Business Of Biotech
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Business Of Biotech
Building An Efficient Biopharma With South Rampart Pharma's Hernan Bazan, M.D.
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On this week's episode, Dr. Hernan Bazan, M.D., co-founder and CEO at New Orleans-based South Rampart Pharma, talks about building an ultra-lean drug development company to address an unmet need observed in his own patients as a surgeon: safe treatments for acute pain. Dr. Bazan explains his strategy for building value through small raises and no full-time salaried employees, co-founding the company with his father -- a scientist and director of the Neuroscience Center of Excellence at Louisiana State University Health Sciences Center -- and why the future of pain management will likely involve multimodal approached personalized to individual patients.
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Ben Comer:I'm your host, Ben Comer, chief editor at Life Science Leader, and today I'm speaking with Dr. Hernan Bazan, co-founder and CEO of South Rampart Pharma, a company developing a novel non-opioid treatment for pain. Hernan is a practicing vascular surgeon at Ochsner Health and is also the John Ochsner Endowed Professor of Surgery and Innovation. In 2024, he was recognized by the NIH as a Helping to End Addiction Long-Term or HEAL Trailblazer, based on the work he's doing at South Rampart Pharma to address the critical need for safer and non-addictive pain treatments in the outpatient and inpatient post-operative settings. Hernan understands the urgent need for safe and effective and non-addictive therapies directly as a surgeon and I'm excited to learn about the development work South Rampart Pharma is doing, what challenges he's faced as a CEO, his approach to lean company operations and what's next for the company's lead candidate, SRP-001. Thanks so much for being here, Hernan.
Dr. Hernan Bazan, M.D.:Well, it's really a pleasure, Ben, I was mentioning to you earlier. I've listened to the Business of Biotech now for, I think, over three years and enjoy some of the true luminaries you've had, like your CFO, Alan Shaw, and a lot of the zingers that he shares, and the practical advice, as well as some of the real innovative biologists that are contributing to the biotech and life science field that the United States shares and contributes to the world. So it's a real true pleasure and honor to be here.
Ben Comer:Well, thank you so much for saying that. I have to give credit to my colleague, Matt Pillar, who really built the podcast to what it is today, and so I appreciate you sticking with us through the change in host. Yeah, yeah, high quality, thank you. Thank you so much. I want to start, as we do on the Business of Biotech, with a little about you and your background. You are, as I mentioned in the intro, a surgeon. Why did you decide to become a surgeon initially? What interested you about that field?
Dr. Hernan Bazan, M.D.:It's a good question in terms of, yeah, there aren't many surgeons, true, that are doing work in life science or biotech? I realize Obviously there are many physicians. I'll tell you, when I went to medical school, I had no idea that I would become a surgeon. I mean, there are certainly some people that think of that early on in the clinical years or the third and fourth years of medical school, and that's when you really get exposed to what it is like to be in a clinic. And it was actually my wife, who was a classmate of mine at Georgetown, who did the surgery rotation first and said you may want to consider this, and it was basically what really solidified it was at the very end of the third year. So I actually was at the NIH in Bethesda where actually she and I met through the Howard Hughes Medical Institute as what's called a research scholar, and it was an incredible two years. And so when I finished those two years, I thought I was going to go into internal medicine and do some specialty like immunology related or hematology oncology, because I had worked two incredible years on immunology and HIV research. And those actual years are important years looking back because they really influence critical thinking, and so if anyone is listening, that's sort of an ascent student investigator and trying to understand between clinical medicine and research and how to marry them. I know probably we'll touch on the NIH later on.
Dr. Hernan Bazan, M.D.:Those types of experiences are real, pivotal because I spent two years working in a lab of a real incredible person named Dr. Ed Berger. He only had four people in his lab then and from that work that he did in 1996, I joined his lab in July and in May of 1996, he published the first HIV co-receptor. For about a decade people knew that for the HIV to enter immune cells in addition to CB4, that there was a second molecule that was needed at the cell surface for the virus to enter. But no one knew what that second molecule was. And Ed, with a group of four people and he was competing with very large labs around the U. S. and a couple around the world was able to discover the first HIV co-receptor because he was under in building four in Bethesda.
