Getting To A First Product Approval With Celcuity's Brian Sullivan

On this week's episode of the Business of Biotech, Brian Sullivan, CEO at Celcuity, talks about winning the company's first FDA approval for Revtorpyk, a kinase inhibitor for breast cancer patients, and why targeting an “untreated disease mechanism” can beat chasing a single mutation. Brian also discusses the process for licensing a shelved Pfizer asset for development, designing Phase 3 trials that challenge assumptions, the benefits of FDA's Real-Time Oncology Review, and managing downside risk while advancing new indications, all while building a launch-ready company without losing pipeline momentum. 

Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.  

Subscribe to our monthly Business of Biotech newsletter.

Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.com

Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

Transcript

RevTorpic Approval And What’s Next

Ben Comer 0:04

Welcome back to the Business of Biotech. I'm your host, Ben Comer, Chief Editor at Life Science Leader, and today I'm speaking with Brian Sullivan, co-founder, chairman, and CEO at Celcuity, a biotech company that received FDA approval on July 14th for Rev torpyk. Uh, generic name gedatolisib, which was indicated in combination with fulvestrant for HR positive and HR2 negative locally advanced or metastatic breast cancer patients without a PIC3CA mutation. It's the company's first product approval, but hopefully not the last. Revtorpyk is also in active development for other breast cancer types, including use as a first-line therapy as well as a metastatic castration resistant prostate cancer uh candidate. Brian is a serial entrepreneur. He worked previously as chairman and CEO at Sterilmed, a medical device company sold to J&J for $330 million in 2011. And before that, he co-founded and led Recovery Engineering, a filtration company that he took public and sold to Procter and Gamble for $265 million in 1999. I'm thrilled to have Brian on the show today to talk about Rev torpyk's approval and what it means for breast cancer patients, how he identified and licensed gedatolisib from Pfizer, his engagement with the FDA up through approval, commercialization plans, and how to balance ongoing pipeline development with a new drug launch. Brian, thank you so much for being here. Oh, it's my pleasure. Thanks for having

Lessons From Two Previous Exits

Ben Comer 1:40

me. Uh, I want to start off uh with a couple of questions on on your background. Uh, I just mentioned that you've led and sold uh two companies, uh a water filtration company, a medical device company that reprocessed single-use devices um prior to uh Celcuity. What'd you learn from those experiences? Uh and what made you want to take uh a swing at cancer therapeutics?

Brian Sullivan 2:06

Well, you know, I started my first company out of college, right? And so one of the benefits of that is that you don't know what you don't know. And and so you you're somewhat fearless because your downside is almost nothing, right? Uh if if I failed, uh, I go to business school, you can take the keys to my car. Uh that was really it. I didn't have a family. You know, it was a young guy, 23 years old. And so I really respect this is by the way, the entrepreneurs who are in their mid-40s, they have a they've had a career, they have a family, they have a mortgage, they have tuition, and then they they take a risk and go off um to start a company. In my case, it was pretty straightforward. Um, but you know, when you build a business, um, you're you're ultimately uh focused on how to solve problems. You realize, wow, you need to get fantastic people who who have a lot of experience in particular areas. And and then you need to always be thinking about um objectively whether what you're you're developing will make a difference and and allow you to win. And so uh, you know, kind of the underlying philosophy I've had about starting a business or thinking about the products to develop is whether or not we're creating what I term a definitive solution. If we step back and are objective about the problem that we're trying to solve, and then think about what is the the ultimate solution, i.e., what's the solution that just takes any other alternative off the table? That's what we want to create. And so when we were developing our first products, that was our goal. So this is ultimately what the consumer is essentially needing to solve the problem that they have. And so similar type of uh analysis when we were thinking about in our medical device space. And then coming to cancer, well, there's a zillion problems to solving cancer, unfortunately, right? It's just it's a very it's an intractable disease. So there's a you know huge canvas, but but then that just creates its own complexity because you can't treat cancer, right? You're you're digging in and and tumor types and subtypes. Um but there's a certain discipline that's required that you learn when you're developing products of how to assess you where that you might have something to add, right? It's not enough just to say, oh, I'd like to treat cancer, I'd like to help these patients, of course. But so do a lot of other people. And so you need to compete for dollars, you need to compete for team uh teams and individuals, uh, and you need to have a prospect of success. And that requires this discipline of really carefully isolating the problem and whether you could come up with something that's differentiated, that that deserves to win in effect if uh you're successful in executing the plan.

Why Breast Cancer Became The Focus

Ben Comer 4:48

Did you have uh, and I I wanted to ask you about um you know the circumstances that led to the co-founding of Cell Cuity in 2012. At that point, did you have that that locked-in focus of, you know, this is a specific cancer type I want to target, this is how I want to target it, or did that by necessity come later? Um yeah.

Brian Sullivan 5:10

So yeah, no, so I I was uh kind of in the middle of negotiations with J and uh our my co-founder, Lannett Slang, our CSO, uh, called me up uh on the way back from this negotiation, and he had an idea uh about developing an instrument that could do the cellular analysis. And I said, Well, I don't really want to develop an instrument, but I would be interested in being able to isolate potential disease activity in ways you know, molecular tests can. And so we went back and forth and basically collectively defined uh the mission. And and because of what we were trying to do, we we basically both agreed that breast cancer was potentially the right opportunity to focus on because there were some biomarkers that were already being used to stratify patients, her two as an example, ER. But those biomarkers weren't very specific or specific enough to you know yield very, very high um response rates. And so we thought, well, there's some undiagnosed activity here that's going on. And then there's some other pathways involved. So, you know, I guess early on we knew breast cancer was the area we wanted to focus on, and then dug in there. And one, you know, one thing, and I'm sure we'll talk about this, one thing led uh to another as we as we you know dug deeper and deeper.

