Surrozen, Inc. CommonSRZN
Recorded

Surrozen, Inc. Common 12th Annual Cantor Fitzgerald Global Healthcare Conference

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PeriodFY 0Duration27 minParticipants3

Transcript

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Steve SeedhouseAnalyst

Welcome everyone to the next session. Thanks so much for joining us at the Cantor Global Healthcare Conference. It's my privilege to welcome Surrozen as our next participating company at the conference. I'm joined up here at the front by CFO Andrew Maleki, and COO Charles Williams. I'm Steve Seedhouse on the biotech team here at Cantor. Really exciting time for the company, and really for the overall space that Surrozen is operating in, which of course, we'll discuss. The company itself has made some exciting recent announcements with respect to advancement into the clinic. I think we should just start right off the top with the initial clinical program that you've designed, and that you announced, the intent of that program, some of the decisions you made into that. Maybe you can just review what you announced.

Steve SeedhouseAnalyst

What you're planning to do here in the clinic with your lead molecule, which you can also introduce as well, Chuck.

Chuck WilliamsCOO

Great. Thanks, Steve, and thanks for having us. What we recently announced is that we'll be entering the clinic later this year. The DUET study is a two-part study. Part one is a single ascending dose, and we'll be enrolling both treatment-naive and treatment-experienced patients. Ultimately, the objective there is to study safety and tolerability and select two doses, which will enter part two of the dose expansion phase, where we'll have an active comparator VABYSMO. The primary endpoint will be at three weeks. We'll give three monthly doses of SZN-8141, and then we'll have four-month follow-up. Really the objective here is to tease out potential differentiation on a couple different fronts. One is on potential anatomical outcomes, so drying. Two is we do have some endpoints geared towards potential reperfusion, which is uniquely suited for the WNT mechanism.

Chuck WilliamsCOO

Then three is really around potential durability given the four-month follow-up we have after the three loading doses that we're giving every month of A141. In terms of timing, as I mentioned, we'll initiate the study later this year, and we will look to have some initial clinical data in the second half of 2027.

Steve SeedhouseAnalyst

Very good. There are a couple decisions with respect to dosing with the control arm, with respect to the endpoints you are measuring, that I think you would have had various options on how to do this study, some more aggressive than others. Can you just talk about what you considered and ultimately contemplating the overall objectives of what you are trying to accomplish here early on, why you settled on what you did?

Chuck WilliamsCOO

Right. I think based on what we have demonstrated preclinically and the promise of combining both VEGF and WNT, we think we have the potential to be best in disease. In terms of what we considered for the design, typically phase I-B/II-A studies have been open label, but the stands have shifted a bit. It has become more competitive. Ultimately we shifted to potentially considering an active control, and then the next question was: What compound do we compare SZN-8141 to? Ultimately we landed on VABYSMO because we think that is the most commercially relevant product. It has demonstrated incremental improvements over anatomical outcomes relative to EYLEA. It is a multifunctional antibody. Ultimately we came to that conclusion that we would answer more questions than less by having an active comparator and by including VABYSMO.

Steve SeedhouseAnalyst

What about the prioritization of DME altogether? This molecule, given the VEGF WNT dual activity should be active in exudative disease, I guess, more broadly, but just maybe you can articulate mechanistically why certain paths are maybe lower-hanging fruit than others and I guess, also taking the long-term view, where do you think development makes sense here?

Chuck WilliamsCOO

Right. DME, I think DME was prioritized, although we did allude in our public disclosure that we will be looking at other We do not need to wait for the DME data in particular, but looking at other indications like wet AMD. I would say principally, there has been more published literature around the role of Frizzled-4 and LRP5, and its role in DME. There is also literature to suggest that their Frizzled-4 is expressed on the choroid, so there is potential for it to be effective in wet AMD as well, and certainly Merck has a wet AMD ongoing trial, and we are looking at, which we will lay out at some later point around what our wet AMD trial would look like.

Steve SeedhouseAnalyst

Okay. Is it contingent in any way on what you see from the field, as it were, the WNT field on wet AMD, or you're pretty confident obviously that at some point that program makes sense one way or another?

Chuck WilliamsCOO

Based on our preclinical data, we've demonstrated in the CNV model, which is the- Yeah wet AMD workhorse model that we're effective there.

Chuck WilliamsCOO

Certainly, we'll take data in from external competitors like Merck.

Chuck WilliamsCOO

Okay. But there are key differences between our molecule relative to theirs that I think are important to consider when thinking about wet AMD.

Steve SeedhouseAnalyst

Okay. Presumably this is I think it's 20 patients per arm in your initial study. Okay. Presumably this isn't formally powered statistically across all of these endpoints, let alone any of the endpoints, and there's some novel ones in here that you mentioned that I would love for you to expand on, particularly the assessments of reperfusion, which would be a novelty, I think, in DME, and something obviously that fits the mechanism, right? That's why you're exploring it in the first place. But maybe you can talk about, I guess, in lieu of a clear statistical result on some of these endpoints, what's a win- across the board here on some of the efficacy assessments that you're looking at?

Chuck WilliamsCOO

Right. I think we wanted a comprehensive data set, and also that's why we included an active comparator to get a sense for a potential signal around differentiation to the market leader, and I think that can manifest itself in a couple ways. It could be improvements in anatomical outcomes or drying. It could be on durability, and it also could be on these reperfusion metrics that we've included as well, given, as you mentioned, Wnt is uniquely suited to potentially address that, which no other therapies currently on the market do.

Steve SeedhouseAnalyst

Do we have a clear bar precedent? Is there natural history data, particularly on reperfusion? Do we know what to expect from those images and from that endpoint for an interventional drug?

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