John Simboli:
0:00
Today I'm speaking with Mike Gaffney, CEO at Cellphire Therapeutics, headquartered in Rockville, Maryland. Welcome to BioBoss. Mike.
Mike Gaffney:
0:09
Thanks, John, delighted to be here.
John Simboli:
0:11
Mike, what led you to role as CEO of Cellphire Therapeutics?
Mike Gaffney:
0:15
It's certainly been an interesting journey. As my wife highlighted, when I joined the company, everything I've done before this, in her mind kind of aligns to what we're doing here. Cellphire is developing, hopefully, life saving cellular therapeutics made from platelets; it stops bleeding. And we'll talk a little bit later about the potential impact we might have. But we're solving what I think people had concluded was an intractable problem. And we're excited about that. So there's a real opportunity to have a big impact, which is quite important to me. My journey here, way back when I was a naval officer, served in the Submarine Force, and I have engineering training as well as that military service. You're at the pointy end of the spear, and it can be kind of scary. And then I spent the last 25 years in a variety of different roles, helping to build businesses, and building businesses is about, as this podcast is a bit about leadership. To the "boss" side, it's easy to say the leadership and the human component of that is the stuff that's quite important and understanding, technically—process, how do you get stuff done? How do you get from here to there. It's always a journey. You can say, here's where I want to get to, but at the end of the day, it aligns to a couple of key principles, which was the other part that I thought was relevant to me joining Cellphire. I can see, from the outside looking at a really good team, some really good people and an opportunity to help a lot of people with our technologies, though they were struggling with some key natural growth elements. Where do you want to spend our time and focus organizationally on the things that will have the biggest impact. We were really good at the science, we had lots of interesting scientific insights and paths we could go down, but there wasn't a sense of direction we identified. In all these cases, I found people that are key. The quality of the talent, the quality of the team, and their alignment engagement with what you're trying to achieve. And we talk about phase appropriate in pharma, kind of lifecycle appropriate for a company and its journey, bringing people from large pharma into a small venture Stage Company. Talent, maybe their insight, maybe their understanding . . . you know, I don't have a team of 20, who are going to execute X, Y, and Z, I need to roll up my sleeves. And I need to be excited about that, though, it may be challenging at points in time. These are some of the components that I bring to Cellphire, which is all part of my journey. How do you attract talent? How do you focus a talented, committed team, focused on an objective, and then attract the partners, capital partners, and the right collaborators to be successful. That's what I've built my career round. And I'm excited to bring that here.
John Simboli:
3:06
From what I understand of the Cellphire technology, if you do get the approvals that you're hoping to get, it could help a lot of people. Some of those people, the portion that are at the pointy end of the spear, that must have a special resonance for you, I would guess.
Mike Gaffney:
3:25
Absolutely. And what's interesting, there's a history here around the military use case. Deployed people who are in harm's way, and we want to make sure they have, and the people helping them have the tools that they need to save lives and avoid the sort of challenges that otherwise happen. We've all seen Mash and things like that. And that's pretty scary stuff. What is really exciting is this is a universal problem, that we're focused on the availability of hemostatic agents, platelets are the only one that really exists that does primary and secondary hemostasis. But that's the only tool that's available. That tool has material limitations. And we think we can solve that problem because of our technology to create an allogeneic, shelf, stable, hemostatic agent that you could put in your backpack, that you could store on your ship, that you could take to third world countries that don't have the infrastructure to address and solve this problem. Because it's a really complicated supply chain, and it's really hard to do. And so that affects people like my sister. She's in Poteau, Oklahoma, it's a very, very rural market. And the closest hospital that has platelets on the shelves is in Tulsa, four hours away. So if there's a car accident, if there's a you know, a delivery, maternal hemorrhage, and the like, that is a massive opportunity to help a lot of people in a lot of different markets. And it's interesting that in a first world economy like the United States, 33% of the hospitals don't have platelets on the shelves. We can solve that problem when we get our products approved. And that's what we talk about every day with our team, and how that will help. Moms, rural areas, third world countries, patients who are fragile and otherwise might have challenges, as well as folks at the pointy end of the spear. And have a big impact, we hope, on life-threatening trauma, and the like, that would be material for the broader clinical needs that are out there.