Dr. Hernan Bazan, M.D.:The NIH has different building numbers. Building 10 is where I was working when I was my first summer there before I joined his lab. That's the big clinical center. Building four is right next to it. That was part of NIAID, the Institute of Allergy and Infectious Diseases, and the head of that at the time was obviously Dr Tony Fauci. And actually Dr Fauci had a group of over 100 people and a significant number of them were looking for the core receptor as well, as was a big lab at UPenn, a lab in France, a lab at NYU and one at UCSF and others, and then with a group of four, what he did was he utilized the technology that was developed by someone that he was under named Bernie Moss. He was a National Academy of Sciences investigator and he had cloned all the proteins, basically for vaccinia virus. Now, why is that important? Because with that he was able to do these expression very efficient expression ability of a way of expressing proteins and he set up something called a fusion assay. And the fusion assay is what I became fast-outlet and that's what he had developed as a way to determine if the HIV alveolar protein is in one side and CD4 is on the other. But we are going to basically alternate different molecules on the cell surface to see which one is the most efficient for the fusion assay, and that's how we're going to discover the first and that's how we really started fusing, which ended up being a CXC chemokine, CXCR4.
Dr. Hernan Bazan, M.D.:And I'll tell you that that paper, Science, I remember before I joined the lab I was reading it in the New York Times and then, when I joined the lab in July, there was all this activity from all over the world and a month later, in one week, there were five papers in science, two in CETL, one in nature, one in PNAS all about the second co-receptor, CCR5, which is actually the more omnipresent one. And so today, why is all this important? Today there's actually a therapy, an antiretroviral meriduric, that actually targets CCR5 and is part of the antiretroviral, and so all of these are really important for understanding what's called viral tropism, like which virus will infect which immune cell Early on it's CXCR4, but then the envelope protein evolves and then it becomes CCR5 tropic. And it was a pivotal time to understand how to conduct incredible virology immunology experiments and then just to also see the pace of research. What I did, my contribution, was to demonstrate something called CCR8 to the other telokine receptors. So that's what I published as I was ending the two years, that that was important for the HN infection of the thymus.
Dr. Hernan Bazan, M.D.:And how did this all tie in to the business of biotech?
Dr. Hernan Bazan, M.D.:So that was a lot of collaboration with, obviously, his group in virology immunology where I was working, but also a very good immunologist named Dr. Phil Murphy in Building 10, also NID, but a lot of immunology, and from that the NIH actually patented that and then licensed it.
Dr. Hernan Bazan, M.D.:So I didn't know really what was going on. I was just a student but, bless, bless their heart, they included me in that the next several years I would get a $150 check twice a year, which was helpful as a, you know, poor resident, you know absolutely. So that was my first sort of uh assessment of what all of how you know really true important basic science that was translationally targeted, you know, could be potentially commercialized. And now, within surgery then I went to, as in the clinical years, there actually is a parallel because within surgery you can make immediate impact on patients and obviously this is an impact but it takes a long time, but that has always resonated with me. And then, obviously, within surgery, there's no more immediate impact in vascular surgery because of the way you can affect patients and that's a field that has a lot of research and tremendous translational potential as well.
Ben Comer:Yeah, yeah. So let's talk about the circumstances that led you to found South Rampart Pharma. Did that come out of your experience as a surgeon, or what kind of drove that idea home about the urgent need for a non-opioid pain therapy?
Dr. Hernan Bazan, M.D.:Right, so this really grew out of a discussion with the other co-founder, the scientific co-founder. It was actually my father, Dr. Nicholas Bazan. He's a very well-known neuroscientist. He's got a large group over 80 people still with 12 PIs on stroke and neurodegenerative diseases and the neurochemistry of different other things like epilepsy and Alzheimer's.
Ben Comer:Where is?
