John Simboli:
0:00
Welcome to BioBoss. Stacy.
Stacy Lindborg:
0:02
Thank you. It's a delight to be here.
John Simboli:
0:04
What led you to your role as CEO at Immunon?
Stacy Lindborg:
0:08
I really step back and I think about where the journey began. It really started with a phenomenal company, so Eli Lilly and Company. I was there for almost half my career. And I think that where you start and who you're exposed to, really can set you off on a different course. And I was given the opportunity very early in my career, and I think as you leave great companies, you also see how different they are. So Lilly is, I think, phenomenal in thinking about people and development and really setting perhaps expectations long beyond you can expect, especially earlier in your career. And they gave me just a series of opportunities that taught me that I had formal training, I had industry knowledge that I was accumulating, and I had the ability to really think at a macro level, as well as really getting to know drug development. And I really think that's what started it. I was very early, given an opportunity to step into more of a leadership capacity for a blockbuster that was a product that took the lead revenue driving for Lilly after Prozac went off patent and was asked to take over the schizophrenia brand for Zyprexa. This is, you know, a product that reached, I think, $ 4.7 billion in peak sales, and we were languishing in schizophrenia sales. So as a young PhD, I found myself with marketing staff, really talented commercial guys reporting to me, the manufacturing capacity, and then R&D and developing new indications. And I think it really taught me how much I loved that intersection between business and science. And then another pivotal role was really getting to look at the portfolio and be accountable for R&D strategy and actually sit with John Lechleiter, at the time the CEO, and I sat at their executive leadership in a week-long, long range plan where we were plotting the year's, what we called y-z, which was when we would lose a lot of patents of drugs that had y's and z's in their names. And, you know, actually talking about how we would reinvigorate the company and the investments, and how we would survive that. And those are really formative experiences early in my career that caused me to be open, then to future opportunities.
John Simboli:
2:45
At what point did you think to yourself, I'm ready to take that step. I'm ready to become the leader of the biopharma company.
Unknown:
2:53
I looked at every job that I was offered at Lilly, which, you know, again, a real strength for them was that they, unsolicited, would come and give new opportunities. I never found that I had to go advocate and ask for ways that I could grow and contribute. And so I really kind of looked at every opportunity, again, first half of my career. Can I learn? Can I contribute? And, you know, and will I grow? I think that really just continued to open, you know, different doors. And I went from Lilly to Biogen. So every company got smaller and smaller. You know, it's interesting. My time at Biogen offered, you know, insights into broader, bigger teams, lots of functions. When I joined my previous company, Brainstorm Cell Therapeutics, you know, I was getting exposed to different modalities. We had an autologous cell therapy. This was a micro-cap company. It was a very different understanding of, you know, really our existence and how we continue to advance an amazing product. I went there as head of global clinical development, and then was asked to step in as Co-CEO in advance to that. And I think it really gave me familiarity with the breadth of stakeholders that one needs to balance and communicate with and as you're thinking about as a CEO. And it really then prepared me when I was asked to consider my current role. So it was ireally a natural evolution, and it felt like any big problem. If you can break it down into what's needed, what do I bring as a strength? What am I going to not know, always have things we don't know, and how am I going to seek advice and get input. And it then feels like it's a, you know, a doable assignment, which we all want to succeed and add value. And I definitely felt prepared, prepared for it,
John Simboli:
4:52
As you assumed the leadership role in your previous company and then in your current one, what kinds of things matched how you thought it might be to be the CEO, what things were different?
