Unicycive Therapeutics, Inc. Common Stock H.C. Wainwright 28th Annual Global Investment Conference

Absolutely. First of all, thank you for having me. Thank you to H.C. Wainwright for hosting us. By way of background, roughly 450,000 patients who are on dialysis need something to manage their phosphate lowering. Phosphate lowering is a problem that has been around for over a decade. If you look at the longitudinal data, what you find, the patients are not able to take medicine. There have been a number of causes for that, but the primary cause is pill burden, and then the associated adverse event that patients have to endure. Oxylanthanum Carbonate has a potential best-in-class profile based on three key parameters. Number one, when it comes down to pill burden, the average number of pills that these patients are taking is 20 to 30 pills per day for lifelong.

Half of them can come from phosphate-lowering therapy. Pill burden with Oxylanthanum Carbonate, it starts with these pills are given 500 milligram with each meal. This is 500 milligram three times a day. That is 500 milligram TID. In the most recent clinical trial, we found that roughly 69% of patients were being able to control with the 500 milligram tablet three times a day. Higher the phosphate, the number of pills can increase, but the pill burden for our drug is one of the most important value add. The second part comes out to be palatability. There are solutions in the market that require patients to take fewer pills, and therefore, there is an argument to be said that you may not be the only pill out there.

The problem with those pills that are fewer in number, that these pills have to be chewed. Chewing a pill creates a problem, and one could argue that I don't really care about how many pills I have to chew, and that would be fine. But we are asking patients to chew pills after every single meal. That creates a problem for patients because these pills taste really, really bad because they have metal in them, and this metallic taste makes them not want to take the pill. That's the second part, is palatability. The third part is, it all comes down to potency. Lanthanum has been known to be one of the most potent phosphate-lowering agent. In a head-to-head, if you run animal studies, you can see lanthanum is pretty high up there.

In our clinical trial, the reason we were able to use 3 pills for 69% of patients to get to a target serum phosphate level in the clinical trial, 5.5 milligram per deciliter below, is because of potency. All of that, to combine this together, provides an opportunity to create a paradigm shift for these patients.

I think it will serve us well to just quickly revisit the whole process because 2 CRLs are really, really painful. The process started with our initial NDA submission, which was in 2024. That gave us a PDUFA date of June last year, June 30, 2025. When we submitted the application, there was no problem with any of our vendors, and therefore FDA accepted the NDA. Vendor was inspected. This is not the primary vendor, but this is a fill finish vendor, a drug product vendor, and they were found to be deficient. It's a single facility deficiency that was the reason that we got our first CRL, which was in June 2025. As a reminder, we went to FDA, we had a discussion with the agency, and based on agency's feedback and our ability to decipher the vendor is ready, we resubmitted our second NDA.

This was after October 2025 FDA Type A meeting. In order for FDA to accept our second NDA, vendor had to be inspection ready. We are talking about December 29, 2025, when we resubmitted our NDA, and we are in September right now. Nine months have gone by. The vendor has not been inspected. Our second CRL was a surprise to us because typically we would imagine that FDA would extend the PDUFA date. Be that as it may, that is the only thing that is pending. For those who are fresh to this story, this is a tablet form. The drug is given in the form of a tablet, which is manufactured by primary vendor, which is drug substance manufacturing vendor. It is in our 10-K. We have disclosed it. It is Shilpa Medicare Limited, is a manufacturing vendor in India, and they had been compliant.

They were inspected in March of 2025. They have no deficiency. It is a subcontractor of Shilpa that was found to be deficient, and the subcontractor is continuing to supply in the U.S. market, commercial grade supply. This is a vendor-specific, facility-specific deficiency, and we believe that FDA is on its way to be able to do the inspection.

We went to look for precedences in trying to understand if there are specific guidelines. What we do know that a vendor has been assigned a facility inspection. There are two points I will make. Number one, FDA says this is a surprise inspection, so they do not have a study, and are going to give you a formal notice when the schedule happens. Number two, this is something we do not really have a direct control over it. What we are doing as a company, we are imploring to the agency by going to their patient organizations, talking to them, as well as talking to some of the elected officials in Washington to request FDA to expedite the inspection.

The way this process works, and the day the FDA inspector or inspectors finish inspection of the facility, they will give the site, within a day or so, a written notice, 483. These are the observations the facility gets. That then allows FDA's office in the back office in Bethesda, Maryland, to change the status of vendor. If the vendor's status is changed from start to finish, we believe based on the regulatory guidance we got, this is a Class 1 resubmission. It's a 60-day cycle. Assuming day 1 is a resubmission, day 30 is a PDUFA date given, and day 60 is the PDUFA date. It's a very rapid review cycle. In certain examples that are out there, and again, this is no way that we would know what the timelines, FDA can expedite this process even earlier than that.