Good afternoon. Welcome to Needham & Company's 25th Annual Healthcare Conference. I'm Serge Belanger, one of the healthcare analysts at Needham & Company. For our next session, I'd like to welcome Unicycive Therapeutics, a company developing therapies for kidney diseases. From the company, we have the CEO, Shalabh Gupta, who's going to tell us about Unicycive. They have an important PDUFA coming up in a couple of months here. I think that'll be a big focus. I'll hand it over to Shalabh, and you can talk to us about Unicycive, and then we'll follow up with a Q&A session after the presentation. Shalabh, welcome. Thank you. Thank you to the Needham team, thank you, Serge, for giving me this opportunity. It's great to speak with all of you. Thank you so much. I'll be making a forward-looking statement, please read them before making investment decisions. By way of background, we are a clinical-stage biotechnology company based in Silicon Valley, California. Serge, as you mentioned, we have a very near-term upcoming catalyst, which is a PDUFA date for a lead drug, which is oxylanthanum carbonate. It is indicated for patients who suffer from hyperphosphatemia, a condition happens to patients when they are on dialysis and they have high phosphate. We are focused our entire energy at the moment on a lead drug, which is OLC. We have a second drug also, called UNI-494, which is a complete response clinical trial. It's indicated for acute kidney injury. Most of my presentation will be focused on OLC. A couple of highlights before we go through the rest, just on this slide. As you can see, we have a cash runway. We announced our Q4 results of 2025, which gives us a cash runway into 2027. We reported unaudited cash as of March 27th of $54.9 million. The PDUFA is less than three months away. We are preparing for a commercial launch. oxylanthanum carbonate was first submitted to the NDA in 2024. We received FDA's response in the form of a complete response letter in June of 2025. There was deficiency with the third-party manufacturing vendor, which is not related to product. We resubmitted our NDA end of last year, and we have a new PDUFA date of June of this year. Let me talk very briefly about what the disease condition we are talking about. In the U.S., there are roughly 550,000 patients who are on dialysis. Dialysis is, as many of you know, it's the last stage of kidney diseases. Chronic kidney diseases affect one in seven adults in the U.S. It's a very high prevalence. Chronic kidney disease can progress over years and decades. At the very last stage of chronic kidney disease or end-stage kidney disease, ESKD, patients have to be on dialysis. We are talking about patients who are on hemodialysis. When they are on hemodialysis, dialysis filter takes off a lot of bad things in the blood. Phosphate is something that does not get. Most of it passes through the filter, so something needs to be given for managing these phosphate levels. The phosphate typically, how it works is that phosphate combines with calcium. People who have normal kidney function, phosphate doesn't create any problem. Since patients who are on dialysis, they have no urine. They are anuric. They don't make urine, that is why they are given their attached dialysis machine. In hemodialysis, in particular, it's around three sessions per week that these patients have to undergo. The point that we want to make is that phosphate is not a trivial condition. 1 mg/dL increase in serum phosphate increases mortality, which is what you see, dark purple graph here. More importantly, it also increases morbidity, patients end up in going to hospitals, increased cardiovascular risk because phosphate combines with calcium and makes blood vessels non-pliable. Blood vessels, when they are normal, they can pump the blood throughout the body. When there is a phosphate and calcium deposited in the form of plaque, it makes them more like a lead pipe, and therefore, patients end up in having heart attacks and die from chronic conditions. That's number one problem. The second problem is that phosphate combines with calcium, gets soft tissue depositions. These patients then have fractures or soft tissue deposition, meaning they have bony protuberance that they come out of their part of soft tissue that can be very, very painful. It is not a trivial problem. It is something which is very well understood. The problem has been there for quite some time. There are six approved drugs, but if you look at that over a decade, number of patients have had a difficulty in managing their serum phosphate level. I won't go through all the details. If you look at just the graph on the purple side, depending on how you measure it, if you take more stringent measure, which is less than 4.5 mg/dL, which is a target serum phosphate level recommended by the guidelines, 75% of U.S. patients are not able to achieve their target serum phosphate level. If you become more relaxed, you still find 44% of patients are not able to achieve their serum phosphate. That begs the question, why is that? This slide answers that question. Many of these patients end up taking 20- 30 pills per day, and half of those pills, which you see the top left, the bar chart, half of these pills are attributed to controlling their serum phosphate. We have done a number of market research, but in particular, one that we did