Dr. Hernan Bazan, M.D.:his lab. So they're located actually here in the city of New Orleans at the LSU School of Medicine and they've been very productive and continuously NIH-funded since the mid-'80s and have made seminal contributions in neuroscience and neurochemistry. And he had done something many years ago in pain, so he had a little bit of experience. Many years before that he had something in ophthalmology in San Francisco with other chairs and they took the company public. So he had a bit of experience in some contexts. And so we were speaking about, obviously, the large void in medicine. And there's a colleague in Spain at the University of Alcalá, a medicinal chemist, and what we were thinking was based on the big challenge which is what was available and still is really available, which is very narrow for pain, and one of them being paracetamol or acetaminophen or Tylenol or Panadol all the same molecule and those response-related issues of liver toxicity, toxicity. So to address that, what the medicinal chemists did as we were discussing this was make a library of compounds in a rational way and there's something in the middle of the molecule that prevents the liver toxicity. So since 1983, it's been known that a large amount of Tylenol or Panadol or acetaminophen can cause liver toxicity. In fact it's still the number one cause of acute formalin hepatic failure, really In the US and in many parts of the Western world, and part of the reason has been because many people realize that it's also present in other formulations, you know cold and sickness and in other things, and so people aren't feeling well and more than they realize, and then, as you know, there's a lot more fatty liver disease, a lot more NASH now, and so there's some susceptibility to that increased dose and it's a dose response. And so this is 1983 when it was published in Journal of Biological Chemistry.
Dr. Hernan Bazan, M.D.:Napki is a metabolite that causes an injury, and so the way this was designed, this library was designed, was to avoid the NAPKI formation. It's called the benzopoietin. So the library that we formed avoids that, maintaining the analgesic or the pain relief, and we were trying to also circumvent the toxicities of NSAIDs, non-steroidal. I can tell you I have patients that have had shoulder injuries and they've gone on to dialysis, and obviously we all know of what the problem is with opioids and abuse potential, and that's what we were all trying to do, is come up with a novel non-opioid Now, even though we were trying to bypass liver toxicity of acetaminophen because these are new chemical entities or NCEs, the regulatory pathway has to be through an Rx or therapeutic and then an over-the-counter. Obviously it's a different regulatory pathway, which is actually important from a development point of view because obviously the market is larger and so that's important in terms of attracting partners and so on later on to take this onward, and so that's really how it all grew and that need and that was the design. And so then what we did was we were able to secure a margin IH grant.
Dr. Hernan Bazan, M.D.:That was the PI from NINDS. They were incredibly supportive. It was what's called a fast track phase one, phase two grant, and that allowed us to do a lot of the characterization. We had already begun doing a lot of the mechanisms of action, about how it works in the brain to reduce pain, how it avoids the liver toxicity, in finer detail because of the second mechanism, which is to maintain hepatotype junctions, and then did a lot of what are called the FDA, ind. This is a new drug application enabling studies, and a lot of those are standardized genotoxicity, animal tox studies into species, a lot of metabolic assessment to make sure they're not toxic, and so on. So then you can actually open an IND and get into the clinic, and so that's what we did with that grant. Then the NIH was able to, we were able to secure a second grant, a business grant, from them and then raise some diluted funding to get us where we are today, which is now phase two already, I mean finished a very successful phase one randomized trial.
Ben Comer:Yeah, I want to pick up on that in just a second, but I'm curious about your location in New Orleans. Do you have a specific? I mean, your father is based there, his lab is based there. Is there another connection to New Orleans or a specific reason why you set up shop there?
Dr. Hernan Bazan, M.D.:Well, when we moved from Argentina when I was young, we were younger and so this is where they had a faculty position. So that's where we were raised and I went to all my training in different places for college and then med school and then residency and fellowship, and so actually one of my main mentors from surgery came back to New Orleans from New York where I did my residency at Mount Sinai Hospital, and so I was his partner for three years and then we stayed here for several years within here for several years, and that's how this grew out. The kids are getting a little older now and there are other opportunities that are rising. So you know, the future may evolve. But that's where the company has been headquartered, because a lot of the knowledge has come from there, from the medical school.
Ben Comer:Got it, got it. Well, let's pick back up on SRP-001. You say you're phase two ready at this point. What are kind of the next steps? Are you fundraising at the moment to kind of power that phase two trial? Give me a sense of kind of what's needed, I guess, for the next step. Sure.
