Voyager Therapeutics, Inc. (NASDAQ:VYGR) Q3 2023 Earnings Call Transcript

Voyager Therapeutics, Inc. (NASDAQ:VYGR) Q3 2023 Earnings Call Transcript November 6, 2023

Voyager Therapeutics, Inc. misses on earnings expectations. Reported EPS is $-0.59 EPS, expectations were $-0.58.

Operator: Good afternoon, and welcome to the Voyager Therapeutics Third Quarter 2023 Conference Call. All participants are now in a listen-only mode. There will be a question-and-answer session at the end of this call. Please be advised that this call is being recorded at the Company’s request. A replay of today’s call will be available on the Investors section of the company’s website approximately two hours after completion of this call. I would now like to turn the call over to Pete Pfreundschuh, Chief Financial Officer. You may begin.

Pete Pfreundschuh: Thank you, and good afternoon. Joining me on the call today is Dr. Al Sandrock, our CEO, and joining us for Q&A is Dr. Todd Carter, our Chief Scientific Officer. We issued our Q3 2023 financial results press release this afternoon. The press release and 10-Q are available on our website. In a moment, I will turn the call over to Al. Before I do this, I want to remind everyone that during call, Voyager representatives may make forward-looking statements as noted in slide 2 of today’s deck. These forward-looking statements include future expectations, prospects and plans. All forward-looking statements are inherently uncertain and are subject to risks and uncertainties that may cause actual results to differ materially from those indicated by these forward-looking statements.

You are encouraged to review and understand the various material risks and uncertainties facing the Company as described in the Company’s most recent annual report on Form 10-K filed with the SEC. As of the filing of today’s quarterly report on Form 10-Q, there have been no material changes to the risk factors described in our annual report. All SEC filings are available on our company’s website. Now, it is my pleasure to turn the call over to Al.

Dr. Al Sandrock: Thank you, Pete, and good afternoon, everyone. Please turn to slide 3. I’d like to start by briefly reviewing Voyager’s investment rationale, platform, pipeline, partnerships and potential. First, the platform: The delivery of gene therapies into the central nervous system, or CNS, has historically proven challenging. Voyager is working to solve this delivery challenge with our TRACER capsid discovery platform. We have generated multiple families of novel capsids with robust CNS tropism following IV delivery. We believe our capsids are best-in-class because we have demonstrated high transduction in multiple brain areas at relatively low doses with the targeting of the liver and dorsal root ganglia neurons. We have also shown the ability to target neurons and glial cells, blood brain barrier or BBB penetrants across multiple species and an identified receptor that is also expressed in humans.

Second, our pipeline: We are advancing two wholly owned and two partnered CNS programs through late-stage research and towards IND filings. The most advanced is our anti-tau antibody program for Alzheimer’s disease, for which we anticipate an IND filing in the first half of 2024. We were encouraged by the data presented by some of our peers at the recent clinical trials on Alzheimer’s disease meeting, which provided for the first time an early clinical evidence showing that tau targeting therapies slowed cognitive decline. These data strengthen our conviction in the value of tau as an important therapeutic target for Alzheimer’s disease. Behind our anti-tau antibody, we have multiple opportunities to advance gene therapies enabled by our novel TRACER capsids into the clinic in 2025, including potentially our wholly owned SOD1 program for amyotrophic lateral sclerosis, or ALS.

Third, partnerships: Voyager has generated more than $200 million this year alone in non-dilutive partnering revenue. We currently have 11 partnered programs, which provide opportunities to achieve milestone and/or royalty revenue to generate data with our capsids and most importantly, to help patients. Finally, potential: Specifically the potential to expand from gene therapy into other approaches of neurogenetic medicine. We have identified multiple receptors associated with our capsid families. We are exploring the potential to leverage one of these, which we call Receptor X to shuttle non-viral genetic medicines across the blood brain barrier. I am increasingly excited about the potential here to expand the reach of our technology into other approaches of neurogenetic medicine.

