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Image source: The Motley Fool. Wednesday, Aug. 12, 2026 at 8:00 a.m. ET President and Chief Executive Officer - Douglas Love Executive Vice President and Chief Medical Officer - Jamie Dananberg Senior Vice President of Ophthalmology Strategy and Innovation - Lloyd Clark Executive Vice President and Chief Innovation Officer - Ted Yednock Chief Financial Officer - Jen Lew Need a quote from a Motley Fool analyst? Email [email protected] Operator: Good morning, everyone, and welcome to the Annexon Business Update Call. [Operator Instructions] As a reminder, this call is being recorded, and a replay will be made available on the Annexon 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 Annexon. Please go ahead, Doug. Douglas Love: Thank you, operator. Good morning, and welcome, everyone. Earlier this morning, Annexon issued a press release announcing that we have expanded our ARCHER II Phase III trial for vonaprument in geographic atrophy, in 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. Joining me today are Dr. Jamie Dananberg, our EVP and Chief Medical Officer, and Dr. 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, where we will be joined by Dr. Ted Yednock, EVP and Chief Innovation Officer; and Jen Lew, our Chief Financial Officer. Before we turn to the updates, I'd like to briefly frame Annexon'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 C1q-mediated neuroinflammation at its source with the goal of rapidly and meaningfully preserving and potentially improving function for patients of serious neuroinflammatory diseases of the body, the brain and the eye. Built on more than 2 decades of foundational C1q biology and a highly translational approach in the clinic, we have generated robust, compelling evidence supporting the potential of C1q inhibition across multiple diseases. Indeed, leveraging our pioneering science and our warrior spirit culture to tackle some of the most pressing diseases in our industry, Annexon is the first and only company to successfully conduct fully randomized placebo-controlled trials of 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. Annexon 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, irreversible blindness that robs millions of people of their independence. Lastly, Annexon 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 option. While disruptive 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 Annexon 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 110 years since GBS was discovered. Tanruprubart is now under regulatory review in Europe, and we are on track to submit the U.S. 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 Annexon and for the GBS community. Tanruprubart 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 III study, where approximately 90% of treated patients responded by week 1, are reproducible in western patients. All 10 patients treated to date in FORWARD improved rapidly, with many showing outsized gains. These unprecedented outcomes together with a well-tolerated safety profile support a highly differentiated benefit-risk profile for the roughly 150,000 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, vonaprument, is advancing in the pivotal ARCHER II Phase III 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-of-concept data and a well-powered, well-executed Phase III study designed to replicate those results. With masked events tracking on plan, month 15 remains our base case for success. At the same time, adding the month 24 endpoint meaningfully strengthens the program and a potential $100 billion-plus franchise. The endpoint is well powered, requires no change to the conduct of the already masked 24-month trial and gives vonaprument additional time to demonstrate the growing treatment effect observed in the proof-of-concept trial. Lloyd will 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 the initiation of the ARCHER II Open-Label Extension, or OLE study. This allows all patients to enter the OLE after month 24 to receive vonaprument, while enabling us to assess its longer-term safety and benefit profile. Shifting to corporate matters, as both the tanruprubart GBS and vonaprument GA programs advanced towards 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 million in non-dilutive 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, following that, Lloyd will then discuss our vonaprument program updates in more detail. Jamie, over to you. Jamie Dananberg: 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 or paralysis, with lifelong residual deficits impacting their health and quality of life. Approximately 22,000 patients each year across the U.S. and Europe are afflicted with GBS, and carries an estimated annual healthcare burden of more than $20 billion in the U.S. alone. Despite more than 110 years since GBS was first described, there is 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 provide incomplete benefit for many patients. Despite treatment, 1-year mortality remains as high as 10% overall and approaches 25% of patients over the age of 65, many patients continue to deteriorate during or shortly after 5-day IVIG treatment, requiring mechanical ventilation, prolonged ICU stays and experiencing months or even years of disability and persistent physical limitations. 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 30 milligram per kilogram infusion of tanruprubart. Across this initial cohort, every patient demonstrated rapid, clinically meaningful improvement in loss of strength within 4 days of treatment. Importantly, 4 patients who are bed-bound early in the course of their disease, regain the ability to walk with or without assistance between days 2 and 8. 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 4 days. 5 additional patients experienced marked functional improvement within 48 hours of treatment. Bear in mind that these outcomes with tanruprubart occurred well short of the 5-day span that is typically required to deliver a full course of IVIG. From a safety perspective, tanruprubart was generally well tolerated. The most significant adverse events were related to GBS itself and expected complications of disease, and were consistent with the safety profile observed in our Phase III 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. Importantly, these findings are consistent with the outcomes we observed in our Phase III study, where approximately 90% of patients demonstrated rapid, clinically meaningful improvement by day 8. Taken together, we believe these results provide further evidence of targeted inhibition of C1q with tanruprubart as 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. 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 U.S. and Europe. This study is designed to expand our experience with tanruprubart 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 FDA in the fourth quarter of this year. Together with ongoing EMA review, these data are intended to further support the generalizability of tanruprubart's rapid clinical benefit across diverse populations and geographies and reinforce the broad treatment label we are seeking for patients with GBS. With that overview, I'll turn it over to Lloyd to discuss the GA ARCHER II Phase III program. Lloyd? Lloyd Clark: Thanks, Jamie. Before reviewing the vonaprument Phase III 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. GA meaningfully impacts the lives of approximately 8 million patients worldwide, including 1.5 million patients in the U.S. 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 vonaprument program, which has the potential to be the first vision sparing therapy for patients with GA. Notably, our Phase III ARCHER II trial enrolled 659 patients, 30 more than our original target to slightly enhance powering. Powering has been further enhanced with strong trial execution, where the patient discontinuation rate has been less than 10%, and dosing compliance has been more than 95%, both which exceeded our targets. All eligible patients have now received at least 12 months of treatment in the trial and the masked event accruals continue to track in line with our projections. This all gives us further confidence in ARCHER II. The strong power and execution of our Phase III ARCHER II trial provide a clear opportunity to seamlessly incorporate a month 24 dual primary endpoint while maintaining the month 15 priority endpoint. The overall study is highly powered at more than 90% for both time points. Importantly, as ARCHER II was already designed to remain masked through month 24, this strategic addition allows us to evaluate the longer-term profile of vonaprument 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 15 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 trial's 2 substudies, with results expected in the first quarter of 2027, or the DMC may recommend the study continue through the month 24 analysis. The ARCHER II study, including month 24 analysis is expected to be completed in the third quarter of 2027. On the regulatory side, recall that vonaprument 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 Annexon, along with retina specialists and the broader GA community, are highly enthusiastic about our vonaprument program and its potential to help the 8 million patients globally with geographic atrophy. With that, I'll turn the call back to Doug. Douglas Love: Thanks, Lloyd. Thanks, Jamie. Nice job. After more than a decade building the scientific and clinical foundation of our platform, we are now entering a pivotal period 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 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 non-dilutive debt capital, bolstered our ophthalmic capabilities at the Board of Directors level with the recent appointment of renowned retina specialists and biotech leader, Dr. Mark Blumenkranz, and the addition of key internal talent across the organization. We've established the most comprehensive and compelling GBS data package ever generated, including the first U.S./EU trial in over 40 years, where all patients treated to date rapidly improved. We've also effectively executed and are executing the GA Phase III program, have now expanded the program to enhance the 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 Annexon 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 6 to 18 months. And I want to thank all of you who are joining us this morning on today's call. With that, I will now ask the operator to begin our Q&A session. Operator? Operator: [Operator Instructions] So our first question comes from Anupam Rama at JPMorgan. Anupam Rama: Congrats on all the progress. I just want to confirm that you guys have shared the dual primary endpoint strategy for ARCHER II with regulators, both in the U.S. and globally. And what feedback you may have gotten on the strategy from the regulators. Douglas Love: Yes. Thanks, Anupam, and appreciate you joining us this morning. The short answer is, yes, both regulators on both sides 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 we've made here this morning allows it to be counted in the label from an efficacy perspective. And I don't know, Lloyd, is there anything you'd like to add on to that? Lloyd Clark: 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 out at month 24 if we want to include efficacy data from that time point. Operator: Our next question comes from Derek Archila at Wells Fargo. Derek Archila: Congrats on the progress here. So I guess maybe the first one is just, kind of bring us back like what kind of really drove the decision for the 24-month endpoint? Obviously, it's something that you can do. But I guess the main thing that I feel like people are going to be asking us is, what did you see in the blinded data? Is there worry around the 15-month endpoint? So maybe give us a sense of like the decision process but also your confidence in that 15-month endpoint. Douglas Love: Yes. Derek, really good question. I'll start, and then invite the others to join in. So first and foremost, super confident in month 15. We are -- it is our base case, and maybe just a little bit of history on how we got here today. We passed the 12-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 it continues to do so today. So we're very pleased by that. To be completely candid, we fielded questions from various investors and strategics on the idea of adding a month 24 endpoint. It absolutely creates a stronger overall profile for vonaprument in this disease. And in effect, builds a moat around this franchise in a way that it will be very difficult with the win 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 sure, Lloyd or Jamie will talk more about that, applying that to month 24 just became increasingly attractive. But really, it was not until we crossed the 12-month hurdle on this study, which is, in effect, the ARCHER I study that we began to really consider, whether or not it can be opportunistic, if you will, and playing a bit of offense here. So Lloyd, maybe I'll turn it over to you if you want to add anything to that. Lloyd Clark: Yes. Derek, thanks for the question. I mean I think I'm going to borrow from Doug. Doug likes to use sports analogies, and this is how it's made a lot of sense to me. We effectively went to the locker room at halftime as we were assessing the month 12 progress of the trial. And we came to 3 important conclusions about the study. The first was that we went to month 15, which gave us additional powering over our initial 12-month calculations. The second was that we overenrolled the study by 30 patients. If you remember, we had such brisk enrollment at the end that we ended up overenrolling by 30 patients. So we had additional power there to spend. And then finally, we've had really, really encouraging patient retention in the study over single-digit percentages of dropouts, which is significantly lower than we anticipated. So sort of at this halftime evaluation of the study, we found ourselves with increased power. And so 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. But we've given ourselves the flexibility through execution to look at a second time point. Operator: Our next question comes from Andrew Tsai, Jefferies. Matthew Barcus: Congrats on the updates. This is Matt Barcus dialing in for Andrew Tsai. We wanted to know what the -- would you expect lesion growth to hit stat sig too by month 24 as a secondary? Douglas Love: Yes. I mean, look, we've talked about this before. I have 2 thoughts on it, and maybe not -- 1 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. And that's been borne out not only by our data, but clearly, the first generation approved therapies, we have 4, 5 years' worth of the data of protecting lesion growth, but no impact on vision. 