Ben Comer 6:23

Yeah, you um a lot has changed in in breast cancer therapeutics uh since 2012. And uh, you know, you you mentioned several of the biomarkers. There's also the BRICA gene uh that that really came into play during that period. Um I'm curious if your clinical strategy had to adapt or pivot in response to to new treatments coming into the market. I mean, I think um Geta Tolisib or Geta Tolusib uh was licensed from Pfizer, I think in 2021. Is that right? Yes.

Brian Sullivan 6:56

Yes.

The PAM Pathway And Drug Hunting

Brian Sullivan 6:57

So here's how we we got to Geta Tolisib. Uh, you know, we were digging into breast cancer. And one pathway, you know, cell signaling pathway that was clearly important and understood to be a driver of breast cancer. But at the time we began looking at it, there were no approved therapies to treat it. And so this was clearly a huge unmet need. How do you treat this pathway? When it was discovered 20 years ago, every major pharmaceutical company had a program to develop a pan PI3K MTORC1-2 inhibitor. Because it was clearly important. Very hard to do, though. Hard to hit six targets in one, hard to do that in a way that could be tolerable to patients. And so all those programs failed. And over time you had this migration to where it's just hitting a single component of this pathway, i.e., PI3K alpha, mTORC1, AKT. Um, but that was suboptimal because this pathway is so complex, it has all these workarounds, redundancies that hitting one target doesn't do enough to prevent this pathway from continuing to serve as a disease driver. So we zeroed in on this pathway just because of that conundrum. Um, untreated mechanism that's clearly important. Nobody else has something that really looks optimal or definitive. And so, even though there's all this other work going on, in a disease setting, if there's clear evidence that a particular pathway is relevant and it's not being treated, it's going to continue to be a disease driver. And so, you know, given um what we viewed as the uh lack of good alternatives addressing this pathway, we felt there was a bit of an open goal uh for us to go. And so, but but that came from a lot of analysis. You know, we set up a program to specifically assess using the cellular analysis program, a platform that we developed, to look at all the drugs out there that had been developed and really isolate why did they fail, what were their attributes, et cetera, in in from a cellular activity functional uh perspective. And that's when we came across Geta Telissa. Essentially, we're looking at 100 candidates to think about trying to sort out what would be the right approach to address this pathway. And then Geta popped out. It was clearly, in our view, the winner. We happened to be working uh with Pfizer already on a collaboration. Pfizer was the owner of that drug. And we didn't know its status. We assumed they were continuing to develop it because it had several trials in process. Okay, so it had clinical data. It had some clinical data. And so that's when we approached Pfizer and said, hey, you guys, you have this uh what looks like a great drug. We didn't have any clinical data, they hadn't published much. Um we'd we'd love to collaborate with you. Maybe we can help you using our cellular analysis uh platform to optimize you know patient selection. You know, we didn't know really enough to you know say much more than that. And that's when we found out that Pfizer had decided to stop developing the drug that essentially put it on the shelf. And that's that was the the turning point really for cell for cell cuity. You know, we were saying, you know, I basically said I can remember sitting in my office thinking, well, we've thought about developing our own drugs. And and then I you know said, well, if there was ever a pathway to focus on, it's the PAM pathway. And if there was ever a drug to target the PAM pathway, it's this drug. So let's let it rip. And so yeah, started having conversations with Pfizer. And you know, thankfully, uh it all it you know, all worked out. Uh where we were able to get the drug in 2021 and then take

Licensing Gedatolisib From Pfizer

Brian Sullivan 10:20

over development of the drug.

Ben Comer 10:21

Was that the first uh in licensing agreement that you had negotiated? Yes. Yes. Was anything was there anything surprising about that process or particularly difficult? Yeah.

Brian Sullivan 10:32

Well, so what was interesting was that you know we were constrained. I mean, we we had you know, we we were funded like a biotech at that point, you know, we had maybe 20 million of cash in the bank. So you know it limited negotiating parameters, right? And sometimes that's good, right? Right. Because ultimately the person on the other side of the table knows you know, you can't go any higher, right? Yeah. Yeah, you can't take 100 million. I don't have 100 million to give you. Um, and so basically negotiated a deal that just very back end weighted, um, so that if the drug was successful, it would be a very fair deal to Pfizer. But if it wasn't, well, you know, we weren't going to go out of business because of it. Um and uh and and so we were able to reach an agreement with Pfizer. I think because we had some uh relationship with them, they they had a sense of how we thought our our capabilities and thought that okay, this drug will be in in good hands and it'll be responsibly developed, aggressively developed. And and that's that's I think part of what we, you know, a lot of what we brought to the table. And and obviously Geta is is the star of the show. I mean, yeah, it's a great drug. And so yeah, we we we were fortunate because we could develop with our platform these very proprietary insights about this drug and in ways that you know maybe weren't you know just weren't possible to develop with uh other tools that people use to evaluate uh evaluate drugs.

