Unicycive is pursuing a 505(b)(2) pathway with composition of matter exclusivity until 2031. on June 30th of this year, the FDA issued a second CRL on the resubmitted NDA, tied entirely to previously identified third-party manufacturing deficiencies, and no concerns at all regarding the clinical efficacy or the safety of the molecule. To discuss Oxylanthanum Carbonate's pathway to approval and launch, let's get started with Shalabh. Shalabh, glad to see you here, and I appreciate you accepting our invitation to talk to our audience today. To start off, Shalabh, especially who are quite new to this story, give us a little bit of the highlights on Oxylanthanum Carbonate itself and why you think this is going to be having the best-in-class profile, especially when we have an issue with adherence in the dialysis patients.
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 mg with each meal. This is 500 mg three times a day. That is 500 mg TID. In the most recent clinical trial, we found that roughly 69% of patients were being able to control with the 500 mg 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.
The FDA has raised no efficacy or safety measure issues, especially across 2 review cycles, and it has asked for no additional data as well. But in your own words, what's the remaining gating item for the approval, and what can the company control?
Yes.
And what's in the control of the vendor?
I think it will serve us well to just quickly revisit the whole process because two 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.
At this point, do you have any idea in terms of the scheduling itself? In general, are you given any notice of any sort at all?
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.
Okay. On August 12th, you also disclosed that the vendor does have written notice, which you just talked about. So, once the inspection happens, how long do you think is the wait time in terms of their final decision?
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 one 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.
But what I would reiterate based on what we understand, what we know, and we have said publicly, FDA has no questions on the product, no questions pending in discussions related to label. The only feedback we got, which was also on the day of PDUFA date, was packaging and carton label suggestions. These are non-controversial. These are suggestions to change the label from one side to the other side. These are something which we immediately already responded to them. So there is nothing else pending in terms of what it takes for the drug to be approved.
Thanks for talking about the carton and the container labeling part. So do you think that part of the application is completely settled, and how would we read the continued labeling work if the CRL is still outstanding?
The label discussions had happened with the agency. We had talked about it before PDUFA. Typically, the final label of the drug is given upon approval, but we have no pending discussion with the agency on label. The packaging and carton label discussion was the only thing we got a feedback. We have no product-specific ongoing discussion. We obviously, because it is a PDUFA and we got a CRL, we are talking to the agency, but this is primarily requesting agency to inspect our vendor to get the vendor back in compliance. To the best of our ability, knowledge, there is nothing pending between us and the FDA about the product itself.
My next question is going to be about FDA and the divisions within the FDA. Obviously, the review folks are not the ones who are inspecting. It is a separate entity by itself.
Sure.
What is the crosstalk between these two agencies, and are you a case of being caught between the two divisions?
Look, what I can say, what we know, that the ultimate decision of being able to do the inspection resides with the FDA. To the extent it was in our control, we have sent to the entire division copying every single entity that is within the FDA involved in this. I think the conversations we have had, I do not suspect that there is any chance that the compliance division doesn't know what is going on with the division that is approving your drug. I think it is just a matter of time. We remain patient, but also very optimistic that this should happen. Again, what I would reiterate, what the company can do, which is to request FDA, which we are doing in a constant dialogue, request elected official. Because vendor inspection is the only pending item.
There is nothing else gating item in terms of getting the drug approved.
Shalabh, you also said that there is a second manufacturing vendor ready and cleared to manufacture Oxylanthanum Carbonate. What is the status of that particular vendor in the application itself today? What work would be required, if at all, that second vendor has to be named?
We reported in June of 2025 that we have a second vendor that has a Let us break it down into several steps, at least a few steps. Number one is that drug substance vendor is the same, which we mentioned is a compliant vendor. The second drug product vendor, fill finish vendor, was inspected prior, and they remain compliant, so there is no issue with compliance. We have a stability data, which is a common thing that is required to put it in FDA application. We are ready to be able to submit with the stability that we have. Our intention was and is to get the first vendor approved, and that is the shortest, most direct path for approval.
But we have what we need from a stability point of view, from a compliance point of view, and the second vendor is able to Should there be a situation, we could replace it. In a typical NDA, FDA allows one vendor to be the primary manufacturing vendor, and that is where we reiterated that that vendor was ready. The vendor inspection is the only gating item. To our surprise, FDA has not been able to do the inspection, and here we are.
Are there any decisions you could make now in parallel that can shorten the switch scenario if it happens? And how much time would that take?
