Eledon Pharmaceuticals Inc. Q1 2023 Earnings Call
Speaker 1: first quarter 2023 earnings conference call. At this time, all lines of lesson only mode.
Speaker 1: Following the presentation, we will conduct a question and answer session.
Speaker 1: If at any time during this call you require immediate assistance, please press star 0 for the operator.
Speaker 1: This call is being recorded on Thursday, May 11th, 2023. I would now like to enter the conference over to your host, Paul Lettl, CFO . Please go ahead.
Speaker 2: Good afternoon, everyone, and thank you for joining Elan's first quarter of 2023 operating and financial results conference call. I am joined today on today's call by David Alexander Grohl, chief executive officer, and Steve Perrin, our president and chief scientific officer. And Jeff Bornstein, our chief medical officer, is traveling today.
Speaker 2: Earlier today, Elordon issued a press release announcing financial results for the first quarter ended March 31, 2023.
Speaker 2: You may access the release under the investors tab on our company's website at allendon.com.
Speaker 2: I would like to remind everyone that statements made during this conference call relating to Eladon's expected future performance, future business prospects, or future events or plans may include forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995.
Speaker 2: All such forward-looking statements are intended to be subject to the safe harbor protection provided by the Reform Act. Actual outcomes and results could differ materially from these forecasts due to the impact of many factors beyond the control of ELADON.
Speaker 2: Allodonic Express through the claims any duty to provide updates to its four-licking statements, whether as a result of new information, future events or otherwise. Participants are directed to the risk factors set forth in the Allodons reports filed with the U.S. Securities and Exchange Commission.
Speaker 2: Now it is my pleasure to pass the call to Eldon CEO , Dr. David Alexander-Groh. DA? Who are you?
Speaker 3: Thank you, Paul, and thank you all for joining us today.
Speaker 3: We began the year by announcing our primary organizational focus on our kidney transplantation program and have since directed our resources and efforts to advance this program forward.
Speaker 3: We believe that to go per bar, our anti-CD-40 ligand antibody can address a significant unmet need in patients undergoing kidney transplants. Through its potential to prevent rejection, maintain high graphed function, and reduce
Speaker 3: the many successives associated with calcinerinhibities, inhibitors or CNIs.
Speaker 3: or found urgency for new treatment options to benefit patients receiving solid organ transplants and kidneys in particular.
Speaker 3: According to the United Network for Organ Sharing, there are now over 25,000 annual kidney transplants in the U.S. the most in history, and yet the standard of care, first line, chronic immunosuppression for this growing market has not changed since the approval of the two actions in the Human Rights Club. Dr. Hatember Lam woh in?? cameras. Dr. Hatember Lam woh in?? cameras.
Speaker 3: in 1994. Our goal is for to go per bar to ultimately replace tackle IMAs as the standard of care post transplant immunomodulator.
Speaker 3: significantly reducing the broad number of side effects associated with that drug, and thus improving graft function and survival.
Speaker 3: This in turn should result in fewer patients requiring repeat transplants, thereby freeing more kidneys to be allocated to first-time recipients and thus allowing more people to receive the kidneys that they need to live.
Speaker 3: At the end of March, we presented open label data from our ongoing Phase 1 B trial, evaluating to go for part in kidney transplantation at the World Congress of Nephrology.
Speaker 3: Our initial three participants did not show any evidence of acute rejection at measured time points, which is important since most rejection in the first year occurs within the first 90 days post-transplant.
Speaker 3: In addition, we observed strong graph functioned in our participants with MEEN EGFRs above 70 at measured time points as far out as week 31.
Speaker 3: These results were highly encouraging and suggest early clinical proof of concept for Tugopropa in this indication, and we look forward to reporting updated data from this study at a medical meeting in the latter part of the year.
Speaker 3: including $35 million up front.
Speaker 3: Subject to achievement of our milestones, this financing will enable us to execute our kidney transplant clinical development plan, including our phase 2 BISTO trial in kidney transplantation.
Speaker 3: We were particularly proud to have this financing co-led by one of our historical investors, BVF partners, as well as by new investor, Armistice Capital.