very early on in the company was to ask conventional nephrologists one immediate question. What is the number one problem these patients you encounter, they suffer from? The single most common answer was the lower pill burden. Just to give you a background about our drug. Our drug is a proprietary molecule. It's a new chemical entity, which used the nanoparticle technology. We have multiple patents, including the strongest patents that are available in our industry, called composition of matter patent, that allow the drug to be covered till 2031. With patent term extension, we have patent coverage till 2035. The patent term extension is given upon approval from FDA. 2035 is a good amount of time that we have patent term protection, or patent term extension. In particular, our drug solves this main problem of pill burden by being able to provide the pill in the form of a small baby aspirin that patients can take with each meal, one pill per day. In our latest clinical trial, which I'll show you the data, we were able to show roughly 70% of patients that can be managed with one small pill three times a day. The pill allows three key advantages. One is potency, because lanthanum, which is an active component in the drug, it binds phosphate very potently. That provides the potency. Because it's highly potent, you can give a small pill. The palatability comes from the fact that these pills don't have to be chewed. I'll show you in next slide, here where you can see some of the pills are available on the market. As you can see, the Velphoro and Fosrenol, these are the pills which can be given a smaller number of pills, but they require patients to chew the pill. In particular, Fosrenol is a drug that requires patients to chew the pill in the form of a thin paste. As you can imagine, many of these patients have a hard time managing their medical condition and asking them to chew a pill and turn into thin paste is a really challenging part. One may say by looking at these things, that this doesn't seem to be so hard. I don't mind chewing three pills a day. You have to remember, these are the patients who are taking 20- 30 pills. They have other medical comorbidities. Chronic kidney conditions tap into patients who have other problems. Most commonly, these patients suffer from diabetes, high blood pressure, hypertension, and they are on a variety of other medications. I mentioned about clinical data. Let me walk you through some salient features of our clinical data. We ran a pivotal study that showed in a small patient population, we were asked to run this study as a part of our regulatory approval process. What we see that when patients are given our drug, the adverse event profile is relatively small. Let me qualify that, because it's a relative number. Diarrhea, we saw 9%, vomiting was 6%. You would say, Well, that seems very subtle adverse event. In all of these drugs, almost all of them, they have some sort of a GI adverse events. As a physician, I can tell you there is really no drug that has no side effects. Almost every drug has some side effects. In particular, if you look at this is a package insert. In other words, this is not taking a drug from one study, comparing a drug from another study, which happens in our industry. We sometimes say very simply that you're comparing apples to oranges. This is a package insert, which is what goes on the label of the drug that has the approval. This is very simple. What is an approval label? If you look at these drugs, and most importantly, I want to draw your attention to Renvela. What you see that the Renvela has a very high adverse event profile. They're all, most of them related to gastrointestinal system and GI system. Vomiting, nausea, and diarrhea, they're all in double digits. Renvela is a polymer. When patients take the drug, they feel bloated, they feel constipation, flatulence, and they don't want to take these pills. Renvela, I point this out because it is the commonest drug that is given. It is a prescription-wide. Roughly 52% of your patients are given Renvela for this. That's the way we want to compare, draw attention, compare and contrast. The other part that you see on green is lanthanum carbonate, which is Fosrenol. I showed you in the previous slide that the Fosrenol can be given in the form of one large pill that require patient to chew the pill. Fosrenol never took off, oftentimes when you think about it, what is the reason Fosrenol did not take off? That goes back to the palatability part, which is that patients are required to chew these pills. Moving on. We ran a study. When the patients were started in the study, their physicians were giving them the drug they thought was the best fit for those patients. We had no input, no influence on them. Moreover, physicians were giving them the dose that was best tolerated that these patients could take. On a baseline when patients were started in this study, 59% of patients were being able to manage, and that the recommendation was to bring them below 5.5 mg/dL. Prior to starting on our study, the percentage of patients who were being able to get managed below 5.5 mg/dL was 59%. Six weeks on our drug, that we call it a titration period, that bar moved from 59% to 90%. Being a physician and being somebody who has spent decades in looking at this type of data, that seems impressive. No matter what we