John Simboli:
5:31
Can you recall what it was about Cellphire that made you say, I think I really want to pursue this one?
Mike Gaffney:
5:35
This was the one that I could see a big impact,
John Simboli:
5:36
Did you ever go through that phase where you fit all of the things that I wanted to do, as well as the thought, Well, I really want to lead this company, but I'm not path that I saw the company would need to take. I could be a really helpful player, a person who could provide the let's figure out what we ought to focus on. Where do we want to spend our time? And had a lot of experience around. It was also a challenge. I've been executive chairman or CEO of lots of sure I want to be the CEO, or did you know from the beginning, different companies. Life sciences is something that I've had some exposure to. When the board approached me about this, we all said, Okay, this is what I'm good at, I can lead, I can help get us focused, again, raise capital. I can work with and build a team. I can attract collaborators and team members. And all that other stuff with the team has been interesting. Not being the expert for them, is been really helpful, because no, this only makes sense if I'm the CEO? I can just ask questions, and that's the sort of stuff that made it, for me, something that I was excited to get involved with. For two years into the journey, and we made a lot of progress to achieve our "We save lives" vision, we feel good about that. But it's been, certainly a leadership challenge. And in a lot of interesting ways.
Mike Gaffney:
7:08
For this company, this is how I've always thought about it, I did a lot of athletic things throughout my life, particularly in high school and college. I wasn't particularly good at many of them. But I really enjoyed the challenges of being on a team. We're setting out to try and achieve these objectives. And there's some lessons there that also relate to business, because they're human lessons of determining, what are we about? How do we treat each other? How do we think about values in that context, and allow ourselves to focus on getting the people in the right spot in a prepared way. I looked at this company and the thing they were missing the most was principled, values-oriented leadership, that would unlock the technical insights, the energy of the team and people, as well as the opportunity to have a big impact. Because we were spending a lot of time on science and we weren't thinking about what is the end in mind. More about us and what we're about. And, you know, service in leadership is, I think the only way to be successful. You don't do anything. When I was in the Navy, I talked about, with my team, there were only two things I was allowed to do. I could operate a periscope, and I could use a pen. And otherwise I was not allowed to touch anything. Those are the things I can operate. The other stuff you guys have to do well. My job is to help you be successful, remove obstacles, make sure we have the right training and talent and resources. And if we don't have them, I've got to go get them. That was the thing that I saw Cellphire was missing, creating the, all lright, here's what we ought to go do. Here's the things that we're probably not going to go do therefor,e and how do we get there together and recruit in those internal or external insights, or leaders tend to make that stuff happen?
John Simboli:
9:16
Could you imagine, in the early steps when you're first looking at Cellphire, one of the reasons this is interesting to me is because it may or may not be differentiated, in terms of products it can create someday?
Mike Gaffney:
9:27
From the outside looking in with Cellphire, the differentiation related simply to the unmet need around hemostatic agents. Platelet availability is a global problem. Platelets are not available in first world markets, much less second and third world markets across the globe. Someone was just telling me today, China is in a crisis, post-COVID And we've seen this in lots of countries, but you know, interesting in a very large population, very dense population and one with, a fair bit of command and control that will allow you to say, hey, everybody's going to donate, rather than the volunteer thing that might happen in United States. And they have a big problem related to how long can you store this stuff. It's a supply chain issue. And you can only store this stuff seven days. If you think of the engineering problem of how do I manage the logistics from donation of an allogeneic product to delivery or use clinically, and I've got seven days to work with, it'd be, I don't have the analogy for this. It'd be like building a house with something that only lasts seven days, it's kind of like building the ice bars, that are really cool, but they melt very quickly. And so you've got a very narrow window. And so unless somebody is paying a lot of money, it's hard to make sense of that business. And that's the need in the marketplace. What we do is we make shelf-stable hemostatic agents from platelets, with a three to five year, depending on the technology, shelf life. So you take seven days, and you create a huge time window that I can now do things with, to address that supply chain issue. That was the thing that kind of checked the box early for me. There is a really important thing, if we're successful, that we can address. What's been interesting, differentiation was about time. That has some benefits to it, but you also run into the Okay, really, how much value do you add other than you can stick this stuff on the shelf? In my early investigation engagements with the team as we're working through the "What do we want to spend our time on? And how do we best position the initial products for success?" was teasing out and starting to see and help the group see, the potential differentiation that there is with our products. And how do we improve the differentiation. Our freeze dried product, we call the technology freeze dried platelet derived hemostat, FPH. Actually, because of the process and the various components, we take platelets, we batch them up and then