Speaker 3: of note, Santa Fe, the global pharmaceutical company, also participated in the financing as did a number of private individuals and families that believe in Eladon's missions and have done so and invested in our company since our early days. With the financing completed, we are now laser.
Speaker 3: our President and Chief Scientific Officer to provide more details on our development programs.
Speaker 3: to provide more details on our development programs. Steve.
Speaker 2: Thank you, DA. I'd like to begin by touching upon the opportunity we see kidney transplantation and why we made the decision to focus our resources on the development of Tego Prubert for this indication. Kidney transplantation is a growing space which has had limited innovation in decades.
Speaker 2: The National Kidney Foundation estimates that 660,000 people live with kidney failure in the United States and that of those are over 100,000 people on the kidney transplant waiting list with about 5,000 individuals dying annually while waiting for a transplant. Since the average deceased donor transplanted kidney only functions for an average of 10 to 12 years.
Speaker 2: and the mid-age transplantation is 50 years old. Most patients will require multiple kidney transplants if they are to live a normal lifespan. Therefore, the need has never been greater to pursue a new treatment option that can prolong the functional life of a transplanted kidney. That is our goal, and we believe this can be achieved with TIGO Prevart, allowing transplanted kidneys
Speaker 2: until the duration of recipients' lives and thereby freeing up precious kidneys so that a greater percentage of patients on the waiting list can receive a kidney.
Speaker 2: As D.A. mentioned, we reported open labeled data from our ongoing Phase 1 B kidney transplant study at the World Congress of Nephrology in March.
Speaker 2: At the time of data submission, three patients had been enrolled in the trial.
Speaker 2: which has sites in Berlin, Canada, Australia and the UK.
Speaker 2: To evaluate signals of clinical efficacy, we reported the estimated global filtration rate or EGFR of each patient that specified time points.
Speaker 2: From large retrospective studies conducted in transplant recipients taking C&I's, we know that a 50th percentile EGFR falls around 50 during the first year post-transplant. Twelve-month EGFR has been shown to be the most significant single predictor of future growth failure.
Speaker 2: And as EGF values decrease, the risk of graph failure and hospitalization increases exponentially. Importantly, studies have shown that the 12-month EGFR is correlated with EGFR value seen as early as 90 days. And thus we believe that the EGFR data we shared at 90 days is highly relevant and potentially predictive in determining graph function and outcome. At the time of our data submission for the conference,
Speaker 2: We had three subjects enrolled in the trial. Results from the first three participants demonstrated no incidents of acute rejection at 56, 167, and 232 days respectively.
Speaker 2: Graph function was a very good and all three participants with the participants having EGFRs of 54, 85, and 77 at the latest available time point of 49, 154, and 217 days respectively. Given the correlation between EGFR levels at 90 days,
Speaker 2: Long-term graph-wrenching is critical, but not the only part of meaningful outcomes we are looking for in kidney transplant recipients. The current standard of care, care, and urban inhibitors help preserve graph survival, but they are also associated with significant side effects such as hypertension, dyslipidemia, new onset of diabetes, and tremors. Moreover, research shows that 10-year post-transplant, almost all transplanted kidneys, will demonstrate evidence of C&I-induced nephrotoxicity. We believe based on the evidence generated to date, that TIGO-Provart has the potential to reduce.
Speaker 2: Turning to the safety results we observed in the study were among the three participants Tego Probarque showed good tolerability, especially among a difficult to treat population. None of the participants experienced acute rejection and there was no evidence of nuance at diabetes after transplant or any impact on glucose level levels and two participants without diabetes at baseline. One participant was discontinued from the study on day 55 after developing BKV remia, a common occurrence following a kidney transplant.
Speaker 2: which occurs in 20% of more of transplant recipients. An additional participant elected to discontinue from the study after 33 weeks, reporting mild alopecia and mild insomnia, which the investigator did not attribute to Tegoprobart.
Speaker 2: The adverse events continued once the patient was switched from take-off to take-off to
Speaker 2: Building off our results from the ongoing phase 1D trial, we remain on track to initiate our randomized open label phase 2 bestow study to assess the safety and efficacy of TIGO Prebarc compared to TACROLIMAS and the preservation of allograph function after kidney transplantation. 120 participants will be randomized one to one to receive either TIGO Prebarc every 21 days or twice daily oral TACROLIMAS.