Moving to slide 4. As you can see, Voyager is advancing quite a robust pipeline. However, we are doing so efficiently. The wholly-owned programs at the top of this slide that noted in orange are the only programs we fund. The rest of our pipeline is funded by our partners. During Q3, Voyager focused on advancing our prioritized pipeline programs toward the clinic. We initiated GLP toxicology studies with VY-TAU01, our humanized anti-tau antibody for Alzheimer’s disease. This program is on track for an IND filing in the first half of 2024. We also continue to advance our SOD1 gene therapy program for ALS. This program is on track for a development candidate selection before the end of this year to support an IND in mid-2025. As we move forward towards the clinic, we are thoughtfully building clinical expertise within the Voyager team, including in regulatory affairs, toxicology and development operations.

I will make one more note before we leave this slide. In September, Alexion, AstraZeneca Rare Disease, announced it had completed a definitive purchase and license agreement for a portfolio of preclinical rare disease gene therapies and enabling technologies from Pfizer. The portfolio includes the license for a novel capsid generated from our TRACER platform to enable a potential gene therapy program exclusively for an undisclosed rare neurologic disease target. The assignment does not impact the terms of the licensing agreement. We are thrilled to have them as a partner on this program, particularly given their public commitment to advancing next-generation genomic medicines. Turning to slide 5. As you can see, Voyager continues to execute on our milestones.

So far this year, we secured partnerships with Neurocrine, Novartis and Sangamo. The Company is well capitalized with approximately $253 million in cash on our balance sheet as of the close of Q3 2023. We expect our cash, cash equivalents and marketable securities, along with expected reimbursements under the Neurocrine collaborations and interest income to provide runway into mid-2025. We selected a development candidate and an initiated GLP toxicology studies for our anti-tau antibody program for Alzheimer’s disease, and we launched three early-stage gene therapy programs, one for Huntington’s disease and two for Alzheimer’s disease. Looking forward, we continued our work to advance neurogenetic medicines. We expect to identify a lead candidate for our wholly owned SOD1 ALS gene therapy program by the end of this year.

As we look towards 2024 and 2025, we anticipate the potential for multiple IND filings across our wholly-owned and collaborative and/or licensed programs. This translates into multiple opportunities to earn milestone payments and even more importantly, once clinical trials begin, several opportunities to establish human proof of concept for our TRACER capsids. Furthermore, there is potential to see early biomarker-based evidence of disease impact in some of these very difficult CNS indications. We continue to engage in active discussions with potential partners regarding collaboration and licensing arrangements around our platform and pipeline. In summary, Voyager continues to advance our lead programs towards the clinic while maintaining our robust platform and early pipeline programs.

We look forward to continued execution this year and next. I’d like to thank the wonderful employees at Voyager for their hard work to keep everything moving forward. With that, we’re happy to take any questions you may have. Operator?

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Q&A Session

Operator: [Operator Instructions] Now, first question coming from the line of Joon Lee with Truist Securities.

Joon Lee: Congrats on the progress. As you consider nominating your genetic medicine beads, you can either do so with the capsids that you have or choose to use the so-called Receptor X that you discovered. What are some considerations as you decide which route to go and which strategies to use? Is it disease-specific or something else? And I have a follow-up.

Dr. Al Sandrock: Thanks, Joon. I’ll start, and I’m sure Todd would want to add some comments. So look, gene therapy remains our core technology. And we’re so excited by our capsids that — that’s going to be the first thing we think about, right? And — but look, genetic medicines I think is best done with multiple modalities. And we are, as we speak, doing this experiment, where we’re going to test whether we could shuttle other modalities into the brain using a ligand against Receptor X. And if those experiments are successful, then we’re going to have more options available to us. I view it very much as a toolbox where we can choose the right modality for the right disease for the right mode of action that we’re seeking. And I think we’re headed to the point where you will have multiple options. Todd?

Dr. Todd Carter: I think that what you’re keying in on is the need for delivery and whatever the modality is, need for delivery at a safe and tolerable dose to achieve efficacy. One of the things that we’re showing with our next-gen — current gen capsids is that we can deliver broadly throughout the CNS at relatively low doses. I think there could be advantages to different modalities, gene therapy as an advantage of a single dose and with those of novel capsids that [indiscernible] delivery and targeting for all targets, but the other modalities that we’re starting to explore for the different advantages as well.

Joon Lee: Great. And in your cash runway guidance into mid-2025, what’s included in that assumption? And are you able to provide any guidance on what milestones we can expect over the next 12 months from any 1 of your 11 partnered programs?

