Vera Therapeutics, Inc. Class A Common Stock Morgan Stanley 24th Annual Global Healthcare Conference

Great. Good afternoon, everybody. Thanks for sticking around for our last fireside today. We are really pleased to have Vera with us. I am going to let Marshall make some introductory comments, and then we will jump into Q&A. Over to you, Marshall. Thanks.

Matthew, thanks for having us and me at your conference. Great to have an interview with you today. I am Marshall Fordyce. I am the Founder and CEO of Vera Therapeutics. Great day for us today and for patients. Today, we shared the final efficacy analysis from our pivotal Phase III trial, showing outstanding efficacy by GFR and by kidney composite endpoint. It was an important update for the field and for Vera, as well as an indication of how launch is going. We shared that so far, about 10 weeks into our first commercial launch, we have over 350 patient start forms or roughly prescriptions as an early indication of demand. Two important updates for the company. Great activity happening now and in the coming time. Here we are in September. The data that we top-lined today are being submitted or have been submitted both for presentation and publication.

It would be great if we could get that done at the next month's major kidney conference, which is called ASN, where we would hope to have an opportunity to present these data in a more fulsome way to the academic world. In conjunction with that, we of course, are pursuing an sBLA in Q4 to target full approval with these top-line data and more for mid-2027. A fantastic moment for us as a company. Happy to dive into detail about both the clinical results that we have shared today, as well as the commercial progress early on in our first launch in the disease IgA nephropathy with TRUTAKNA.

Wonderful. Yeah, no, I mean, really exciting updates for today. Maybe first, can we put the clinical data into context? What does what you share mean to patients? How should people think about progression of the kinds of patients that you have put into the study and how you have changed that progression?

Sure. I mean, we ran a global randomized double-blind placebo-controlled trial in the typical patient who is at high risk of disease progression. To put it into context, think about who are these patients and what do they experience on current standard of care. They are 40 years old. Their GFR is on average 60, which means that they have already lost roughly 40% of their kidney function by 40 years old. If you follow the placebo arm, they are losing up to 5 to 10 mLs per year in our trial. These are patients who are 40 on their way to dialysis by the age of 50. That puts you into the context of what disease situation are we trying to alter. What we have shared is data from the final efficacy analysis. We have ended the randomized phase.

What we have shared is that the GFR difference, meaning the kidney function difference between TRUTAKNA and placebo, is 5 mLs per minute per year. That is significant. That means that over a 2-year period, 104 weeks, which is the extent of the data we looked at, if you are on placebo, you are losing 10% of your kidney function. That is a bad situation. We essentially have normalized the GFR for patients on TRUTAKNA. The GFR slope for those patients over that 104-week period was -0.6, so just under 1. People without disease lose about 1 ml per minute per year. This is on average what a person without disease experiences. It is also what international guidelines are trying to target for patients to reverse these bad outcomes for patients.

We shared the primary endpoint, the confirmatory endpoint that we agreed with FDA, which is at 1 year at 52 weeks, and we also looked at the totality of the data where lots of patients went out to up to 2 years, and that is the 2-year GFR slope comparison. So at 5.0 as a treatment delta is the largest number we have seen in the field. Moreover, we shared clinical outcome data. What happens to those patients on placebo? Well, in our trial, 8 of those patients met hard, tragic clinical outcomes. They required dialysis, transplant, or they died. 8 of them on placebo. On TRUTAKNA, none met that outcome. If you add another criteria, which is a significant reduction in GFR of greater than 30%, so that plus the hard clinical outcomes, we call that the composite kidney endpoint, we showed a hazard ratio of 0.24.

The inverse of that, we also call the risk reduction, was 76%. That is a massive risk reduction. That really is the best we have seen in any IgAN trial, and you can look even broader at other kidney trials. That is a very big effect size for a new medicine. On these data, we plan to continue to lead the field and set a new standard of care for patients. Today, TRUTAKNA is now available to patients in the U.S. through accelerated approval. I think these data will be incredibly important for patients, for providers, and for payers as we advance our effort to change standard of care.

And obviously, you showed some stuff on the commercial side, and I want to get to that, but maybe just a couple of other questions on the profile. Obviously, there is another therapy with a similar mechanism filed. Otsuka has their drug on the market. Can you talk a little bit about the breadth of the data of the competitors and how you think you compare?

Sure. First, I think it is really important when you look at a disease area that has a standard of care with a lot of hope that we can raise the bar. It is great that there are multiple players in that space. That increases the share of voice for changing standard of care. We actually think that is very helpful for patients and for Vera's potential to really penetrate that market. That mechanism is an APRIL-only mechanism as opposed to dual BAFF/APRIL. From an efficacy perspective, we see our delta between active and placebo at slope for 2 years is 5.0. Theirs is 4.5. We have also seen no data yet on the composite kidney endpoint that I am describing. We look forward to seeing that. We are really the first among the B-cell modulators to share that.

Safety looks strong for TRUTAKNA, and we also have the first autoinjector on the market. This is a very simple device that is simple to use on a weekly basis. I have it here in my hand. No button push needed. It simply is an injection once per week, and it takes just a few seconds. That is what is being asked of patients today as we are out in the field, and this is something that I think we really see a lot of acceptance from both patients and physicians.

Then I think the last thing, maybe just comment, you have a dual mechanism, APRIL and BAFF. There are other B-cell modulators in this class that have chosen one of the mechanisms. Any differences you think you are seeing from that in the clinical data so far?

Well, I think the clinical data need to mature further, and we just happen to be the first BAFF/APRIL on the market today. I think I would be looking at long-term kidney outcomes that we've shown today and also GFR delta as being the most important to patients, providers, and payers. I think it remains to be seen how that plays out across the field. But look, this is a really important new step for patients, for the field in setting a new standard of care.

Great. So why don't we talk about commercial? You obviously gave some updates, but maybe before we get there, can we just talk a little bit about market size, how you think about the market size, and what sort of standard of care for patients is now and what that tells you about patients that are being treated versus how you might expand that market?