Speaker 2: The primary endpoint will compare the mean EGFR at 12 months for participants receiving to GoPubark vs. TACROLIMUS. The primary endpoint will compare the mean EGFR at 12 months for participants receiving to GoPubark vs. TACROLIMUS.
Speaker 2: Secondary objectives will include safety and tolerability, participants in graph survival, biopsy proof and acute rejection, and the incidence of new onset diabetes militarized after transplant.
Speaker 2: I'd like to conclude by briefly covering our IGAN program or following our announcement to deprioritize the program at the beginning of the year, we continue to collect safety data from the patients previously enrolled to provide additional insight into take-off about safety profile. The data we presented at WCN from 16 patients.
Speaker 2: and the high-dose cohort of 10 mg per kg every 3 weeks showed Teglopruvar to be safe and well-tolerated with no serious nor severe adverse events reported and no early discontinuations. Four participants had completed at least 24 weeks on treatment, and five others completed at least 12 weeks. We are encouraged by the safety profile Teglopruvar continues to display.
Speaker 2: winding down the vast majority of our iGain activity and spend in the second quarter of 2023.
Speaker 2: With that, I'd now like to turn the call over to Paul for a financial update.
Speaker 4: Thank you, Steve.
Speaker 2: The company reported a net loss of 10.8 million
Speaker 2: dollars or certified cents per share for the three months ended March 31, 2023 compared to a net loss of 9.9 million.
Speaker 5: or 69 cents per share for the same period in 2022.
Speaker 5: Research and developed expenses were 8.1 million, for the three months ended March 31, 2023, compared to 6.6 million for the comparable period in 2022, and increased to 1.5 million.
Speaker 5: The increase is primarily due to higher clinical development expenses, primarily with external CROs of 2.1 million, and an increase in personnel costs due to increased headcount.
Speaker 5: The increase was partially offset by decreases in stock-based compensation, manufacturing, and consulting expenses.
Speaker 5: General and administrative expenses were $3 million for the three months ended March 31, 2023, compared to $3.2 million for the comparable period in 2022, a decrease of $200,000. The decrease was primarily related to the lower stock-based compensation costs. Earlier this month, we announced the entry into a Definitive Securities Purchase Agreement below $4.3 million for 2021-23.
Speaker 5: with select healthcare investors that will provide up to 185 million in gross proceeds to a private placement.
Speaker 5: The purchase agreement included an initial upfront of financing of 35 million and additional aggregate financing up to 105 million subject to achieving critical development milestones, volume weighted share price levels, and trading volume conditions. Plus up to 45 million upon the full exercise of warrants being issued in
Speaker 5: cash and cash equivalence.
Speaker 5: With that financial update, I will turn the call back over to the DA.
Speaker 3: Next, Paul. I am proud of the progress that Eladon has made in the early part of 2023 and feel we are now well positioned to make significant strides in our evaluation of to-go-pro-barc as a potential much needed replacement for CNIs in kidney transplantation.
Speaker 3: We are highly encouraged by the data generated to date in our ongoing Phase 1B study and look forward to both its continued enrollment and to providing a clinical update later in the year.
Speaker 3: Finally, following our financing, we now have a well-capitalized path to launch and execute our Phase 2 Bistotrial.
Speaker 3: while we continue to report data from the open-label Phase 1b study in parallel.
Speaker 3: Operator, please begin the Q&A session.
Speaker 1: Thank you ladies and gentlemen. Should you have a question? Please press the star followed by the one on your touch on phone. If you would like to withdraw your question, please press the star followed by the two. One moment please for your first question.
Speaker 1: Your first question comes from Pete several pulos from Canter Fitzgerald. Please go ahead.
Speaker 6: Hi, D.A. Stephen Paul. I want to congratulate you on the successful financing and I'm happy to see that the Tego kidney transplant program is moving forward. So one of your investors stood out at me when I saw the press release for the financing, which was a sanitary. It has a well-established kidney and transplant franchise.
