Annexon (NASDAQ:ANNX) Q2 2026 Earnings Call

0:00 Good morning, everyone, and welcome to the ANNX on business update call. At this time, all attendees are in a listen only mode, and a question and answer session will follow the formal remarks. As a reminder, this call is being recorded, and a replay will be made available on the ANNX on website following the conclusion of the event. I'd now like to turn the call over to Doug Love, president and chief executive officer of ANNXON. Please go ahead, Doug. Thank you, operator. Good morning, and welcome, everyone. Earlier this morning, ANNXON issued a press release announcing that we have expanded our ARCHER II Phase III trial for vodipruma in geographic atrophy and a press release announcing key business updates and second quarter financial results. Copies of these press releases are available on the company's website and through our SEC filings. On today's call, we will be making forward looking statements, including statements relating to the existing clinical data and the therapeutic and commercial potential of our investigational drug candidates.

0:55 Joining me today are Doctor. Jamie Dannenberg, our EVP and chief medical officer, and doctor Lloyd Clark, SVP of ophthalmology strategy and innovation, who will discuss our GBS and GA programs, respectively. I will then close before we open the call for questions. We will be joined by doctor Chad Yednok, EVP and chief innovation officer, and Jin Liu, our chief financial officer. Before we turn to the updates, I'd like to briefly frame ANNXON's broader opportunity and our excitement about building a leading fully integrated biotech company driven by our mission to help millions of people live their best lives. Annexon was founded on discoveries from Stanford University to create a new class of targeted immunotherapies that stop c one q immediate mediated neuroinflammation at its source with the goal of rapidly and meaningfully preserving and potentially improving function for patients with serious neuroinflammatory diseases of the body, the brain, and the eye.

1:54 Built on more than two decades of foundational c one q biology and a highly translational approach in the clinic, we have generated robust, compelling evidence supporting the potential of c one q inhibition across multiple diseases. Indeed, leveraging our pioneering science and our water spirit culture to tackle some of the most pressing diseases in our industry, ANNXON is the first and only company to successfully conduct fully randomized, placebo controlled trials in GBS, a life threatening and debilitating disease that is sudden and completely indiscriminate in who it strikes, robbing otherwise healthy people of their normal lives. Nexton is also the first and only company to demonstrate significant vision preservation in a fully randomized sham controlled study in geographic atrophy, a mass population disease of irreversible blindness that robs millions of people of their independence.

2:49 Lastly, ANNXON is the first and only company to develop and clinically study an oral small molecule designed to selectively inhibit the classical pathway with the potential to offer those with serious complement mediated autoimmune conditions a convenient and flexible oral dosing opt option. While obstructive science is not always quickly recognized, we are more energized than ever by the opportunity to create significant value with not just one, but with multiple potential blockbuster paradigm shifting programs designed to bring hope and better outcomes to millions of people worldwide. Turning to our GBS program update. This program reflects the foundation of ANNXON and our determination to take on challenges others have not. We are pleased to have generated the first positive placebo controlled pivotal data in the one hundred and ten years since GBS was discovered.

3:41 Tamrupilbart is now under regulatory review in Europe, and we are on track to submit The US BLA in the fourth quarter of this year. Last week, we reported clinical outcomes from the first cohort of patients enrolled in our FORWARD study across The United States and Europe, marking an important milestone for ANNXON and for the GBS community. Tadrupebark flat out works, and these data are more than the next step in our development program. They provide compelling evidence that the rapid meaningful clinical improvements seen in our phase three study, where approximately ninety percent of treated patients responded by week one, are reproducible in Western patients. All 10 patients treated to date in Ford improved rapidly with many showing outsized gains.

4:27 These unprecedented outcomes, together with a well tolerated safety profile, support a highly differentiated benefit risk profile for the roughly hundred and fifty thousand people worldwide diagnosed with GBS each year. We plan to include these data in our BLA submission in the fourth quarter. Turning next to our GA program. Our second drug candidate, vodiprutinib, is advancing in the pivotal ARCHER two phase three trial for patients at risk of irreversible vision loss. Today, we announced a strategic expansion of the program by adding an independent month 24 dual primary endpoint alongside the existing month 15 primary endpoint. To be clear, we remain excited and confident about the month 15 readout expected in the fourth quarter of this year supported by a powerful mechanism of action, robust preclinical package, compelling dose dependent proof proof of concept data, and a well powered, well executed phase three study designed to replicate those results.