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 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 6 months of the study, we have a 10% protection over just a 6-month period of time in RPE growth in the second 6 months of the ARCHER study. So we expect that will continue, whether that will be stat sig at 15 months, 24 months, a little bit TBD, but we do expect we will get there in time. So Lloyd, I don't know what you want to add on to that. Lloyd Clark: Yes. No, Doug, I totally agree 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. The community is going to 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 II data, and we recognize that we 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. Operator: Our next question comes from Salveen Richter of Goldman Sachs. Salveen Richter: What would be the commercial outlook if there -- when you think about what you plan to see for separation at month 15, but more of a static outlook at 24 months? And how would a delayed time to response be perceived despite vision preservation here? Douglas Love: Thanks for your question. I guess, maybe a couple of things. We expect to be positive at month 15. So month 15 is not kind of just kind of a speed bump, look, but we expect stat sig at month 24. We are -- the base case is still winning at month 15. And I guess what I would say, would invite others to weigh in on this, whether that positive outcome occurs at month 15 or month 24, the word delay certainly cannot be associated with it. No drug has ever done it. The approved drugs out 4, 5 years' worth of data, and they haven't done it. So doing it more than half the time quicker than anybody has ever done it would be certainly not a delay. But I don't know, Lloyd, if there's anything you'd like to add on this. Lloyd Clark: Yes. Our work with the retina community suggests that this is a transformative therapy with 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 15 time point. But we also have tremendous confidence that this drug will make 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. Jamie Dananberg: 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 2 years, which just adds to the overall story of vision protection for patients, not just at 15 months, but onward. Operator: Our next question comes from Joey Stringer at Needham. Joseph Stringer: I had a question just on the alpha allocation. So with the month 15 and month 24 now independent kind of registrational time points, here where you can hit success at either time point, does the month 15 still carry the full alpha? Or has the statistical threshold there tightened? Douglas Love: Yes, Joey, good question. Lloyd, I'll turn it over to you and Jamie to talk about the alpha. Lloyd Clark: Yes, right. Obviously, yes, we are splitting alpha between month 15 and month 24. But as I stated earlier, our base assumptions at the initiation of the study have been exceeded due to strong trial execution. 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 using found money in terms of strong trial execution to add a secondary time point. So 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. Operator: Our next question comes from Ananda Ghosh at H.C. Wainwright. Ananda Ghosh: Congrats on the quarter. Maybe the first question I have is like, if you can briefly talk about how the powering is designed for the sub-studies. And the second thing is, if the blinded pooled event that you see in line with the projections, is that track with what you have seen in your Phase I, Phase II, like the POC trial? Douglas Love: Yes. Good question, Ananda. Yes, so both -- actually, Lloyd, I'll just turn it over to you. Lloyd Clark: Sure. The first question about powering, yes, we are splitting alpha, and we haven't disclosed specifically what that alpha split is going to be. But, again, what I would tell you is that this change based on our execution updates allows us to split this out and retain Phase III powering at the substudy level and continue to be well overpowered for the Phase III 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. We have multiple models to predict where we're going to 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 2 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 II. So on target with masked event rates, and that leads to confidence with the month 15 primary endpoint. Operator: Our next question comes from Phil Nadeau at TD Cowen. Philip Nadeau: Three from us. First, in terms of the Q4 disclosure, I guess what exactly 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 Q1 2027. Is that correct? Or I guess, what are the scenarios for that data is a -- or for that release, is it possible that futility could be triggered, and the trial will be stopped? That's first. Second question, a 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. And third, just a question on GBS. With the Q4 filing, have you had further discussions with the FDA and the number of patients and follow-up necessary from FORWARD? Or are you just going with your prior understanding. Douglas Love: Yes. 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 for the GA questions. On the GBS front, we are in ongoing discussions with the FDA. 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 and a program-specific level. Those are ongoing discussions, and we feel quite confident that with the addition of the FORWARD data, we will be filing for BLA in Q4 of this year. So we're encouraged all around on that. 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 we're excited by that because patients obviously need this therapy. With regard to GA and disclosure, in Q4, 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 we'll continue to look at that over the course of the study. And thus far, it's been continue on, continue on. At Q4, 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, see if you want to add anything in addition to that. Lloyd Clark: Yes. No, that's absolutely. So we'll find out in Q4, if the study is positive, or, as Doug said, if we continue on to month 24. If the study is positive in Q4, that will trigger the initiation of the 2 substudy analysis of which would be available in the first quarter of 2027. But you will get results on the overall study in Q4 as promised. And then the other question about powering. Yes, we have not shared specifically what the powering is. But again, I want to reiterate that both time points remain well powered in a conventional Phase III level, both month 15 as well as month 24. Operator: Our final question comes from Jon Wolleben at Citizens. Jonathan Wolleben: A couple follows from me. Wondering if in 4Q, the decision is to continue to month 24, if you will be seeing the data from the DMC and providing that publicly as well. And then just a question, you mentioned your masked event rate is in line with projections. Can you tell us what that looks like? And then how do you think about month 24 projections without that data from ARCHER? Douglas Love: Yes. Thanks, Jon. Thanks for joining us. Yes, first and foremost, Jon, could you repeat your first question? I forgot. I actually lost -- I'm sorry. Whether we do month 24. Yes, whether we would be seeing. Let me just start on that quickly, Lloyd, I just want to make a quick point on that. Now 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 III program and the DERBY study, in particular, it was a 12-month primary endpoint, but to read out and with following patients out to month 24 and masked fashion. They did not hit stat sig at month 12 and ultimately looked again at month 18. We wanted to make sure if we were in that circumstance, we did this prospectively. So we're doing this with the full light of day and with alignment -- 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 want to add on to that. Lloyd Clark: Yes. No, absolutely. So we'll -- there will be no patient-level data released in the Q4 of 2026. We'll then initiate the substudy analysis. And if both substudies are positive, then we'll have -- likely we'll have a different conversation about data in the first quarter of 2027. But again, you'll have the results of the full analysis in line with the Q4 2026 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 24 months, given that our Phase II study was only 1 year. Well, keep in mind, as we've discussed publicly, we did an extensive review of event rates. We planned a 2-year study from the start. And so we've used a number of data points including our Phase II data, which is very, very valuable to us, but a number of other data points, including trials that lasted much longer than 12 months, to arrive at models for events. And in general, events in geographic atrophy continue 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. So we have that modeled, and we anticipate a similar behavior of that model year 2 compared to year 1. Operator: So I'll now turn it back over to Doug to close out the call. Douglas Love: All right. 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. 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Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is pivoting to a dual primary endpoint strategy for the ARCHER II Phase III trial in geographic atrophy (GA), adding a month 24 analysis to the existing month 15 target to maximize the probability of success and strengthen the potential label. The decision to expand the GA program was driven by 'found power' from over-enrollment, high patient retention (less than 10% discontinuation), and masked event rates that are tracking precisely with internal projections. In Guillain-Barré Syndrome (GBS), the FORWARD study demonstrated that tanruprubart's rapid clinical benefit is reproducible in Western populations, with 100% of the first cohort showing meaningful improvement within four days. Management attributes the GBS program's success to the drug's ability to halt C1q-mediated neuroinflammation at the source, leading to unprecedented functional gains such as rapid weaning from mechanical ventilation. The company is transitioning from a R&D-focused entity to a fully integrated biotech, supported by a new $200 million credit facility that extends the cash runway into 2028. Strategic positioning in GA focuses on vision preservation rather than just lesion growth, as management argues that protecting photoreceptors and the ellipsoid zone is the more clinically relevant metric for patient independence. Annexon is on track to submit the Biologics License Application (BLA) for tanruprubart in GBS to the FDA in the fourth quarter of 2024, incorporating data from the FORWARD study. The month 15 primary endpoint for the ARCHER II GA trial remains the base case for success, with a readout expected from the Independent Data Monitoring Committee in Q4 2024. If the month 15 endpoint is met, the company will proceed to analyze two separate substudies with results expected in Q1 2027; otherwise, the trial will continue to the month 24 analysis in Q3 2027. The dual primary endpoint strategy requires a split of statistical alpha between the two time points, but management maintains that the study remains well-powered (over 90%) for both due to strong execution. Ongoing engagement with the EMA via PRIME designation and the product development coordinator pilot is expected to expedite the regulatory path for vonaprument in Europe. The $200 million credit facility with Oxford Finance provides non-dilutive capital to support global commercialization efforts and diversifies the capital structure. The ARCHER II trial will remain masked through the month 24 analysis to preserve the integrity of the data, even if the month 15 look is positive. Management explicitly noted that while RPE lesion growth is a historical focus in GA, they do not view it as the primary driver of vision protection, representing a strategic departure from current approved therapies. The appointment of Dr. Mark Blumenkranz to the Board of Directors is intended to bolster internal ophthalmic expertise ahead of pivotal readouts. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management described the move as 'playing offense' after crossing the 12-month hurdle and realizing they had excess statistical power from high compliance and over-enrollment. The 24-month data is intended to build a 'moat' around the franchise by including longer-term efficacy data directly in the product label. Executives clarified that the statistical threshold for month 15 has not meaningfully tightened because the 'found money' from trial execution offsets the alpha split. The study remains overpowered for the combined analysis and retains standard Phase III powering at the substudy level. Management pushed back on the importance of lesion growth, stating that approved drugs have shown lesion protection for years without impacting vision. They expect to eventually show statistical significance in lesion growth at later time points as a secondary benefit of protecting the overall neuronal unit. The company will disclose whether the study met the primary endpoint at month 15 or will continue to month 24, but no patient-level data will be released to maintain masking. If the study continues to month 24, it will remain fully masked to all parties until the final analysis.