Dr. Hernan Bazan, M.D.:So I think anyone listening who's a CEO co-founder will tell you that every single day you're fundraising. Obviously there's a lot of strategy and operations and management, but absolutely every day you're trying to evolve the technology, and to do that you need to secure good capital in an intelligent way, and so we're well on the way with the race. And so we're well on the way with the race, and so we're aiming to execute the phase and network with and get to know really well a very experienced individual. His name is Dr Todd Bertocci. Todd is based in Salt Lake City. He's a former anesthesiologist and actually ex-Air Force guy, really reputable and very experienced and very experienced.
Dr. Hernan Bazan, M.D.:And the great thing about him is that he, for now a couple of decades, has taken reformulated, well-known drugs that are combined, reformulated and doing acute pain trials. And that experience is so critical because pain is subjective and what one is trying to do in a clinical trial is to subjectify something that's subjective, because your threshold of pain may be much higher than mine or vice versa, and so you always have to individualize it to the subject and trial. And the reason that's important is that you can actually reveal what the endpoints really are, in addition to, obviously other things you may be measuring, which is reconfirm, and safety and pharmacokinetics, how it's absorbent, and so on and so forth, confirming safety and pharmacokinetics, how it's absorbing, so on and so forth. And so we formed that partnership, we've done the protocol and I feel very confident that the phase two trial will be very successful because of the amount of detail that we've paid to how to enroll, how to measure the primary and then the secondary endpoints in an acute pain situation, and so on and so forth for pain writ large.
Ben Comer:But have you seen any studies or are you aware of any progress in that direction for specific types of pain that would not be kind of self-reported and subjective, that would be more able to be objectively observed, whether with imaging or whatever else?
Dr. Hernan Bazan, M.D.:Yeah, that's an important question. So actually, in a nutshell, there is no pain biomarker. It's something the NIH actually has been very interested in and for the previous several years they've actually had specific RFAs to try to elucidate biomarkers, a pain biomarker there was a very interesting paper just a few weeks ago in Nature, aging, a very interesting paper just a few weeks ago in Nature Aging, taking a proteomic approach to look at Alzheimer's biomarkers. And so for sure one could take a similar approach of looking, let's say, at acute pain, for example, what our phase trial will be, which is removing of two impacted or partially impacted third molars or wisdom teeth, pool and do an analysis of the blood, of the serum, and to look for what is a proteomic signature in those subjects compared to, say, placebo and how are they affected, compared to those that receive something like SRP-SR1, the normal adenopya that we have, versus placebo. Or even just control people that aren't getting any sort of tooth pull, whistling tooth pull. And so you know there are, even though none have been revealed to date. Perhaps there are approaches like that that was just recently done for Alzheimer's, that could be applied for temple and that.
Dr. Hernan Bazan, M.D.:But you're absolutely right, pain is not all the same, so that's more nociceptive pain, acute pain, neuropathic pain is an even larger problem, a clinical problem being on patients that have diabetes, that have diabetic neuropathy, and that may be different than say, chemotherapy. It's a splatin-induced neuropathic pain that may have its own biomarker and so, yes, to answer your question, there's no specific biomarker and likely the different types of pains would have the different biomarker signature once they can be elucidated. But that is an active area of research. So, in addition to if a biomarker can be elucidated, that it would be helpful for measuring either primary or secondary endpoint in trials. It would perhaps also be helpful for individualizing treatment on patients Right and in whom to focus, and we'll talk about this probably at the end.
Dr. Hernan Bazan, M.D.:You know, multimodality versus single agent, especially in the future, as new pain medicines come on the market that work differently, and then you know when then to subject someone to something that has an abuse potential, like opioids, which are still going to be the most effective for treating pain, albeit the ones with the highest adverse effect profile effective for treating pain, albeit the ones with the highest adverse effect profile. So it could actually not just be just a biomarker for predicting outcomes of trials, but there are many ways that I think it could be helpful clinically. Obviously, it would have to be cost effective, and so right now it's very much at its nascent form, you know pre-discovery. But I think one day we'll get there.