Speaker 6: So, well, well, versed in the space. Can you provide any color on those interactions and what do you think drew this company to invest in this molecule and program? Do you think it was a totality of the data generated? You know what take goes to date, across all programs, or was it kidney specific data?
Speaker 6: Can you provide any color on those interactions and what do you think drew this company to invest in this molecule and program? Do you think it was a totality of the data generated with TEGO to date across all programs or was it kidney specific data?
Speaker 3: Hey Pete, thanks for the question. You know, in terms of sanity, we obviously appreciate having them as a new investor. As you mentioned, they know the space quite well. They've also had said in the past that in terms of...
Speaker 3: the way they viewed their interactions or their development in the space. They were not looking at kidney transplantation.
Speaker 3: I think they looked at us and saw a good investment opportunity. This was
Speaker 6: or in any way different from what other investors received in this financing. All right, thank you. I have a couple of questions on the Bissell study. The data presented, you know, for Tego at the Kennedy Transplant Station, you know, World Congress of Honor Farology. You know, there was one patient who had BK of Arimia. You know, can you sort of touch on how common BK of Arimia is in kidney transplant? And, you know, how is it going to be handled in the Bissell study? You know, will it be up to the investigators to withdraw the patient from the study or will there be some type of protocol in place? Sure. Thanks for that question, Pete. Steve, I'll turn that over to you.
Speaker 2: Yeah, BK viremia, Pete, is a great question. BK viremia is pretty common. It's common across all polypharmacy that is associated with the prevention of transplant rejection. It occurs in 10% to 20% of studies, and it does vary from site to site, country to country, and it does vary regiment to regiment.
Speaker 2: The standard practice for dealing with the viral load with BKV Remi is to wean people off the immunosuppressant drugs that are required to prevent rejection and that's done at the discretion of the PI depending upon viral load and then there's this balance between letting the immune system of the...
Speaker 7: much less.
Speaker 6: Okay. I mean, I don't know if you disclose, but is there an opportunity to sort of wean off of Tego and then sort of put him back on as time progresses?
Speaker 2: So being an antibody typically, you know, the administration, as you know, is every three weeks.
Speaker 2: And so if somebody's viral load creeps up shortly after dosing, you know, the investigator has a period of time where they could try to manage other immunosuppressants to see if they can manage viral load and get it back down prior to the next infusion. There is some flexibility on, you know, if you wanted to delay the next infusion of Tago Provart a little bit.
Speaker 2: But as we know with biologics, you don't want to pause an infusion for too long due to increased risk of antidrogant antibody responses. Again, we'd be in close dialogue with PIs if that's the route that they chose to take. And we would give them guidance based on what we know from our preclinical and clinical data to date on how to manage that.
Speaker 6: Okay. And then, thank you for that. And another question again on the BISTO study, you know, one of the goals, you know, will be to reduce steroid use, you know, and there will be a steroid tapering, from my understanding, until they're completely removed from each of the patient's treatment regimens.
Speaker 6: Can you just talk a bit about the clinical benefit? It may be still on these patients, tapering them off, and how do you plan to capture that benefit? Yeah, do you want me to take that one? Sure.
Speaker 2: Yeah, the steroids, PITAs, you point out another great question is the primary difference between our Phase 1-B study and the Phase 2 Bistosto study where in the Bistosto study, they will start weaning participants off steroids fairly quickly at the transplant and they will be off steroids by six months.
Speaker 2: This is not an uncommon practice. Many sites globally do a complete steroid taper, and there is variability among sites that do that, the biggest.
Speaker 2: thing that's beneficial here to patients is again the side effects of steroids can be significant. And so getting patients off as many of the immunosuppressant drugs in a cocktail is critically important for managing side effects. And so we think it's a potentially great upside.
Speaker 2: that we feel that with take-oprobot on board, we can completely wean people off of steroids in a fairly rapid manner by six months.
Speaker 3: All right, again, right? No, nobody, people don't like to be on steroids long. It's a DA. People don't like to be on steroids long term. They've got just impacts in terms of blood sugar control, moods, ability to sleep.