Rapid, Positive Clinical Outcomes in GBS FORWARD Study Reinforce Consistency and Reproducibility of Tanruprubart Treatment Effect Demonstrated in Phase 3 and Real-World Evidence Studies; BLA Submission Expected in Q4 2026 Vonaprument Phase 3 GA Program Expanded with Month 15 / 24 Dual Primary Endpoint Strategy and Launch of Open-Label Extension Study; Month 15 Primary Endpoint on Track for Q4 2026 POC Data for ANX1502, a First-in-Kind Oral C1 Inhibitor for Autoimmune Disease, Expected in Fall 2026 $200 Million Credit Facility Strengthens Balance Sheet and Capabilities; Anticipated Runway Extended into 2028 Company to Host Business Update Call Today at 8:00 a.m. ET BRISBANE, Calif., Aug. 12, 2026 (GLOBE NEWSWIRE) --  Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing the next generation platform of targeted immunotherapies aimed at neuroinflammatory diseases that impact nearly 10 million people worldwide, today highlighted portfolio progress, announced key anticipated milestones, and reported second quarter 2026 financial results. The Company will host a business update call today at 8:00 a.m. ET to discuss corporate and clinical developments across its C1q-focused neuroinflammatory pipeline. Please register for the event here. “2026 is a defining year for our company, with meaningful progress across both our Guillain-Barré syndrome (GBS) and geographic atrophy (GA) programs that position us to potentially deliver two transformative therapies for millions of patients in need. The quality and consistency of the data generated to date reinforce our confidence in the differentiated potential of our C1q-targeted approaches to address neuroinflammatory diseases at their source, and we are encouraged by the growing enthusiasm from patients and physicians,” said Douglas Love, president and chief executive officer of Annexon. “With our leadership capabilities and financial position strengthened, we are entering an exciting period of execution, with multiple important clinical and regulatory milestones expected over the next 6 to 12 months and a significant opportunity to create value for patients and stakeholders.” 2026 Strategic Priorities and Key Milestones Tanruprubart: Potential to be the first targeted, fast-acting therapy for GBS, an indiscriminate life-threatening neuromuscular emergency affecting 150,000 people annually worldwide and driving an estimated $20+ billion annual healthcare burden in the U.S. Early improvement in strength and clinically meaningful reduction in disability shown with tanruprubart in the first ten U.S. and European patients with GBS from the ongoing, open-label FORWARD study. Early outcomes reinforce the consistency and reproducibility of tanruprubart treatment effect previously demonstrated in Phase 3 and real-world evidence studies. EU Marketing Authorisation Application under review with the European Medicines Agency supported by robust data package demonstrating rapid benefit on function and disability in placebo-controlled studies and Real-World Evidence study demonstrating favorable outcomes versus current treatments, intravenous immunoglobulin and plasma exchange. Next Milestone: Biologics License Application (BLA) submission with U.S./European data from FORWARD trial expected in fourth quarter of 2026. Vonaprument: Potential to be the first targeted vision-preserving therapy for GA, a leading cause of blindness affecting more than 8 million patients worldwide. The ongoing, global, double masked Phase 3 ARCHER II trial remains on track, and all eligible patients have received at least 12 months of treatment, with masked event accrual consistent with projected timelines. Vonaprument continues to be generally well-tolerated with a low discontinuation rate (95%), reinforcing significant enthusiasm by physicians/patients. To maximize the best-in-class potential of vonaprument, a Month 24 dual primary endpoint was added while maintaining the Month 15 primary endpoint. This strategic enhancement was enabled by the strong power and execution of the Phase 3 ARCHER II trial. With a dual primary endpoint strategy, ARCHER II can achieve success in protecting against vision loss at either Month 15 or 24, which are independent efficacy timepoints. Annexon also launched an open-label extension (OLE) study to evaluate the the long-term safety and benefit of vonaprument in patients with GA.  Following completion of the 2-year ARCHER II study, all patients have the option to receive monthly vonaprument treatment in the OLE study. Next Milestones: Month 15 primary endpoint on track for the fourth quarter of 2026, with final trial completion, including the Month 24 primary endpoint expected in the third quarter of 2027. ANX1502 for Autoimmune Conditions: First-in-kind oral small molecule inhibiting activated C1s, with convenient and flexible dosing. Dosing is complete. The ongoing proof-of-concept (POC) study is evaluating pharmacokinetics (PK) and pharmacodynamics (PD) in relation to food intake, and reduction in complement and bilirubin markers as a measure of hemolysis in patients with cold agglutinin disease (CAD). Next Milestone: Update on POC trial in CAD anticipated in the Fall of 2026. Corporate Updates Entered into a strategic credit facility of up to $200 million with Oxford Finance LLC, with an initial $50 million drawn at closing, bolstering Annexon’s financial position, and diversifying its capital structure. Appointed Mark S. Blumenkranz, M.D., M.M.S., a retinal surgeon and biotechnology entrepreneur with more than four decades of clinical, scientific and corporate leadership experience, to Annexon’s board of directors as the Company prepares for potential commercialization. Second Quarter 2026 Financial Results Cash and operating runway: Cash, cash equivalents and short-term investments were $209.2 million as of June 30, 2026. Annexon’s current cash, cash equivalents and short-term investments and funds from the credit facility are expected to fund operations and anticipated milestones into 2028. Research and development (R&D) expenses: R&D expenses were $46.6 million for the quarter ended June 30, 2026, compared to $44.2 million for the quarter ended June 30, 2025. The change in R&D expenses is primarily associated with the Phase 3 ARCHER II trial of vonaprument in GA and contract manufacturing expenses of our product candidates. General and administrative (G&A) expenses: G&A expenses were $10.6 million for the quarter ended June 30, 2026, compared to $7.6 million for the quarter ended June 30, 2025. The change in G&A expenses reflects ongoing corporate consulting and professional services costs for the advancement of our registrational programs. Net loss: Net loss attributable to common stockholders was $55.3 million or $0.28 per share for the quarter ended June 30, 2026, compared to $49.2 million or $0.34 per share for the quarter ended June 30, 2025. Corporate Webcast Details Annexon will host a webcast at 8:00 a.m. ET today, August 12, 2026. Please register for the webcast here. The live webcast and replay may be also accessed by visiting Annexon’s website at https://ir.annexonbio.com/events-and-presentations/events. About Annexon Annexon Biosciences (Nasdaq: ANNX) is advancing the next generation platform of targeted immunotherapies for nearly 10 million people worldwide living with serious neuroinflammatory diseases. Our founding scientific approach focuses on C1q, the initiating molecule of a potent inflammatory pathway that when misdirected can lead to tissue damage and loss of function in a host of diseases. Our targeted therapies are designed to stop classical complement-driven neuroinflammation at its source to provide meaningful functional benefit and alter the course of disease. Annexon’s mission is to deliver game-changing therapies to patients so that they can live their best lives. To learn more visit annexonbio.com. Forward Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: the potential for the company’s two late stage registrational programs to improve the lives of millions of patients; timing of and topline data from the Month 15 primary endpoint and Month 24 primary endpoint in the pivotal Phase 3 ARCHER II trial; the potential of vonaprument to be the first targeted vision-preserving therapy for GA; the potential of tanruprubart to be the first targeted and fast-acting therapy for GBS; expectation of multiple important clinical and regulatory milestones over the next 6 to 12 months; timing of a BLA submission with supportive initial U.S./European data from FORWARD trial; timing of POC trial data for ANX1502 in CAD; anticipated cash runway into 2028; and continuing advancement of the company’s portfolio. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the final results from the Phase 3 ARCHER II trial; the company’s history of net operating losses; the company’s ability to obtain necessary capital to fund its clinical programs; the potential for delays in the company’s clinical trials, including if the FDA and comparable foreign regulatory authorities do not accept data from clinical trials for product candidates outside the United States; the early stages of clinical development of the company’s product candidates; the effects of public health crises on the company’s clinical programs and business operations; the company’s ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company’s product candidates; the company’s reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company’s ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled “Risk Factors” contained in the company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company’s other filings with the Securities and Exchange Commission. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contact: Joyce AllaireLifeSci [email protected] Media Contact: Beth [email protected] _______________________

Annexon, Inc. (NASDAQ:ANNX) shares declined 6.37% in premarket trading on Wednesday after the biopharmaceutical company reported a wider-than-expected second-quarter loss as spending increased across its late-stage clinical programmes. For the quarter ended June 30, Annexon recorded a loss of $0.28 per share, compared with the Wall Street consensus estimate for a loss of $0.24 per share. Net loss attributable to common stockholders widened to $55.3 million from $51.0 million in the corresponding quarter last year, reflecting increased investment in the company’s advanced clinical development programmes. Research and development expenses rose to $46.6 million from $44.2 million a year earlier. The increase was primarily linked to spending on the Phase 3 ARCHER II study evaluating vonaprument for geographic atrophy, together with higher contract manufacturing costs. General and administrative expenses also increased, reaching $10.6 million compared with $7.6 million in the prior-year period, as Annexon incurred additional costs related to advancing its registrational programmes. “2026 is a defining year for our company, with meaningful progress across both our Guillain-Barré syndrome and geographic atrophy programs that position us to potentially deliver two transformative therapies for millions of patients in need,” said Douglas Love, president and chief executive officer of Annexon. Annexon highlighted continued clinical progress across its development pipeline, including positive early results from the ongoing FORWARD study of tanruprubart in Guillain-Barré syndrome. The company expects to submit a Biologics License Application for tanruprubart during the fourth quarter of 2026, representing an important potential regulatory milestone for the programme. The planned submission forms part of Annexon’s efforts to advance its complement-targeted therapies towards potential commercialisation. Annexon is also progressing the development of vonaprument for geographic atrophy through its Phase 3 ARCHER II trial. The company added a Month 24 dual primary endpoint to the study while retaining the Month 15 primary endpoint. The Month 15 endpoint remains on schedule for the fourth quarter of 2026, providing another significant upcoming clinical milestone for the company. Annexon reported $209.2 million in cash, cash equivalents and short-term investments as of June 30. The company also entered into a $200 million credit facility with Oxford Finance LLC and drew an initial $50 million when the agreement closed. The additional financing is expected to extend Annexon’s anticipated cash runway into 2028, providing funding as it advances tanruprubart and vonaprument through their respective late-stage development and regulatory programmes. Annexon stock price

