Voyager Q1 results, updates

 Company announces clearance of IND application with FDA for anti-tau antibody VY-TAU01 for the treatment of Alzheimer’s disease; expect to begin single ascending dose trial in the coming weeks -

- Development candidates selected for Neurocrine-partnered GBA1 and Friedreich’s Ataxia gene therapy programs; potential for three gene therapies, including SOD1-ALS, to enter the clinic in 2025 -

- Appointed neurology clinical development expert Toby Ferguson, M.D., Ph.D., as Chief Medical Officer -

- Strong cash position of approximately $400 million as of March 31, 2024; expected to provide runway through multiple clinical data readouts into 2027 -

Anticipated Upcoming Milestones

• VY-TAU01 anti-tau antibody for Alzheimer’s disease: Voyager expects to dose the first subject in a Phase 1a single ascending dose trial in healthy volunteers in the coming weeks and initiate a Phase 1b multiple ascending dose trial in patients with early Alzheimer’s disease in 2025. The multiple ascending dose trial has the potential to generate initial data for slowing the spread of pathological tau via tau PET imaging in 2026.

• VY9323 SOD1 silencing gene therapy program for ALS: Voyager expects to file an IND in mid-2025 and initiate a Phase 1 clinical trial in ALS patients. The Phase 1 trial has the potential to generate proof-of-concept data based on biomarkers.

• Partnered programs: Voyager and Neurocrine Biosciences expect to file INDs for the GBA1 and Friedreich’s Ataxia gene therapy programs in 2025.

Conference Call

Voyager will host a conference call and webcast today at 4:30 p.m. ET to discuss first quarter 2024 financial and operating results. To participate via telephone and join the call live, please register in advance here: https://register.vevent.com/register/BI1f6af80e7a614ca7925cbad2f35a55c6. Upon registration, telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number and a unique passcode. A live webcast of the call will also be available on the Investors section of the Voyager website at ir.voyagertherapeutics.com, and a replay of the call will be available at the same link approximately two hours after its completion. The replay will be available for at least 30 days following the conclusion of the call.

https://finance.yahoo.com/news/voyager-therapeutics-reports-first-quarter-200100384.html