Voyager Therapeutics(VYGR)

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Voyager Adds Fourth Wholly-Owned Alzheimer's Disease Program to Pipeline, Complementing Existing Tau and Amyloid Assets with New APOE Approach
Globenewswire· 2025-07-16 11:00
Core Insights - Voyager Therapeutics is expanding its Alzheimer's disease franchise with a new program targeting apolipoprotein E (APOE), specifically modulating the expression of the high-risk APOE4 variant while delivering the protective APOE2 variant [1][5][6] - The TRACER capsid platform is utilized for intravenous delivery, allowing the bifunctional payload to effectively cross the blood-brain barrier and target relevant brain regions [2][4] - The company aims to leverage its expertise in Alzheimer's biology to advance multiple therapeutic targets, including tau, amyloid, and APOE, to improve patient outcomes [3][5] Company Overview - Voyager Therapeutics is a biotechnology firm focused on using human genetics to treat neurological diseases, with a pipeline that includes programs for Alzheimer's disease, Friedreich's ataxia, Parkinson's disease, and amyotrophic lateral sclerosis (ALS) [5][7] - The company's Alzheimer's disease franchise now includes four wholly-owned assets, including the anti-tau antibody VY7523 and gene therapies targeting tau, amyloid, and APOE [3][5][6] Research and Development - Preclinical studies demonstrated that a single intravenous injection of the TRACER capsid significantly reduced endogenous APOE4 levels while increasing APOE2 expression in relevant brain regions [2][6] - VY7523 is currently in a multiple ascending dose clinical trial, with initial tau PET data expected in the second half of 2026 [6] - VY1706, a tau silencing gene therapy, has shown up to 73% knockdown of tau mRNA in non-human primates and is advancing towards IND in 2026 [6] Technology Platform - The TRACER capsid discovery platform enables rapid identification of novel AAV capsids for gene therapy, facilitating effective delivery across the central nervous system [4][7] - The platform has been validated in cross-species preclinical studies, demonstrating widespread payload expression in the CNS at low doses [4][7]
Voyager Therapeutics (VYGR) FY Conference Transcript
2025-06-17 12:00
Summary of Voyager Therapeutics Conference Call Company Overview - **Company**: Voyager Therapeutics (VYGR) - **Industry**: Clinical stage neurotherapeutics focused on genetically driven medicines for serious CNS diseases - **Pipeline**: Includes multiple programs targeting tau, gene therapy enabled by next-generation capsids, and 11 partner programs with companies like Novartis and Neurocrine [2][9][50] Core Strategies and Differentiation - **Strategy**: Leverage genetics to treat neurological diseases by targeting validated human genetic targets and improving delivery into the brain [3][11] - **Delivery Challenges**: The blood-brain barrier limits the efficacy of non-small molecule drugs, necessitating the use of alternative modalities like antibodies, gene therapy, and oligonucleotides [4][12] - **Capital Efficiency**: Emphasis on capital efficiency and biomarker-driven derisking to ensure the development of differentiated medicines with transformative benefits [6][14] Key Programs and Developments - **Alzheimer's Programs**: Voyager has three programs targeting Alzheimer's, focusing on tau and amyloid. The company aims to develop multiple treatment paradigms similar to oncology [19][20] - **Anti-Tau Antibody Program (VY-7523)**: Currently in a Phase 1b trial, with a focus on TauPET as the key readout expected in the second half of 2026 [21][22] - **Tau Silencing Gene Therapy (BY-1706)**: A vectorized microRNA therapy showing up to 73% knockdown of tau in nonhuman primates, with expectations for long-term effects from a single IV administration [32][33][34] Market Position and Partnerships - **Partnerships**: Voyager has a strong partnership with Neurocrine, with two INDs planned for 2025 and potential milestones of up to $35 million [50][51] - **Market Potential**: The partnered pipeline has potential milestones of $7.4 billion, with significant royalties from high-value targets like GBA for Parkinson's and SMA [56][57] Financial Outlook - **Cash Position**: Voyager has $295 million in cash, providing a runway into mid-2027, which does not include milestone payments [59][61] - **Investment Opportunities**: The company is positioned as a multimodality company, not just a gene therapy firm, with multiple upcoming data readouts expected to drive investor interest [62][63] Future Catalysts - **Upcoming Data**: Key data readouts expected in the next 6-12 months include results from the tau antibody program and Neurocrine's IND filings [63][64] - **Focus on Tau**: Voyager's comprehensive approach to tau-related therapies positions it as a leader in the field, with multiple treatment options being developed [62][39] Additional Insights - **Regulatory Pathways**: The company aims to replicate the success of Novartis' Zolgensma by focusing on genetically validated targets and efficient regulatory pathways [17][18] - **Innovative Delivery Mechanisms**: Voyager is exploring the use of identified receptors to enhance delivery of therapeutics across the blood-brain barrier, differentiating itself from competitors [42][45][48]
Voyager to Present at H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference
Globenewswire· 2025-06-10 11:00
LEXINGTON, Mass., June 10, 2025 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to leveraging genetics to treat neurological diseases, today announced Alfred W. Sandrock, Jr., M.D., Ph.D., Chief Executive Officer of Voyager, and additional members of management will participate in a pre-recorded fireside chat at the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference. An on-demand webcast of the pre-recorded fireside chat will be available and may ...
