterocolitis is essentially a death of the GI tract. So, your GI tract gets infected and ultimately the cells die and that disrupts flow. What we've seen in our preclinical work, Heath, is that the product in treated animals, the GI tract is in fact developing. We're seeing the tract developing.
what we didn't see in our preclinical work was any perforations where the gut actually died, opened up and it got infected and what was in the intestinal cavity gets inside and what's inside gets out. So we believe that our product will eliminate surgical necrotizing interplays. We can provide the nutrients or the proteins to allow the body to accept food.
grow and become healthy without that surgical component. Can we shift the curve of this disease so that the most severe cases don't happen and that maybe you get a mild case? And while we're not a vaccine, that's not a bad analog for what we are. If you get NEC, maybe you get a less severe case, but we're going to prevent the worst cases. So ⁓ we believe that Laurel wouldn't have had potentially some of the
neurodevelopmental issues that she does struggle with. Because what we know is if you have to have surgery at this age, and again, about one third of the babies, the 3,000 that are diagnosed, will require surgery. There's the correlation between having a neurologic deficit if you've had to have surgery is extremely high, well over 70%. So if you can prevent the surgery, you can take
a lot of the comorbidities, neurologic deficit out of the equation, which we think is a tremendous opportunity. And frankly, from a ⁓ very pragmatic approach, it's where most of the cost is for this disease. Laurel's first year of life was well over $985,000, so just about a million dollars in costs in her first year of life. And those numbers are pretty...
pretty typical for a baby that gets neck. It is, you're a million dollar baby and that's an expensive disease.
Heath Fletcher (13:32)
Yeah, no, pretty much so. You started talking about it ⁓ briefly about on being on the funding track and looking sure ⁓ investments, which is why you are involved in the Money Ball program. Yeah. So tell me about ⁓ when did you decide actually maybe for a second here, when did you become when did you come on board? ⁓
Robert Boyce (13:58)
So I joined Playcos in 2019. So the company's about three years old. ⁓ We had some early proof of concept data that said, hey, this is probably going to take. And one of our board members, ⁓ with whom I worked at Johnson & Johnson back in the day, you will, ⁓ called me up. She's on the board and said, hey, I think this is a really good opportunity for you. And I think you ought to take a serious look. And I did. Got to meet the founder.
looked at the science and said, yeah, I think there's something here. And so I left my last startup to ⁓ join PlayCoast.
Heath Fletcher (14:37)
Alright, and fast forward, we're here now and at some point ⁓ you decided that getting on board with BLPN and the Money Ball program was going to be, what triggered you to do that? What was kind of the inspiration behind that?
Robert Boyce (14:53)
Sure,
well, I first came on board with the BLPN. This will be now my third BLPN JP Morgan conference. you know, I first, I don't even know how I was first introduced, but I came across Christian and the team and they were organizing sort of a how to manage JP Morgan conference. And I was really impressed with the...
program that they had put together in the knowledge base that existed and then had an opportunity to participate, visit the team, and was really impressed. And so, we've been participated and active with the BLPN for several bio conferences now. And as I said, this will be my third JPMorgan conference being engaged with the group because I think they do a great job of helping me get prepared, helping me get exposure, me being
Lake Coast get exposure at the event to folks that can make a difference in where we're headed.
Heath Fletcher (15:56)
What were you experiencing in that pitching process that you felt you needed a little bit more support on or little bit more strengthening? ⁓
Robert Boyce (16:05)
know, there's a lot
of things. I think we've got a good story. It's really tighten up the ask. To me, the biggest challenge where presentations I've done have really hinged is, know, they want to one of doing any presentation is know your audience. The challenge is when you're ⁓ knowing is this audience someone who can fund me for
$5 million? Can they fund me to $10 million? Can they fund me to $20 million? And, you know, it's that's a challenge in making sure you've got the right message for the right audience is key. I think that that's been very helpful at the BLPN and is knowing who's on the other side of the table at different times because I've presented through the BLPN to folks that are, you know, can help me with my $20 million. It isn't some that would be more appropriate for five.
Heath Fletcher (17:04)
And it's important for you to understand that because what you ask or how you ask is different.
Robert Boyce (17:11)
Exactly. And the positioning. right now I'm targeting a $20 million raise. I could pivot that to an $8 million raise and then a follow on. I've got a business plan laid out that will allow me to bring in $60 million now in, know, milestones, you know, with clear cut milestones.
And so working with the BLPN, I've been able to hone that in to, okay, you're looking for five to eight million bucks. What are you asking for? How are you gonna put the, you what's the use of funds for that? And what are the milestones? Okay, you're asking for 20. Now, okay, what are you gonna do with 20? Well, I'm gonna do the eight million, which is my IND enabling work. And then I'm gonna follow that up with a phase one to study. And that's what it's gonna look like. if.
So that's 20 million all in. If someone were to come and syndicate for $60 million, what we would do is significantly accelerate our manufacturing to take my cost of goods down so that on my ramp, I will have to see profitability much sooner. So I've built a plan with guidance from folks on the team to look at different ways to approach different investors. And we need...
in excess of 60, it's a matter of when and
Heath Fletcher (18:41)
Interesting. And you find investors are they're all looking for something different? Or they all they're all looking at you going, okay, let's hear what this guy has to say. ⁓ Are they going to tell as you tell me what I want to hear? Is he telling me the facts? Right? How are they? What's in their head? What are they going through right in that moment?