think about it is a small patient population, which I said it more than once. It's a very smaller duration of a study. This 31% improvement looks really, really remarkable. I've had personal experience in talking to a number of physicians, and they say this is a very impressive performance. If you look at the bar chart in the green, you'll see 41%, meaning these are the 41% of patients who were not able to achieve their targeted phosphate level. They'll attain the fixed rate that was 10%. In other words, only 10% of patients who were not able to achieve their target serum phosphate level. This was a surprise to us because Fosrenol does not have a disappointing level of efficacy. The second part of the study was also looking at the dosage, and the caveat that I outlined in the previous slide. I'll continue with that. In a small study with a short duration, we saw that one pill three times a day was able to address to 69% of patients, they were able to get to that target serum phosphate level. What gives us even more excitement, even more confidence, is that we bring this to market, if we show data anywhere similar to here as we continue to expand, this is a drug that can potentially solve problems for many, many patients. We'll talk more about it. We did a patient-reported outcome, so PRO. There are some of them here. Obviously, you could think about it that if you have a small pill that they're taking with the size of baby aspirin, patients will feel better. They feel this is a preferred therapy. They feel satisfied. Some of these things are reflected in the slides. Coming back very quickly on the commercial part. We are a small biopharma company. If somebody has asked me how do you think about commercialization, first thing I say, commercialization of any drug is not simple or trivial matter. By recognizing that we remain grounded and focused to commercialize the drug. I want to show you in the next few slides why we believe in us, that we have an opportunity to do well for patients, do well for physicians, and do well for our investors as a small company to be able to launch the drug. This is a market which we've talked about before. We will remind you that a large number of patients are not able to take the drug. What we are able to do here is that this nanoparticle technology allows us to be able to create a profile of the drug that they can take with a lower pill burden. Building upon that, the way the patient population is divided in this market is that roughly two-thirds of the patients are paid by the government directly, which is a form of CMS, Centers for Medicare & Medicaid Services, and one-third, which is 36% here. We're just saying, broadly speaking, are paid through commercial insurance. We want to be able to provide a seamless and frictionless experience for patients and physicians. Our view is that with a potential best-in-class profile of the drug, if we have a frictionless experience for physicians and patients, it will help them to be able to adapt the drug and take the actual clinical promise of the drug in real world. We are creating a hub service which allows the physician to write a prescription, a patient to get the drug, while we manage the back end part of our reimbursement and going through their insurances. This slide is useful for those of you who are not spending excuse me, their days and hours in looking through the reimbursement landscape. Beginning of 2025, January 1, 2025, our government changed the plan from a Medicare Part D, Part D as in David, to Part B, as in boy. What it does is that the drugs, which are drugs like in this class, which is lowering phosphate, they went from Medicare Advantage plan to Medicare Advantage Part D plan. Typically, Medicare Part D is for medical benefits, and what it does is that it allows the drug to be, for a few years, to be in a part of TDAPA, which is a transition period, and then going to bundled. During that TDAPA period, the best advantage happens is that these drugs get to seamlessly reimburse by CMS. Building upon that a little bit further, this is a U.S. map, and the reason we put this map out there, because when we talk about our ability to launch the drug, people always say, Well, can you help me understand how can you launch a drug with a small team and small sales force? Everything is relative. When we say small is a different number for different people. What I can say to be more qualified, that is small, a little bit more clearly, is that we are not looking to hire hundreds and hundreds of reps. If you look at the U.S. map, what you find the top five deciles of physicians who prescribe 50%+ of these prescriptions are still roughly 2,100 physicians. That is 2,100 physicians prescribe 50% of all these drugs in the patient population. If you look at the map, as you can see, the purple dots is not equally distributed throughout the country. It's not a rare disease, so you can't have a very, very small sales force. It's also not a primary care drug like a treatment for diabetes, where patients are spread all over the country and you need a huge sales force. There are a couple of other nuances which I want to call out here. Number one, I mentioned to you there are other drugs approved in the market. Two, this is a disease condition where physicians understand if you are a board-certified nephrologist in the U.S., you don't need to