Ben Comer 11:55

So you uh you brought uh you brought the drug in, uh Cellcuity, you know, was was already formed as a company, although you didn't have a lot of cachet, I'm sure you had to then start uh fundraising for clinical development. Did you encounter any, were there any investors out there who were sort of put off by the idea of you know this was a Pfizer drug, they just they they chose not to develop, you know, was that uh serve as a kind of black mark for some investors?

Brian Sullivan 12:24

Well, it was kind of it worked both ways. Uh, but the first question I would get uh from people uh when I would describe the attributes of this drug and the early phase data, because it was very promising. You know, the the the approach, i.e. this multi-target inhibitor, early phase data was very promising. So they were going, well, wait a sec, what did we miss? I mean, this looks great. Why why would Pfizer kick this to the curb? And and my response was look, they, you know, Pfizer has as big a company as there is, they had the revenue from COVID, they had a zillion potential ways they could go. And so, you know, they were looking for, yeah, they had other criteria that they were applying for their uh pipeline. So, and that's that's life and times. A lot of drugs get outlicensed because of other priorities that rise to the top. Um, but that was a very much of a question like, what are we missing here? Uh, is this too good to be true? Um, and if it's uh so good, why isn't Pfizer doing it? The flip side, though, is that Pfizer has outlicensed drugs that ended up being very successful. Yeah. And so essentially it it worked both ways. Say, well, look, you know, Pfizer, you know, they they develop good drugs. Sometimes they don't fit into their portfolio, but when they've been outlicensed, they've turned into big, big wins. And and so ultimately, you know, we you know, I had to answer a lot of questions, and just as you asked, and um, and we we raised about 60 million you know, but a couple months after uh we closed the deal. And that was important for us because you know basically the data was good enough in our view to to warrant going to phase three. We'd initially thought we might go to phase two, do a small randomized study, just confirm the phase one B data. But if you really dug into the data and kind of did statistical analysis and kind of develop a view on the probability of success, you know, so I concluded that the probability of success was high enough that it would really be detrimental to pause development by three years essentially to get confirmation in a phase two setting. I felt, you know what, that that you know, you're paying one way or the other. And I felt that uh, you know, it's more important to optimize and accelerate development as much as possible. Take the risk of phase three. Right.

Ben Comer 14:37

I I wanted to ask about, you know, we we've talked a little bit uh about the mTOR pathway, you know, what was in intriguing and

Funding The Phase 3 Leap

Ben Comer 14:45

compelling about the the pathway itself and the target for you, but um what about uh uh the unmet medical need, I guess from a from a patient perspective. You you saw this this market opportunity. Can you describe the unmet need uh in in breast cancer that that you're planning to address with this problem?

Brian Sullivan 15:02

Sure. So there are some great drugs that were developed for the first-line setting, CTK-4-6 inhibitors. But unfortunately, after patients progressed on those drugs, the alternatives were offered, you know, in some cases, just two to four months of medium progression-free survival. So very short period of time. Uh there had been a drug Navaris developed called Alpalipsip, uh, which was an alpha inhibitor uh that had just been approved in 2019. It was a tough drug. Very toxic, high, high levels of hypoglycemia. It didn't, you know, offered, you know, kind of only modest, you know, you could say, but but not um as much benefit as people were hoping. So this second line setting for uh HR-positive breast cancer was considered to be very tough, i.e., not a lot of good alternatives. Doctors would like to per to delay giving chemo to patients at that stage because you start getting into irreversible side effects and so on patients. So there was a hole in that in the treatment paradigm. And that's where we we felt A, that would be the first place we go, right? First second line. But we also had some first line data uh from the early phase study that was very promising. I mean, great data. And so we thought, okay, we we can see the development path. We're gonna get, you know, focus on getting an approval in the second line setting and and and then quickly go, which we've done, and to the first line setting with additional uh phase three, uh phase three trials. But but basically the second line setting just had enough uh significant unmet need that that we felt the probability of success was high and that we could elevate uh if we're successful, uh the standard of care as a result and and really make a profound difference uh for the patients. And and the data suggests that that we've done that. You know, we we we we really we think the data, and I think the feedback we've gotten from oncologists is that we'll we'll we'll establish a new standard of care for these patients.

Ben Comer 16:53

How large is the the patient with this first indication? How how large is the patient population?

Brian Sullivan 16:59

So about 37,000 women in the US each year kind of are get to the second line setting. They they've progressed on their first line treatment. Um and so you know that's a in in the tumor uh landscape, that's a huge uh patient population. Yeah. And then uh roughly 60% of them lack a PIC through CO mutation, 40% have a PIC through CO mutation. Because these these patients have different alternatives for treatment. You know, we uh designed our phase through study to separately uh uh analyze patients with and without a mutation. And that's proved to be very advantageous for us uh and for patients, because we really isolated the treatment effect in these two populations. Most people didn't think our drug would work in the patients who lacked mutations because the paradigm has been, well, C mutation, hit mutation, you know, this you know, um targeted therapies. Um and uh but this pathway is different. Uh it

Unmet Need After CDK4/6 Progression

Brian Sullivan 17:55

plays a key role in driving metabolism of cells, it regulates the energy source that cells rely on to uh you know, glucose, to, to hyperproliferate. And so our hypothesis uh was well, this this pathway is intrinsically involved, independent of whether there's a mutation.