Speaker 3: All right, again, Mr. President. No, nobody, people don't like to be on steroids long. It's a DA. People don't like to be on steroids long term. They've got just impacts in terms of blood sugar control, moods, ability to sleep.
Speaker 3: potential hair loss. So, removing if we're able to allow people to to taper completely off steroids.
Speaker 3: that would be another win on top of removing the CNIs for patients.
Speaker 6: And in terms of a clinical study, you know, any secondary or exploratory endpoints that you're going to use to sort of capture that benefit.
Speaker 4: I'm sorry. I'm going to go. You can go. I'm sorry.
Speaker 2: I don't think that, Pete, there's any exploratory endpoints that specifically deal with the tapering of steroids.
Speaker 3: But obviously, it'd be captured as part of the safety profile of Tego, much like in our other studies. We're going to look at removing steroids from both arms. So it would be comparative, but in terms of the steroid specific side effects, one would see the benefits.
Speaker 3: if one compared the data at historicals.
Speaker 6: Okay. All right. Thank you very much. And again, congratulations on the financing.
Speaker 8: and all the progress. Thank you, Pete.
Speaker 6: Here next question comes Tom Smith from SVB Securities. Please go ahead.
Speaker 9: You mentioned that you've enrolled six patients to date and you're targeting a medical meeting later this year for an update. So I wonder if you can elaborate on some of the venues you're considering and just walk through sort of your expectations in terms of how many patients and then a follow up you think you could have by then.
Speaker 3: Thanks, Tom. It's DA. So, we'll look at a medical meeting towards the end of the year. There are a number of kidney meetings, including Kidney Week, where we might be able to present. Since we already have...
Speaker 3: is six patients, as we just mentioned, even without counting potential new patients that come into the study, that would mean that all of the patients would have over 90 days, would most probably have over 90 days on drug by that point.
Speaker 3: So it would go from somewhere in the 90-day timeframe all the way out to a year or so.
Speaker 9: Okay, got it. That makes sense. And then maybe just following up on the Sanofi investment, I understand they aren't pursuing solid organ transplant at this point for their CD40 ligand for Frexilimab. Maybe if you could just remind us of the differences between TEGO and Frexilimab and then just taking a little bit bigger picture.
Speaker 9: So I want to give you a comment on sort of the broader strategic interest in this space and how you're thinking about partnership or other business development opportunities at this point.
Speaker 3: Sure, so the two molecules are antiso, both ourselves and Santa Fe, have an anti-CD-40 ligand.
Speaker 3: And we're using a full antibody approach. And so the two molecules are probably, if you look at the broader competitive landscape, the two that are the most similar, the difference has really been around strategy and where we've each.
Speaker 3: Each company has chosen to focus. We've now chosen to focus on transplant. Santa Fe's focus has been on larger population indications, including showgrounds.
Speaker 3: they're running trials in MS and they've discussed rheumatoid arthritis before. So that is the difference in terms of the approach that we're taking.
Speaker 4: Did you have a second part to the question?
Speaker 9: Yeah, yeah, that's helpful and then yeah, I was just wondering if you could comment on
Speaker 3: sort of a broader strategic interest in the space and you know how you're thinking about business development and partnership opportunities at this point? Yes, it's in terms of broader interest in the space. I think there are a lot of companies that are interested in the broader immunology space. It's become one of the key area focus for
Speaker 3: have the capital we need if we hit our milestones to be able to take this drug and develop it all the way through to getting face to data and beyond.
Speaker 3: So that's very much we're going to be focused on, which is executing our trials and continuing to generate data with the GoPro bar.
Speaker 9: Got it. That makes sense to me. All right guys, I appreciate you taking the questions and congrats again on the progress.
Speaker 9: That makes sense to me. All right, guys. Yeah, I appreciate you taking the questions, and congrats again on the progress. Thank you. Appreciate it, Tom.
Speaker 10: Thank you, Tom.
Speaker 1: Your next question comes from Ramy Katkuda from Lifesign Capital. Please go ahead.