Interested in Annexon, Inc.? Here are five stocks we like better. Annexon expanded the ARCHER II trial of vonaprument in geographic atrophy to include an independent 24-month endpoint, while maintaining its planned fourth-quarter assessment of the existing 15-month endpoint. The full study, including 24-month analyses, is expected to conclude in the third quarter of 2027. The company remains on track to submit a U.S. Biologics License Application for tanruprubart in Guillain-Barré syndrome in the fourth quarter. In an initial 10-patient FORWARD cohort, all patients experienced clinically meaningful muscle-strength improvement within four days, though the results are preliminary. Annexon secured access to up to $200 million in non-dilutive financing through an Oxford Finance credit facility, extending its cash runway into 2028 as both lead programs approach regulatory and clinical milestones. Annexon (NASDAQ:ANNX) said it expanded its pivotal ARCHER II trial of vonaprument in geographic atrophy, adding an independent 24-month dual primary endpoint alongside the study’s existing 15-month primary endpoint. The company said it remains confident in a planned fourth-quarter assessment of the 15-month endpoint while seeking to capture longer-term efficacy data for a potential product label. President and Chief Executive Officer Doug Love said the company’s two lead programs are approaching important regulatory and clinical milestones: tanruprubart in Guillain-Barré syndrome, or GBS, and vonaprument in geographic atrophy, or GA. Annexon also said it entered into a credit facility with Oxford Finance during the second quarter that provides access to up to $200 million in non-dilutive capital and extends its cash runway into 2028. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat Tanruprubart is under review through a marketing authorization application in Europe, and Annexon said it remains on track to submit a Biologics License Application to the U.S. Food and Drug Administration in the fourth quarter. The company plans to include data from its ongoing FORWARD study in that submission. Jamie Dannenberg, Annexon’s executive vice president and chief medical officer, presented initial results from the first 10 patients in the FORWARD study, who each received a single 30 milligram-per-kilogram infusion of tanruprubart. According to the company, all 10 patients showed clinically meaningful improvement in muscle strength within four days of treatment. Four patients who were bed-bound regained the ability to walk with or without assistance between days two and eight. One patient who required mechanical ventilation was weaned from the ventilator within four days. Five additional patients showed marked functional improvement within 48 hours of treatment. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be Dannenberg said the initial cohort included patients ranging from 12 to 78 years old and represented moderate-to-severe disease. Tanruprubart was generally well tolerated, with the most significant adverse events related to GBS and its expected complications, according to the company. The results were consistent with Annexon’s prior Phase III findings, in which the company said about 90% of treated patients demonstrated rapid, clinically meaningful improvement by day eight. The FORWARD study is intended to broaden the company’s experience in U.S. and European patients, including pediatric patients, while assessing pharmacokinetics, pharmacodynamics, function, biomarkers and safety. → First Solar’s Profit Engine Faces a New Policy Test in Washington Annexon said GBS remains a serious neuromuscular emergency with no approved targeted therapies that meaningfully alter its course. Dannenberg said intravenous immunoglobulin, or IVIG, is the current standard of care but is not FDA-approved for GBS and may provide incomplete benefit for some patients. In GA, Annexon enrolled 659 patients in ARCHER II, exceeding its original target by 30 patients. Lloyd Clark, senior vice president of ophthalmology strategy and innovation, said patient discontinuation has remained below 10% and dosing compliance has exceeded 95%, both better than the company’s targets. All eligible participants have received at least 12 months of treatment, and masked event accrual remains in line with Annexon’s projections, Clark said. The company said the trial is powered at more than 90% at both the 15-month and 24-month time points. The added 24-month endpoint will not change the ongoing masked conduct of the trial, which had already been designed to follow patients for 24 months. The company said the addition is intended to provide more time for vonaprument to demonstrate the growing treatment effect it observed in its proof-of-concept study. An independent data monitoring committee is expected to assess the 15-month primary endpoint in the fourth quarter. If the committee determines that the 15-month endpoint has been met, Annexon expects to begin separate analyses of the trial’s two sub-studies, with results anticipated in the first quarter of 2027. Alternatively, the committee could recommend continuing through the 24-month analysis. Annexon expects the full ARCHER II study, including the 24-month analyses, to be completed in the third quarter of 2027. Management told analysts that the company will remain blinded to patient-level data if the trial continues to the 24-month analysis. The company also said it has not disclosed the specific split of statistical alpha between the 15-month and 24-month endpoints, but maintained that the 15-month analysis remains well powered. GA affects about 8 million people globally, including roughly 1.5 million in the United States, according to Annexon. Clark said currently approved treatments have not demonstrated preservation of visual acuity. During the question-and-answer session, management said its central objective for vonaprument is preserving vision rather than solely slowing lesion growth. Love said Annexon expects to see protection of retinal pigment epithelium lesion growth over time, citing a 10% protection over a six-month period in the second half of the company’s earlier ARCHER study. However, management said it views photoreceptor and neuronal-cell protection, including measurement through the ellipsoid zone biomarker, as particularly important in the neurodegenerative disease. Vonaprument has FDA Fast Track designation, while the European Medicines Agency has granted the program PRIME designation and selected it for its Product Development Coordinator pilot, Annexon said. The company also announced the initiation of an ARCHER II open-label extension study that will allow patients to receive vonaprument after month 24 and enable longer-term safety and benefit assessments. Love said Annexon has also continued work on an oral small-molecule therapy designed to selectively inhibit the complement classical pathway, though no additional clinical or regulatory details were provided during the call. Annexon Inc is a clinical-stage biotechnology company focused on the discovery and development of complement-targeted therapies for patients with neurodegenerative and neuroimmune diseases. The company's research platform centers on the inhibition of the C1 complex, a key initiator of the classical complement pathway implicated in several rare and life-threatening disorders. By selectively targeting upstream complement activation, Annexon aims to prevent the aberrant immune-mediated damage that characterizes conditions such as Guillain-Barré syndrome (GBS) and autoimmune neuropathies. At the core of Annexon's pipeline is ANX005, a humanized monoclonal antibody directed against the C1q subcomponent, currently in Phase 2 clinical trials for acute GBS and chronic neurodegenerative indications. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Annexon Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Topline Pivotal Phase 3 Data for Vonaprument for the Treatment of Geographic Atrophy (GA) Expected Q4 2026, with Potential to Redefine Vision Preservation in GA Tanruprubart EU Marketing Authorization Application (MAA) Under Review as the Potentially First Targeted Therapy for Guillain-Barré Syndrome (GBS); Biologics License Application (BLA) Submission with U.S./European FORWARD Data Expected in 2026 Proof-of-Concept (POC) Data for ANX1502, a First-in-Kind Oral C1 Inhibitor for Autoimmune Disease, Expected in 2026 Strong Balance Sheet with Cash, Cash Equivalents and Short-Term Investments of Approximately $225 Million as of March 31, 2026, and Anticipated Runway into Second Half 2027 BRISBANE, Calif., May 07, 2026 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing the next generation platform of targeted immunotherapies aimed at neuroinflammatory diseases that impact nearly 10 million people worldwide, today highlighted portfolio progress, announced key anticipated milestones, and reported first quarter 2026 financial results. “As we execute toward major milestones in 2026, we are sharply focused on our strategic priorities across the organization,” said Douglas Love, president and chief executive officer of Annexon. “In GA, where no vision-preserving therapies are available for the approximately 8 million people impacted worldwide, we’re eagerly anticipating topline pivotal data from our ARCHER II Phase 3 trial in the fourth quarter of the year. ARCHER II is designed to reproduce the ARCHER Phase 2 data where vonaprument demonstrated the preservation of photoreceptor neurons and vision on multiple measures. In GBS, a debilitating rare disease and leading cause of acute neuromuscular paralysis that can strike anyone, any time and anywhere, our EU MAA for tanruprubart is under review for approval as the potentially first targeted therapy for the treatment of GBS. Enrollment continues in our U.S./EU FORWARD study, which is designed to broaden experience across western geographies to support our planned BLA submission in 2026. Finally, our POC study for ANX1502, a first-in-kind oral inhibitor designed to treat a host of neuromuscular diseases, is ongoing with data anticipated in 2026. With a bold mission to address neuroinflammatory diseases for millions worldwide, and a strong balance sheet powering us through several upcoming catalysts, we are more energized than ever by the potential and the building momentum of our highly differentiated complement platform.” 2026 Strategic Priorities and Key Milestones Vonaprument: Potential to be the first targeted vision-preserving therapy for GA, a leading cause of blindness affecting more than 8 million patients worldwide. ARCHER II is an ongoing global, pivotal, Phase 3 sham-controlled, double-masked trial of vonaprument in 659 patients with GA, a disease driven by early photoreceptor degeneration leading to vision loss. Enrollment was completed in July 2025. The primary endpoint is the proportion of patients with confirmed best corrected visual acuity 15-letter loss at two consecutive visits, measured at month 15. Global registration path has been established with U.S. and European regulators for ARCHER II; vonaprument is the only program to receive PRIME designation from the European Medicines Agency (EMA) and FastTrack Designation from the U.S. Food and Drug Administration for GA. Additional information on vonaprument pivotal GA program from the March 2026 Investor Day event can be accessed here: C1q blockade with vonaprument targets the key driver of vision loss in GA by protecting photoreceptor neurons to preserve visual acuity. In contrast, C3/C5 inhibition blocks clearance of dysfunctional cells at the lesion edge, slowing lesion growth without preserving vision. Phase 2 ARCHER findings demonstrated vonaprument consistently preserved visual function and ellipsoid zone retinal structure, reinforcing the therapeutic potential of protecting photoreceptor health early in disease progression. Phase 3 ARCHER II trial mirrors the Phase 2 patient selection profile, enriching for higher-risk patients by including patients with foveal involvement and excluding those with poor baseline vision, where 15-letter loss is less frequent. Next Milestone: Topline Phase 3 ARCHER II trial data expected in fourth quarter of 2026. Tanruprubart: Potential to be the first targeted and fast-acting therapy for GBS, a leading cause of neuromuscular paralysis impacting 150,000 people annually worldwide. MAA under review with EMA supported by robust data package demonstrating rapid benefit on function and disability in placebo-controlled studies and Real-World Evidence study demonstrating favorable outcomes versus current treatments, intravenous immunoglobulin and plasma exchange. Ongoing FORWARD study in the U.S. and Europe designed to expand Western experience with tanruprubart, including in pediatric patients. The study will evaluate initial pharmacokinetics (PK), pharmacodynamics (PD), early impact on function and biomarkers, and safety data to support generalizability of tanruprubart’s rapid benefit across geographies and broad intended label for the treatment of GBS. Next Milestone: BLA submission with initial U.S./European data from FORWARD trial anticipated in 2026. ANX1502 for Autoimmune Conditions: First-in-kind oral small molecule inhibiting activated C1s, with convenient and flexible dosing. Ongoing POC study evaluating PK/PD in relation to food intake, and reduction in complement and bilirubin markers as a measure of