Ben Comer 18:12

I wanted to ask, you know, about that decision uh for you know to include the mutation and not include the mutation, like how you were able to, you know, what make what what sounds like a really critical decision uh about the trial protocol.

Brian Sullivan 18:27

Right. So it's interesting. Um when you're you're thinking about a phase three study design, you're balancing a lot of considerations, right? The cost global study. Uh so your inclination is to you know do something that will minimize your patient population. And in our case, you know, we were we were solving for what we felt the right information would be to demonstrate that this was the right drug for all patients, irregardless of their mutation. And we felt the only way to do that was to separately power and analyze uh those populations. You also had different standards of care uh for control. And again, I think sometimes we're very frugal, but at the same time, you if you're going to do something, you have to do it right. Just because you're small doesn't mean you can get away with doing it kind of halfway. You're either in or you're out. And so we were in. And the frugality helps you because you're not wasting money on this other stuff. I mean, so if people look at what our expense run rate was, it's I always get a lot of comments of guys, you guys are spending a lot less than a lot of biotechs. I said, well, you know, that's probably because of my entrepreneurial background or you're starting something from scratch, you know, you're cheap. Um, so we weren't spending a lot of money in what I would call non-working dollars, which meant you had more dollars to go directly into, in this case, a phase three trial. Uh and uh and and that was uh that was key. Uh but you had, you know, the end result is you also have a lot of skeptics, right? Because wait, you're you're going against the grain. These drugs are only supposed to work when there's a mutation present. Why is this drug going to work without a mutation? And and so then you're getting to the fundamental nature of the pathway. And again, it's a science story. But and we we we took it on. All the other drug developers in this space were focused on just patients with mutations. And so here you have all these major pharma, Lilly and Navardis, um other companies have these targeted you know, therapies only focused on uh patients with mutations, you know, PIC3C mutations. And here's this who are these guys and why are they tacking left when everybody was tacking right? You know, what do you what you what do you guys know? I mean, so there's and that's part of life. And uh if if you're confident though, you you say, well, that's fine, you know, you guys are wrong, and we'll prove you right.

Ben Comer 20:47

And thankfully, you know, we we we were found to be corrupt. And the the indication is for patients without

Designing Trials Beyond PIK3CA Mutations

Ben Comer 20:55

the mutation, this initial indication, right?

Brian Sullivan 20:57

Yeah, because that's the larger population, and that it just turned out that we were able to get the data faster because these patients really have a crummy prognosis. There aren't very good alternatives for patients lacking mutations. So it just so happens, and that was one of the other benefits. We get the the data would in essentially be available independently, and we could proceed with an approval as soon as the first data set was available, which happened to be the wild site, and that worked out for us. Now we have an approval. Uh, we have our data from mutant. We'll be sub you know submitting a supplemental NDA for the mutant population. Uh, but uh we'll be able to launch. And so that's obviously the whole goal is to make the drug available uh for these patients as quickly as you can. And and so we were also solving for that too.

Ben Comer 21:41

Um, get it received FDA's breakthrough therapy and fast track designations, uh, is also included in the FDA's real time oncology review or RTOR. Um, can you talk me through that RTOR process? Uh you start submitting clinical data prior. Prior to the full NDA, is that how it works? Correct. No, exactly.

Brian Sullivan 22:03

And so, you know, the FDA, one uh I guess confirmation of the unmet need is that FDA only grants breakthrough designation when they believe there's a significant unmet need. Right. So, you know, we we were addressing one, and that the if if our data held that there's prospect of establishing a new standard of care. So that in turn supported the RTOR. And the benefit of RTOR is that you're submitting on a rolling basis. And we submitted initially the first submission, you had three submissions or subsubmissions. Three submissions, uh, and the first one was essentially our database, uh, uh, you know, the clinical database. So they can start to do their own analyses uh and determine, you know, their uh or begin that assessment. And then your CMC package. So you know, things that require the longest lead time. And then you've you fill in the blanks with other with other modules. Uh but the FDA is essentially taking a risk and saying, okay, even though we don't have the full package, we believe A, the data, which you know, we provided them a top line, it warrants you know uh taking a risk of beginning an FDA review because the probability of it leading to an approval, a positive approval decision is high. And so they have to feel very good about the data, all the other work that we had done to say, hey, we're willing to take this risk that it won't be a waste of our time. And good for the FDA. I mean, I you know, I would say we've had a fantastic relationship with the FDA. I mean, very collaborative. Um, I mean, they, you know, obviously very tough, but at the same time, um, you know, we've learned from them and and to the extent uh, you know, in many cases, they have very good suggestions and and we we developed a better clinical trial design as a result of that collaboration, developed a better package just as a you know for our modules and our NDA because of the feedback we got. So we really leveraged the breakthrough status to get you know kind of as much feedback as we could along the way to make sure we were aligned with them, and then took advantage of their expertise. I mean, they they've obviously seen and seen a lot of different things. So uh, you know, all hands on deck. We want as much help as we can get.

Ben Comer 24:17

Uh biotech companies work uh really hard to get to NDM, uh to get to NDA submission and then have to wait typically, you know, months for a Padofa date, an approval decision to arrive. Uh, you've just gone through that that waiting period. Can you describe the company's activities uh during that NDA to PADUFA date period? You know, what you were focused on, what your top priorities were at that time.