Speaker 11: Hey guys, thanks for taking my questions as well. Thanks for your time. Thanks for your time. A couple quick ones for me. I guess first off, are you guys using the IBOX scoring system and the VISTA study?
Speaker 2: Yes, that's being evaluated as an exploratory endpoint. Great question, Rami. We're obviously really excited that agencies are starting to look at alternative endpoints like Ibox, which could be really transformational as far as helping to assess.
Speaker 2: early stage clinical trial development and the ability to estimate long-term graphed functioning survival. So great question.
Speaker 11: And Rami, just to add to what Steve said, we're doing it as part of our collaboration with CareDx. So if you remember, we announced collaboration with CareDx, and that covers a number of biomarkers and algorithms, including Ibox. Got it. Makes sense. And then going off of previous question, with recent regulatory successes in the ALS field, can you touch upon potential routes to meet the need for development of Togo in that indication?
Speaker 11: Right now, this financing is going to allow us to advance to go probar in transplantation. And that's what we are primarily focusing on. We'll continue to look for...
Speaker 3: other ways to potentially finance the GoPro Bard in ALS as we've
Speaker 3: that said before and we believe in order to advance the Gopro-Bardell-Ales, what we would like to do is is a trial that would be well designed and does have a the best possible chance of success.
Speaker 11: to do a smaller trial, potentially one that would require less money, we don't think would help fundamentally answer the question of whether Tugopu-Bard would work in ALS, and as such wouldn't be the best solution for patients and for the field.
Speaker 11: to have a trial that would be substantially
Speaker 11: set to truly be able to answer the question of how well the GoPro board is working in that indication.
Speaker 1: Got it. Thanks so much. Your next question comes from Verna Bernardino from H.C. Please go ahead.
Speaker 12: Hi, Dave, Steve, and Paul. Good afternoon, and thanks for taking my questions. Congrats on bolstering the balance sheet and appreciate the presentation of the kidney transplant. This question has less more to do with that data and I apologize for the music, so hopefully you can hear me well enough.
Speaker 12: and perhaps more to do with a study with the Gopro-BART in IGAM. Given what you perhaps see as side effects biomarkers that are looked at and perhaps endpoints you're considering for, again, less to do with the Kippy transplant, but perhaps a future study in IGAM.
Speaker 12: Is there anything that is informing you that targeting NICD for LIGAM as a...
Speaker 12: as a strategy to perhaps replace calcineurin inhibitors is informing you that targeting anti-CD4 ligand is working. Because as you know, with the calcineurin inhibitors, you've seen that as dose goes up, so does side effects, so does efficacy.
Speaker 12: except for perhaps a bit of an exception that we've seen with local forum. So, it's wondering if anything there you've seen so far, and I know the patients, the number of patients have been low so far, so you don't have a concrete idea about how to answer this question. It's wondering if there's something you're seeing now that's perhaps informing you of future study, and whether targeting at PCD-40 like that is turning out as you expect. Sorry for the long preamble.
Speaker 11: Vernon, thank you for the question. Steve, I'll turn that over to you to talk about what we're seeing or what we've seen in terms of biomarkers as well as how you interpret the data that we've generated today with regards to Gopro-Bards efficacy.
Speaker 2: Yeah, sure, D.A. Great question, Vernon. Thank you for that question. We've actually gleaned an amazing amount of data from very diverse indications to date in a very short period of time, as you know. We demonstrated very robust target engagement in our ALS study showing that we knocked down both T and C.
Speaker 2: T and B cell markers of target engagement in a very dose proportional way. That translated into functional decreases in over 20 pro-inflammatory markers that sit downstream of co-stimulatory signaling. So again, very good functional data showing that Tegel-Probark modulated the immune system.
Speaker 2: in that study and it did so in a very rapid way after the first infusion, which was quite exciting.
Speaker 2: globally across all of our indications, the safety profile of Tego continues to look very exciting and very encouraging. We haven't seen any serious adverse events in any of our studies. And these are patient population as you just suggested that, you know, these patients in transmet and ALS are very sick and yet the drug is shown very good safety profile at this point.
