Our next presenting company, Eledon, that are posted at the back of the room and also at the registration desk. Eledon just reported impressive phase 2 BESTOW data on tegoprubart for kidney transplant patients. Not only was the efficacy not inferior to tacrolimus, but I was also very impressed by the safety profile of Tego. Here to tell us more about these results and the plan from here is D.A. Gros, CEO. Thanks for being with us.
Thank you, Ted. Thank you for hosting us, and of course, thank you all for joining today. I will be making some forward-looking statements, so please look at our disclosures, including on this slide, carefully. In terms of where the company is today, tegoprubart, as Ted just mentioned, recently finished our phase 2 or reported out the data from our phase 2 in kidney transplantation. To date, as a result, with this trial, we now have had over 150 patients that have used Tego, including over 100 patients that have used it post-transplant. So we now are building quite a robust efficacy and safety database. From a cash perspective, we finished the last quarter with $93 million or over $93 million in cash and subsequently have completed a $57.5 million financing last month, which gives us sufficient funds to allow us to reach the second quarter of 2027.
In terms of milestones that we expect, there are many of them over the next 12 months, principally due to being able to progress Tego. So we're going to look to approach the FDA and to talk about path to market for kidney transplantation, which is what BESTOW was about, islet cell transplantation, and xenotransplantation, where we have programs. We also have a number of other trials, including with investigator-sponsored studies that we'll be launching. Today, we are developing Tego focused on transplantation. We are active in kidney transplantation, where now the patients from both our phase 1b and phase 2 have run into a long-term extension study. We have multiple programs going on in islet cell. We are getting ready to launch a program in kidney tolerance at Mass General Hospital, and we are clinic-ready for liver transplantation. We presented preclinical data in liver over the summer.
One of the areas where we've received the most press has been around our work in xenotransplantation, so that's putting in pig organs into humans, where Tego is being used as the cornerstone immunosuppression. There we have experience working with United Therapeutics in their cardiac xenotransplantation program, and we have an ongoing collaboration with eGenesis and Kidney Xeno, where eGenesis is getting ready to launch their Phase 1/2/3 study using Tego. The reason we're focused principally in transplantation right now around kidneys is that that's where most of the market is. There are about 48,000 transplants a year that are done in the U.S., and of those, 60% are in kidney transplantation. The kidney transplantation market, while it may be large from a dollar perspective, is rare disease-like in terms of its concentration.
There are about 25,000 Americans a year, 27,000 Americans a year that are getting kidney transplants annually, 10 times as many people living with a kidney transplant. As you know, we don't have enough organs in the U.S., and so there are about 100,000 Americans waiting for a transplant. The way we view our ability to help reduce that number is in two ways. One is by allowing organs to survive longer. The longer organs will survive, the fewer repeat transplants would be necessary, and today, 11% of those adults in the waitlist are waiting for repeat transplants, but one in nine transplants done every year are people that have already had a transplant, so if we could allow organs to survive longer, then fewer people would need those repeat transplants. We don't throw away organs in the U.S.
If they don't go to an individual, then they would go to somebody else. The second way, of course, would be through xeno, which we discussed. What's nice about the transplant market is that it is very concentrated, so it's a market that one doesn't need to be a big pharma in order to approach. There are only about 250 transplant centers in this country, of which 40 do half of the transplants and about 100 sites do 80% of the transplants. Transplantation is necessary for life. So after a transplant, the immune system is very good at recognizing the foreign organ and will attack it unless there is sufficient immunosuppression.
There are two types of immunosuppression that are given: induction immunosuppression, which is given at the time of transplant, but where we're competing is with what's called chronic or maintenance immunosuppression, which is the immunosuppression that's taken for the life of the organ. That market is large. In fact, the current standard of care, which has been used now for over 30 years. This is the drug that we're looking to replace, a drug called tacrolimus. Despite being a small molecule and being over 30 years old, branded tacrolimus today remains about a $1.5 billion market. The issues with tacrolimus are principally around the safety profile of the drug. Principally, it is both directly as well as indirectly toxic to kidneys. It's a nephrotoxin, so it's directly toxic to the kidneys, but it causes diabetes.
It also causes hypertension, which are ironically the two leading causes of kidneys to begin with that lead to transplantation. As an aside, tacrolimus is also associated with other side effects that patients particularly dislike, including things like tremor or headaches or brain fog. These adverse events, particularly the direct and indirect effects on the kidneys, are one of the reasons why kidneys today only work 10 to 15 years post-transplant. Now, since the average age of transplantation in the United States is only 50, that means that patients that are 20, 30, 40, 50, even 60 years old might need multiple transplants to live a regular life. And as we just discussed, obviously, we don't have enough organs. Flipping now to BESTOW and to the data that we presented, BESTOW was the first study that compared a CD40 ligand antibody head-to-head to the standard of care tacrolimus.