We are ready with the second vendor. Frankly, we are ready with the application. As a company that is very focused on getting the drug on the market as soon as possible for patients, for investors, and for us as a company, we've been working on it for a long period of time. The switch can happen within a matter of days. It's not something that will require a lot of time. We have everything ready. I would reiterate, the fastest, most direct path for getting the drug on the market with the review cycle of resubmission that we understand is at 60 days at the most, is to go with the first vendor. Again, the vendor has been assigned. They have no specific date, but we believe we are closer to that inspection today than we were before.
Assuming that we're going to get through this soon, and for long-term purposes, especially with the sort of adoption that you're expecting, would the single manufacturer be enough to do all the supply, or do you plan to have a second manufacturer down the line?
Drug substance, we have already a fairly substantive quantity of our drug substance ready. Drug product, we were planning to use two different vendors, and the idea was to be able to create redundancies. Upon approval, we are ready to be able to launch it nationally, to be able to supply the U.S. market as quickly as we need to. So we are ready. In fact, while waiting for approval process or getting the vendor back in compliance, we've been focused on, I'm sure you'll cover a couple of the commercialization part, having the discussion with the dialysis organizations which have a role to play in terms of being able to get the drug to the patients.
Yeah
as well as getting ourselves ready commercially.
Moving on, in terms of reimbursement, TDAPA is central to your commercial model, and designations are decided on a quarterly basis, and the payments are done roughly in six months from then. With the shifting approval date, how should we think about the TDAPA timing itself?
Absolutely. First of all, I want to just remind, this June, the draft guidance that came out from CMS that clearly says a couple of points that will be worth mentioning. Number one, the class TDAPA, which means the binders of the class, the TDAPA ends as of December 31, 2026. Number two, a drug like ours would get two year plus three years. So it is two-year full, 100% reimbursement, and then followed by three year at 65% reimbursement. And the third part is, RK, we understand we are absolutely focused on getting drug as soon as we can get the approval, but TDAPA applications are quarterly basis, so they open up on January 1, April 1, so on so forth. Depending on the date, and we can apply TDAPA as soon as the drug is approved. At the moment, we expect the timelines to be not changing.
The TDAPA four times a year application is open and hasn't changed whatsoever.
On the commercial readiness aspect, can you provide us some of the highlights that you and the management is working on?
The context has been similar to what we said before. There are certain basic things that you need to be able to launch a drug in the U.S. market. We talk about reimbursement hub. There are state licenses that are required in order for us to launch, and there are things we can do today to be ready. We chose to put sales force hiring upon approval. But rest of the part, which is to add some senior team members, we have done it. Having the discussion with dialysis organization is something I do want to talk about it because ultimately the drug goes to patients and these are, with the current environment in the reimbursement world, this drug is supposed to be prescribed during dialysis. So dialysis organizations, especially as you know, it's a very small number of dialysis organizations that control majority of the patients.
Top three dialysis organizations cover roughly 87%-90% of the patients. So we are talking to all the organization, big ones, but the top few of them we are in intense dialogue with because this allows us the time to have that discussion with them. Also, with the clear CMS guidelines, which says that the class is ending as of December 31, there is interest from their side to be able to collaborate with us.
How does the TDAPA designation help when you're talking with the dialysis organizations? Is that an additional benefit to have, especially when you're talking with these folks?
Yeah
does it work against you?
The dialysis organizations are actually, they have been given this incentive to be able to get this type of drugs on the market. Most of the TDAPA specific products have worked very nicely with the dialysis organization. It is an economic benefit. Also, I want to mention there is a QIP, that is a quality metric that has been introduced that the CMS is going to measure how dialysis organizations operate based on the quality of their treatment of phosphate level. People talk about characteristics. The carrot part is the financial reimbursement. The stick part is that the quality metric and phosphate is now in play. This is going to be implemented in near term, starting from January of 2027. These are draft guidance that they get become confirmed a little bit later this year.
We believe there are all the opportunities exist and whatever was in the play before is still there. Nothing has changed from the commercial opportunity. The extra time that we have, which we unfortunately are waiting for the approval, allows us to have that discussion with dialysis organizations.
Okay. The last question from me is on the financials. As of June, you had about $61 million in cash and marketable securities. What sort of a runway does this give? Also, you had made some arrangements previously with credited investors regarding launch finance. How much of that is still in place and will continue to stay in place?
The warrants haven't changed. That warrant, whatever the arrangement is there, that is still in place. We have sufficient cash into 2027, and we believe we don't have to worry about cash in the very near term, and we would be able to launch it with the cash in hand.
Thank you, Shalabh.
Thank you.
Thanks for being here.
Thank you so much.