Stacy Lindborg:
5:03
In my last role, I was sharing a job, I was working with a phenomenal partner, with a very established business sphere, or expertise, a broad network, a lot of things that really made us very complementary. And I think even now at Immunon, I have a partner an executive director who was CEO for 13 years, and had a very different and complementary set of experiences, a very trusted relationship, both of them have been. So I think I came in and I mean, I even think about my own leadership style, what resonates really deeply with me, and it's been a central part of how I've led across my entire career, is more servant leadership. And I think you know that really is ultimately grounded in humility. And I think that when we put ourselves in too big of a place, and we're fearful then of finding out something we don't know, versus just appreciating that we all are going to bring things that you know will shine compared to other people. But then we all have to learn it takes away a pressure of not showing up, you know, and I don't. I don't know that anybody intentionally does that, but feeling this pressure that you have to know everything certainly I don't. I don't shy away from a viewpoint on strategy and execution, but I think that style is you ultimately think about an organization. You have a head of an organization. I have accountabilities in my job, but really the most critical thing that I have to be thinking about is my team, and how is my team going to accomplish what is a very difficult task of bringing forward a novel therapeutic extending the life of people that have cancer, which is what we're focused on right now, and find ways that you're empowering them, you're removing obstacles, you know, you're really fostering an environment where people can thrive, and ultimately recognizing that for myself, but also for my team, no one has all the answers. Our business, the world that biopharma lives to change, at the end of the day, and even as you get to the commercial realm, no one has all the answers. We all come with a great plan, and I think that our ability to learn and evolve and be nimble, ultimately, and I view humility as a huge part of that. Because, you know, if we think we, if we think we know everything going into it, I think you know our business will teach us otherwise. But it keeps us focused on, what did we learn, and how do we improve the next cycle, and what do we anticipate differently? How do we adapt, and how do we accomplish it together? I think that's really critical.
John Simboli:
7:49
I want to go next with a question about your statistics background. That sounds like an unusual contribution you can make. There probably aren't that many people who come from strong PhD background in statistics. So how does having expertise in statistics? How does that play into your ability to lead?
Stacy Lindborg:
8:10
I think it plays in significantly. And I you know, as I look across my career, I would say, starting out, you know, a degree in statistics is a very core job. There is a broad need, but it's focused on direct application. So you know, when I think about designing experiments, knowing how to interpret data, knowing how to understand what the FDA expects, there are so many aspects where you can actually bring innovation and bring precision and efficiency to the drug development side. When I think about even some of the more interesting kind of perspectives, like when I was in the R&D strategy role at Lilly, my knowledge of how the company made decisions for an individual product at a Protocol Review Committee, you're optimizing a product. As a company, we were trying to optimize a very broad portfolio. And because I understood what it was like to hear a governance committee have a decision around, how do we optimize this indication, this, you know, this protocol in a string of protocols, and then step back and look at, how do you optimally produce as many products as possible. I actually realized we were answering and solving for the wrong problem. It turned out to be a great Nature paper, that publication that followed a really preeminent Nature manuscript that Steven Paul he was head of R&D, really it encompassed learnings of productivity through the lens of drug development over many years for Lilly and had some really great collaborators as authors. I came in kind of at the tail end. But you know, at the end of the day, we have to be able to grapple with uncertainty. When you think about, as a CEO, you have to be able to know where your. risks are. A lot of that is inherent with Bayesian thinking and ultimately being able to truly parse out assumptions. Really look at, you know, the historical evidence for things that maybe influence your decisions. I mean, decision theory alone, oftentimes, is bringing out assumptions that maybe we have in our heads, but we aren't verbalizing. And you you think about putting a team together in the way the conversation goes. I mean, I think, you know, again, there's a core component that's so critical. We all need to have something that we really get about our business and my training puts me in a very natural place, especially for Immunon In phase 3, and really understanding the novelty of what we can bring forward in our plans and how we can expect regulators to react, but I think, more broadly, actually, my ability to dig in and know what a trial design can't even answer. It helps me as a CEO to really think more broadly about how we go beyond the basic conclusions that ultimately come from it and just ask the bigger questions that we need to address.
John Simboli:
11:10
What were the things when you first learned about the possibility that Immune on might be a place that you might might be interested in you? You might be interested in it. Can you recall what it was that you said, yeah, this is really interesting to me?
Stacy Lindborg:
11:23
I had an inside track on the company. So I was recruited to be on the board by our, at the time, our executive chairman, Michael Tardugno, was the CEO, and I joined on the board about three years before. I think it was June 2021. And so I had, you know, three years of learning about the technology, understanding the science, seeing how strong of a culture the company had, a positive culture, a nimbleness, the talent that would come into the boardroom, that would be presenting. And so there was this very natural insight, you know, that was very attractive. And when Mr. Tardugno approached me, he was supporting my transition, you know, to CEO. He had retired, and we had a need we weren't expecting to need to fill. I think when you have trusted relationships, you also know that you have a shared vision of what we can do and really the opportunity that stands before us. I felt that Michael's insight into, you know, the potential really just aligned so perfectly with mine and and it was such a phenomenal environment that I, unlike many other positions, you know, if you're taking something where you're just interviewing, you really don't know what you don't know. I came into this really, with a very clear expectation that really that played out, I think, very similar to what I expected.