Ben Comer:And those are ways that it could, I think, be utilized. Yeah, and we will come back to the landscape for pain therapies. But you mentioned cost effective and I wanted to follow up on what you were saying about fundraising efforts. You started out the company with some grants, with some diluted funding. You're now raising, I believe, a Series A and I think correct me if I'm wrong targeting an $8 million raise, which is a lot less than a lot of the biotech companies that you see out there raising funds, and I'm curious about how you might explain that and your kind of approach to lean operations, and does that feed in with this? You know importance of a new pain therapy being cost effective.
Dr. Hernan Bazan, M.D.:Yeah, so it's. You know it grabs headlines when you do a 30, 40, 45 million raise, for sure, and it's good. Our approach has been different and the reason that it's been different is because pretty much all the funding that we've raised has gone into the R&D, into technology development and adding value to the venture. And in fact this was the subject of what you and I were talking about earlier, before this, which is the recent Wall Street Journal piece, sort of about our lean approach where no one is on full salary and it's just fractional work by the people that are working for the company, the team that we formed, which is a stellar team I'll share both our CFO, our director of CMC chemistry, our director of toxicology, pharmacology and our regulatory and what we're trying to do is move and move forward as efficiently as possible.
Dr. Hernan Bazan, M.D.:Now, if we raised, say, $35, $40 million, we could then do a couple of pipelines we could do. We were talking about neuropathic pain. We could do neuropathic pain and that would take probably about two and a half to three years, many sites and those endpoints are important endpoints that meet. They're probably not going to be as clear as, let's say, an acute pain trial which can actually be executed in well under a year, which can actually be executed in well under a year, and this includes writing, locking the data, data lock, writing it and submission to the FDA. And so what we decided to do rather than focus on two pipelines because we were going to do that as well as do we have an intravenous formulation to develop an IV and an endosuspension? We're going to develop that as well we decided to based on some market feedback. I'm just focusing on acute nociceptive pain acute pain to demonstrate, based on how we know it works in the brain and the animal models that we have, that demonstrate efficacy, demonstrate pain relief, to just demonstrate clinical efficacy with a more focused round. And that way it didn't dilute everyone as much and we could be more efficient in terms of the timeframe. And then, obviously, with this face-to-data, it would potentially make this a lot more transactable.
Dr. Hernan Bazan, M.D.:And so, in terms of, you know, moving the technology forward, and so all these things are important, you know considerations. I think the way we're structured in the lean way is also, you know, moving the technology forward, and so all these things are important. You know considerations. I think the way we're structured in the lean way is also, you know, a reason that we can forego. And why do that? You know it's important, right? Because one obviously part of the audience may be people that are in operations and so on. You know you hire someone full time, you know it's going to be for at least a year at a pretty significant salary, and if he or she is not really producing in three or four months, you still got to pay them for the full year and you've lost a year of work. And so we've tried to take a different approach, based on conflicts that we have and so on and so forth, and the team, the startup team that we formed, to use this approach to really just put everything into the R&D and into value formation and forward movement.
Ben Comer:Yeah, and I would encourage business and biotech listeners to look up the Wall Street Journal piece when Hernan says that he's running a lean operation. That is not a buzzword. He is paying cash. He does not have full-time salaried employees. He's working on mornings and nights and weekends and is actually running a lean organization. One thing that you didn't yet speak to that I wanted to ask about and I think this is important in the context of opioids as the standard of care for pain therapy and the fact that they're very cheap, available in generic form how does this kind of model fit into eventually getting to a price that is ultimately accessible to patients, that is, you know insurers are going to pay for, et cetera?
Dr. Hernan Bazan, M.D.:Yeah. So that's been one of the big arguments for a while that what's available is dirt cheap. So why is there a market? Or should there be a market, why put funding into this? And I think this is where Virgin Pharmaceutical should take a lot of credit. So, as you may some may know, some may not they've done an incredible job of pushing forward a new set of molecules and on January 30th 2025, got FDA approval for acute pain treatment with a molecule that's now called Gernomax that targets a sodium voltage 1.8, gated channel NAV 1.8. Now why is that important? It's because what they were able to demonstrate about how the market responded to this is very positive. So their market cap changed in a very significant way, such that within a week, it was a several billion dollar upswing in their market cap of the whole company.