we manufacture in a process and we lyophilize, the freeze dry them, because of the impact on the cells in that process. We actually have an amplification of certain components that will deliver some interesting therapeutic effects. And that differentiation, in addition to shelf life, is in very significant populations, we think we can have a big, big, big impact. So I was talking earlier about the military use case, maternal hemorrhage context, rural markets, trauma, and there are lots of people on anti-platelet therapies, 10 million people United States are on anti-platelet therapies. If they have an urgent or even just a regularly scheduled procedure, that's hard for a surgeon, a clinical team to address. It turns out that our stuff, FPH, in that context, actually performs better in vitro, by a long way, compared to liquid stored platelets. And having that come to the forefront for the team, we had the data, we had the science, there was kind of a this was an interesting experiment. We've also got some really interesting experiments about the potential impact on intracranial hemorrhage, where there are no therapeutics. And both of those are categories where there aren't great solutions, there are not tools. Surgeons talk all the time about if someone's on anti-platelet therapy, it's really hard to stop the bleeding in a surgical procedure or even a traumatic event, it's even worse. Brain hemorrhage. similarly, I don't have great tools. We're solving a problem that people have kind of just accepted as intractable. And now we think we can solve it and have a huge impact from a differentiation perspective. And as we're talking to investors or collaborators, we're highlighting, not only is this stuff shelf stable for three years, and easy to administer, but also here are populations where we've got millions of people with significant disease or clinical burdens. And the science is telling us we can differentiate in the material way. That's really exciting. I didn't know that when I got here. But that's part of the venture journey is let's look at the data and see what it says. Having the team highlight that for me, being I don't know, dumb enough or smart enough, or somewhere in between, to say that's interesting, let's learn more about that, has been, I think, an important part of the company journey. That willingness to listen is leadership is an important part of that service.
John Simboli:
14:47
Can you talk to me about differentiation in the sense that, my understanding is that currently, blood has to be, of course, accounted for each person's blood type. Your product, potentially, has a, I don't know if the word universality is the right word, but has that much broader application? Is that true? Do I have that right?
Mike Gaffney:
15:06
Yes, in the in the context of our product and its universal use, that makes it simpler to go to the shelf and say, Okay, I just need to grab that. That said, the blood banks who manage most of these products, they do an excellent job of matching components. What's relevant to us is we can do both things, we can establish universality in a shelf stable way so it's very well understood. And then, different from the blood banks, because we do a batch process, we can actually test to confirm that. Rather than I've typed you, John, I've typed Mike. And then I also need to test you for viral contaminations, everything else, but if something happens later, that I find out about, oh, gosh, you had COVID, and that creates issues as a donor, then I've got to pull it back. A very complicated supply chain that the blood banks have to manage. We can address that upfront with our ability to take small samples from the batch, just like any biopharmaceutical batch, and do the testing and the quality control upfront. So there are some benefits from a safety perspective, that once approved, we think our product will bring to the market, from the differentiation. And that's important because you know, we want to improve what we're doing. We want improve the broader solutions that are available, because otherwise, why are we doing this?
John Simboli:
16:30
When you meet someone, let's say through a family connection, and perhaps they don't really know much about biopharma, or they don't know much about what Cellphire is doing? They may say, well, what are you doing? What's your job like? How do you explain that in the terms of what I do all day? How do you say it? And do they understand it?
Mike Gaffney:
16:53
The simple, declarative answer is, I have a lot of meetings. I have a lot of phone calls. So that doesn't resonate with anybody at all, because that's just not exciting. It's not an interesting thing. And in those meetings, every day, you're trying to make a little bit of incremental improvement. There's no big aha or big event. There's very few seminal events. It's incremental improvement. I was talking about when I was a venture capitalist, about the difference between a very good management team, and just an okay, or good management team is 10%. 10%, every day. If you can make a 10% improvement every day, be 10% better. At the end of the day, you're going to build a really interesting, successful company. And that's what we strive for, in that context. So the tactical or specific answer is I have a lot of meetings. And it's with all the things that you would expect, our existing team, what are what are we spending our time on strategy? How are we getting stuff done? Accounts payable, accounts receivable, all that sort of stuff. I generally don't talk about that. Instead, I talk about, the potential impact, and what's the problem, because that's the stuff that matters to people. And I think it's important for our team and me, when we're having those meetings, we're trying to be 5% and, hopefully 10% better, that we have a sense of here's where we're going. That's hard to do, because you get involved in day to day, people challenges, you get tired, you get hungry, whatever it might be. And it's important to me to focus on that. So I answer the question around, here's what we're trying to do. As opposed to what do I do?
