Operator: And our next question coming from the line of Jay Olson with Oppenheimer.
Jay Olson: Just a follow-up on BIIB080 data at CTAD. Can you just talk about how your anti-tau antibody will be clinically differentiated from other antibodies and also other modalities like anti-tau ASOs.
Dr. Al Sandrock: Yes. So, our vectorized siRNA will knock down the expression of all forms of tau. And so, in some ways, it mirrors what BIIB080, the antisense against tau does. The mechanism is different, but the end result, we think, will be pretty similar. Of course, will be differentiated from BIIB080 in that and it’s a onetime treatment using our — one of our proprietary TRACER derived capsids. So, we’ll deliver an IV and we’ll be able to get transduction across multiple brain regions pretty much across the CNS, which I think is a big advantage. That’s a very different approach from the anti-tau antibody, which will not address intracellular tau, for example. We don’t believe the — we think the antibody will bind to extracellular forms of tau. And what we hope to do with that antibody is to block the spread of tau. So, two very different approaches and we’ll see which one works the best. Could be that both works, which would be great.
Jay Olson: And I had a follow-up question, if I could. Assuming your first IND will be for your anti-tau antibody, what’s the cadence of subsequent INDs and which are the next most likely candidates for filing INDs? And then, maybe a financial question since you’ll be in the clinic next year. Can you just talk about how you plan to finance those clinical trials?
Dr. Al Sandrock: So, let me start with your first question. So, after the IND that we anticipate for the VY-TAU01 antibody in 2024, the next IND wholly-owned program will be the SOD1 gene therapy program for ALS, which we anticipate we will file an IND in 2025. In addition, our partners at Neurocrine have indicated that they plan to select and move two gene therapy programs into IND by 2025. I assume that means the Parkinson’s and Friedreich’s ataxia program since they are the most advanced. But you’ll have to ask them, which two programs they mean. And then, Sangamo has indicated that they’re planning to move the Prion program into an IND in 2025 as well. And then those are the ones we know of. I mean some of our other partners that are pure capsid licenses, for all I know, they’re planning to file INDs in 2025 as well.
But we don’t know that for certain because we don’t know their time lines. But yes, so I hope to see a steady stream of INDs for the foreseeable future at Voyager with or without our partners.
Jack Allen: Great. Super helpful. And then maybe, Peter, if you could please comment on the financial plans for funding the clinical trials next year.
Pete Pfreundschuh: Yes. So, Jack, the — with regards to the wholly-owned programs that Al just mentioned, so those are our tau antibody program and then also the ALS program. We’re building those programs on a wholly-owned basis where we’re funding and financing those as we’re advancing those both to IND as well as towards the clinic. So, it is our assumption and we’ve modeled that as part of our cash runway guidance that we provided to you and updated today. So, that is — that’s clearly our ideas to fund and finance those and advance those along. Of course, as we get to various milestones as we move forward in the future, we’ll always be thoughtful about the next step and maybe partnerships around those programs, if we decide to do that.
But as of right now, those are modeled into our cash guidance and runway. With regards to the partner programs that Al alluded to where we have milestones that could come up over the next couple of years, specifically in 2025 with regards to Neurocrine and Sangamo, the beauty of those programs is those are financed off our balance sheet. And so, that’s not part of our overall financing and funding runway. I think the one thing I would add to that is, specifically on Neurocrine, Neurocrine is becoming from a pass-through R&D expense perspective, a bigger piece of our overall research and development expense on a quarterly as well as year-to-date basis. And so, to that note, we’ve actually added some non-GAAP guidance information at the back of the earnings release that hopefully helps you guys understand kind of how much really doesn’t sit on our balance sheet, when you look at our research and development expense growing on a quarterly basis or on a full year basis.
So I think that provides a lot of kind of look-through with regards to the pass-through that’s associated with that partnership. And again, that does not sit on our balance sheet. So hopefully, that helps, Jack.
Operator: And our next question coming from the line of Laura Chico with Wedbush.
Laura Chico: I guess, I just wanted to circle back with respect to CTAD. And there was also some data showing some novel tau biomarkers at the meeting. Just out of curiosity, as you’re thinking about preliminary clinical studies, just curious if something along those lines would be used, or how are you thinking about kind of categorizing patients in terms of their tau load at entry?
Dr. Al Sandrock: Thanks, Laura. I mean, yes, there’s a lot going on in the field of tau. And in terms of the selection of patients, at the present time, we’re thinking that we will likely mirror what BIIB080 has done in terms of starting with early-stage Alzheimer’s disease, people with mild cognitive empowerment plus early stages of dementia. And we will likely also insist on a certain tau burden, because what we want to do certainly with the antibody program is to block the spread of tau, so it would be sort of like a region of interest, if you will, primary endpoint on the spread of tau. So, we’d have to pick people who are at one of the early block stages, probably stage 2, which can be visualized by tau PET imaging to see if we can block the spread of tau.
That’s how we’re thinking. And in terms of new tau biomarkers, there’s a lot of fluid-based biomarkers that are coming out a lot of ptau — various types of ptau biomarkers, which I think are also exciting. And I think we will probably also evaluate those in our tau programs as well. But I think for — there’s nothing like PET imaging to evaluate the spread of tau, which is what we want to see if we can block with the anti-tau antibody.