John Simboli:
12:57
This idea about a statistical background and how it would play out. I'm curious, what did you see yourself becoming, and did you become that?
Unknown:
13:08
My mom told me for my early years, every time she would ask, my answer was that I wanted to be a mom. And I think a lot of that was influenced by the fact that my mom was a stay at home mom. So it was what I saw. It's interesting, because I am blessed to be a mom. I have two children, and I honestly think that in the process of becoming a mom, as I went through my early career, with no constraints, loving working, working very hard, you didn't really have to think about intentionality of how you spent your time, and it was easy to give more time. And I enjoyed it. Always loved what I've done, and you know, honestly, it's such an honor to get to contribute in this sector, in this field. But I found that after I had kids, I knew in kind of my heart and this actually, I had a very direct conversation with somebody very senior in one of the companies I worked for. My job had a little bit of flexibility in it, and he was trying to convince me, you know, don't worry about it. If you have a light Friday afternoon, just enjoy it. Take the time. And I it really crystallized in my mind that, you know, if I'm going to be away from my children, I really want my time to count. It really mattered to me, and it helped me think about prioritizing the right time, making time for them, but then really wanting to make a difference in my job. And when I now connect it to my current job, where I'm working in a field that is targeting, our first indication is focused on ovarian cancer. It's women's health. When I talk to women that are battling ovarian cancer, I was at a walk very recently, led by the National Ovarian Cancer Coalition, and a few women were willing, they were kind enough to share their stories with me. And they both happened to have genetic mutations. Because of that, their children had already been tested, and they knew they had cancer. And it was, I think I felt it on a different level, because to imagine my daughter being diagnosed with ovarian cancer is really different than for me. So I actually think that thinking about it, I actually think it really makes me think on a very different level. In my job today.
John Simboli:
15:29
W`hen someone asks you, like maybe someone you honor and trust, but someone who's not from our industry, they say, Well, what's your job? What do you do? How do you answer? When someone says, Yeah, that's really, I'm amazed by what you do. But then they said, but, but what do you do each day?
Stacy Lindborg:
15:44
Well, if you get down to that level, you're meeting with the team, talking about the near term steps. So we're in phase 3. How are our how's our site activation relative to forecast? How are patients being enrolled? You're meeting with investors. You're meeting with banks. You're ultimately I mean, when I read each quarter, when I read our quarterly, we have to formally report out our earnings. We have a formal document, a 10-Q. And every time I read it, I'm reminded that I am labeled as the chief decision making officer in the company. So we need to have a long term plan, a short term plan, and we have to have money to keep moving. And so I need to be connecting in with my leaders. I've got phenomenal people under me that are driving programs, but need to bounce ideas off of. They need to be able to articulate where we're exceeding expectations, where we're not, and what we're going to do about it. And then, of course, make sure that we pivot where needed. But I'd say one of the more core components, that is a really central part, is making sure we have the resources to advance. And what's really, really just thrilling with the role of a CEO. So we have our own internal CMC group based in Huntsville, Alabama. So I get to talk deep science, actually, talking about how we're prepping for commercial product and advances that have to happen. But we're actually starting, we produce all of the active pharmaceutical ingredient that now patients are being treated with, in our labs. I talk finance, I talk quality, we talk clinical trials and science, new indications. I mean, honestly, it is just a thrilling opportunity to talk to deep experts who are passionate and dedicated, and we're pivoting between short-term and long-term execution strategy. And then getting to translate that outside the company. So it really is an amazing job.
John Simboli:
17:57
If several of those people you were just describing were in a room, and I would ask a question, well, what is it about Stacy's leadership style that is defining about her? And it makes it work. Any idea what people want to say?
Stacy Lindborg:
18:12
I will actually ask for feedback when I'm doing end of year performance reviews. And I will encourage my team to always feel that if there is feedback, in fact, I think it's a way that you respect people, is to offer constructive feedback. And if you're communicating in a way that's minimizing somebody acting in a way that could be more powerful for the company, it's a it's a wonderful strength. So I definitely have people that will comment on being surprised by the aspect of humility in my job, which I personally think is a strength, but it's it's a difference. I've been told, and I think I also aspire to this, that I don't ever want to ask something of my team that I'm not willing to do myself. So I work hard. I have very high expectations of myself. And I think we set really, you know, phenomenal goals that we want to accomplish. Those are some of the aspects, and I think it's important that we have fun. So we're going to work hard, but hopefully we laugh along the way and and get to know each other and enjoy life as we go through it.