hemolysis in patients with cold agglutinin disease (CAD). Next Milestone: Update on POC trial in CAD anticipated in 2026. First Quarter 2026 Financial Results Cash and operating runway: Cash, cash equivalents and short-term investments were $225.0 million as of March 31, 2026. Based on focused investments in its lead late-stage programs, Annexon expects to fund operations and anticipated milestones into the second half of 2027. Research and development (R&D) expenses: R&D expenses were $35.8 million for the quarter ended March 31, 2026, compared to $48.2 million for the quarter ended March 31, 2025. The change in R&D expenses is primarily associated with the Phase 3 ARCHER II trial of vonaprument in GA, global regulatory filings of tanruprubart for GBS and contract manufacturing expenses of our product candidates. General and administrative (G&A) expenses: G&A expenses were $10.3 million for the quarter ended March 31, 2026, compared to $9.2 million for the quarter ended March 31, 2025. The change in G&A expenses reflects ongoing corporate consulting and professional services costs. Net loss: Net loss attributable to common stockholders was $44.1 million or $0.23 per share for the quarter ended March 31, 2026, compared to $54.4 million or $0.37 per share for the quarter ended March 31, 2025. About Annexon Annexon Biosciences (Nasdaq: ANNX) is advancing the next generation platform of targeted immunotherapies for nearly 10 million people worldwide living with serious neuroinflammatory diseases. Our founding scientific approach focuses on C1q, the initiating molecule of a potent inflammatory pathway that when misdirected can lead to tissue damage and loss of function in a host of diseases. Our targeted therapies are designed to stop classical complement-driven neuroinflammation at its source to provide meaningful functional benefit and alter the course of disease. Annexon’s mission is to deliver game-changing therapies to patients so that they can live their best lives. To learn more visit annexonbio.com. Forward Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: the potential for the company’s two late stage registrational programs to improve the lives of millions of patients; timing of and topline data from the pivotal Phase 3 ARCHER II trial; the potential of vonaprument to be the first targeted vision-preserving therapy for GA; the potential of tanruprubart to be the first targeted and fast-acting therapy for GBS; timing of a BLA submission with supportive initial U.S./European data from FORWARD trial; timing of POC trial data for ANX1502 in CAD; anticipated cash runway into the second half of 2027; and continuing advancement of the company’s portfolio. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the final results from the Phase 3 ARCHER II trial; the company’s history of net operating losses; the company’s ability to obtain necessary capital to fund its clinical programs; the potential for delays in the company’s clinical trials, including if the FDA and comparable foreign regulatory authorities do not accept data from clinical trials for product candidates outside the United States; the early stages of clinical development of the company’s product candidates; the effects of public health crises on the company’s clinical programs and business operations; the company’s ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company’s product candidates; the company’s reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company’s ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled “Risk Factors” contained in the company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company’s other filings with the Securities and Exchange Commission. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contact: Joyce Allaire LifeSci Advisors [email protected] Media Contact: Beth Keshishian 917-912-7195 [email protected] _______________________

ARCHER II Topline Pivotal Phase 3 Data in Geographic Atrophy (GA) Expected Q4 2026; Vonaprument has Potential to Be the First Vision-Preserving Therapy for GA Tanruprubart MAA Filed in Europe with Potential to Be the First Targeted Fast-Acting Therapy for Guillain-Barré Syndrome (GBS); U.S./European FORWARD Study Data Expected to Support Planned BLA Submission in 2026 ANX1502 Advancing as First Oral C1 Inhibitor for Autoimmune Disease; Proof-of-Concept (POC) Data Anticipated in 2026 Strong Balance Sheet with Cash, Cash Equivalents and Short-Term Investments of Approximately $238.3 Million as of December 31, 2025, and Anticipated Runway into Second Half 2027 BRISBANE, Calif., March 30, 2026 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing the next generation platform of targeted immunotherapies aimed at neuroinflammatory diseases that impact nearly 10 million people worldwide, today highlighted portfolio progress, announced key anticipated milestones, and reported fourth quarter and full year 2025 financial results. “We’re energized by this defining period for Annexon. Two decades of C1q and classical complement pathway research have enabled our bold mission of pioneering a new class of targeted immunotherapies that reshape how neuroinflammation is treated. Today, our scientific platform has translated into two late stage registrational programs with the potential to improve the lives of millions in large, underserved markets worldwide,” said Douglas Love, president and chief executive officer of Annexon. “Leveraging one mechanism to stop neuroinflammation at its source, vonaprument is designed to protect photoreceptor neurons to preserve vision in GA, while tanruprubart is designed to protect peripheral nerves to support faster, more complete and durable recovery in GBS.” Mr. Love continued, “Grounded in robust vonaprument Phase 2 ARCHER data and strong execution of the ongoing Phase 3 ARCHER II trial, we are on track to report topline pivotal data in the fourth quarter of this year. ARCHER II is the first study to evaluate visual preservation as the primary endpoint in patients with GA and the first pivotal study with an aligned global regulatory path. Additionally, we have filed for Marketing Authorization Application (MAA) in the EU for tanruprubart and are preparing for potential approval of the first targeted therapy for GBS. We’re also focused on the ongoing US/EU FORWARD study which is designed to broaden experience across western geographies to support a planned U.S. Biologics License Application (BLA) submission in 2026. Lastly, we anticipate POC data for our first-in-kind classical complement oral inhibitor, ANX1502, in autoimmune disease this year. Overall, with a strengthened balance sheet and continued focus on our core priorities, we are well-positioned to deliver multiple near-term value driving catalysts in the year ahead.” 2026 Strategic Priorities and Key Milestones Vonaprument– Potential to be the first targeted vision-preserving therapy for dry age-related macular degeneration (AMD) with GA, a leading cause of blindness affecting more than 8 million patients worldwide. ARCHER II is an ongoing global, pivotal, Phase 3 sham-controlled, double-masked trial of vonaprument in 659 patients with GA. Enrollment was completed in July 2025. The primary endpoint is the gold standard for visual acuity, measuring proportion of patients with confirmed best corrected visual acuity (BCVA) 15-letter loss at any two consecutive visits through month 15. Global registration path established with U.S. and European regulators for ARCHER II. Vonaprument is the only GA program to receive PRIME designation from the European Medicines Agency (EMA). Vonaprument selected by EMA for the exclusive Product Development Coordinator (PDC) pilot launched in July 2025 to assist PRIME designation holders in navigating regulatory interactions, including expedited scientific advice, MAA submission readiness activities, and ad-hoc queries throughout the development program. Annexon hosted a March 2026 Investor Day event featuring retina specialist key opinion leaders highlighting the differentiated vonaprument anti-C1q mechanism of action, product profile, Phase 2 ARCHER vision-preservation and related structure data, and Phase 3 ARCHER II clinical development strategy in GA. Key takeaways included: Upstream C1q blockade with vonaprument first protects functional photoreceptors to preserve vision. In contrast, downstream C3/C5 inhibition blocks clearance of already dysfunctional retinal pigment epithelium (RPE) cells and photoreceptors, slowing lesion growth without preserving vision. Phase 2 ARCHER study demonstrated vonaprument consistently protected vision on multiple clinical measures and protected ellipsoid zone (EZ) structure, a key anatomic measure of photoreceptor health and function, with greatest effect in the central retina critical to visual acuity. Phase 3 ARCHER II trial maintains a similar patient selection profile as the Phase 2 trial, with strategies designed to enrich for patients at higher risk of vision loss by ensuring appropriate enrollment of foveal patients and excluding patients with poor vision at baseline in whom 15-letter loss occurs far less frequently. Next Milestone: Topline Phase 3 ARCHER II trial data expected in fourth quarter of 2026. Tanruprubart – Potential to be the first targeted fast-acting therapy for GBS, a leading cause of neuromuscular paralysis impacting approximately 150,000 people annually worldwide. MAA filed with EMA supported by robust data package demonstrating rapid and durable benefit on function and disability and supportive neuroinflammatory markers in placebo-controlled studies, and favorable outcomes versus intravenous immunoglobulin (IVIg) and plasma exchange (PE) in a Real-World Evidence study. Ongoing FORWARD study in the U.S. and Europe designed to expand Western experience with tanruprubart, including in pediatric patients. The study will evaluate initial pharmacokinetics (PK), pharmacodynamics (PD), early impact on function and neuroinflammatory biomarkers, and safety to support the generalizability of tanruprubart’s rapid benefit across geographies as well as a broad intended label for the treatment of GBS. Next Milestone: BLA submission with initial U.S./European data from FORWARD trial anticipated in 2026. ANX1502 for Autoimmune Conditions: First-in-kind oral small molecule inhibiting activated C1s, with convenient and flexible dosing. Ongoing enrollment of open-label, single arm, POC study evaluating twice-daily dosing of ANX1502 over four weeks in patients with cold agglutinin disease (CAD). Updated dose timing regimen relative to food intake based on key learnings in initial CAD patients, and continuing to assess PK/PD and reduction in complement and bilirubin markers as a measure of hemolysis. Next Milestone: Update on POC trial in CAD anticipated in 2026. Fourth Quarter and Full Year 2025 Financial Results Cash and operating runway: Cash, cash equivalents and short-term investments were $238.3 million as of December 31, 2025, including $86.3 million in gross proceeds from a November 2025 public offering. Based on focused investments in its lead late-stage programs, Annexon expects to fund operations and anticipated milestones into the second half of 2027. Research and development (R&D) expenses: R&D expenses were $42.7 million for the quarter ended December 31, 2025, and $184.7 million for year ended December 31, 2025, compared to $43.4 million for the quarter ended December 31, 2024 and $119.4 million for the year ended December 31, 2024. The change in R&D expenses is primarily associated with the advancement of the Phase 3 ARCHER II trial of vonaprument in GA and global regulatory filings of tanruprubart for GBS. General and administrative (G&A) expenses: G&A expenses were $7.6 million for the quarter ended December 31, 2025 and $31.7 million for the year ended December 31, 2025, compared to $9.1 million for the quarter ended December 31, 2024 and $34.6 million for the year ended December 31, 2024. The change in G&A expenses reflects ongoing corporate efficiencies and disciplined prioritization of resources. Net loss: Net loss attributable to common stockholders was $48.3 million or $0.28 per share for the quarter ended December 31, 2025, and $208.5 million or $1.34 per share for the year ended December 31, 2025, compared to $48.6 million or $0.33 per share for the quarter ended December 31, 2024 and $138.2 million or $1.01 per share for the year ended December 31, 2024. About Annexon Annexon Biosciences (Nasdaq: ANNX) is advancing the next generation platform of targeted immunotherapies for nearly 10 million people worldwide living with serious neuroinflammatory diseases. Our founding scientific approach focuses on C1q, the initiating molecule of a potent inflammatory pathway that when misdirected can lead to tissue damage and loss of function in a host of diseases. Our targeted therapies are designed to stop classical complement-driven neuroinflammation at its source to provide meaningful functional benefit and alter the course of disease. Annexon’s mission