AAV-based gene therapy program for tau silencing, including expectations for and timing with regards to achievement of preclinical and clinical development milestones for VY1706 related to the IND application process in the second quarter of 2026, initiation and enrollment of clinical trials, and achievement of first-in-human dosing in AD in the second half of 2026, pending successful IND clearance; Voyager’s ability to advance its clinical-stage anti-tau antibody program in AD, VY7523, including timing of expected clinical tau PET imaging efficacy data and other clinical data in the second half of 2026; Voyager’s ability to advance gene therapy product candidates under the Novartis licenses and collaboration and Neurocrine collaboration, including the anticipated submission of an IND and initiation of clinical trials by Neurocrine for NBIB-‘223 in FA, pending successful IND clearance; the availability of and potential for third-party clinical data for a tau-targeting agent to confirm or derisk the tau knockdown approach in the treatment of AD; Voyager’s anticipated financial results, including the anticipated receipt by Voyager of revenues or reimbursement payments from collaboration partners; Voyager’s cash runway, anticipated cost savings, including as a result of cost-cutting and efficiency initiatives, and our ability to execute across our pipeline and platforms; the mission, goals and value drivers for our business; and the ability to generate sufficient cash resources to enable Voyager to continue our business and operations through multiple clinical inflection points. The use of words such as “may,” “will,” “might,” “would,” “could,” “should,” “expect,” “plan,” “anticipate,” “believe,” “potential,” “intend,” “seek,” “predict,” “estimate,” “project,” “target,” or “continue” and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
All forward-looking statements are based on management’s current estimates and assumptions and are subject to a number of risks, uncertainties and important factors that may cause actual results to differ materially from any forward-looking statements in this press release. Factors include, among others, the risks and uncertainties inherent in the development of product candidates, including the timing, initiation, and conduct of preclinical studies and clinical trials, including potential delays in timing as a result of slower than expected site initiation, slower than expected enrollment, the need or decision to expand the trials or other changes, which may impact our ability to meet our expected timelines and may increase our costs; the expectations and decisions of regulatory authorities; the availability of data from and outcomes of Voyager’s preclinical studies and clinical trials and those conducted by our partners and collaborators, including that success in earlier preclinical studies may not be repeated or observed in ongoing or future preclinical studies or clinical trials, ongoing and future clinical trials may not meet their primary or key secondary endpoints, which may substantially impair development, and we may encounter adverse events that could negatively impact further development; Voyager’s ability to demonstrate that current or future product candidates are safe and effective for their proposed indications; the availability, commercial potential and success of Voyager’s wholly owned candidates; the availability of data from and the outcomes of third-party preclinical studies and clinical trials and the potential impact on Voyager’s development plans; the continued development of Voyager’s technology platforms, including Voyager’s TRACER and nonviral discovery platforms; Voyager’s scientific approach and program development progress and the restricted supply and increased costs of critical research components; the development by third parties of capsid identification platforms that may be competitive to Voyager’s TRACER capsid and nonviral discovery platform and programs; Voyager’s ability to create and protect intellectual property rights associated with the TRACER capsid and nonviral discovery platforms, the capsids and ligands identified by the platforms, and the development of clinical candidates and related data from Voyager’s pipeline programs; the willingness and ability of Voyager's collaboration partners to meet obligations under collaboration agreements with Voyager and their projections with respect to such programs; the need to align with our collaborators, which may hamper or delay our development efforts and timelines; the possibility or timing of Voyager’s receipt of program reimbursement, development or commercialization milestones, option exercise, and other payments