Ben Comer:So there's a belief that this is going to get used. Is what you're saying, absolutely?
Dr. Hernan Bazan, M.D.:Speaking, that the market was positive on it. And then, when you go to December, when they showed some chronic pain data that we don't need to get into the market, cap also reacted in a certain way, and so these are important contemporary readouts that there is in fact, a market appetite for it. We all know that clinically, there's a huge void. We all know societal, there's a huge void. To the question that you were just asking, though yes, what's available are generic and they're cheap. Would people pay for it? So obviously there's a lot of pricing model. That goes on and so on and so forth, and so what I understand their asset is it's a twice a day dosing, and it's $31.50 per day, so there can be a premium that can be paid. That then will be realized by the investors in a way that it's balanced so that patients can still benefit, and so it's not a buy logic. It's not going to command thousands of dollars, but it's not too cheap either, so that I think that the market has demonstrated that, in fact, there is an appetite for paying a premium for something that's new, safe and effective. Now, regarding their asset, again, they've done a great job with demonstrating this. I think they've said it themselves that this is sort of a first pass Right, and they and others are working on others to improve it.
Dr. Hernan Bazan, M.D.:Our approach is a bit different because they're working in the periphery, on full nerves. We work centrally in the brain. We know that a radiolabeled SRP-SR1 crosses the blood on peripheral nerves. We work centrally in the brain. We know that a radiolabeled S-herpes or SRO1 crosses the blood-brain barrier. We know where it works, in the midbrain, which is called the PAC region, the peritoneal gray area region, and we know that the SRO1 and that's what we've published recently. We actually just this morning got notice about a second mechanism and epigenomics and genomics paper that we're revising, to be published, hopefully very soon as well, to further elucidate the mechanism of action should translate clinically to efficacy, because the way SRP-SER-01 works is through production of something called AM-4-O-C, and that's actually how acetaminophen works.
Dr. Hernan Bazan, M.D.:Yet because it doesn't have the liver toxicity, it's got a much wider therapeutic index, and so what I can show with you, ben, is that in the hospital, when we gave patients IV Tylenol, post-knee scope or mini laparotomy or even a modern laparotomy or hip replacement, their use of dilaudid or morphine or fentanyl goes down tremendously. These are opioids and so it's actually at a high dose. It's quite effective, and so that's what we're trying to achieve with SRP-0-4-1. Ibutamil just can't be used for a long time because of liver toxicity, even intravenously, and so we're trying to take a really clinically validated mechanism of action sexually in the brain that besides the M4-4, we're elucidating the genomic and epigenomic mechanisms I think that's important to understand other pain pathways and are working to demonstrate how this efficacy will be translated with what we'll see clinically.
Ben Comer:Right yeah, so this is not targeting the sodium channel in the same way that that vertex is geronimic.
Dr. Hernan Bazan, M.D.:Correct and that's important because the future of pain, ben, will probably be multimodality, so similar to how we treat now hypertension, you know blood pressure, so you know there'll be a calcium channel blocker for blood pressure, there's a thiazide diuretic, there's a nice inhibitor that may be used in certain patients, a beta blocker, and so there are different classes that can be added to manage hypertension blood pressure. For chronic pain, which there are over 51 million Americans that have chronic pain, the effective treatment of chronic pain, rather than being take one acid or combine two that have significant kidney and or liver injury or put a third that has a significant abuse potential, hopefully the future will be a couple of acids that work different, that are effective and that have a pretty wide therapeutic index, that don't have much of an adverse effect profile, and that's how I think we move the needle in the safer treatment of pain.
Ben Comer:And potentially personalized to some extent Correct. Yeah, Hernan, you've written that pain is a global juggernaut of suffering, which I found quite poetic and I wanted to mention it during our conversation, but I'll use that as a lead in to ask the question. South Rampart was founded in 2016. You're coming up on 10 years as a company. Are you where you kind of hoped you would be starting out in 2016? And what could you say has been the biggest challenge or most surprising challenge that you've faced in this? You know, 10 years of work.