is to deliver game-changing therapies to millions of patients to help them live their best lives. To learn more visit annexonbio.com. Forward Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: the potential for the company’s two late stage registrational programs to improve the lives of millions in large, underserved markets; the potential for tanruprubart to be the first targeted therapy for GBS approved in the EU; the potential therapeutic benefit of tanruprubart, if approved, compared to existing therapies; anticipated timing and results of regulatory interactions related to tanruprubart; the design, objectives and timing of the open-label tanruprubart FORWARD study; the company’s ability to gain clarity from the FDA on the generalizability package to support a BLA submission; the company’s ability to achieve regulatory approval for tanruprubart; the potential therapeutic benefit of vonaprument; timing of and results from the Phase 3 ARCHER II trial; vonaprument’s distinct potential neuroprotective mechanism of action and potential to provide protection from vision loss; the potential for vonaprument to be the first targeted vision-preserving therapy to be approved in Europe and the U.S. for dry AMD with GA; timing of proof-of-concept trial for ANX1502 in cold agglutinin disease and the company’s ability to provide an update upon study completion in 2026; the potential for ANX1502 to disrupt the current treatment antibody-mediated autoimmune diseases; the company’s ability to potentially reformulate enteric-coated tablets to potentially improve drug release profile that is more resistant to food effect for use in late-stage clinical development in autoimmune diseases; the company’s ability to commercialize its product candidates, if approved; continued development of vonaprument and ANX1502; anticipated cash runway into the second half of 2027; the potential benefits from treatment with anti-C1q therapy; and continuing advancement of the company’s portfolio. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the final results from the Phase 3 ARCHER II trial; the company’s history of net operating losses; the company’s ability to obtain necessary capital to fund its clinical programs; the potential for delays in the company’s clinical trials, including if the FDA and comparable foreign regulatory authorities do not accept data from clinical trials for product candidates outside the United States; the early stages of clinical development of the company’s product candidates; the effects of public health crises on the company’s clinical programs and business operations; the company’s ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company’s product candidates; the company’s reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company’s ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled “Risk Factors” contained in the company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company’s other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contact: Joyce Allaire LifeSci Advisors [email protected] Media Contact: Beth Keshishian 917-912-7195 [email protected]

Late-Stage Neuroinflammation Platform Advancing Global Registrational Programs in Guillain-Barré Syndrome (GBS) and Geographic Atrophy (GA) Current Tanruprubart GBS Dossier On Track for MAA Filing in January 2026; Potential to Be the First Approved Targeted and Fast-Acting Therapy for the Treatment of GBS; Continued FDA Discussions Regarding Generalizability Package in Support of BLA Filing Topline ARCHER II Pivotal Data for Vonaprument in Dry AMD with GA on Track for Second Half of 2026; Potential to Be the First Approved Vision Sparing Therapy for the Treatment of Eight Million GA Patients Worldwide ANX1502 Cold Agglutinin Disease (CAD) Proof of Concept Study Ongoing with Expected 2026 Completion; Potential to Be the Only Oral C1s Inhibitor for the Treatment of Multiple Neuroinflammatory Autoimmune Diseases Strong Financial Position and Execution Extends Operations into 2027, Through Several Important Milestones, Including Tanruprubart Global GBS Filings, Vonaprument Topline GA Phase 3 Data, and ANX1502 Autoimmune Proof of Concept Data BRISBANE, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform targeting neuroinflammation across life-changing complement-mediated neuroinflammatory diseases of the body, brain, and eye, today highlighted portfolio progress, announced key anticipated milestones and reported third quarter 2025 financial results. “We’re pleased with the focused execution of our business strategy across our late-stage neuroinflammation platform, and the strong momentum we’ve built over 2025 heading into a meaningful 2026. Our next-generation complement inhibitor candidates continue to demonstrate the power of stopping neuroinflammation at its source, enabling multiple programs advancing toward key near-term milestones,” said Douglas Love, president and chief executive officer of Annexon. “Our registrational Guillain-Barré Syndrome program is on track for EU Marketing Authorisation Application (MAA) submission in January 2026, positioning it to become the first targeted therapy for GBS, a disease that annually affects 150,000 people worldwide. Dialogue with the FDA is also ongoing regarding the generalizability package supporting the U.S. Biologics License Application (BLA) submission. Furthermore, our registrational Phase 3 trial for vonaprument in GA is on track to deliver topline data in the second half of 2026. The study is designed to confirm the significant vision preservation observed in our Phase 2 trial and benefit the eight million people affected by GA worldwide.” Mr. Love continued, “Finally, we are building on the early learnings from our ANX1502 program, the first and only clinical stage oral inhibitor of C1s. We’ve observed targeted drug levels in fasted CAD patients, and we continue to dose to deepen our understanding of ANX1502’s profile, anticipating study completion in 2026. With a prioritized capital plan, our runway is extended into 2027 through each of the above anticipated milestones. Overall, Annexon is uniquely positioned to drive near-term value while pursuing additional opportunities to achieve our mission of helping millions of patients suffering from devastating neuroinflammatory diseases.” Recent Corporate and Clinical Program Updates Tanruprubart (ANX005) in GBS: Targeted neuroinflammatory inhibitor of C1q and the classical pathway delivered in a single infusion to rapidly halt aggressive neuroinflammation and damage in GBS, an acute, rare, neuromuscular emergency that affects ~150,000 people worldwide each year. There are no FDA-approved therapies for GBS and limited evidence of effectiveness from the current standards of care (SOC) therapy used in GBS. Productive regulatory interactions with European Rapporteurs and Pediatric Committee of the European Medicines Agency reaffirm the current tanruprubart GBS data package is on track for MAA filing in January 2026. Collaborative discussions with the FDA on the generalizability package to support the BLA submission are ongoing. Large biomarker dataset from the Phase 3 trial reinforces that, distinct from current standard of care therapies, tanruprubart has a rapid impact on the acute inflammatory process across all GBS subtypes, supporting the consistency of its rapid benefit on function and disability across geographies. U.S. and European FORWARD open-label study designed to broaden Western experience with tanruprubart, including in pediatric patients, is ongoing with initial pharmacokinetic (PK), pharmacodynamic (PD), biomarker and functional data anticipated in 2026. Continued ongoing discussions with pharmaceutical companies on collaboration opportunities to commercialize tanruprubart for GBS in various geographies. Next Milestones: Tanruprubart MAA submission expected in January 2026. Update on FDA BLA submission upon further regulatory dialogue. Initial FORWARD data anticipated in 2026. Vonaprument (ANX007) in Dry AMD Patients with GA: Neuroprotective inhibitor of C1q and the classical complement cascade delivered intravitreally for dry AMD with GA, a leading cause of blindness affecting more than eight million people worldwide. There are no approved therapies for GA targeting the preservation of vision. Registrational Phase 3 ARCHER II trial, a global, sham-controlled, double-masked trial, completed enrollment early in July 2025 while also exceeding enrollment targets for a total of 659 GA patients. ARCHER II is the first study to evaluate a therapy for dry AMD with GA targeting visual function as the primary endpoint measured by the gold-standard best corrected visual acuity 15-letter loss (BCVA ≥15LL). Vonaprument selected by European Medicines Agency (EMA) for the exclusive Product Development Coordinator (PDC) pilot launched in July 2025 to assist Priority Medicine (PRIME) designation holders in navigating regulatory interactions, including expedited scientific advice, MAA submission readiness activities, and ad-hoc queries throughout the development program. Recent positive engagements with FDA and EMA support the established vonaprument ARCHER II global regulatory approval path for protection of vision in patients with GA. Further analyses of the Phase 2 ARCHER trial reinforce that structural protection of photoreceptors within the center of the retina is critical to visual acuity, consistent with neuroprotective mechanism of vonaprument. In the Phase 2 trial, vonaprument treatment showed 73% reduction in risk of vision loss measured by the gold-standard BCVA ≥15-letter loss endpoint, protection of photoreceptors with greatest impact near the center of the retina, and trends towards greater RPE protection over time and also near the center of the retina. Next Milestone: Topline Phase 3 ARCHER II trial data expected in second half of 2026. ANX1502 for Autoimmune Conditions: First-in-kind oral C1s inhibitor, has the potential to offer disruptive advantages of clinically validated upstream classical complement inhibition with the convenience and flexibility of oral administration. Currently evaluating an enteric-coated tablet formulation of ANX1502 in an open-label, single arm, POC study in patients with CAD. Drug levels at and exceeding pre-defined target in fasted CAD patients observed in the POC trial, and dosing is ongoing to further enhance the understanding of ANX1502’s PK/PD profile, including effect on complement and clinical markers of hemolysis. POC study completion anticipated in 2026. Next Milestone: ANX1502 program update upon CAD study completion in 2026. Third Quarter 2025 Financial Results Cash and operating runway: Cash and cash equivalents and short-term investments were $188.7 million as of September 30, 2025. Based on focused investments in its lead late-stage programs, Annexon has extended its runway and expects to fund operations and anticipated milestones into late first quarter 2027. Research and development (R&D) expenses: R&D expenses were $49.7 million for the quarter ended September 30, 2025, compared to $30.1 million for the quarter ended September 30, 2024. The increased R&D expenses are primarily associated with the advancement of the Phase 3 ARCHER II trial of vonaprument in GA and investments toward completion of tanruprubart global filings for GBS. General and administrative (G&A) expenses: G&A expenses were $7.3 million for the quarter ended September 30, 2025, compared to $9.3 million for the quarter ended September 30, 2024. The decline in G&A expenses reflects ongoing corporate efficiencies and disciplined prioritization of resources. Net loss: Net loss was $54.9 million or $0.37 per share for the quarter ended September 30, 2025, compared to $34.8 million or $0.25 per share for the quarter ended September 30, 2024. About Annexon Annexon Biosciences (Nasdaq: ANNX) is developing the next generation of complement inhibitors to stop neuroinflammation as first-in-kind treatments for millions of people living with serious neuroinflammatory diseases of the body, brain and eye. Our novel scientific approach focuses on C1q, the initiating molecule of classical complement’s potent inflammatory pathway that when misdirected can lead to tissue damage and loss in a host of diseases. By targeting C1q, our immunotherapies are designed to stop this neuroinflammatory cascade before it starts. Our pipeline spans three diverse therapeutic areas – autoimmunity, neurodegeneration and ophthalmology – and includes targeted investigational drug candidates designed to address the unmet needs of nearly 10 million people worldwide. Annexon’s mission is to deliver game-changing therapies to patients so that they can live their best lives. To learn more visit annexonbio.com. Forward Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: the potential therapeutic benefit of ANX005, if approved, compared to existing therapies; anticipated timing and results of regulatory interactions related to ANX005; the design, objectives and timing of the open-label tanruprubart FORWARD study; the company’s ability to gain clarity from the FDA on the generalizability package to support a BLA submission; the company’s ability to make an MAA submission for European registration in January 2026 and to achieve regulatory approval for ANX005; the potential therapeutic benefit of ANX007; timing of and results from the Phase 3 ARCHER II trial; ANX007’s distinct potential neuroprotective mechanism of action and potential to provide protection from vision loss; the potential for ANX007 to be the first drug approved in Europe and the U.S. for dry AMD with GA; timing of proof-of-concept trial for ANX1502 in cold agglutinin disease and the company’s ability to provide an update upon study completion in 2026; the potential for ANX1502 to disrupt the current treatment antibody-mediated autoimmune diseases; the company’s ability to commercialize its product candidates, if approved; continued development of ANX007 and ANX1502; anticipated cash runway into late first quarter 2027; the potential benefits from treatment with anti-C1q therapy; and continuing advancement of the company’s portfolio. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the final results from the Phase 3 ARCHER II trial; the company’s history of net operating losses; the company’s ability to obtain necessary capital to fund its clinical programs; the potential for delays in the company’s clinical trials, including if the FDA and comparable foreign regulatory authorities do not accept data from clinical trials for product candidates outside the United States; the early stages of clinical development of the company’s product candidates; the effects of public health crises on the company’s clinical programs and business operations; the company’s ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company’s product candidates; the company’s reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company’s ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled “Risk Factors” contained in the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company’s other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contact: Joyce Allaire LifeSci Advisors [email protected] Media Contact: Beth Keshishian 917-912-7195 [email protected]

Tanruprubart (formerly ANX005) for GBS Advancing Through Regulatory Interactions; MAA Submission in Europe Anticipated in First Quarter of 2026; Ongoing Discussions with FDA Regarding Generalizability Package to Support a BLA Accelerated Completion of Enrollment for Global Phase 3 ARCHER II Trial of Vonaprument (formerly ANX007) for Dry AMD with GA; Selected for EMA PRIME Product Development Candidate Pilot; Topline ARCHER II Data Expected in Second Half of 2026 ANX1502 First-in-Kind Oral C1s Inhibitor Exposure Exceeded Target Concentration in Fasted Patients; Evaluation in Relation to Food Intake Ongoing in Proof-of-Concept CAD Study, Update Expected by Year-end 2025 $227 Million in Cash Supports Operations into the Fourth Quarter of 2026 Through Vonaprument Topline Phase 3 Data in GA BRISBANE, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today highlighted portfolio progress, announced key anticipated milestones and reported second quarter 2025 financial results. “We are well positioned to achieve our mission of helping millions of people with devastating complement-mediated diseases live their best lives by the consistent validation generated by our innovative C1 platform across multiple potential best-in-class therapeutics,” said Douglas Love, president and chief executive officer of Annexon. “In Guillain-Barré Syndrome (GBS), approximately 90% of tanruprubart-treated patients improved by week 1 and more than twice as many patients achieved a normal state of health at week 26 vs. placebo in our Phase 3 study. As a result, we are actively engaged in global regulatory interactions to bring tanruprubart to patients worldwide, which includes preparing to submit our Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the first quarter of 2026. In parallel, we are also working with the Food and Drug Administration (FDA) to gain clarity on the generalizability package to support a Biologics License Application (BLA) submission.” Mr. Love continued, “We are also increasingly excited by the positive momentum of vonaprument for dry age-related macular degeneration (AMD) with geographic atrophy (GA), exemplified by the accelerated enrollment of our Phase 3 ARCHER II trial coupled with the established global registration path to provide a potentially new vision preserving treatment for the eight million people with GA worldwide. We are on pace to deliver topline pivotal data in the second half of 2026. For our oral C1s inhibitor ANX1502, we are optimistic as the exposure demonstrated thus far has exceeded our target threshold in patients without concomitant food intake. We are confirming these findings in fasted patients to achieve proof-of-concept (POC) for this first-in-kind oral program, and we anticipate providing an update later this year. Finally, we remain disciplined with our financial and operational execution, and are capitalized into the fourth quarter of 2026 through our pivotal Phase 3 data in GA.” Recent Corporate and Clinical Program Updates Tanruprubart (ANX005) in GBS: Targeted immunotherapy delivered in a single infusion to rapidly halt aggressive neuroinflammation and damage in GBS, an acute, rare, neuromuscular emergency that affects ~150,000 people worldwide each year. There are no FDA-approved therapies for GBS and limited evidence of effectiveness from the current standards of care (SOC) therapy used in GBS. Ongoing regulatory interactions to support advancement of tanruprubart towards potential worldwide registration. MAA submission for registration in Europe expected in the first quarter of 2026. Ongoing discussion with the FDA on the generalizability package to support a BLA submission, with update expected upon further regulatory clarity. In parallel, continuing ongoing discussions with pharmaceutical companies regarding collaborating on the commercialization of tanruprubart for GBS in various geographies. Tanruprubart helped patients get better sooner and more completely versus SOC with a comprehensive and unprecedented data set that continues to build across five GBS studies: Completed placebo-controlled POC and pivotal Phase 3 studies conducted in Southeast Asia with high disease prevalence and ability to run gold standard placebo-controlled studies. Completed generalizability package including a Real-World Evidence study matching the Phase 3 patients to immunoglobulin (IVIg) or plasma exchange-treated Western patients from a 2,000 patient GBS prospective, observational study, and comparing outcomes versus SOC where tanruprubart demonstrated favorable outcomes versus SOC on all assessed clinical measures. Completed drug-drug interaction safety study with tanruprubart on top of IVIg that included E.U. and Southeast Asian patients. Ongoing FORWARD study in U.S. and Europe designed to broaden Western experience with tanruprubart by measuring pharmacokinetics (PK), pharmacodynamics (PD), early efficacy in week 1, and safety in up to 30 subjects including pediatric patients. Positive outcomes with tanruprubart treatment in the Phase 3 trial were highlighted as part of oral and poster presentations at the 2025 Peripheral Nerve Society (PNS) Annual Meeting. Next Milestone: Tanruprubart MAA submission expected in first quarter of 2026, and update on FDA BLA submission timing upon further regulatory clarity on the generalizability package. Vonaprument (ANX007) in Dry AMD Patients with GA: Neuroprotective inhibitor of C1q and the classical complement cascade delivered intravitreally for dry AMD with GA, a leading cause of blindness affecting more than eight million worldwide. There are no approved therapies for GA targeting the preservation of vision. Accelerated enrollment of 659 patients completed for ARCHER II, a global, pivotal, sham-controlled, double-masked Phase 3 trial. Global registration path established with U.S. and European regulators supports potential of vonaprument to be the first treatment approved in both Europe and the U.S. for protection of vision in patients who have dry AMD with GA, assuming positive Phase 3 results. Vonaprument selected by EMA for the exclusive Product Development Coordinator (PDC) pilot launched in July 2025 to help Priority Medicine (PRIME) designation holders efficiently navigate regulatory interactions, including expedited scientific advice, MAA submission readiness activities, and ad-hoc queries throughout the development program. Bolstered ophthalmology expertise with appointment of Lloyd Clark, M.D., as senior vice president, ophthalmology strategy and innovation. Dr. Clark brings more than 25 years of experience as a practicing retina specialist with deep expertise in drug development, portfolio strategy and bringing novel therapies to market. Phase 2 ARCHER data showing significant preservation of vision and central retinal photoreceptors necessary for visual acuity presented at the 2025 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting and at the 2025 Retina World Congress. Next Milestone: Topline Phase 3 ARCHER II trial data expected in second half of 2026. ANX1502 for Autoimmune Conditions: First-in-kind oral small molecule inhibiting the activated form of C1s, an enzyme carried by C1q to initiate the classical cascade, has the potential to offer the advantages of selective upstream classical complement inhibition with the convenience and flexibility of oral administration. Exposure exceeded target concentrations in fasted patients treated to date in ongoing, open-label, single arm, POC study evaluating enteric-coated tablets of ANX1502 in patients with cold agglutinin disease (CAD). Evaluation of PK/PD in relation to food intake, and reduction in complement and bilirubin markers as a measure of hemolysis, are ongoing. PK/PD learnings from CAD patients anticipated to inform application of ANX1502 in broad array of other autoimmune diseases, leveraging oral delivery to potentially disrupt biologics-treated indications. Next Milestone: Update on POC trial in CAD anticipated by year-end 2025. Second Quarter 2025 Financial Results Cash and operating runway: Cash and cash equivalents and short-term investments were $227.0 million as of June 30, 2025. Annexon continues to expect its cash, cash equivalents and short-term investments as of June 30, 2025, to be sufficient to fund the company’s planned operating expenses and late-stage milestones for its lead programs into the fourth quarter of 2026. Research and development (R&D) expenses: R&D expenses were $44.2 million for the quarter ended June 30, 2025, reflecting the advancement of the Company’s priority programs, including GBS, GA and ANX1502, compared to $25.0 million for the quarter ended June 30, 2024. General and administrative (G&A) expenses: G&A expenses were $7.6 million for the quarter ended June 30, 2025, compared to $8.6 million for the quarter ended June 30, 2024. Net loss: Net loss was $49.2 million or $0.34 per share for the quarter ended June 30, 2025, compared to $29.6 million or $0.23 per share for the quarter ended June 30, 2024. About Annexon Annexon Biosciences (Nasdaq: ANNX) is developing therapeutics that stop classical complement-driven neuroinflammation as first-in-kind treatments for millions of people living with serious neuroinflammatory diseases of the body, brain and eye. Our novel scientific approach focuses on C1q, the initiating molecule of classical complement’s potent inflammatory pathway that when misdirected can lead to tissue damage and loss in a host of diseases. By targeting C1q, our immunotherapies are designed to stop this neuroinflammatory cascade before it starts. Our pipeline spans three diverse therapeutic areas – autoimmunity, neurodegeneration and ophthalmology – and includes targeted investigational drug candidates designed to address the unmet needs of nearly 10 million people worldwide. Annexon’s mission is to deliver game-changing therapies to patients so that they can live their best lives. To learn more visit annexonbio.com. Forward Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: the potential therapeutic benefit of ANX005, if approved, compared to existing therapies; anticipated timing and results of regulatory interactions related to ANX005; the design, objectives and timing of the open-label tanruprubart FORWARD study; the company’s ability to gain clarity from the FDA on the generalizability package to support a BLA submission; the company’s ability to make an MAA submission for European registration in the first quarter of 2026 and to achieve regulatory approval for ANX005; the company’s discussions with pharmaceutical companies regarding collaborating on the commercialization of tanruprubart for GBS in various geographies; the potential therapeutic benefit of ANX007; timing of and results from the Phase 3 ARCHER II trial; ANX007’s distinct potential neuroprotective mechanism of action and potential to provide protection from vision loss; the potential for ANX007 to be the first drug approved in Europe and the U.S. for dry AMD with GA; the potential benefits of participating in the EMA’s PDC Pilot for PRIME designation holders; timing of proof-of-concept trial for ANX1502 in cold agglutin disease and the company’s ability to provide an update by year-end of 2025; the potential for ANX1502 to disrupt the current treatment antibody-mediated autoimmune diseases; the company’s ability to commercialize its product candidates, if approved; continued development of ANX007 and ANX1502; anticipated cash runway into the fourth quarter of 2026; the potential benefits from treatment with anti-C1q therapy; and continuing advancement of the company’s portfolio. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the final results from the Phase 3 ARCHER II trial; the company’s history of net operating losses; the company’s ability to obtain necessary capital to fund its clinical programs; the potential for delays in the company’s clinical trials, including if the FDA and comparable foreign regulatory authorities do not accept data from clinical trials for product candidates outside the United States; the early stages of clinical development of the company’s product candidates; the effects of public health crises on the company’s clinical programs and business operations; the company’s ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company’s product candidates; the company’s reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company’s ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled “Risk Factors” contained in the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company’s other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contact: Joyce Allaire LifeSci Advisors [email protected] Media Contact: Beth Keshishian 917-912-7195 [email protected] _______________________