Brian Sullivan 24:42

Well, when you submit uh data uh to the FDA in an NDA, they're reviewing it and they're asking questions. You know, they're called information requests. So so there's an iterative process involved. It's not like they just send you an approval letter uh six months later, I wish.

Breakthrough Status And RTOR With FDA

Brian Sullivan 25:00

But uh so they're they're doing a review. Um but at the same time, you know, we were finishing up enrollment of our uh other phase three study, this and the mutant population. Um, and and then while we were waiting for the uh Pradufma date, we we read out that data. We presented that at ASCO. Uh so we quickly, while we were working on our NDA, or rather waiting for the Pradufma uh date, we actually were preparing our SNDA for the next uh for the next submission. You can't submit while you have another way when you have an active NDA. But uh so essentially we were already collaborating with the FDA. We had an S uh we had a pre-SNDA meeting with the FDA for our next indication while they were reviewing our NDA. Uh and we had other meetings with the FDA to talk about our first line studies and getting their advice on design. So we we we have a lot of initiatives in process, you know, two psych two phase three first line studies, our SNDA, you know, mute population, you know, the castration resistant prostate cancer, um, et cetera. So a lot to a lot to keep us busy.

Ben Comer 26:06

Is there is there a risk, though, in continuing other clinical programs, uh, particularly with uh get a tolysib, for example, you know, if there's let's say an adverse event had popped up and you'd have to run all of a sudden report this negative thing during an NDA review process, uh, you know, even if it's a different indication, how'd you think about that?

Brian Sullivan 26:28

Well, I and that's a good question. Um and so, you know, the big part of uh of an entrepreneur's um uh responsibility is assessing risk, you know, upside, downside. And and that includes assessing what the probability is of the downside. Now, if the downside's horrific, right? You don't you want to avoid it at all costs. Sure. Um, but but we felt that we had enough data, you know, we had over before we started our phase three study, I think we had data from over 500 patients in a variety of different settings. And so we felt that the the safety signal was uh and the safety profile was well characterized. We we did not believe that we were likely to get surprised. In fact, we felt that it it would be very, very unlikely. And any uh event that occurred would would would be viewed as anomalous. So uh it was a consideration, but we felt it that it was too low a risk uh to really stop us because ultimately, you know, time is your enemy, right? You know, if patients who are in need today of better therapies, you know as a business, you you you want to try to accelerate as much as you can. So we made some calculated bets. I mean, we started our phase three study on the first-line population before we had our first data. And I had some investors say, well, what if it doesn't work out? Said, well, again, that's a possibility. I think it's a low probability event. And so when I'm factoring in the benefit upside of accelerating the development here, I said, just taking a year out of the development process for this phase three indication uh could yield a billion dollars of incremental net present value to the business. So it's a big decision, or rather, big opportunity, i.e., consequential. And and I felt the downside was was nominal. I mean, in terms of, okay, um, I'll have spent maybe $20 million to get that phase three going. And if I shut it down because the data is unfavorable, so be it. So I'm betting 20 million to potentially have a billion dollar upside. And that's that's a big part of how you you manage, you know, and if you're an entrepreneur or any business person, you have to estimate your upside-downside, have a you know, a good ability to characterize those so that you know it was you can just focus on the downside, but if the upside is huge, it's a good bet, right? A 50 to one bet. Well, that's good, and low probability of the downside occurring, and say, man, you don't get many bets like that in life. So that that's ultimately what you're doing is you're managing a risk and and you are proceeding a pace. And um, and and so you know, those those are all considerations. But um and then in retrospect, they can say, you know, well, it all worked out. But

NDA Review Work While Advancing Studies

Brian Sullivan 29:10

of course, yeah, right. You never know. I mean, it it you know, stuff does happen in this space, right?

Ben Comer 29:15

So absolutely right. Tell me about your commercialization plans. I read uh in the press release um that you plan to launch in in late Q3, which is is right around the corner. Um, what what have you got uh cooking on the commercial front?

Brian Sullivan 29:30

So another um aspect of the drug development business that is daunting is that uh while you're developing your or rather you're running your phase three trials, you kind of have to assume success because the time required to build out a commercial organization is several years. Yeah. And that and develop the capabilities and do the research needed. So we we began you know our commercialization process several years ago, two and a half years ago, and then it slowly built out the team in 24, and then 25 kicked it into gear, where by the end of 25, we had for the most part our commercial organization, except for the Salesforce, built. And so you essentially have to go to where you think the puck will be, um, assume success. And uh, and so then in the Q you know, late Q1, Q2, we brought on our Salesforce, fantastic uh group of individuals, they're really, really great. Uh, and and then you know, you train them and get them ready to go. So we we've essentially you know built out our commercial team uh and all the capabilities, market access, right? Working with the payers, uh, the insurance companies, working with strategic accounts, so all that capability that's required, having a patient hub so you're able to essentially um handle uh medical inquiries or or patient inquiries, having patient support services in place. So for some patients, they won't be able to afford the drug or the copay. Well, we we've made it as a policy that you know essentially we're not we want to do everything we can to make sure any patient, regardless of their insurance status, will have access to our drug. Um and so that's all you know infrastructure that needs to be built. You want to develop insights, right? How do doctors think about this or that? What is what about you know, this uh if you think about this adverse event, how do we present that? And so you you want to gather as much information as you can to optimize, you know, how you go to market, make sure you're training your sales force accordingly, and then you know, release the hounds in the appropriate time.