Dr. Hernan Bazan, M.D.:Yeah, that's a good question. So I think we're exactly what we envisioned. We're now a clinical stage with robust human data that demonstrates that SRP is safe tolerable efficacy. We've really been able to elucidate robust pharmacokinetics, the PK, how it gets rapidly absorbed and distributed. Now I've optimized the protocol for the phase two efficacy. I've established some significant contacts, and so the phishing funding model that we've utilized has allowed us to achieve all these significant milestones.
Dr. Hernan Bazan, M.D.:And again, remember, this is from complete synthesis, and so the good news is we're not taking someone else's intellectual property that we have to sub-license or something like that. This is all, fortunately, things that we've developed that have spun up from the university that the founders are in in the composition of Matter IT that obviously has been nationalized in all key industries. So I think it's where we are coming into just over eight and a half, soon to be nine years, and then, within 12 months, months will be phase three ready. And so you know, as you know these things, it's never linear. It goes, you know, oscillates up and down, but that's how we view it now going forward, and you know, regarding you, you know you asked what the biggest challenges have been. Um, again, obviously anyone will tell you that the biotech sector funding is always up and down. So, as I mentioned earlier, constantly in a fundraising mode, nih has been very supportive. I had a call yesterday early morning. I was in San Francisco at 6 am with my NIH program director, nnds, who is extremely supportive, and you know they're going through some challenges, some significant challenges facing up to 40% cuts and, more importantly than that, is how the review of new grants has changed now a couple of times just this past few months, about how they're reviewed and through which centers and institutes, and so it's unfortunately translated into some reviews I'll just mention it just not being quality reviews because of the way they're being handled, and I think they're quickly trying to fix it.
Dr. Hernan Bazan, M.D.:I'm very confident in the staff that's there. They're high-quality staff and they're going to get the work done. Confident in the staff that's there. They're high quality staff and they're going to get the work done. And there's a lot of very good scientists and leaders within the NIH and they're going to get this done. They're going to see through this, and so you know you just have to be creative when you lead a company like this. Looking at you know the Luda from the NIH, arpa-h is an incredible resource as well. And then being savvy and communicating just with investors financial investors, whether the VCs or angel groups that have a healthcare assessment but also engaging already with strategic reforma and giving them, sharing with them what you're doing, so you can get feedback and utilize that feedback and how you make decisions in an efficient way.
Ben Comer:Yeah. Yeah. I'm glad you mentioned that you brought up NIH, because I think it's not always clear to folks who aren't working directly with the NIH what exactly is happening. If you read headlines, you might think that the NIH is just completely ending all of its funding or, you know, an enormous majority of the funding is, like, has been halted, not going out the door. People are losing their jobs way through a kind of, you know, period of turmoil, obviously under the Trump administration, but you're somewhat confident in A the people that are working there and their capabilities and, b that their mission will continue. Is that correct or is there anything?
Dr. Hernan Bazan, M.D.:Oh, absolutely, yeah, absolutely. I mean, you know, listen, the government has always had the right to prioritize, make their priorities be their priority and emphasize it. That's always been the case. If you look at the history, the last 40, 50 years, they may just change things. You know a dozen things from your years. Just this year there are many things being changed, but that's always in the purview of the US government.
Dr. Hernan Bazan, M.D.:The staff at the NIH, the leadership in the institutes, the ones that are the program directors, I can tell you are very good scientists, very good at administrating and very good at working to do things in an efficient, fair way.
Dr. Hernan Bazan, M.D.:I think if all of this helps to increase the efficiency, that's going to be a huge positive and I think it is becoming a huge positive.
Dr. Hernan Bazan, M.D.:You know there are going to be headlines, but I absolutely have full confidence in the day-to-day operations and people are going to just adjust and deprioritize certain work and prioritize certain new work to meet the new priorities of the administration.