5:28 With masked events tracking on plan, month 15 remains our base case for success. At the same time, adding the month 20 '4 endpoint meaningfully strengthens the program in a potential $100,000,000,000 plus franchise. The endpoint is well powered, requires no change to the conduct of the already masked twenty four month trial, and gives von Eprumet additional time to demonstrate the growing treatment effect observed in the proof of concept trial. Lloyd would discuss this shortly, but in short, the ARCHER program is stronger with this enhancement. Related to the GA program, we were also pleased to announce initiation of the ARCHER two open label extension, or OLE, study. This allows all patients to enter the OLE after month twenty four to receive vinappropriate while enabling us to assess its longer term safety and benefit profile.

6:21 Shifting to corporate matters, as both the Tan Rupert Barre GBS and Vona Pruneet GA programs advanced toward registration, we also, in the second quarter, took a strategic step to further strengthen our financial position. During the quarter, we entered a credit facility with Oxford Finance that provides access up to $200,000,000 in nondilutive capital, extending our cash runway into 2028. This facility enhances our financial and operational flexibility as we prepare for global commercialization while further diversifying our capital structure, strengthening our balance sheet and supporting both near and longer term growth strategies. With that overview, I will now turn the call over to Jamie to review the recent data for our GBS program.

7:08 Following that, Lloyd will then discuss our bond improvement program updates in more detail. Jamie, over to you. Thanks, Doug. Before reviewing the forward data, I'd like to briefly highlight the significant unmet need in GBS. As Doug mentioned, GBS is an indiscriminate, life threatening neuromuscular emergency with a rapid devastating onset compounded by long term life altering consequences. GBS can strike anyone, anywhere, causing paralysis, respiratory failure, and even death. Without immediate intervention, patients face continued neuroinflammation and peripheral nerve damage caused by GBS that leads to muscle weakness of paralysis, with lifelong residual deficits impacting their health and quality of life.

7:54 Approximately twenty two thousand patients each year across The US and Europe are afflicted with GBS, and it carries an estimated annual health care burden of more than $20,000,000,000 in The US alone. Despite more than a hundred and ten years since GBS was first described, there are still no approved targeted therapies that meaningfully alter the course of the disease. Current standard of care, intravenous immunoglobulin or IVIG, is not FDA approved for GBS and provides incomplete benefit for many patients. Despite treatment, one year mortality remains as high as ten percent overall and approaches twenty five percent of patients over the age of 65. Many patients continue to deteriorate during or shortly after five day IVIG treatment, requiring mechanical ventilation, prolonged ICU stays, and experiencing months or even years of disability and persistent physical limitations.

8:50 These challenges underscore the urgent need for therapies that can rapidly stop the underlying disease process and improve patient outcomes. Turning now to the FORWARD study. We are very encouraged by the initial results from the first cohort of 10 patients treated with a single thirty milligram per kilogram infusion of tenrupevart. Across this initial cohort, every patient demonstrated rapid, clinically meaningful improvement in muscle strength within four days of treatment. Importantly, four patients who were bedbound early in the course of their disease regained the ability to walk with or without assistance between days two and eight. We also observed outsized improvements in some of the most severely affected patients. The one patient who required mechanical ventilation early in the disease course was successfully weaned from the ventilator within four days.

9:41 Five additional patients experienced marked fluctuate marked functional improvement within forty eight hours of treatment. Bear in mind that these outcomes with tenrupepart occurred well short of the five day span that is typically required to deliver a full course of IVIG. From a safety perspective, tenrupepart was generally well tolerated. The most significant adverse events were related to GBS itself and expected complications of the disease and were consistent with the safety profile observed in our phase three study. It's also worth noting that this initial cohort represented a broad cross section of GBS patients, including both males and females ranging from 12 to 78 years of age and spanning moderate to severe disease.