be reminded again and again that serum phosphate levels have to be managed. There is a lot of awareness in the market for this. There are other drugs in the market. There are people who have come to us and told us that as soon as the drug gets approved, it makes no brainer in the sense for them to be able to prescribe the drug. We feel there is an opportunity here to make a difference for patients, physicians, and our investors. Building upon that further, pre-TDAPA period is the time when we get the drug approved and we are launching. In order for us to get access to Medicare Fee-for-Service, which is the one that I showed you one-third of the market and Medicare Part B, we will have to apply for TDAPA. It's a simple application process. We are ready to apply as soon as the drug is approved. During the TDAPA period, as I mentioned, the drug has a seamless, frictionless reimbursement from the government, and that allows us to be able to launch the drug. On one hand, I said that drug launches are hard, but by acknowledging something is hard, you realize that you have to remain very focused. You realize that there is an opportunity to do well if we execute, and that is where we are focused on. Post TDAPA, all these drugs go into bundle. I won't go through this. I talked about this very beginning, that we accomplished a composition of matter patent that allows to patent term extension through 2035. These are very near-term milestones, and Serge and I will be talking again after this presentation about Q&A. We have a near-term milestone. We have financing that allows us to be able to launch the drug. We are ready. What's usually for us, we have a TDAPA designation that allows us to be able to provide the drug to as many patients as possible with the support of the CMS reimbursement mechanism. The second drug I mentioned that we won't talk much about it, but we have a second drug that has been given possibly the designation, ODD, by the FDA, and we'll focus on that after approval and launch of the first drug. Just very quickly, we have a small team, which I've mentioned, but we have a very solid team. We have people who have been in this industry, have had multiple NDAs, approved drug approvals. We have in corporate side, people who have spent decades in nephrology market and specifically in dialysis market. Drug is listed here, but we have a number of other people we brought in under drug leadership who have had the experience of bringing a drug to market, specifically working in dialysis market. We have a support of some of the world's leading nephrologists. Dr. Chertow, Dr. Pergola. These are the physicians who have been involved in many of these clinical trials of phosphate-lowering therapy. Dr. Wolf and Dr. Mehta have been also giving us advice both on the first drug as well as on the second drug. Continuing further, we have a number of leading institutional investors, which we are very grateful to them for their support and their investment. We are really excited about what is ahead of us. With that, I'm going to pause here and happy to take any questions and answer any questions that may come up. Serge? Well, thanks for the overview. Maybe if we can start with the upcoming PDUFA. If I recall, there was a CRL last year, so just maybe talk about how you addressed that issue and what you think the risk is for this upcoming PDUFA in late June. Absolutely, Serge. As I mentioned, the CRL last year was not related to drug. It was related to a subvendor, not our main drug substance vendor. Let me just explain to you and provide you a little context. The drug is made in the form of a tablet. Roughly 85% or so work is done in the form of making that powder, which it is called in technical term, drug substance. Powder goes into forming a tablet. The drug substance vendor had no issue. They were inspected by FDA. They had no problem. It was a vendor that was putting this powder into form of pill and packaging and shipping. They had the issue. We went to FDA after CRL in the form of a Type A meeting to understand how best we can address, how quickly we can get the drug on the market. If you think about the initial vendor as Vendor A, who is making the final tablet, we had a Vendor B also that has been able to make the replicate and make the final drug product. When we met with FDA, our question was that, Help us, agency. How do we get to the finish line? They gave us a feedback based on the progress the Vendor A had, which is the original vendor. The best way, the fastest way for the drug to be approved is to work through Vendor A. Based on their feedback, based on the progress the Vendor A had made, we resubmitted our NDA December of last year, and FDA accepted the NDA, which gives you a confidence. It's not me saying it. FDA would not accept your NDA if they believe there was no progress made. Serge, what I can tell you, knowing what I know, that we feel very confident that whatever those challenges were, the vendor has addressed it, and in the very near term, we believe we can get past those past challenges and get through the regulatory approval process. There is nothing, as I know it's there in the facilities, but let me just clarify one more time. It's in multiple facilities. No preclinical toxicity issue, no clinical issue, no safety issue, nothing with the clinical trial. It is a facility issue. Unfortunately, we