Ben Comer 31:30

Right. Can you give me a sense of how large the sales force is for uh for a drug like this?

Brian Sullivan 31:36

So the the fo we they're um is it so we had oncology sales specialists and they'll be targeting the oncologists, and there's 90 of them. Uh then then that's split into 10 regions. So you know uh you have 10 regional directors uh managing um those specialists. And then you have a separate team that's focused on the insurance companies, you know, the payers, national accounts. So that's a separate group of individuals. And then you have another group of individuals focusing on the strategic accounts, these large, like the U.S. Oncologies of the World or Dana Farber's or you know, City of Hope, these very large systems uh that also have you know other impact on uh the whole uh decision-making process for other other accounts. And so, and then uh and that's you know, so you have essentially folks working from the top down, folks working from the bottom up. And uh and then you do the math and figure out what you need. And and you know, the math says to cover all the oncologists that are really treating the most patients, um, you know, you need this many reps. And so it it's it's possible to you know kind of make a very considered decision about the sizing of that force.

Ben Comer 32:43

And then as far as the the commercial folks that you hired prior to the sales force, like the early people that you brought starting two years ago that you that you brought in, who were those individuals? You know, who were who were those first

Managing Risk While Moving Faster

Ben Comer 32:55

kind of commercial people in the So yeah, the first people uh were the senior people.

Brian Sullivan 32:59

So chief commercial officer Eldon Meyer, you know, launched the number of drugs, a lot of experience in big pharma, small pharma, um had had successfully launched the blockbuster before. Uh and then our head of marketing, VP of marketing, head of commercial operations, head of market access, medical affairs, which kind of is a dotted line to commercial, but key for commercial launch and obviously supports uh clinical development. So those individuals are the next people. So we had to build that senior team, and they in turn would build a team underneath them. And this would be you know the people who are focusing on communications or managing uh MSLs, you know, uh medical science, liaisons. And and and so you you build that, you know, those kind of couple layers of individuals who can really get the projects going, managing these initial um efforts. And then as you get closer, you you know, then then it's a lot of execution. Okay, the people who are gonna be responding to inquiries that we might get from the field. For instance, and other or other elements of the or components of the organization, we need to expand our safety team quite a bit, the pharmacovigilance, because yes, we're gonna be dealing with thousands of oncologists potentially. We need to build out IT systems that you don't need when you're in clinical development. So there's probably 30 different systems we needed to develop. And and it affects every part of your organization, our finance team. You know, you have to have separate accountants that are in or group managing revenue recognition, managing, you know, the coordination for reimbursement, et cetera. And uh and so it's a very complex undertaking to transform from clinical development stage company to a commercial organization. And it's not just getting a sales force in place, it's really a holistic shift and expansion of your organization, all these other requirements.

Ben Comer 34:43

Did you ever consider uh a commercial partner? Are you still considering a commercial partner? How do you think about that versus you know, setting up, building up your in your own uh commercial function, which is not easy as you've just described?

Brian Sullivan 34:57

Well, you know, because I had started a couple of businesses from scratch and built out commercial organizations and launched successfully in tough markets, like you know, in my first company, we were uh working with uh all the major retailers in in the country, in the world, really. And so we we had by the time you know we ended up kind of selling to Product Mamble, we had 40,000 retail outlets, which is a complex undertaking. Yeah. Um my second company, we had 2,000 hospitals we were working with, where we had people embedded in those hospitals that that were supporting our uh our work. And so, you know, I I'd kind of thought through how to and executed you know what were essentially fairly sophisticated and complex commercial or or field support organizations before. And so it's just a matter of breaking it down into its pieces and and identifying you know what you need and then executing. And if right or wrong, I've I've always felt that you know could figure out how execute it accordingly. Um and uh and then you go from there. And and uh so had no doubt that or uh we were gonna launch this ourselves. Now, XUS, you know, globally, it's a much different story in our view. Um, we were starting the global regulatory submission process. We will have an MAA submit it to Europe, you know, the European Medicines Agency by the end of this year. We're submitting uh to other key countries or or begun the regulatory process with them. So we will have a global footprint, uh we'll most likely have partners uh to uh execute uh the launch in those countries.

Ben Comer 36:34

You have just described what happens to an organization when the product is approved and you now have to commercialize it. It's fundamentally changing the company from an RD-focused organization exclusively to a company that's now doing both things at once. I'm I'm curious how you manage that balance and focus uh, you know, between

Building The Commercial Launch Machine

Ben Comer 36:55

ensuring a successful commercial launch, uh, which is no small task in 2026, and continuing your pipeline development uh efficiently. How do you how do you think about that? How do you avoid overextending the company? Right.