10:26 Importantly, these findings are consistent with the outcomes we observed in our phase three study, where approximately ninety percent of patients demonstrated rapid, clinically meaningful improvement by day eight. Taken together, we believe these results provide further evidence of targeted inhibition of C1Q with tenrupevart has the potential to fundamentally change the treatment paradigm for patients with GBS by delivering rapid and meaningful clinical benefit after a single infusion. Finally, I'd like to briefly touch on where we are from a regulatory and clinical development perspective. Our marketing authorization application is currently on track and under review by the European Medicines Agency and is supported by a comprehensive data package.

11:11 This includes robust placebo controlled studies demonstrating rapid improvement in function and disability as well as real world evidence showing favorable outcomes compared with current standard of care, including IVIG and plasma exchange. At the same time, we continue to advance the FORWARD study across The US and Europe. This study is designed to expand our experience with tanrupevart in Western patients, including pediatric patients, while further characterizing its pharmacokinetic and pharmacodynamic profile, early effects on function and biomarkers, and overall safety. Importantly, the forward data are expected to support our planned biologics license application, or BLA, submission to the FDA in the fourth quarter of this year. Together with our ongoing EMA review, these data are intended to further support the generalizability of tenrupevart's rapid clinical benefit across diverse populations and geographies and enforce reinforce the broad treatment label we are seeking for patients with GBS.

12:12 With that overview, I'll turn it over to Lloyd to discuss the GA ARCHER two phase three program. Thanks, Jamie. Thanks, Jamie. Before reviewing the vonaprunement phase three program, I'd like to briefly highlight the significant unmet need in geographic atrophy or GA. As Doug mentioned, GA is a neurodegenerative disease that leads to gradual loss of central vision, difficulty seeing in low light, and blurry or distorted vision. The GA patient whose average age is nearly 80 years old suffers most from the loss of their independence when everyday activities like reading, driving, and recognizing the faces of loved ones becomes more challenging as their disease advances over time.

12:58 GA meaningfully impacts the lives of approximately eight million patients worldwide, including one point five million patients in The US alone, and the incidence is projected to increase due to the aging population. A vision preserving treatment in GA is the greatest unmet need in the retina space today. Currently current approved treatments have not shown to preserve visual acuity and new innovations are needed. Now turning to our VONIPRUMET program, which has the potential to be the first vision sparing therapy for patients with GA. Notably, our phase three ARCHER two trial enrolled six fifty nine patients, 30 more than our original target to slightly enhance powering.

13:47 Powering has been further enhanced with strong trial execution where the patient discontinuation rate has been less than ten percent and dosing compliance has been more than ninety five percent, both which exceeded our targets. All eligible patients have now received at least twelve months of treatment in the trial, and the masked event accruals continue to to track in line with our projections. This all gives us further confidence in ARCHER two. The strong power and execution of our phase three ARCHER two trial provide a clear opportunity to seamlessly incorporate a month twenty four dual primary endpoint while maintaining the month fifteen primary endpoint. The overall study is highly powered at more than 90% for both time points.

14:37 Importantly, as Archer two was already designed to remain masked through month twenty four, this strategic addition allows us to evaluate the longer term profile of VON improvement for inclusion into the label without change to the study operation. Here's how the timeline works from here. An independent data monitoring committee or DMC will assess the study's month fifteen primary endpoint, and we expect to report that assessment on schedule in the fourth quarter of this year. At that point, the DMC may find that we've met the month 15 primary endpoint, which would allow us to move into the separate and additional planned analysis of the trials two sub studies with results expected in the first quarter of twenty twenty seven, or the DMC may recommend the study continue through the month 20 '4 analysis.

15:34 The ARCHER two study, including month 24 analyses, is expected to be completed in the third quarter of twenty twenty seven. On the regulatory side, recall that VON Approvement has Fast Track designation from the FDA. It is also the only geographic atrophy program with prime designation from the EMA and has been selected for the EMA's product development coordinator pilot, which provides enhanced regulatory support, including expedited scientific advice and MAA submission readiness. Together, these designations facilitate more frequent engagement with regulators as we advance this program towards potential registration. We at ANNXON, along with retina specialists and the broader GA community, are highly enthusiastic about our VON improvement program and its potential to help the eight million patients globally with geographic atrophy.

