VYGR

Business Context and Reporting Period

Company: Voyager Therapeutics, Inc. (VYGR)
Filing Type: Form 8-K (Current Report)
Date of Report: June 1, 2026
Reporting Period: Single event date (June 1, 2026)
Business Overview: Voyager Therapeutics is a biopharmaceutical company developing gene therapies. This filing reports a regulatory milestone for its investigational tau silencing gene therapy, VY1706, intended for the treatment of Alzheimer's disease (AD).

Key Financial Metrics

This Form 8-K is a current report regarding a specific corporate event and does not contain financial statements. Consequently, the filing text does not provide clear values for revenue, profit, cash flow, margins, debt, or liquidity. Investors should refer to the company's most recent Form 10-K or 10-Q for financial data.

Material Changes and Events

• Regulatory Clearance: The U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for VY1706.
• Product Candidate: VY1706 is an investigational tau silencing gene therapy targeting intracellular and extracellular tau for Alzheimer's disease.
• Clinical Trial Initiation: The Company plans to initiate a multi-site, open-label, dose-escalation clinical trial.
• Timeline: Dosing is expected to begin in the second half of 2026.
• Study Design:
  • Population: Adult participants with early AD and confirmed tau pathology via PET imaging.
  • Enrollment: Up to 18 patients across three cohorts.
  • Administration: One-time intravenous dose.
  • Maximum Dose: Not exceeding 5 x 10¹³ vector genomes per kilogram (highest dose tested in non-human primates).
  • Endpoints: Primary endpoint is safety and tolerability; secondary endpoints include tau biology effects via cerebrospinal fluid biomarkers and tau PET imaging.

Guidance, Outlook, and Risks

Management Commentary and Outlook: Management expects to achieve first-in-human dosing in AD in the second half of 2026. The filing contains forward-looking statements regarding the timing and achievement of clinical development milestones.

Risks and Uncertainties: The filing highlights significant risks that could cause actual results to differ from expectations, including:

• Uncertainties in clinical trial initiation, enrollment, timing, cost, and results.
• Regulatory authority decisions and potential adverse events.
• Ability to replicate positive preclinical results in clinical trials.
• Technical hurdles in development, manufacture, and supply of product candidates.
• Sufficiency of cash resources to fund operations and corporate objectives.
• Competitive developments in capsid or non-viral identification platforms.

Unusual Items: None reported in this filing.

Key Facts for Investor Verification

• Verify the actual start date of dosing for the VY1706 clinical trial against the projected "second half of 2026" timeline.
• Monitor the Company's cash runway and capital requirements to fund the upcoming clinical trial and ongoing operations.
• Track enrollment progress for the 18-patient, three-cohort study.
• Review safety data once the primary endpoint (safety and tolerability) is evaluated.
• Confirm the Company's ability to manufacture the vector at the specified dose levels (up to 5 x 10¹³ vg/kg).