It was a two-arm study. The patients were randomized 50/50 to both arms. The primary endpoint that we used was eGFR, which is kidney function. Kidney function is one of the best proxies of long-term graft function, which is why we used it as the endpoint that we were interested to look at. Historically, as you can see on the left-hand side of the slide, the typical eGFR at one year is about a 53. You'll also note on the left side, the red line is eGFR on CNIs, principally on tacrolimus, and the line goes down with time. And that's the fact of the direct and indirect toxicities of tacrolimus that just eat away at those kidneys. Now, we looked at a secondary endpoint, which is actually the provable endpoint, and that is a triple endpoint.
That's a composite that looked at biopsy-proven acute rejection, graft loss, and death. The way we structured the study was the primary endpoint was not what the composite endpoint was, but the composite endpoint was the key secondary endpoint. In terms of what the data showed, the data showed that we were able to, despite the fact that we weren't powered to do so, we were able to achieve what is historically the composite endpoint. We hit the non-inferiority margin of 20% for that three-point composite. We also demonstrated that Tego had excellent graft function. We demonstrated some of the highest graft function that's ever been shown in a clinical trial in post-kidney transplantation, although we did not show a statistically significant difference between ourselves and tacrolimus. Where we did show a striking difference was on the safety profile, as you'll see in the coming minutes.
So in terms of kidney function, as you can see here, mean eGFR over the 52 weeks was a 69 on patients that were on Tego versus a 66 on tac. We were powered to detect an endpoint difference, so we did not show a statistical difference. That said, at every time point, Tego was superior to tac. In terms of the subgroup analyses, again, all the pre-specified subgroups, except for a subgroup looking at deceased kidneys, Tego showed superiority. When it came to the triple endpoint, which you see here, we were using the 20% non-inferiority margin, not inferior. There were similar rates of graft loss and death, as well as biopsy-proven acute rejection. In terms of adverse events overall, Tego and tac, when looked at just the number of events, they were quite similar, both in terms of the severity as well as the overall numbers.
But here you begin to see the difference. So if we then look at all of the AEs and we separate them by any AE that was common, that was seen at least 5% of the time, and we then said, "Okay, what were the AEs where one group had 2x or more? The risk of having that side effect as the other group?" All of them are listed on this slide. So if we start with where tacrolimus was inferior to tegoprubart, which was proteinuria, so protein in the urine, we had, as you can see here, more patients on the tac arm that had proteinuria.
Now, if we look at this proteinuria, most of these patients, except for the ones that had an autoimmune disease that was underlying the reason they lost their kidneys and they had recurrences of that disease, the proteinuria that were seen were low-grade proteinuria and were transient. So they typically started within the first 180 days, and they lasted about up to two months on average, and then resolved without any further medical care. Now, if we flip to look at the tacrolimus arm, tacrolimus showed multiple times the bacteremia, so the blood infections, sepsis, blood infections that led to hospitalizations. Sepsis is one of the leading causes of death post-kidney transplant. Similarly, tacrolimus showed multiple times the levels of hyperglycemia. Tac is known to be toxic to the beta cells that make insulin. Tied to that, tac had seven times the rate of new-onset diabetes.
So this is a diabetes that resembles type 1 diabetes, that it is not associated with insulin resistance, but the destruction of the pancreas, and is the number one complaint that physicians have when we talk to them about using tac. Tac was associated with multiple times the risk of hyperkalemia, which can lead to arrhythmias. Tac was associated with tremors. So one in four patients that started tac developed tremors. This is the number one complaint of patients when they're on tac. And then tac had a cardiovascular signal. It had more hypertension, hypertensive crisis. It had about 5% of the patients developed heart failure as well. And the final thing that I will leave with regards to the tac AEs is tac was associated with more delayed graft function.
So that's when somebody gets transplanted with a new kidney, and that kidney doesn't start functioning right away, and those patients need to go back on dialysis. So that if we compare a potential 100 patients on tac versus a potential 100 patients on Tego, those patients that would be on tac would be expected to have an extra 115 days of post-transplant dialysis versus those on Tego, which, as you can imagine, psychologically is very hard for the transplant patients. And then just in terms of cost and extra hospitalization, it would be very significant for the system.
So overall, looking at these data, we believe that this is sufficient to allow us to go into phase 3, and we look forward to talking to the FDA in the first half of next year about what a path to approval in the phase 3 could look like. Assuming the FDA is supportive, that would allow us to launch our phase 3 in kidney transplantation in the second half of the year. I know I went slightly over, but if I've got a couple of seconds, I'm happy to take any questions. I mean, with such an improvement over phase 3, how do you think that's going to factor into the sizing and just the overall conduct of phase 3? So in terms of the sizing of the phase 3, we expect it'll probably be 200-300 patients per arm, and the powering is less around the safety.
The powering would be more around the triple endpoints that I mentioned, so make sure we have sufficient patients to hit the non-inferiority. But we're developing that number of patients, if you include the other patients that we already have in our long-term extension studies, should be enough for the FDA in terms of what we expect and want to see for a long-term safety database. Okay. Thank you.