16:32 With that, I'll turn the call back to Doug. Thanks, Laurie. Thanks, Jamie. Nice job. After more than a decade building the scientific and clinical foundation of our platform, we are now entering a pivotal peer where the work can translate into new medicines for patients and significant value for shareholders. The time is now. Imagine a world where GBS can be halted within a week and people at risk of GA related blindness have a a real choice to preserve their vision. Simply put, we're playing to win for patients, stakeholders, and each other. To support that goal over the course of this year, we have strengthened the balance sheet with nondilutive debt capital, bolstered our ophthalmic capabilities at the board of directors level with the recent appointment of renowned retina specialist and biotech leader doctor Mark Blumenkradz, and the addition of key internal client talent across the organization.

17:25 We've established the most comprehensive and compelling GBS data package ever generated, including the first U US EU trial in over forty years where all patients treated to date rapidly improved. We've also effectively executed and are executing the GA phase three program, have now expanded the program to enhance its probability for overall success, and we're continuing the steadfast work to deliver on the first and only oral therapy targeting the complement classical pathway. Each element is significant on its own. Together, they create the potential to drive substantial asymmetric value for ANNXON and for others. So in closing, I want to thank the patients, medical teams, supporters, employees, and advisers who have joined us on this journey. We look forward to continuing to partner with you as we fully leverage the foundation we've laid over the next six to eighteen months.

18:21 And I wanna thank all of you who joined us this morning on today's call. With that, I will now ask the operator to begin our q and a session. Operator? Great. Thank you, Doug. Yes. So at this time, we will be conducting a live q and a session. To our covering analysts, please use the raise hand feature to be added to the queue. Kindly hold for a brief moment while we pull for questions. So our first question comes from Anupam Rama at JPMorgan. Congrats on all the progress.

19:12 I just want to confirm that you guys have shared the dual primary endpoint strategy for Archer two with reg with regulators both, in The US and globally and and what feedback you may have gotten, on the strategy from regulators. Thanks so much. Yeah. Thanks, Anupam, and and and appreciate you joining us this morning. Yeah. The short answer is, yeah, both regulators on on both sides of the of the pond have been very clear that if we want to include month 24 in the label, we would need to apply alpha to month 24. As you know, month 24 was already the design of the study for safety purposes. This addition that we've made here this morning allows it to be counted in the label from an efficacy perspective.

19:59 And I don't know, Lloyd, is there anything you'd like to add on to that? No. I think that's very clear. I mean, we have full alignment at month 15, and we've had several discussions with both regulatory bodies about the importance of putting alpha at month 24 if we wanna include efficacy data from that time point. Thanks. Thanks, Anupam. Thanks so much for taking our question. Absolutely. Thanks, Anupam. Our next question comes from Derek Arcia at Wells Fargo. Please go ahead, Derek. Hey. Good morning, and thanks for the question taking the questions, and congrats on the progress here. So I guess maybe the first one is just know, kind of bring us back, like, what kind of really drove the decision for the twenty four month endpoint? Obviously, it's something that you can do.

20:45 But I guess the the main thing that I feel like people are gonna be asking us is what did you see in blinded data? Is there worry around the fifteen month end point? So maybe, you know, give us a sense of, like, the decision process, but also, you know, your confidence in that fifteen month end point. Yeah. Good morning, Derek. Really good question. I'll start and then invite the others to join in. So the first first and foremost, super confident in month fifteen. We are it is our base case, and maybe just a little bit of history on how we got here today. We passed the twelve month point for all patients receiving their dose. So we have a really strong handle at this particular point in time on how the study is faring. We're very confident in our targets for masked event rates. As we've said, it's continued to track over the last several months, and and it continues to do so today. So we're very pleased by that. You know, to be completely candid, we fielded questions from various investors and strategics on the idea of adding a month 24 endpoint.

21:45 It absolutely creates a stronger overall profile for vina improvement in this disease, and in effect, builds a moat around this franchise in a way that it will be very difficult with the wind for others to come in and usurp us in a reasonable period of time. And so the notion that being able to run a really effective study that gave us additional power, and I'm sure Lloyd and or Jamie will talk more about that, and applying that to month 24 just became increasingly attractive. But, really, it was not until we crossed the month 20 the twelve month hurdle on this study, which is in effect the Vona Archer one study that we began to really consider whether or not we can it can be opportunistic, if you will, in playing a bit of offense here. So, Lloyd, maybe I'll turn it over to you, see if you wanna add anything to that. Yeah. Derek, thanks for the question. I mean, I think that I'm gonna borrow from Doug. Doug likes to use sports analogies, and this is how it's made a lot of sense to me. We we effectively went to the locker room at halftime as we were assessing the month twelve progress of the trial.