John Simboli:
19:20
In the shortest version that would make sense, when someone says who is or what is Immunon, how do you like to answer that?
Stacy Lindborg:
19:27
We're a clinical stage biotech company that's focusing on immunotherapies, novel immunotherapies that are harnessing our immune system, our natural immune system, to fight tough diseases. Specifically, we have been focused on cancer across our life cycle. If I were to expand on that, I would talk about how the immunotherapy, you know what the approach is that we're using. There are lots of different approaches to trying to harness the immune system. We're using a DNA-based plasmid that is using a synthetic carrier that basically takes the therapeutic and allows it to get into the cells of women, that's in our most advanced case, with ovarian cancer. And these cells are programmed to start releasing really important cytokines that would naturally occur in our body, and basically releasing the ability for our body to fight cancer. So we give it, basically, kind of a recipe for the body to not only see the tumors. So the ovarian cancer, which is really different than many other kinds of cancers, is immunologically cold, so the immune system can't see it. We are able to change the tumor micro-environment, the setting where the tumors are, which is in the peritoneal cavity, to a hot tumor environment, which allows our product to flourish. And in fact, we know that both healthy cells and cancer cells, alike, uptake the product and then start producing IL-12, interferon gamma, TGF alpha, this powerful change to the micro-tumor environment. It's an amazing process. That's the goal of the therapy. We can actually measure through ascites, which is the fluid in the peritoneal cavity. We can take it out, and we can actually see these many-fold increases that the product is doing what we want. We see downstream effects. And then when we get to clinical data, we can see that women, the median, is substantially improved. So we're seeing, really, what the Holy Grail is with ovarian cancer, that we're able to, for the first time, extend overall survival. A combination chemotherapy is the current standard of care. So more women are getting it before surgery. That used to be some were treated before surgery, some were treated surgery and then and then chemo. Really what we're seeing now is that if women can tolerate and can accept it, almost everybody is starting to now move to new adjuvant chemo, which allows the tumors to shrink. Then you can surgically remove more, so you're getting more of the cancer, and then they continue with chemotherapy. So that's the standard of care. If we think about, I'll just start with immunotherapies, because that's what our product is. So our, really the payload, and what we're really triggering the immune system to start producing is IL-12. It's a very important cytokine. There have been quite a few attempts at delivering IL-12, and I think a lot of it comes back to how is it being delivered. So a lot of the early attempts, and this even goes back to when immunotherapies were first being discovered. IL-12 was at the heart of the very exciting and very productive evolution for cancer treatments that have occurred with many, many tumors. But with IL-12 in particular, many of the early attempts were actually administering recombinant 12 directly into the blood, IV. And what you would see is these massive spikes. Actually, there's not a very long half life. There were very strong toxic effects. There were even people that died in clinical trials. So IL-12, while a very exciting, promising arena, ended up being very impossible to dose at a high enough level and do so safely. And what we discovered was a way to bring it directly into where the tumors are, to focus. That's exactly where you want to have the treatment. To allow cells to be manufacturing, then, this. Rather than delivering IL-12, we're not actually administering IL-12. We're actually delivering a DNA plasmid that is allowing the body to produce it. It keeps it contained. We're able to show that we don't see systemic distribution. Therefore, we got around the safety concern. And I believe that because we're actually administering it inter-peritonealy, it actually is exactly where it needs to be. And therefore the survival benefits that we see. So I think the delivery, the mechanism of how to get it into the nucleus of the cell, not have degradation of the product needed. There's a lot of technical things you had to overcome, but the platform itself is the real innovation and harnessing science that's very well established.
John Simboli:
24:25
How big is the scope of the problem?
Unknown:
24:27
In the US, 20,000 women are diagnosed every year, and we see about, pretty consistently, 13,000 deaths. At a worldwide level, it's 300,000 newly diagnosed. So it is a very stable and unfortunate, you know, kind of picture that we're seeing over time. It's a chronic, it's one of the cancers that we really have seen, we've seen progress in the later treatment phases, but not in front line. And it is, it's time. It's really needed.