Dr. Hernan Bazan, M.D.:But absolutely, the NIH is going to remain pivotal, and it has to right, because if you look back at 80, 100 years ago, the industry was railroad, oil and steel and now the industry is data, biotech and AI and listen, we're kind of losing the AI race to China right now and we may lose it Hopefully we won't but we can't lose the biotech and life science to China and EU, and I think everyone understands that's in this field, that the way to do that is to keep on supporting the nih and uh obviously, then to take technologies, like we're doing and many others are doing, and then commercialize them, and so that's, I think that that adds uh obviously not only a lot of value to the health and well-being of of humans, but also to to the economy and jobs and so on and so forth. So I think all those things are going to be realized in a way that, well, it's make the hopefully this system, ecosystem more, even more efficient. And you know, you just have to adjust.
Ben Comer:Yeah, I mean. Patience aside, I think it's undeniable that biotech is an economic engine. In fact, I'm glad you made that point because I know that the EU we just published an article on Life Science Leader about a number of initiatives that the EU is enacting because they see it as a strategic investment to attract biotech R&D, to streamline regulations, to get drugs and innovation to the market faster. It's recognized I guess is what I'm saying by nearly everyone that there are numerous benefits to having a strong biopharma ecosystem. So I'm glad you mentioned that we're getting close to the end of our time here.
Ben Comer:Ernan, I did want to just clarify one thing. Srp-001 is ready to begin phase two trials and I think what you're saying is you're hopeful that at the end of phase two you'll have produced some transactable data. Is that ultimately the goal that you would partner or potentially do a deal with the company to move the asset into phase three and ultimately to commercialization? Or is it possible that you'll pursue that yourself as South Rampart Pharma all the way through to approval? What's your thinking on that?
Dr. Hernan Bazan, M.D.:Right. Good question, ben. Obviously there are many options on the table. As you can imagine, when you're at that stage. There's a lot of value in working with a medium or large pharma once it's phase three ready, with phase two data, because obviously the amount not just the capital but of resources that they have to do that Absolutely we certainly have the context to conduct the phase three and then by then, yes, we would have obviously a full-time operations team, because it'd be in a different landscape that we'd be operating in to execute those.
Dr. Hernan Bazan, M.D.:And then there are the possibilities that certain pipelines are licensed out while others are being developed. So, for example, acute and chronic pain may be licensed out, while then the company develops the intravenous formulation, because that's its own other application, and or neuropathic pain has its own and or topical. So there are a multitude of possibilities. Obviously, then, if there's a significant amount of capital with interest, and then going to public markets is another option by the team at that time, that could be also considered. So there are a multitude of opportunities. I think my commitment is to get this developed as efficiently as possible so that once efficacy is demonstrated, safety, it can be utilized to contribute to the well-being of patients.
Ben Comer:Yeah, and I should also mention that you have some, I believe, ind-enabling studies kind of in the wings behind this initial acute pain indication with SRP-001. And so that's a potential option for you is to bring this lead candidate through. And it's acute pain after a wisdom tooth extraction. Is that right, correct?
Dr. Hernan Bazan, M.D.:That's the phase two. That's the phase two. That's the phase two. Right, the IND enabling are more for the intravenous formulation for the IV, because the phase two is for the oral. So, yeah, so there are a multitude of pipelines and possibilities that are in the future.
Ben Comer:Yeah, you could potentially, you know out-license after your phase two and use that, you know, turn that back around into R&D on some of your other programs. Potentially, for sure, for sure, excellent. Well, it's been really a pleasure speaking with you, hernan. Thank you so much for coming on the show.
Dr. Hernan Bazan, M.D.:No, I enjoyed it, ben, and listen again. Great job on what you're doing. Since you've taken this over, I've learned a lot from listening to many of the sessions that you've had, so great job. Keep it up, and thanks for keeping these discussions out in the open and clear.
Ben Comer:Thank you so much. I appreciate that We've been speaking with Dr Ernan Bazan, co-founder and CEO of South Rampart Pharma. 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 new weekly video casts of these conversations every Monday under the Business of Biotech tab at lifescienceleadercom. We'll see you next week and thanks, as always, for listening.