Robert Boyce (18:59)
Well, yeah, my perspective, Heath, is that every investor is ultimately, while they're there to make investments, they see hundreds and hundreds. They're also looking for reasons to say no. And the key is, how can I ensure that my presentation resonates so that they don't say no this time? the goal of any
initial pitch is not to raise money. It's to expose a potential investor to a story that's fact-based, that drives to a therapy which you have science and data to support that leads me to say, you know, Ram, I'd like to talk a little bit more about that. I'd like to
scratch a little bit below the surface to understand a little bit more about Laurel and this disease, a little bit more about your patient population and the pricing. And I'd like to learn a little bit more about your FDA interactions and what the regulatory risk is and how you have mitigated it and how you plan to mitigate it going further. So it's all about spending all of the time to create the building blocks of the model.
of the story so that you can get that down to an effective five minute presentation, which is actually the culmination of hundreds and hundreds of hours of labor to make sure you can defend every word of that presentation.
The only other thing I'll say is making sure that you take that complex story and simplify it. I think a lot of the people that I've seen struggle are very bright, very capable scientists with great ideas that struggle to get the story in a compelling way. And so I think that, again, that's something that
has been the BLPN team has been very in the coaching has been very helpful is making sure you've got the right balance between the story, the facts, enough data to support the initial idea. You need to have it all, but yeah, be sure you don't spend too much time on the science.
Heath Fletcher (21:38)
Yeah, you can baffle people with science with brilliance, right? If you put too much of it there. And interesting, your ⁓ position being CEO ⁓ is that you're not the founder. And often sometimes, or often the founder is usually in the pitching seat, right? And do you find that there's a significant difference between being the founder and delivering a pitch as it is being the CEO and delivering a pitch?
Robert Boyce (22:05)
Now, I think it can go both ways. I applaud, I'm here, so therefore I must, but I applaud Scott Washburn, our founder, for saying early on, this is not my skill set. He's an idea guy and he's tremendous at it and he's constantly pulling us forward with the science and leveraging it into a lot of places, but this isn't his strength. There are a lot of founders who are
Deller presenters and can articulate the story deep into the science, but also bring it to the surface. I look at my core strength and coming out of the military, having flown airplanes, the Navy, and then I went to J &J on the marketing side. I come to it as, where's the story? Do I have the facts? I bring, I'm a data hound. ⁓
much as I don't create the data and I'm not a scientist, I'm mathematician by training. So I have an analytical bent, I'm a storyteller. And if the facts are there, I like being able to tell that story.
Heath Fletcher (23:22)
Great. What's been your biggest challenge in the process here that you find, ⁓ whether it's from the perspective of the company or your own personal perspective?
Robert Boyce (23:34)
I think that the biggest challenge that I'm facing right now is it's in large part, it's the macro challenge that that anyone investing right now is that, you there's challenges with science, there's challenges with ⁓ the regulatory agencies and where things are going. And some of that disruption is taking the luster off of the buyer industry as a whole.
Certainly that's created significant headwinds and that we're not unique in that. So that's certainly a challenge. Unique to Plakous, ⁓ regenerative medicine is an area that if you understand, you can value. But it's an area that a lot of people don't look at or think about per se. So that's something certainly that I focus to try and put people at ease that
being a birth tissue derived product, our product is still fundamentally safe. We don't have supply chain issues. ⁓ And the benefit, the upside, is that we've got a product that's going to be well accepted in our patient population. And to this point, the data truly support that we are, in fact, regenerating that GI tract in these itty bitties.
at least in the preclinical model of premature porcine model that we're currently using.
Heath Fletcher (25:10)
And a few more questions here before we wrap up. But what stage are you guys at right now anyways?
Robert Boyce (25:17)
So right now we're, I guess, looking for a series A. So we're in the process now. So we're pre-clinical. We're raising money to finish up an IND enabling study and get the manufacturing ready for the TOC study and an IND submission. We're in the midst of a technology transfer to our contract manufacturing partner. That's going very well and looking to have
product queued up so that once the funds come, we're ready to run that final tox safety study and submit an IND. So we're looking in that respect, it's about $8 million that we're looking to raise that'll get us through the IND and into that phase one, two clinical study. ⁓ We've raised about 10 million today. About half of that, he
through NIH funding and the other half through primarily ultra-high net worth investors in convertible notes, a series of convertible notes. So we've done well with what we have, but it's time to take the next step. So ultimately, we'd love to find a partner to help lead that series A raise.
Heath Fletcher (26:42)
Okay well on that note if someone's looking to get more information from you how do they connect with you Rob?
Robert Boyce (26:48)
Well, certainly Rob Boyce at Plakous Therapeutics, can contact me through the website and certainly on LinkedIn. It's probably nowadays the best way to connect through, reach out, and I'm pretty active there. And yeah, we'd love to talk if anybody out there is interested in an investment, knows someone who may be interested in this rare pediatric space. But you know, we're going to make a difference for a group
patients that has been neglected for too long and has great opportunity for a long life to make a big difference.
Heath Fletcher (27:26)
It's an cause. So, well, good luck with everything in coming weeks. You're heading to JP Morgan Week in San Francisco in January, correct? Hopefully we'll see each other in person there and catch up again. So anyways, best of luck with all of that. And thank you for joining me today, Rob. I really appreciate your time. Thanks, Steve. You're in the story. ⁓
Robert Boyce (27:37)
Looking forward to it.
And then thanks
to the Healthy Enterprise, I really appreciate the opportunity.