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.
A researcher handling a vial of adeno-associated virus gene therapy for a preclinical program.
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?