were stuck with that. I am saying that knowing what we know, we feel super excited about that, and we can't wait for the drug to be approved and be able to launch it. Great. Remind me again, are you seeking approval of a single tablet size or multiple tablets? If you say the approval is based on the three different strengths. The drug comes in the form of 500 mg, 750 mg, 1,000 mg. Got it. Okay. Is there anything that you'll be looking for in the label for the product to be differentiated and be able to compete in the hyperphosphatemia market? Absolutely. All these drugs, almost all of them, have a label which is called primary hyperphosphatemia, as in the only drug that does not have a primary hyperphosphatemia, meaning that they are the first-line treatment, is Velphoro, which is set to be in combination with a binder or if the patient fail on binder. We expect a first-line approval. Number two, differentiated, the drug is given in the form of a tablet. Because we are following the 505(b)(2) pathway, our label would look somewhat similar to that of Fosrenol. Just building on that, Fosrenol label allows it the first-line treatment. Where we'll be differentiated, we will be different is that our Fosrenol label says that chew the tablet whole, and we have ability to give that tablet in the form of an oral pill that can be swallowed, so that's appreciated. The last but not the least is that we believe there is an opportunity for us to discuss with the agency, which I don't know just yet how it will go, to be able to include that clinical trial data in the final package insert. Okay. You highlighted on one of the slides that there is up to five other options currently available for this market. Just curious which one you will be looking to displace. You highlighted that the pill version is significantly lower, the tolerability is better. Just curious which one you are targeting for displacement. Absolutely, Serge. Very good question. The commonest drug, that's why I focus on Renvela. The commonest drug that patients are given is Renvela. That is 52% of the market. The next commonest drug is a calcium-based drug, which are drugs like TUMS. Those are the two biggest competitors incumbent in the marketplace. Renvela has done well. Doug, who's on our team, launched Renvela for Genzyme and grew to over a billion-dollar sales. A lot of these patients are on generic version of Renvela, but patients don't want to take the pill. I showed you that with seven profiles. It's a lot of pills. Some of these patients are taking 12- 18 pills a day, then they still are not able to achieve their target serum phosphate level. Wow. Okay. You talked about TDAPA. I guess, what is the key for getting traction here in this market? Obviously getting TDAPA is going to be part of it, but you need to enter contracts with the various dialysis organizations. How important will that be going forward? Can you start doing that work prior to approval, or do they require a label and pricing to get into those discussions? All very good question. To answer holistically, we are in discussion with these dialysis organizations. Lot of work that gets done after the drug gets approved. I do not see a world where we can announce, Oh, we partner with this dialysis organization. That's not happening till the drug gets approved. The groundwork has been done, Serge, not for days or months. We've been doing it for years because there are six dialysis organizations, if you will, and I'll name two here, that manage 95% of this market. If you talk to six people or six key organizations, you have 95% of the market covered. The two big ones are Fresenius and DaVita, and we have a lot of respect for their clinical team and the business team, and we're talking to both of them. We will be looking forward to announcing these things as we get approval and launch the drug. They're important, Serge, and this is a win-win for them because they have a benefit of having a drug in TDAPA and such a great clinical profile. We have an opportunity to work with them. We'll be looking forward to announcing that as these are the next milestones, if you will, after the approval in the second half of this year and early next year. Yeah. In terms of pricing, I know it's too early for you to talk about pricing. Like you said, there's five other products out there, I'm sure that gives you some kind of guidelines on where you can price the product. Sure. Maybe just highlight the ranges right now. Sure. I think it will be worthwhile to your point, just to highlight some of the top two, if you will. The most expensive drug today is Xphozah, which is a drug which is priced at $41,000 per patient per year. Our next two most expensive drugs are Auryxia and Velphoro that are around $45,000, $46,000. You can take I say all the time that we can't give you specific pricing, but if you take any of the book and $41,000, $45,000, $46,000, you get to some range. One thing which, it is good that you brought this up about. There are generics in this market. Historically, in the past at least, generics has gone down in the market and the branded shares have increased. There are generics there too. They are differently priced. Sometimes, ironically, people think, Well, the generic is sold for X thousand dollars. You see, generics are generics. This is a class of drug. This is a disease condition where