Voyager Demonstrates ALPL Receptor-Mediated Blood-Brain Barrier Transport of Novel AAV Capsids in Molecular Therapy Publication
Globenewswire· 2025-05-15 11:00
Core Insights - Voyager Therapeutics has published data demonstrating the ability of alkaline phosphatase (ALPL) to transport a novel AAV capsid across the blood-brain barrier (BBB) [1] - The research indicates that the novel AAV capsid VCAP-102 shows a 20- to 400-fold increase in gene transfer across multiple brain regions compared to AAV9 in both rodents and non-human primates [2] - The company is advancing two gene therapy programs towards IND filings this year with a partner, leveraging the findings from the ALPL research [2] Group 1: Research and Development - The publication in Molecular Therapy outlines the generation of VCAP-102 and identifies ALPL as the primary receptor for crossing the BBB [2] - Voyager's next-generation capsids have demonstrated significant transduction rates, with up to 98% of dopaminergic neurons in the substantia nigra being transduced [2] - The TRACER™ capsid discovery platform enables rapid discovery of novel AAV capsids, facilitating gene therapy for neurological diseases [3] Group 2: Strategic Partnerships and Pipeline - Voyager's pipeline includes programs targeting Alzheimer's disease, Friedreich's ataxia, Parkinson's disease, and ALS, among others [4] - The company collaborates with partners such as Alexion, AstraZeneca Rare Disease, Novartis Pharma AG, and Neurocrine Biosciences to advance its gene therapy programs [4] - The multi-modality approach of combining viral and non-viral delivery methods is seen as critical for addressing unmet needs in neurological diseases [3]
Voyager Therapeutics (VYGR) Reports Q1 Loss, Lags Revenue Estimates
ZACKS· 2025-05-06 22:10
分组1 - Voyager Therapeutics reported a quarterly loss of $0.53 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.35, and compared to a loss of $0.20 per share a year ago, indicating an earnings surprise of -51.43% [1] - The company posted revenues of $6.47 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 66.26%, and down from $19.52 million in the same quarter last year [2] - Voyager Therapeutics shares have declined approximately 38.5% since the beginning of the year, contrasting with the S&P 500's decline of -3.9% [3] 分组2 - The current consensus EPS estimate for the upcoming quarter is -$0.31 on revenues of $19.19 million, and for the current fiscal year, it is -$1.41 on revenues of $90.91 million [7] - The Medical - Biomedical and Genetics industry, to which Voyager Therapeutics belongs, is currently ranked in the top 31% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]
Voyager Therapeutics(VYGR) - 2025 Q1 - Quarterly Report
2025-05-06 20:02
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 Results
2025-05-06 20:01
Financial Performance - Voyager ended Q1 2025 with a cash position of $295 million, expected to provide runway into mid-2027[2] - Net loss for Q1 2025 was $31.0 million, compared to a net loss of $11.3 million in Q1 2024, representing an increase of 174.0%[8] - Voyager's total operating expenses for Q1 2025 were $41.2 million, compared to $35.7 million in Q1 2024, an increase of 15.2%[8] - Voyager's total assets decreased to $353.2 million as of March 31, 2025, down from $393.1 million as of December 31, 2024[19] Revenue - Collaboration revenue for Q1 2025 was $6.5 million, down from $19.5 million in Q1 2024, a decrease of approximately 66.8%[8] - GAAP collaboration revenue for Q1 2025 was $6.473 million, a decrease from $19.516 million in Q1 2024[23] - Net collaboration revenue for Q1 2025 was $4.845 million, down from $16.338 million in Q1 2024[23] Expenses - Research and development expenses increased to $31.5 million in Q1 2025 from $27.1 million in Q1 2024, a rise of 16.3%[8] - General and administrative expenses rose to $9.6 million in Q1 2025 from $8.6 million in Q1 2024, an increase of 11.6%[8] - Total research and development expenses for Q1 2025 increased to $31.526 million, compared to $27.092 million in Q1 2024[23] - Net research and development expenses for Q1 2025 were $29.898 million, up from $23.914 million in Q1 2024[23] - Reimbursable research and development services incurred in Q1 2025 amounted to $1.628 million, down from $3.178 million in Q1 2024[23] Clinical Development - The company anticipates IND submissions for the Neurocrine-partnered FA and GBA1 programs in 2025[3] - Initial tau PET imaging data from the MAD clinical trial of VY7523 is expected in the second half of 2026[3] - A single IV dose of VY1706 achieved up to 73% knockdown of tau mRNA in NHPs[5]