John Simboli:
18:48
As you can recall being a young person, eight or nine or 10, or whatever is the correct appropriate age for you, and you've tried to remember Oh, yeah, when I grew up, I want to be, and for most of us, that was like, what would my parents think I should be when I grow up kind of stuff. Can you recall what that image was? And does it have anything to do with what you're doing today, professionally?
Mike Gaffney:
19:08
Quick answer was, well, I want to be a nuclear physicist. which is like, Okay, you're eight or nine? As I look at that, one, it's silly, it sounds egocentric, or how smart am I and everything else, but what I was really saying is I want to do something that's hard. And I want to do something that has some technical challenges to it. And that has, in my mind at that time, and I think it's still consistent, has an important element of service. Because my dad was a submarine officer, as well. And he actually studied nuclear engineering when he was at the Naval Academy. I think that was the derivative way to say those things. There's somethin about that impact and what he was about from a service perspective, what his friends were about. And those three components of do something hard, do something that has some real technical challenges to it, and would have a bit of positive service benefit, was really what I was saying. I didn't know I was saying that at the time. But I think that was, as I look back, how I interpret that eight or nine thing.
John Simboli:
20:27
When you look at other companies that may be looking to solve similar problems, do you see others? If you do see others, do see your approach being a different way of looking at the problem?
Mike Gaffney:
20:40
There are always competitors. And they fall into two categories, folks who are pursuing very small, incremental improvements to the existing source or supply, So going from seven days to 14 days, things like that. And then there's a number of others. And I totally understand where this comes from, that are doin "This is really cool science, we're going to make these things from mesenchymal stem cells, or we're going to make an artificial one. And it's going to be made up of nanobots and all sorts of stuff." And ultimately that stuff will work. We are doing the, which appeals to my engineering brand, we are doing the practical thing. Let's make this stuff shelf stable. It's not going to be sexy science. But when we're successful, it's going to save a lot of lives. So we don't have that sexy, wow, this is cool sort of platform sizzle to it. But we know what we're trying to get done. And it's going to impact millions of lives around the world when we're successful.
John Simboli:
21:44
Let's say you're at an investor conference, and you give a description, more or less like what you just told me, but of course, in an expanded format, and then you're going toi get probably some people who say, Oh, I see, you're like the first group that you mentioned, the incremental group, or some other investors might say, Oh, I see. You're in the the sexy scientific platform approach. And then you probably spend some time saying, well, actually, this is where we are. Is there a pattern in which people might pigeonhole incorrectly? And then how do you help them get back on track?
Mike Gaffney:
22:22
The biggest pigeonhole challenge the company has relates to the broader biopharmaceutical market environment, is scientifically driven. And it should be because at the end of the day, it's scientific developments really where the technology sparks. The challenge for Cellphire and the investors kind of taking a look at it is, it's not going to be sexy. And it's not just science that is going to allow us to be successful. It's being smart about where do we focus our clinical development for approval? It's going to do that with a mind to where are the big unmet needs and differentiation, where we talked about earlier, but also, how do we supply against the demand from a supply chain and production perspective, in a way that achieves an attractive economic outcome for both customers, the patients as well as for the company. Which is different, it certainly falls in the psychotherapeutic world, where that has become much clearer over the last 10 to 15 years that that's an important part of that successful business model. But a lot different than small molecule, or even stem cell production solution sets where you have no constraints on how you think about your production process and everything else. So that's a different thing. So helping them understand that and also understand that's actually a relatively low risk proposition. It's not does it work or not? It's how do you execute against all those components to be successful? Bringing that technology that, does it work or not, in these clinical settings, to market. That's where the risk sits. And we're so far advanced around understanding the science and where our products are, from a developmental perspective, they're in phase two, that for us, it's about folks who are willing to spend enough time and are interested in how we might have that sort of impact from a commercial perspective. We're not sexy. And how do you then get over the sales challenge of everybody wants sexy science. That that's the problem or challenge that I have in communicating and representing the company and what we're about doing, what we're looking to achieve and where we need capital and investors support to be successful.