22:47 And we came to three important conclusions about the study. The first was that we went to month fifteen, which gave us additional powering over our initial twelve month calculations. The second was that we over enrolled the study by 30 patients. If you remember, we had such brisk enrollment at the end that we ended up over enrolling by 30 patients. So we had additional power there to spend. And then finally, we've had really, really encouraging patient retention in this study over single single digit percentages of dropouts, which is significantly lower than we anticipated. So sort of at this half time evaluation of retention the study, we found ourselves with increased power. And and so we we made the strategic decision to apply that power to a second time point. So we have not weakened the study at month 15 by any way. We're still extremely confident for where we stand at the month 15 time point.

23:45 But we've given ourselves the flexibility through execution to look at a second time point. Very helpful. Thank you. Thank you. Great. Thanks for the questions, Derek. Our next question comes from Andrew Tsai at Jefferies. Please go ahead. Hey. Congrats on the updates. This is Matt Barkis dialing in for Andrew Tsai. We wanted to know what the well, would you expect lesion growth to hit stat sig two by month '24 as a secondary? Yeah. I mean, look. You we we've talked about this before. I I have two thoughts on this, and then maybe not one is maybe not the most popular. On some level, we care about lesion growth. On another level, we don't as it relates to vision. And that's not because we don't think it's important to protect RPE cells. It is. They provide trophic support under the neurons that are responsible for vision. But it's not important to protect lesion growth for the purposes of protecting vision.

24:40 And that's been born out not only by our data, but clearly the first generation approved therapies that have four or five years worth of data of protecting lesion growth, but no no impact on vision. And it it's it's it's a bit of a curious circumstance for me in this particular therapeutic area that we continue to get that question because it's just not the biology for what we're seeking in this disease. Right? And and I think that's very well elucidated. That being said, we were encouraged that by protecting photoreceptor cells over time, we're showing a healthier overall neuronal unit, which is showing greater protection to the lesion over time. And so when you look in the second six months of the study, we have a ten percent protection over just a six month period of time in RPE grow growth in the second six months of the Archer study. So we expect that will continue.

25:31 Whether that will be stats, get fifteen months, twenty four months, a little bit TBD, but we do expect we will get there in time. So, Lloyd, I don't know what you wanna add on to that. Yeah. No. I Doug, I totally agree with that with that discussion. We recognize that RPE lesion growth is still important for us to discuss. We recognize that that's where the community is today. The community will not be there tomorrow, though. The community is gonna be more interested in protecting photoreceptors and neuronal cells as measured by ellipsoid zone. We do anticipate seeing protection of RPE lesion, at the later time points, based on our phase two data. And we recognize that we'll continue to have to discuss this from a historical perspective, but I would encourage you to continue to pay close attention to ellipsoid zone as a primary biomarker for this neurodegenerative disease.

26:31 Great. Thanks for the question, Matt. Our next question comes from Salveen Richter at Goldman Sachs. Please go ahead, Salveen. Salveen, you might be on mute. Sorry about that. Good morning. Thanks for taking my question. What would be the commercial outlook if there when you think about what you plan to see for separation at month fifteen, but more of a stat sig, outlook at twenty four months? And how would a delayed time to response be perceived despite, vision preservation here? Good morning. This is Salveen. Thanks for thanks for your question. I guess maybe a couple of things. We expect to be positive at month fifteen. So month 15 is not kinda just kind of a speed bump look, but we expect stats say get month 24. We're we are the base case is still winning at month 15. And I guess what I would say, but invite others to weigh in on this, whether that positive outcome occurs at month fifteen or month twenty four, the word delay certainly cannot be associated with it. No drug has ever done it. The approved drugs have four or five years worth of data, and they haven't done it. So doing it, you know, more than half the time quicker than anybody's ever done it would be certainly not a delay. But I I don't know, Floyd, if there's anything you'd like to add on this.