Brian Sullivan 37:10

Well, again, I mean, everything starts with making sure you have the right people. Um, and so we have very good leadership uh at all of these critical positions from our chief commercial officer, chief medical officer, we have a chief strategy officer, uh, you know, or head of uh pharmaceutical development. And and so that's that's a starting point. You can't do anything without the right people. But then we spend a lot of time thinking through plans and the budgets to carry out those plans, how to manage those plans, how to you know, see whether we're executing against them. And and so then if you do that uh and you have a good way of of uh focusing on them, you you can execute you know broadly, but it has to be very deliberate. Um, and you can overextend yourself either because you don't have the right people or you don't have enough money uh or uh you you haven't set yourself up to review your your status. So so I think that's that's something that I've learned with my other businesses, how to maintain momentum, right? And uh what people ask me, oh Brian, it must be great. You've got this drug approval. Do you take time to reflect? I said, well, to be frank, about a minute. Because there's there's you know the momentum that comes from an approval, obviously the launch, but then the implications in terms of what else you can do, or you have a lot of other things in process. And and so, you know, a key to really developing in a high growth company that really delivers on its promise is to learn how to manage both not only today, but the future. And so you need to maintain have the ability to focus on short and long term uh to ensure that you can't get too just focused on the short term. Uh, and and that's why you have great people leading these functions that you know carry it, keep the momentum. You know, I'm very involved, but you know, very quickly and have always you know but made sure our clinical development plan is robust, even even at a pre-commercial stage, you know, having two phase three first line studies is is not typical. And uh, but given the potential, it just was warranted and we capitalize ourselves accordingly. And so now there's more stuff we can do, which execute.

Ben Comer 39:20

Well, on finding good people, was your network large enough by this point that you know you could go to kind of friends or friends of friends? Or it, you know, cancer is is such a specific and and complex area. You really need the you know, the best specialists in some ways uh to bring into the company. How did you how'd you go about staffing those roles?

Brian Sullivan 39:42

Well, it at the start, I I had to rely on search firms, right? I didn't have a network and didn't come from the industry. So to get the senior people uh had to use search firms and and very lucky and very happy uh that we were able to build the team we did. But they, because of their experience, had networks. And so one thing we're all quite proud of is that the sales force we hired was all through internal uh referrals. So that we we started off with people that you know essentially people could vouch for and that knew would fit into our culture. And so we minimized, we felt the risk of either having a culture misfit or somebody wasn't quite at the caliber that we were hoping for. Uh, but that was a good because we had over time built a great network. We had hired the kind of people that had all those relationships. And and and as we've advanced, then for the most part, you know, we if we if possible, not every position is uh makes that possible. Yeah, if we can find an internal candidate, or rather, a candidate from uh that's an internal reference, it's it's great because you know they know what we're looking for, they're top-notch people. They're not going to recommend a sub-par individual, they're gonna look for a top-notch person that they've worked with. And and uh and and again, because you know the opportunity we're pursuing is is very significant. It's a very attractive uh setting to be in. Breast cancer is important. This drug has the potential to be a very, very important drug. And so we're uh able, I think, to really plausibly go after as good a people as are out there. And I think we've we've done a great job of getting you know really great A people you know throughout the organization.

Ben Comer 41:28

Um on your pipeline, uh

Partnering Strategy And Hiring Great People

Ben Comer 41:30

you've got this approval now, obviously. Uh what and I I believe you mentioned a phase three in the first line setting. Um, but give me a sense of of what's coming next, maybe in in breast cancer and then outside of breast cancer.

Brian Sullivan 41:43

Well, the pathway that our drug is treating, this PAM pathway, is intrinsically involved in this disease. And it's not uh it's not a result of an adaptive mutation or evolution based on prior treatment. And so patients who are treatment naive, these are women who you know may have had early breast cancer and uh 10 years later it comes back, it recurs, or a woman who had early breast cancer, but it comes back right away. Those are kind of two different populations. And and so, you know, our early phase data was very promising in that setting with these women. You know, we we reported uh 48 months medium PFS for women who had a your treatment naive, uh, which is an unbelievably favorable uh preliminary, small sample size 40 patients, but that's about as good as it gets. Uh and so felt that that was more than support, more than sufficient to justify phase three in that first-line population. And and it's also a large population, unfortunately. You know, 60 either 90, roughly between the two groups of women who are treatment naive that we're targeting separate clinical trials. Uh there's there's over 90,000 women a year in the US who are diagnosed and and require that first treatment for metastatic disease. Uh so you know, that's as large a population as exists in cancer for uh a first-line uh CI. So it's an appropriate place to try to develop a good solution for, and we do believe this is the next, this is what's required of a drug like GETA to um uh you know create a uh a step function improvement uh in the outcomes for these patients. It's an untreated disease mechanism. Many studies or many drugs and that's that's great, are uh improving on an existing therapy or drug class. And so they're replacing maybe a drug. In our case, and this is usually areas where you have the highest probability of success, we're treating an untreated disease mechanism, i.e., uh hyperactive PAM signaling. And so you you will have again, it depends on the drug, et cetera. But but if you have a great drug, and now we've demonstrated we do, uh, and you have a an untreated disease mechanism, you can assign a pretty high probability of success to those future studies. And and so we Think it's reasonable for us to be very confident uh that that we'll have positive readouts in those studies. I mean, obviously we have to show up with the goods, but we we think it's a high probability event.

Ben Comer 44:11

Uh this is not very important in the grand scheme of things, but I'm gonna ask just because I'm curious, uh, Rev Torpik, do you anticipate that that name will stay the same with new indication approvals, or will you have uh, you know, you'll just sort of add the indications, or will you have a you know, new product name?