John Simboli:
25:04
At this point, do you allow yourself, personally or in your meetings, to to describe how it's going to affect the lives of people? Military, it seems pretty straightforward. People can maybe grasp that. Maybe in terms of Emergency Room needs and things like that. How big a deal is this if your drugs get approved?
Mike Gaffney:
25:23
So it's, it's a very big deal. It falls into multiple categories. So I'll kind of pick one or two. So my daughter, my oldest daughter, Claire, she goes to business school in New England, and has an internship in Seattle. So she drove in three days, from New England, to Seattle, and my wife and I spent the whole time worrying about that. Pictures I actually show our team, I won't show them here, but it's a horrific car crash on the side of a rural road. And you look at that and say, Oh, my gosh, the likelihood of those people surviving without great care is very, very small. And the statistic is American Red Cross serves half of the hospitals in the United States. 33% of them don't have platelets on the shelves. So, okay, Claire, make sure when you get into that accident, if it happens, you're within 10 miles of that hospital that has that liquid stored, platele on the shelves until we get our products approved. That's the sort of impact we can have. There are patients who have immune reactions to receiving transfusions. And because of those immune reactions, that has significant clinical effects and particularly fragile patients, where there aren't good solutions, we can solve those problems for them. Maternal hemorrhage is one of the largest killers of women globally. And the only tool or the best tool that exists, and there are a number of folks who tried to solve this problem, is platelets. But most third world countries don't even have platelets, anywhere much less, you know, kind of on the shelf. So the impact we can have in our day to day lives in ways that touch all of us is significant. What's interesting is, people just accept what we have. Because the solution set that's available is either that really cool science that's 30 years away from ever getting to the shelves, or incremental improvement that doesn't address this massive gap of safety, efficacy, and availability. That's the thing that will have a big impact at the end of the day. That's where I have to start the conversation because otherwise people don't get, Okay, it's not cool science, why did you choose to spend time on it? Let me just tell you a story, Claire driving driving to Seattle in three days, which is nuts. But that's Claire, you know, what were her parents doing? We were hoping she was driving by hospitals that have platelets on the shelves, knowing that in South Dakota, knowing that in Idaho and other states, there's not a lot on the shelves, and we're just going to hope she doesn't get into an accident there.
John Simboli:
28:08
For the two products categories that you have right now, can you just describe them for a little bit in broad terms, and maybe talk perhaps about how the pipeline expresses your vision for what you're setting out to do with the company?
Mike Gaffney:
28:20
We talked about two technologies. We have a cryopreserved or frozen. And then we have the freeze dried.The cryopreserved is about, we're working closely with the army on this, they've been a great funding partner, addressing availability as quickly as we can, from a timeline or approval perspective. We're doing some things, technically, that we think will expand that market to a degree but it's cryopreserved, it's frozen, so you have to have a cold chain, we think we can improve the product. So the cold chain would actually include your home freezer, John, so you can have a unit on the shelf or the hospital can in a rural market, because they don't have an ultra cold chain.. And we're targeting somewhere on the 27-28 timeframe for approval. That will be a nice and important impact, near term, on that availability, rural markets, as well as the military use case. But you can't put a frozen platelet unit in your backpack. You can't do that as easily in rural ane in third world hospitals. That's where the freeze dried platelet haemostatic technology comes from. As I mentioned earlier, we're starting to tease out and we've done, I think a good job as a team, where can we really have an impact and what is that differentiation? It's not just availability, but it's about efficacy and clinical impact. And there's three categories: one, which we're really excited about is the ability to help an orphan or ultra orphan population that is very fragile because they have genetic platelet disorders and in their disease progression, there's a lot of challenges. One particular category Hermansky Pudlak Disease, put like disease, and most of those within a particular genetic allele will require a lung transplant by the time they're 40 or 45. So transfusion reactions, events related to that will make them ineligible, will disqualify them. We can control and match the product to those particular patient's immune situation so that doesn't create any issues. What this industry calls an HLA match. For the that population, we put it on the shelf, it's available to their clinicians, they pull it off, and not only say, Okay, this is something that will be useful and stop your