FDA Meeting for Tanruprubart (formerly ANX005), the First Potential Targeted Therapy for GBS, Scheduled for Second Quarter 2025 Ahead of Planned BLA Submission Open-Label Tanruprubart FORWARD Study Designed to Broaden Patient and Healthcare Community Experience in North America and Europe, Initiating in Second Quarter 2025 Accelerated Enrollment in Phase 3 ARCHER II Trial on Pace for Completion in Third Quarter 2025 for ANX007, the First Potential Treatment for Dry AMD with GA; Pivotal Topline Data Expected in the Second Half of 2026 Completion of Proof-of-Concept Trial for First-in-Kind Oral C1s Inhibitor ANX1502 in Cold Agglutin Disease Anticipated Mid-2025; Potential to Disrupt the Current Treatment of Antibody-Mediated Autoimmune Diseases $263.7 million in Cash, Cash Equivalents, and Short-term Investments as of March 31, 2025 Funds Late-Stage Milestones for Lead Programs and Anticipated Runway into Second Half 2026 BRISBANE, Calif., May 12, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today highlighted portfolio progress and reported first quarter 2025 financial results. “Our innovative C1 platform has yielded multiple wholly owned late-stage programs that have been shown to stop harmful neuroinflammation and lead to positive outcomes for patients across an array of diseases,” said Douglas Love, president and chief executive officer of Annexon. “Our most advanced program, tanruprubart, is approaching filing for the treatment of Guillain-Barré Syndrome (GBS) having consistently demonstrated rapid and sustained functional improvements in multiple placebo-controlled trials. Given the decades-long void of innovation, GBS remains a high unmet need without FDA-approved therapies or substantial evidence of effectiveness from the current standard of care, and we are eager to continue our dialogue with the FDA during our upcoming meeting this quarter in advance of our planned BLA submission. Furthermore, we are excited for the launch this quarter of the open-label FORWARD study designed to provide North American and European physicians and patients investigational access and experience with tanruprubart’s single infusion approach to tackling GBS.” Mr. Love continued, “Our second late-stage asset, ANX007, is poised to be the first vision-preserving treatment for dry age-related macular degeneration (AMD) with geographic atrophy (GA) globally, offering the potential to benefit more than eight million patients worldwide. With positive engagement by the retina community, we are on an accelerated pace to complete enrollment of the ongoing Phase 3 ARCHER II trial in the third quarter and deliver pivotal topline data in the second half of 2026. Finally, we anticipate completing the proof-of-concept (POC) trial for our oral small molecule ANX1502 in mid-2025, further characterizing its initial drug profile in patients with autoimmune disease.” Mr. Love concluded, “With continued strong strategic execution and runway into the second half of 2026, we are well-positioned to drive immense near to mid-term value and fulfill our mission of helping millions of patients live their best lives.” Recent Corporate and Clinical Program Updates Flagship Programs Tanruprubart (ANX005) in Guillain-Barré Syndrome (GBS): First-in-kind monoclonal antibody designed to block C1q with a single infusion to halt ongoing neuroinflammation and nerve damage in the acute phase of disease. GBS is a rare, neuromuscular emergency that affects approximately 150,000 people worldwide each year. Strong therapeutic potential underscored by consistent demonstration of rapid and durable functional improvements and a differentiated safety profile across multiple placebo-controlled clinical studies. There are no FDA-approved therapies for GBS and no substantial evidence of effectiveness from the current standards of care therapy used in GBS. The rare and acute nature of GBS has shaped our clinical development program conducted primarily in Southeast Asia to generate a comprehensive data package. This package includes successful placebo-controlled POC and Phase 3 data, Real-World Evidence indirect comparison data of tanruprubart’s treatment effect versus current standards of care, and drug-drug interaction safety data with tanruprubart with current standard of care. To further our strategic development plan, preparing to initiate the open-label tanruprubart FORWARD study, measuring pharmacokinetics, pharmacodynamics, early efficacy in week 1, and safety in up to 30 subjects in the United States, Canada, and Europe, which is designed to broaden Western patient, physician and healthcare community experience. Real-World Evidence study to be featured in an oral presentation on Monday May 19, 2025 at the upcoming 2025 Peripheral Nerve Society (PNS) Annual Meeting taking place May 17-20, 2025 in Edinburgh, UK. Additional poster presentations will also reinforce early and durable benefits of tanruprubart including improvement in quality of life for patients with GBS. Next Milestone: Initiation of the tanruprubart FORWARD study expected in the second quarter of 2025. FDA meeting with the Center for Drug Evaluation and Research (CDER) scheduled for the second quarter of 2025 ahead of planned BLA submission. ANX007 in Dry Age-Related Macular Degeneration (AMD) Patients with Geographic Atrophy (GA): First-in-kind, non-pegylated antigen-binding fragment (Fab) designed to block C1q and the classical complement cascade locally in the eye. Dry AMD with GA is a leading cause of blindness that affects more than eight million patients worldwide with no approved therapies targeting the preservation of vision. Global registration path established with U.S. and European regulators supports potential of ANX007 to be the first treatment approved in both Europe and the U.S. for protection of vision in patients who have dry AMD with GA. ARCHER II is a global, pivotal, sham-controlled, double-masked Phase 3 trial expected to enroll approximately 630 patients who have dry AMD with GA. Phase 2 ARCHER data showing significant preservation of vision and central retinal photoreceptors necessary for visual acuity presented at the 2025 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting and at the 2025 Retina World Congress. Next Milestone: Phase 3 ARCHER II trial enrollment expected to be completed in third quarter of 2025; top line data expected in second half of 2026. ANX1502 for Autoimmune Conditions: First-in-kind oral small molecule inhibiting the activated form of C1s, an enzyme carried by C1q to initiate the classical cascade, has the potential to offer the advantages of selective upstream classical complement inhibition with the convenience and flexibility of oral administration. Ongoing enrollment in open-label, single arm, proof-of-concept study characterizing the pharmacokinetics, pharmacodynamics, dosing regimen, safety and initial efficacy of enteric-coated tablets of ANX1502 in up to seven patients with cold agglutinin disease (CAD). Next Milestone: POC trial completion in up to seven CAD patients anticipated in mid-2025. First Quarter 2025 Financial Results Cash and operating runway: Cash and cash equivalents and short-term investments were $263.7 million as of March 31, 2025. Annexon continues to expect its cash, cash equivalents and short-term investments as of March 31, 2025, to be sufficient to fund the company’s planned operating expenses and late-stage milestones for its lead programs into the second half of 2026. Research and development (R&D) expenses: R&D expenses were $48.2 million for the quarter ended March 31, 2025, reflecting the advancement of the Company’s priority programs, including GBS, GA and ANX1502, compared to $21.0 million for the quarter ended March 31, 2024. General and administrative (G&A) expenses: G&A expenses were $9.2 million for the quarter ended March 31, 2025, compared to $7.6 million for the quarter ended March 31, 2024. Net loss: Net loss was $54.4 million or $0.37 per share for the quarter ended March 31, 2025, compared to $25.2 million or $0.21 per share for the quarter ended March 31, 2024. About Annexon Annexon Biosciences (Nasdaq: ANNX) is developing therapeutics that stop classical complement-driven neuroinflammation as first-in-kind treatments for millions of people living with serious neuroinflammatory diseases of the body, brain and eye. Our novel scientific approach focuses on C1q, the initiating molecule of classical complement’s potent inflammatory pathway that when misdirected can lead to tissue damage and loss in a host of diseases. By targeting C1q, our immunotherapies are designed to stop this neuroinflammatory cascade before it starts. Our pipeline spans three diverse therapeutic areas – autoimmunity, neurodegeneration and ophthalmology – and includes targeted investigational drug candidates designed to address the unmet needs of nearly 10 million people worldwide. Annexon’s mission is to deliver game-changing therapies to patients so that they can live their best lives. To learn more visit annexonbio.com. Forward Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: the potential therapeutic benefit of ANX005, if approved, compared to existing therapies; anticipated timing of the pre-BLA meeting and BLA submission for ANX005; potential benefit of ANX005, if approved, compared to existing therapies; the design, objectives and timing of the open-label tanruprubart FORWARD study; the company’s ability to achieve regulatory approval for ANX005; the potential therapeutic benefit of ANX007; timing and pace of completion of enrollment and results from the Phase 3 ARCHER II trial; ANX007’s distinct potential neuroprotective mechanism of action and potential to provide protection from vision loss; the potential for ANX007 to be the first drug approved in Europe and the U.S. for dry AMD with GA; timing of proof-of-concept trial for ANX1502 in cold agglutin disease; the potential for ANX1502 to disrupt the current treatment antibody-mediated autoimmune diseases; the company’s ability to commercialize its product candidates, if approved; continued development of ANX007 and ANX1502; anticipated cash runway into the second half of 2026; the potential benefits from treatment with anti-C1q therapy; and continuing advancement of the company’s portfolio. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the final results from the Phase 3 ARCHER II trial; the company’s history of net operating losses; the company’s ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company’s product candidates; the effects of public health crises on the company’s clinical programs and business operations; the company’s ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company’s product candidates; the company’s reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company’s ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled “Risk Factors” contained in the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company’s other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contact: Joyce AllaireLifeSci [email protected] Media Contact: Sheryl SeapyReal [email protected]