John Simboli:
25:00
The data will tell you, and the science will tell you what's next and where you go. But at this stage, do you allow yourself to think, Oh, if this succeeds the way I hope it will, or the way I think that it will, it'll have this effect. What effect do you permit yourself to consider?
Stacy Lindborg:
25:14
We intend to transform the standard of care in frontline ovarian cancer. And it's very clear, if we replicate the findings from Phase 2, that will happen. I mean extending, so the five year survival rate is less than 40% and so if you're able to show that the median extension in this trial is 13 months. I mean, in that context, it's very, very critical. So the best chance you have at a cure is right when you're newly diagnosed. Hitting the earliest time point that you're aware that the cancer is there. And you know, this is a place where Immunon is really different from, if you look at the standard development path for, and I'll just stay with ovarian cancer for now, you know, it is somewhat easier and a maybe a more likely to succeed plan to go after a following, you know, second or third line, or to even go in the maintenance period. And when you look at those protocols, what you're usually requiring is that the patient has responded to the frontline treatment. So we know that there is a percentage of women that will not respond to chemotherapy, and therefore they would not contribute to learning about a product. They would, unfortunately, are just going to have worse outcomes. When you're studying frontline you're getting everybody you don't know who's going to respond. It is a riskier proposition, and it's a harder space. This is what I'm learning from gynecological oncologists. Simply because they're very sick, they're very frail, there's a very strong burden of cancer. We know that 80% of women are diagnosed in late stage, because you don't have distinct symptoms, therefore for diagnoses to occur. And so, but it's also one of the most exciting things. It was a really bold move for the company when we decided frontline was the way to go. And if I tie this back to where do I hope we'll be, you know, right now, we're studying a relatively short treatment course. So the weekly doses that are given in phase 2 and now in phase 3, really amount to six months of treatment. But we have women that are now well beyond five years, and we still see a treatment, an overriding treatment benefit. If you've already shown a propensity to extend life, now, what if you could actually do so on a much broader time frame, and maybe even in combinations with other treatments that ultimately have not been able to work in a cold tumor micro environment, we are able to convert to hot tumor micro environment. What things might we learn, and how could that actually manifest in a way that really benefits patients?
John Simboli:
27:58
When people hear the Immunon story. What do they get right? What do they get wrong? And how do you help them to better understand the story?
Stacy Lindborg:
28:05
What people will often default to, they'll know an approach to an immunotherapy, and maybe don't distinguish that there are lots of ways that we can innovate and we can actually create immunotherapy. So they may assume that we have a viral vector or a virus that we're using to deliver our product. They may assume that we're actually administering recombinant IL-2, or any other ways that you could bring forward a novel therapy. And I think you know it's important, and we intentionally designed a non-viral DNA platform. It's actually hitting the two main arms of the immune system, adaptive and innate immunity. And even for some of our clinicians, when we're having conversations, you know, and we're talking about critical points to make, they'll emphasize how critical it is that, look, we're not just delivering a cytokine or protein. We're really activating both arms of the immune system. And when you think about the distinct advantages, you know, from a safety standpoint, that's obviously a critical part of the delivery, of how we're delivering our product, the stability, the scalability that we can actually go beyond. There are many solid tumors that we've studied pre-clinically that we know will be rapid growth for our company and added value we can bring to patients. You know, really, it becomes about the uniqueness of this product and how we can grow.
John Simboli:
29:38
Can you speak with me about your phase 3 trial plans?
Stacy Lindborg:
29:41
We have a novel design, but one that's really predicated in the FDA, that will allow us to move very quickly if we see an effect in women that are HRD-positive, meaning they have mutations that suggest, based on our data, that they would respond quickly. So we'll be able to do interim analyses. If we see an effect, we'll be able to get the BLA, so the biologic license application, to the FDA quickly for review and approval, full approval in that subgroup, but it would match the urgency that I think the population demands while we study this broader, all-comers population. So 2 in the protocol, and really even the ongoing phase 2 study, it is amazing how consistent every single endpoint and subgroup points to an Immunon treatment effect over the standard of care. And that consistency gives us just such confidence as we go into this phase 3 trial. This very well powered 500 patient trial that allows for early action, for success and access to the public that needs it.l
John Simboli:
30:55
Stacy, thanks for speaking with me today.
Stacy Lindborg:
30:57
Thank you. It has truly been a highlight of my day.