Pete Pfreundschuh: So, Joon, thanks for the question. I think, first and foremost, I would say that, we continue to be very diligent in our cash resources that are on our balance sheet. And I think what we did for you guys today is we just kind of updated the guidance to be a bit more precise as to runway guidance for the business. As you know, our guidance is based upon only the cash that we have physically sitting on the balance sheet. It does not include any additional potential milestones that we would receive from the 11 partnered programs that Al alluded to earlier, so that potentially could extend that guidance and runway as well as some further BD as Al alluded to earlier as well. We continue to be very thoughtful and are looking potentially to do some further collaborations and deals from a licensing perspective.

So, that’s kind of the guidance with regards to the runway. It does take us into the middle of, we said mid-2025. In terms of inflection points and milestones, obviously, some big milestones and inflection points that we talked about. We mentioned as part of this earnings call, we plan on getting into the clinic in the first half of next year, specifically with regards to the tau program. So, that would be filing the IND and getting in the clinic. And then obviously, the SOD1 program we talked about 2025 with regards to filing IND and advancing that program. That does not include the milestones associated with some of our partner programs, which as we’ve referenced in the past, we do have some partnerships, both Sangamo as — with regards to Neurocrine, they alluded to also advancing two programs for Neurocrine and Sangamo one program to IND in 2025.

So those are additional milestones that we’re looking forward down the road. Hopefully that helps with regards to guidance and also provide you with some context around milestones during that time period.

Operator: And our next question coming from the line of Jack Allen with Baird.

Jack Allen: Congratulations to the team on the progress. Maybe the first one on the timing of some of these updates. You mentioned that the studies are ongoing as it relates to the shuttle program. I was wondering when those preclinical studies might read out and when we could get a disclosure surrounding that. And then similarly for the SOD1 candidate selection expected by the end of the year, how should we think about disclosures going forward as you select that candidate? And then I have a quick follow-up as well.

Dr. Al Sandrock: So I’ll ask Todd to answer the first question, and I’ll let attempt to answer the second one.

Dr. Todd Carter: Sure. So the shuttle program, that’s in early stages of discovery right now. At its early stage, we haven’t really given any guidance as to the time line. We’re looking forward to being able to update you in the future, but we don’t have specific dates yet.

Dr. Al Sandrock: As far as the SOD1 program, we expect to announce when and if we’ve announced — identified a development candidate, we’ll let you know. And also, we’ll let you know when we start our GLP toxicology studies, and generally speaking, we’ll let you know whether or not we’re on track for the IND in mid-2025.

Jack Allen: Great. And then, shifting gears to the tau program. I know we just had CTAD recently. Al, I was wondering if you could speak to some of the evidence from the meeting that provide you additional support as you look to move forward this tau antibody. And then I know one of the questions around the meeting was taking antibodies and giving them via IV or more rapid injections as well. What are your thoughts as it relates to the initial formulation for the tau program as you look to bring this into the clinic?

Dr. Al Sandrock: Well, I think the meeting continues to, I think, validate that tau is a very exciting target for Alzheimer’s disease, potentially the next target after the anti-amyloid treatments that will produce hopefully new medicines for patients. I think — by that, I’m referring to the fact that we’ve already seen that — certainly, the knockdown approach will affect the spread of tau by tau-PET imaging. And now we saw at this most recently meeting that it seems to lead to a slowing of clinical decline. Small numbers, still early days, but I think I would look at the data as encouraging. I think it’s also interesting that the anti-amyloid antibodies really work best in people with a low tau burden, right? And that’s predictable, I believe, because many of us believe that beta amyloid plaques or the formation of plaques seems to somehow trigger the spread of tau.

So I think — and in fact, tau appearing in certain parts of the brain in the medial temporal lobe is actually part of normal aging. But it’s only when you have the presence of amyloid plaques in the brain that you start to see it spread into other areas of the brain, which is actually pathologic. So, we continue to be excited by tau as a target, and that’s why we have two programs in it, the lead one being an antibody that we have seen block the spread of tau in animals quite well, actually, quite robustly. And then, we have the tau — vectorized tau, a knockdown approach, a vectorized siRNA, which in some ways could mirror the efficacy seen. We hope that we’ll mirror the efficacy seen with the antisense oligonucleotide approaches but also knockdown expression of tau.