Brian Sullivan 44:28

No, that that'll be our name. I mean, that's that'll be the drug. And uh and so it's uh and that's the common practice. I mean, I think you might only change the name of the drug if you go into a different disease setting. For instance, in oncology, you'll have the same name, but Avastin, right? The uh Veg F antibody from Roche, you know, that was a vast uh Avastin for cancer and forget the name, but a separate name, but went AMD. Um and and they they basically kind of rebrand it uh because you're really talking to a whole different community uh in that saying it's a whole different dosing, a whole different set of circumstances.

Ben Comer 45:04

But yeah, and the same is true with like Humera and InbREL and uh the um though

Pipeline Expansion And Subcutaneous Formulation

Ben Comer 45:10

those drugs. Uh but then you have uh I was do you've I've seen other instances where companies will change the the name for one reason or another. Um the GLP ones, I guess, are the kind of uh front and center uh example there. But um, yeah, in cancer, you're gonna even if it's uh prostate cancer, you you would still be brain cancer.

Brian Sullivan 45:29

Oftentimes what you'll do if you if you change the molecule, like with these GLPs, they're kind of they're changing the molecule. They're still hitting the target, but they might be hitting it, you know, multiple targets. Like Lily's now hitting three different targets. Well, it's a different molecule, different name, and and that's typically the driver of uh either it's a new setting or it's a new molecule, even though you're already got one molecule that's that's going after that uh that setting.

Ben Comer 45:53

Got it. Okay. Um, we're uh getting to the end of our time here, Brian. I I before I let you go, I wanted to ask about um your top goals uh for the rest of 2026. I I imagine successful launch is probably pretty high up there. But uh what do you yeah, what do you hope to achieve uh the uh for the rest of this year?

Brian Sullivan 46:14

So getting uh uh have a fantastic launch um uh is top of the list. Um having our uh SNDA submitted for the mutation uh cohort uh that we evaluated in this uh second line setting. Um you know, reporting additional data uh for our prostate cancer study and then proceeding, you know, based on that data, we hope, uh, to the phase two uh setting where we'll do some uh additional work uh to characterize the activity and in uh these men with castration resistant prostate cancer. Uh and then to you know continue to think through our life cycle development uh plan. This pathway, the PAM pathway, is implicated in a lot of different cancers as well as a lot of other disease areas outside of cancer. And so we want to make sure we are um uh properly uh evaluating uh other areas where we could potentially develop this drug. And and then one other project uh should mention is that we're developing a new formulation of getta. Your ghetto is now infused, it's a 30-minute infusion. Uh we're developing a subcutaneous formulation that will allow you to inject it um in as a shot, essentially. Yeah, no, I'm sorry, go ahead. Yeah, no, and so that's uh that's an important project for us. That that would be most important really for the population that we're treating. This first line population where their current standard of care gives them 24, 25 months. If our trial is successful, we probably would be giving them at least 33 months as an example. Well, that's a long time uh to be you know coming in you know three times a month for an infusion. We would get, we think, a good share of those patients because the benefit would be warrant that. But to the extent we can improve that experience, that would be good important. And so sub Q, in our view, would help uh expand penetration potential. It it'll be help it, we don't think it'll change much of the penetration potential in the current settings we're focused on. Certainly won't hurt, uh, but not necessary. But in the first line endocrine sensitive setting, yeah, sub Q would be good. So we're we're we're moving that through the pipeline as well. Uh evaluating, you know, and optimizing a variety of different candidates. There's a lot of variables to optimize uh when you're developing a new formulation. And so that work is ongoing and and we want to kind of continue to make progress on that front as well.

Ben Comer 48:34

With the subcutaneous uh formulation, um, would patients potentially be able to use that at home, or would it be still administered in the doctor's office?

Brian Sullivan 48:42

Um yeah, it's too early to commit. Um that would be the goal, right? You know, we have a uh a profile that we're shooting for, functional requirements for uh this formulation. Uh we we'd like to be able to achieve that. Um, but if we're able to only develop a drug that you know would require going into just a doctor's office, we still think that would be a win. Um it would just you know create much more flexibility for the patient. Um but so you you know you shoot for what what would be optimal, uh, and that's that's what we're shooting for. But if you get something that's still very good and accomplishes and delivers an improvement for the patient, we'd proceed with that too.

Ben Comer 49:19

Yeah, I mean a quick

2026 Goals And Closing

Ben Comer 49:20

shot over a 30-minute infusion, uh it's a huge thing.

Brian Sullivan 49:22

No, exactly. Right. Exactly. So you know, you you you want to be careful not to rule out what could be a very good alternative if you're not able to optimize or or achieve what you think is the optimal uh in this case formulation.

Ben Comer 49:34

Um, Brian, thanks again for being here. I really enjoyed speaking with you.

Brian Sullivan 49:38

Oh, you're welcome. No, it's my pleasure.

Ben Comer 49:40

We've been speaking with Brian Sullivan, co-founder, chairman, and CEO at Cellcuity. I'm Ben Comer, and you've just listened to the Business of Biotech. Find us and subscribe anywhere you listen to podcasts, and be sure to check out our weekly video cast of these conversations every Monday under the Business of Biotech tab at lifescience leader.com. We'll see you next week, and thanks as always for listening.