Speaker 2: and very predictable pharmacokinetics as well. So that opens up an opportunity when you kind of summarize all of that data in total that as we had hypothesized in general going back over 30 years of data that blocking this pathway really has an opportunity in multiple autoimmune indications.
Speaker 12: as well as in the transplant indications that we're pursuing. Do you plan to present any, even if it's preclinical data, that continues to validate the approach?
Speaker 2: I mean, in the preclinical side, we have multiple collaborations going on, both with allograft HEAVILY resin skills
Speaker 2: transplant experiments as well as in the xenotransplant space. As we've mentioned, we have a collaboration with eGenesis that's ongoing. So we anticipate as we continue to execute on those primate studies, both in allograft and xenograft, that we'll present them at some point at scientific conferences. Perfect. And I'm glad to see the both are balance sheets and so looking forward to more data. Thanks again for taking my time.
Speaker 11: I guess a question I was thinking I was reading, I read this recent New York Times article about transplantation. It's very compelling. I was wondering how are doctors and patients responding to the initial data in your renal transplantation program? Is that potentially building more awareness for your phase two trial? I have another question. Thanks. One of the reasons most people do this research, this Susan
Speaker 11: Thank you. That is a wonderful
Speaker 11: opinion piece that was published in the New York Times and I encourage really everyone on the call if you haven't had a chance to read it to do so. Steve, let me turn it over to you in terms of...
Speaker 2: Yeah, sure. Thanks, Dave. And a great question. I agree. The receptivity has been absolutely amazing. I mean, there's a long history, as we know, of blocking this pathway going back 25 to 30 years with many different antibodies in preclinical models in particular. But the field was set back in the early 2000s with the first generation antibodies. And yet to this day, blocking this pathway and blocking CD40 ligand in particular has been the most potent way to prevent transplant rejection. It was also a very, very potent strategy.
Speaker 2: to ameliorate autoimmune diseases in multiple different models. So the second generation antibody, Tagoprobar that we now have clinical data for us, has really generated an incredible amount of excitement as we've reached out to potential sites for the Bisto study and, you know, doing feasibility. And the PIs have been very impressed with the EGFR data.
Speaker 2: that we have to date, albeit on a handful of patients, but folks have been very excited because of the opportunity to reengage this pathway after so many years.
Speaker 11: Does the magnitude and duration of any potential EGR benefit or which tech alliance might potentially dictate the path forward clinically or regulatory? Thanks. Yeah, so we obviously would want to show a, we're looking at EGFR and this is a superiority study. So we're going to want to see a statistically superior delta in terms of eGFR versus standard of care and the larger that delta is the better. I would note that even small deltas in EGFR can make a difference clinically. So for example, we know that as early as six months,
Speaker 11: If you a 10 point delta in EGFR means an 11% delta in the chance of a patient being, of a post-transplant patient being hospitalized. Similarly, the lower the EGFR the more likely the patients are to be hospitalized multiple times.
Speaker 11: And finally, of course, EGFR is associated with the risk of graft failure. So the lower the EGFR, the higher the risk of that kidney being lost. And that graph, that increase is almost exponential, pretty much exponential, once one...
Speaker 11: has an eGFR that goes below 50 or 55, which is the mean eGFR in the year post-transplant. So if we would be able to move the needle in those patients by even only 10 points, that would be very meaningful since we're looking at an exponential increase in terms of risk.
Speaker 11: Steve? I appreciate that. Yeah. I was going to see if Steve wanted to add anything.
Speaker 2: Yeah, no, but yeah, I agree. I mean even small differences in EGFR based on very large retrospective studies can really impact long-term graph functioning survival. So even even smaller differences will be very, very important.
Speaker 11: Thanks for all of the progress.
Speaker 13: Thanks for that. Thanks for all the progress. Thank you.
Speaker 11: And there are no further questions at this time. I will turn the call back over to Mr. Groh for closing remarks. Thank you for your assistance operator and thank you all for joining us today on this call. Have a great evening.
Speaker 1: Ladies and gentlemen, this concludes your conference call for today. We thank you for joining and you may now disconnect your lines.
Speaker 1: Ladies and gentlemen, this concludes your conference call for today. We thank you for joining and you may now disconnect your lines.