27:56 Yeah. Our our work with the retina community suggests that this is a transformative therapy, with, you know, rapid adoption over the currently available therapies regardless of when it's available commercially. Again, we have tremendous confidence in the phase in the month fifteen time point, but we also have tremendous confidence that this drug will make a a big benefit to patients. And so our goal, our primary goal, is success of this program. This change by adding the month 24 time point increases our probability of success for the entire program, which would deliver a transformative therapy to the market. One other quick point, Salveen. This is Jamie. Just bear in mind, we have full confidence in month 15. What month 24 gets us is the ability to put efficacy data in the label at two years, which just adds to the overall story, of vision protection for patients, not just at fifteen months, but onward.

28:55 Got it. Thank you. Thanks for the question, Salveen. Our next question comes from Joey Stringer at Needham. Please go ahead, Joey. Thanks for taking our questions in the morning. I had a question just on the alpha allocation. With so with the month fifteen and month twenty four now independent kind of registrational time points here where you can hit success at at either time point. Does the month 15 still carry the full alpha, or has the statistical threshold there, tightened? Yeah. Good morning, Joey. Good question. Lloyd, I'll turn it over to you and Jamie to talk about the alpha. Yeah. Yeah. Right. Good morning, Joey. Obviously, yes, we are splitting alpha between month 15 and month 24.

29:44 But as I stated earlier, our our our base assumptions at the initiation of the study have been exceeded due to strong trial execution. And so, really, what we're looking at in terms of overall powering based on where we stand today is a negligible difference at month 15 compared to where we thought we would be at the initiation of the study. And so, essentially, what we're doing here is we're we're we're we're using found money in terms of strong trial execution to add a secondary time point. So we are not we are not in any substantive way reducing the likelihood of the month 15 win, but rather we're using the additional powering that we've achieved through execution to add a second time point.

30:33 Great. Thank you. Thanks, Joey. Yes. Thanks, Joey. Our next question comes from Ananda Ghosh at HC Wainwright. Please go ahead, Ananda. Yeah. Hi. Thanks, and congrats on the quarter. Maybe, you know, the one the first question I have is, like, if you can, briefly talk about how the powering is designed for the substudies. And the second thing is if the blinded pool pooled event, you know, that you see in line with the projections, is that track with what you have seen in your phase one, phase two, you know, like the the the POC trial? Thank you. Yeah. Good question. Good good morning on that. Yeah. So both actually, Lloyd, I'll just turn it over to you. Sure. The first question about powering, yes, we are splitting alpha. We haven't disclosed specifically what that alpha split's gonna be. But, again, what I would tell you is that this this change based on our on our execution updates allows us to split this out and retain phase three powering at the substudy level and continue to be well overpowered for the phase three at the combined study. So we feel really confident about where we are in terms of powering, not substantially different with the second time point than where we would have been at the beginning of the study. In terms of masked event rates, again, that really is our really our best metric in terms of understanding how trial execution is going. We follow that on a regular basis.

32:03 We have multiple models to to predict where we're gonna be. We continue to be on track, and that gives us this strong confidence that Doug talked about in the month 15 time point. It gives us confidence two ways. It gives us confidence that we understand the disease process well because otherwise we'd be off in terms of event rates. And secondly, it gives us confidence in what we observed in terms of a treatment effect in the phase two. So on target with masked event rates, and that leads to confidence with the month 15 primary endpoint. Thanks so much. Thanks, Ananda. Our next question comes from Phil Nadeau at TD Cowen. Please go ahead, Phil. Good morning. Thanks for taking our questions. Three from us. First, in terms of the q four disclosure, I guess, what exactly will we will we learn? It sounds like you might be able to disclose whether you hit the primary endpoint, but the data won't come out to q one twenty twenty seven.

33:02 Is that is that correct? Or I guess what what are the scenarios for that data? Is is a or for that release, is it possible that futility could could be triggered and and the trial will be stopped? That's first. Second question, follow-up to the last one. We're curious if you're willing to disclose what actually the powering is today at month 15 and month 24. Then third, just a question on GBS. With the q four filing, have you had just further discussions with the FDA on the number of patients and follow-up necessary from forward, or, are you just going with your prior prior understanding? You. Yeah. Thanks, Phil. Thanks for joining us this morning. Maybe we'll start with GBS. I'll quickly answer that by Jamie, and then we'll turn it over to, Lloyd others for the, for the GA questions. On the GBS front, we are in ongoing discussions with the FDA.

