Pipeline Development - The company is advancing a proprietary pipeline focused on neurological diseases, particularly Alzheimer's disease (AD), with two key programs targeting tau: VY7523 and VY1706[74] - VY7523, an anti-tau antibody, reduced tau spread by approximately 70% in preclinical studies and is currently in a Phase 1 multiple ascending dose clinical trial, with initial data expected in the second half of 2026[74] - VY1706, a gene therapy targeting tau mRNA, demonstrated a 50% to 73% reduction in tau mRNA levels in non-human primates and an investigational new drug application is anticipated in 2026[74] - The GBA1 program targets both Gaucher and Parkinson's diseases, with clinical trials expected to begin in 2026[76] - The TRACER platform is utilized across all gene therapies in the pipeline, enabling rapid discovery of AAV capsids with enhanced CNS tropism[77] Collaborations and Partnerships - The company has partnered with Neurocrine on five gene therapy programs, with milestone payments expected to total up to $35 million related to clinical trials for the GBA1 and FXN programs in 2025-2026[75] - The collaboration with Novartis includes an upfront payment of $80 million and potential milestone payments totaling $625 million across two programs, with royalties in the high single-digit to low double-digit percentages[81] - Total partnerships have provided over $500 million in non-dilutive funding, with the potential to earn up to $7.4 billion in milestone payments across the partnered portfolio[76] - The company has initiated a collaboration agreement with Neurocrine for four programs, with Neurocrine covering all preclinical development costs[86] - The 2023 Neurocrine Collaboration Agreement includes potential development milestone payments of up to $985.0 million for the GBA1 Program and up to $175.0 million for each of the three 2023 Discovery Programs[87] - The company received a $3.0 million milestone payment in October 2024 following the selection of a development candidate for a gene therapy program under the 2023 Neurocrine Collaboration Agreement[87] Financial Performance - The company reported a net loss of $31.0 million for the three months ended March 31, 2025, compared to a net loss of $11.3 million for the same period in 2024[108] - Research and development expenses increased to $31.5 million for the three months ended March 31, 2025, up from $27.1 million in the same period in 2024[108] - The accumulated deficit as of March 31, 2025, was $357.2 million, indicating ongoing significant losses[95] - The company anticipates continued significant expenses and operating losses due to ongoing clinical trials and research activities[95] - Collaboration revenue decreased to $6.5 million for the three months ended March 31, 2025, down from $19.5 million in the same period of 2024[109] Cash Flow and Funding - Net cash used in operating activities was $37.9 million in Q1 2025, compared to a net cash provided of $58.8 million in Q1 2024[119] - Net cash provided by investing activities was $41.2 million in Q1 2025, a significant improvement from $96.1 million used in Q1 2024[121] - Net cash provided by financing activities decreased to $0.1 million in Q1 2025, down from $112.9 million in Q1 2024[122] - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $295.1 million[124] - The company expects to need substantial additional funding to support ongoing research and development and operational expenses[123] Market Risks and Economic Factors - The company is exposed to market risk related to interest rate changes, with policies in place to manage this risk[134] - The company is not currently exposed to market risk related to changes in foreign currency exchange rates[135] - Future contracts with vendors located in Asia and Europe may subject the company to fluctuations in foreign currency rates[135] - Inflation has generally increased the costs of labor, goods, and services for the company[135] - The company does not believe that inflation had a material effect on its business during the three months ended March 31, 2025[135]
Voyager Therapeutics(VYGR) - 2025 Q1 - Quarterly Report