bleeding, like some of the products that are out there, but it also is matched to you. This is John's category of folks from a disease perspective, we call that orphan genetic product. And an HLA matched impact is something that clinicians are very excited about, because they do not have that alternative easily today. You can do it, it's hard, in certain circumstances. The blood banks do a good job within the limits of what they're able to do. We can address that on a global basis. The bigger ones that are really interesting, in terms of the broader impact, relate to we'll call it generic FPH for perioperative use, trauma,surgery, emergency department use, folks who are on anti platelet therapy. In that context, there's there's probably a million a year that could benefit from a product like this. And this would fit into the hemostatic agent tool that's available to a clinician and an important one, where they can say, Gosh, this will be best for this patient in this circumstance. And then, further down the pipeline is one related intracranial hemorrhage. I will share that we've got a collaborator at UCSF, Dr. Shibani, Pati, who's got some really impactful videos of internal post trauma, brain bleeds within mice, controlled cortical injury. And every time I show these, these images, she has one with and without, one with an injury and with our product, with an injury and without our product, and we're both of an age you remember this, War on Drugs, what is your brain on drugs? It looks like scrambled eggs. That's what the injury without our product looks like. And then you look at the same injury, in the mouse, with our product, it looks like the eggs are whole. And you go oh, my gosh, the clinicians, they jump up and they sort of run around the room and talk to you about oh, my gosh. We have to call them down and say, Okay, we have a preclinical model, it seems to have a really big impact. All the other therapies that Dr. Pati has studied have not had this sort of an impact. But we've got a road to go here about approval. But those are the kind of key things in our pipeline, and hopefully a bit about the passion that we have in terms of the potential human and clinical impact that we can have.
John Simboli:
33:09
Several of those three categories or portions of those three categories as it sounds to my ear just hearing for the first time, is they are really unmet medical needs. It's not like an a first line. Second line. Third line is just there is no line for some of those, correct?
Mike Gaffney:
33:25
That's correct. That's absolutely right. And that's that kind of intractable, there isn't a good solution. And we just kind of assume we can't do it. In our team, not me, the Chief scientists, all the scientists who've been here for 10-15 years. They're the ones that brought it here, right. And my job and our job now is to get it approved so we get in the hands of clinicians. And there are some very significant unmet needs that are in front of us that we hope to have an impact on.
John Simboli:
33:55
Going back to the early part of our conversation about when the you made that choice to be the leader at Cellphire, how did you or the company go about choosing where to have the headquarters be located and where to where to focus your activity?
Mike Gaffney:
34:10
So the company, as it predated me, is in Rockville, Maryland, not far from NIH, National Cancer Institute and all that sort of stuff. So there's a nexus of science that kind of makes sense. Importantly, two funding partners for the company historically and today are also nearby. The Army up at Fort Dietrich in Frederick Maryland, has been an important partner along the journey for the company in developing both the cryopreserved and now actually helping out on the freeze-dried program. And then the other is BARDAm an entity within Health and Human Services, which I described as when I talked to people who aren't in the industry as DARPA for biologics, and they've been a wonderful partner. So being in the Maryland area, it makes a ton of sense. What you get here is a lot of great scientists and a lot of folks who are passionate about impact, military people and the like. So all those things are good. The area talks about itself as number three, or number four in the biotech world. But the difference between number three and number four and number one, and number two, is massive. So the challenge you have here is you have a lot of really smart scientists and a lot of people who are passionate, you have a lot less of an ecosystem of people who have the experience of taking science all the way through and being successful with that. What is that ecosystem of executives, regulatory people, people with CMC experience, people with all the clinical development and clinical execution experience, investors, all those things are necessary to success. And our challenge, being here, is building on those strengths with the government science, those relationships from a non-dilutive funding and engaging external to our particular market with those people and organizations that can be helpful to us as we go on our journey.
John Simboli:
36:13
Mike, thanks for speaking with me today.
Mike Gaffney:
36:15
John. It's been a pleasure. And BioBoss is doing great things for the industry. So that said, thank you for the opportunity.