Voyager Reports First Quarter 2025 Financial and Operating Results
GlobeNewswire News Room· 2025-05-06 20:01
Core Insights - Voyager Therapeutics reported a strong cash position of $295 million, expected to last until mid-2027, excluding potential milestone payments from partnerships [2][8] - The company is advancing its pipeline, particularly focusing on tau-targeting programs for Alzheimer's disease, with IND submissions anticipated in 2026 [2][5] Financial Results - Collaboration revenue for Q1 2025 was $6.5 million, down from $19.5 million in Q1 2024, primarily due to decreased revenue from Neurocrine collaboration [14] - Net loss for Q1 2025 was $31.0 million, compared to $11.3 million in Q1 2024, attributed to lower collaboration revenue and increased operating expenses [14][19] - Research and development expenses increased to $31.5 million in Q1 2025 from $27.1 million in Q1 2024, driven by higher program-related spending [14][19] Pipeline and Development Updates - The tau silencing gene therapy VY1706 demonstrated up to 73% knockdown of tau mRNA in non-human primates after a single intravenous dose [5] - The company is preparing for IND submissions for VY1706 and the Neurocrine-partnered Friedreich's ataxia and GBA1 programs in 2026 [6][14] - Voyager's anti-tau antibody VY7523 is currently in a multiple ascending dose clinical trial for Alzheimer's Disease, with initial tau PET data expected in the second half of 2026 [6][14] Upcoming Milestones - Multiple presentations at the ASGCT 2025 annual meeting are planned, including data on VY1706 and VY7523 [5][6] - The initiation of clinical trials for the FA and GBA1 programs is expected in 2026, with potential milestone payments totaling $35 million [6][14]
Voyager Next-Generation CNS Capsids Featured at ASGCT 28th Annual Meeting
Globenewswire· 2025-04-28 20:30
Core Insights - Voyager Therapeutics announced eight presentations at the ASGCT annual meeting, focusing on advancements in gene therapies for neurological diseases, particularly Alzheimer's disease [1][2] Group 1: Gene Therapy Developments - The company highlighted its TRACER capsids, which have shown the ability to transduce 43%-98% of neurons and 87%-99% of astrocytes in non-human primates after a single intravenous dose [2] - The tau silencing gene therapy VY1706 demonstrated up to 73% knockdown of tau mRNA in non-human primates following a single intravenous dose of 1.3e13 vg/kg [2][6] - Presentations will include data on anti-amyloid gene therapy and enhancements to capsids aimed at immune evasion to broaden patient eligibility [2][6] Group 2: Presentation Details - Oral presentations will cover various topics, including the intravenous delivery of VY1706 and its effects on tau levels in the central nervous system [7] - Other presentations will focus on the discovery of AAV9-derived capsids that evade neutralizing antibodies and machine-learning applications for capsid screening [7][8] Group 3: Company Overview - Voyager Therapeutics is dedicated to leveraging human genetics to treat neurological diseases, with a pipeline that includes programs for Alzheimer's disease, Friedreich's ataxia, and Parkinson's disease [9] - The TRACER platform has enabled the development of novel capsids for gene therapy, enhancing the potential for high brain penetration following intravenous dosing [9][8]
Voyager Presents Robust Preclinical Data from Tau Targeting Gene Therapy and Antibody Programs at AD/PD™ 2025
Newsfilter· 2025-03-31 11:00
- Single IV administration of tau silencing gene therapy VY1706 significantly reduced tau mRNA and protein levels, with broad brain distribution and liver de-targeting, in NHP study - - Preclinical murine data strengthen case for specifically targeting pathologic forms of tau with the clinical-stage anti-tau antibody VY7523 - - Voyager to host live webcast on April 7 recapping key AD/PD™ 2025 data - Dr. Ferguson will be speaking on two panels at AD/PD™ 2025: Challenges and Opportunities for Anti-Tau Therapi ...