drugs are not interchangeable. Renvela profile is very different than Auryxia. Auryxia profile is different than Velphoro. Oxylanthanum and carbonate is completely different. I just want to say that it's a nuanced market. Not very common where your generics and brand is, and generics have gone down and brand has continued to increase. Does the presence of generics lead to a pre-authorization barrier for potential adoption or there's a lot of patients that don't tolerate the product, so maybe that gets away from it? That's right. In the commercial side of the business, which is like if you're a private insurance, they need a pre-prior authorization, 100%. To get through the prior authorization, Most of these patients, Serge, if you go on doctor clinician, they move out of this prior auth because they can't take the drug, they don't respond to it. We are not talking six months or six years. We are talking about six weeks, usually four to six weeks. These patients don't tolerate it. That's the commonest profile of that patient. Physicians are frustrated. Physicians, they want to find any solution that will help the patient. Okay. We cover other companies that have products covered by TDAPA. There's always discussions about new legislation that could improve it? Yeah. Anything that you're keeping an eye on that is near term or maybe even medium term? Absolutely, Serge. Look, you pointed out something that most of us forget. We have an ability to make a huge difference for patients and investors. The current legislation, there is a one bipartisan bill which some of our colleagues in the industry that have TDAPA products have gone there. We as a company, Unicycive, is supportive of this. We have a lobbying group in Washington which we are part of, which we believe that allows an opportunity for TDAPA to go from two years to three years. As you can imagine, that will have a huge impact on upside for us, a positive impact. I don't talk about that that much because we are focused on launching the drug, and we believe there is so much opportunity for investors to think about very near-term. If that were to come into path, I can't give you the specific timeline end of this year. What we do know, it will be part of a bigger omnibus bill in the sense this is a bill that will be part of some larger bill. This has a bipartisan support, which is again, a little bit rare these days in our government. There are folks from industry, there are folks from the government. They are both equally motivated to allow this class of drugs that are covered by TDAPA to have broader access. We are excited about that. It will be huge upside for the company. We feel we have a bigger role to play. We are definitely as a part of that group. Kidney Care Partners is an organization that industry, that has got all the major dialysis organizations in it. We are proponent of it. Okay. PDUFA is in late June. Obviously, you get approval before then. Do you wait until you have formal TDAPA reimbursement to launch? Meaning that will be pushed out till, I don't know, takes four to six months. Yeah. We will launch after approval. Our goal, Serge, is to give patients, physicians, and everybody in the healthcare system access to that drug. We believe the drug clinical profile is so compelling that the more people get used to it, Serge, the better it is for the launch of patient for everybody. We plan to launch it before TDAPA. If you remember, TDAPA covers, it's one third of the market that is Medicare fee for service, but the commercial is not dependent on TDAPA application. Okay. In terms of funding, I think you mentioned there's $50 some million on the balance sheet. That allows you to launch the product or do you need additional funding to get to the full launch? We said roughly $55 million, $54.9 million to be precise, was as of March 27th. This is an unaudited number. Got it. This is very recent, very near-term number. We announced that because we wanted to make sure that people understand that we have resources. Upon approval, within 21 days, we have the first tranche of warrant that are use it or lose it with the warrant tranche that bring in another $25 million. We feel we are adequately financed for near term. Okay. Think we only have a few minutes left. Do you just want to highlight something that you think maybe is still underappreciated by investors in the street about Unicycive and your product? If I were to summarize everything in three key bullet points, if you can't remember anything else, this is a potential best-in-class profile drug in a large market. The sales of these drugs were over $1.5 billion in the U.S., this class of drugs in general. We have an opportunity to address this market. It is a concentrated market where a small company can launch the drug and be successful. We have support from industry-leading healthcare investors. Serge, we remind ourselves that a small team can do big things if we remain focused, and that has been the ethos from very beginning we built the company. I'm really excited to be talking to you as we get the drug approved and launch it in upcoming months. All right. Well, thanks for spending time with us this afternoon. We appreciate it. Good luck as you approach this upcoming PDUFA. We'll be in touch. Thank you, Serge. All right. Thank you to you, and thank you to Needham for hosting this. Thank you.