33:49 So I will say that we're really encouraged with the posture of the FDA both at the macro level and then at the micro level at a program specific level. Those are ongoing discussions, and we feel quite confident that with the addition of the four data, we will be filing for BLA in in q four of this year. So we're we're encouraged all around on that. This this program is moving in. Of course, the discussions and interactions with the EU are going really, really well as well, and things have advanced on multiple fronts there. So GBS is coming, and and we're excited by that because patients obviously need this therapy. With regard to GA and the disclosure in q four, as Jamie or as Lloyd spoke to, the DMC will take a look at this and make a determination. They always have the opportunity to declare the study futile, and they have been and will continue to look at that over the course of the study, and thus far, it's been continue on, continue on. At q four, they'll have an opportunity to disclose whether the study is positive at month 15 on the overall study or to continue on to month 24. And I'll just open it up to you, Lloyd, to see if you wanna add anything addition to that. Oh, yeah. No. That's absolutely so we'll find out in q four if the study is positive or, as Doug said, if we continue on to month 24.

35:11 If the study is positive in q four, then that would trigger the initiation of the two sub study analysis of which would be available in the first quarter of twenty twenty seven. But you will get result results on the overall study in q four as promised. And oh, and then the other question about powering. Yes. We have not shared specifically what the powering is, but, again, I wanna reiterate that both time points remain well powered at a conventional Phase III level, both month 15 as well as month 20 '4. Thanks for the questions, Phil. Our final question comes from John Wallabin at Citizens. Please go ahead, John.

36:00 Hey, good morning. Thanks for taking the question. A couple of follow ups for me. Wondering if in four q, the decision is to continue in month twenty four, if you'll be seeing the data, from the DMC and and, providing that publicly as well. And then just a question, you mentioned your mask event rate is in line with projections. Can you tell us what that looks like? And then how do you think about month twenty four projections without, that data from Archer? Thanks, guys. Yeah. Thanks, John. Thanks for joining us. Yeah. First and foremost, John, could you repeat your first question? I forgot. I actually lost you. Oh, I'm sorry. Where where the we do not have day. Yeah. Whether we'd be seeing let me just start on that quickly, Lou. I just wanna make a quick point out that, no. The short answer is no. It will be masked all the way through month 24, which is the predesigned setup for that. Bear in mind, there's precedent for this. This has been done before. So if you look at the Apellis phase three program and the derby study in particular, it was a twelve month study primary endpoint, but to read out and and with following patients out to month 24 in a mass fashion, they did not hit stat sig at month 12 and ultimately looked again at month 18.

37:11 They did we wanted to make sure if we were in that circumstance, we did this prospectively. So we're doing this, you know, with the full light of day and with alignment with with the regulators with regard to that. But to do so, you do need to remain masked at the time you take your first look at your data. So, Lloyd, I'll turn it over to you, see if you wanna add on to that. Yeah. No. Absolutely. So we'll we'll you there will be no patient level data released in the q four of twenty twenty six. Now we'll then initiate the substudy analysis. And if both substudies are positive, then we'll have we're likely we'll have a different conversation about data in the first quarter of twenty twenty seven. But, again, you will have the results of the full analysis in line with the q twenty twenty six q four twenty twenty six guidance. In terms your question about event rates was a great question about how do we essentially, how do we model event rates out to twenty four months given that our phase two study was only one year? Well, keep in mind, as we've as we discussed publicly, we did an extensive review of event rates, and we planned a two year study from the start. And so we've used a number of data points, including our phase two data, which is very, very valuable to us, but a number of other data points, including trials that lasted much longer than twelve months to arrive at models for events. And in and in general, you know, events in in geographic atrophy continued to progress for several years. So we have a good handle on what the events should look like in the second year based on our review of multiple different protocols.

38:43 So we have that modeled, and we anticipate a similar behavior of that model in year two compared to year one. Great. Thanks for the questions, John. So I'll now turn it back over to Doug to close out the call. Alright. Well, thank you all for joining us on the call today. We really appreciate your time and attention and for the good questions. We look forward to continuing to communicate as we advance, over the remainder of the year, and we wish you all a good day. Thanks again.