Voyager Therapeutics, Inc.
For the period ended Jun 30, 2026. Filed Aug 6, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001104659-26-057097
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001640266-26-000006
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 105 previous paragraphs and 149 current paragraphs.
71 unchanged; 25 reworded; 47 added; 3 removed; 6 previous and 6 current paragraphs rearranged.
Tables are not compared: 42 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (47)
Current report
VY1706 is designed to reduce the production of tau in the brain. The core of VY1706 is a vectorized small interfering RNA, or siRNA, that targets microtubule-associated protein tau, or MAPT, messenger RNA, or mRNA, to decrease levels of both intracellular and extracellular tau in the brain. This core is encapsulated in a Voyager TRACER™ AAV capsid that leverages alkaline phosphatase, or ALPL, a well-conserved, novel receptor identified by us, designed to deliver the siRNA into the brain following a one-time IV dose. In a preclinical program spanning multiple species, VY1706 has demonstrated a favorable tolerability profile and has been shown to reduce tau protein by up to 75% in key non-human primate, or NHP, brain regions relevant to AD while de-targeting the liver. In a good laboratory practice, or GLP, toxicology study of VY1706, the results of which were presented in July 2026 at the Alzheimer's Association International Conference, VY1706 demonstrated a favorable tolerability profile, with no adverse clinical pathology or histopathological findings observed in NHPs in the CNS, dorsal root ganglia, and peripheral organs (including liver) up to the highest dose tested of 5 x 1013 vector genomes per kilogram. Additionally, VY1706 was shown to reduce MAPT mRNA and tau protein by up to 75% in key NHP brain regions relevant to AD through six months.
Current report
In the second quarter of 2026, the U.S. Food and Drug Administration, or FDA, cleared our Investigational New Drug, or IND, application for VY1706, enabling initiation of a clinical trial of VY1706 in adults with early AD who have evidence of tau pathology in the brain as confirmed by positron emission tomography, or PET. In July 2026, Health Canada cleared our Clinical Trial Application, or CTA, enabling the inclusion of Canadian clinical trial sites in the trial. The multi-site, open-label, dose-escalation clinical trial is expected to enroll up to 18 patients across three cohorts, with the highest dose not exceeding 5 x 1013 vector genomes per kilogram. VY1706 will be administered in the trial as a one-time IV dose. The primary endpoint of the trial is to evaluate the safety and tolerability of VY1706. Secondary endpoints are designed to assess VY1706’s effect on tau biology, including changes in cerebrospinal fluid, or CSF, biomarkers of tau and changes in tau pathology measured by tau PET imaging. Dosing is expected to begin in the fourth quarter of 2026. We expect to provide three critical data updates during the trial, beginning with initial acute safety data, which we anticipate announcing in early 2027, pending enrollment progress and timing. The second and third anticipated data updates include initial capsid platform validation, which we define as gene expression as measured by CSF tau, and initial asset proof-of-concept, which we define as changes in tau pathology measured by PET imaging data. We anticipate the potential to observe initial CSF tau biomarker-based data beginning in the second half of 2027, pending enrollment progress and timing.
Current report
initiate and conduct clinical trials in connection with our VY1706 tau silencing program, which we expect to initiate in the fourth quarter of 2026, and continue to conduct clinical trials in connection with our VY7523 anti-tau antibody program;
Current report
continue investing in our proprietary antibody program, non-viral therapeutics platform, gene therapy platforms and programs, and other research and development initiatives;
Current report
continue investing in and supporting TRACER, our proprietary discovery platform to facilitate the selection of TRACER Capsids, and our investment to discover TRACER Capsids with broad tropism in CNS and other tissues with cell-specific transduction properties for particular therapeutic applications;
Current report
increase our investment in the discovery and development of additional modalities for receptor-mediated non-viral delivery of therapeutic payloads to the CNS, including but not limited to our ALPL and other BBB-receptors;
Current report
conduct joint research and development under our strategic collaborations for the research, development, and commercialization of certain of our pipeline programs, including our FA Program, pursuant to the 2019 Neurocrine
Current report
Collaboration Agreement, our GBA1 Program, pursuant to the 2023 Neurocrine Collaboration Agreement, and the Novartis HD Program, pursuant to the 2023 Novartis Collaboration Agreement;
Current report
initiate additional preclinical studies and clinical trials for, and continue research and development of, our other programs;
Current report
continue our process research and development activities, as well as establish our research-grade manufacturing capabilities;
Current report
identify additional diseases for treatment with our AAV gene and non-viral therapies and BBB-crossing technologies and develop additional programs or product candidates;
Current report
seek marketing and regulatory approvals for any of our product candidates that successfully complete clinical development;
Current report
maintain, expand, protect and enforce our intellectual property portfolio;
Current report
identify, acquire or in-license other product candidates and technologies;
Current report
expand our operational, financial and management systems and personnel, including personnel to support our clinical development, manufacturing and commercialization efforts;
Current report
increase our clinical trial insurance coverage as we expand our clinical trials and increase our product liability insurance once we engage in commercialization efforts; and
Current report
continue to operate as a public company.
Current report
employee‑related expenses including salaries, benefits, and stock‑based compensation expense;
Current report
costs of funding research performed by third parties that conduct research and development, preclinical and clinical activities, manufacturing and production design on our behalf;
Current report
the cost of purchasing laboratory supplies and non‑capital equipment used in designing, developing and manufacturing preclinical and clinical study materials;
Current report
consultant fees;
Current report
facility costs, including rent, depreciation and maintenance expenses;
Current report
the cost of securing and protecting intellectual property rights associated with our research and development activities;
Current report
fees for maintaining licenses under our third-party licensing agreements; and
Current report
payments under our research and collaboration agreements.
Current report
we are required by the FDA or the European Medicines Agency or other regulatory agencies to redesign or modify trials or studies or to perform trials or studies in addition to those currently expected;
Current report
there are any delays in the receipt of regulatory clearance to begin our planned clinical programs; or
Current report
there are any delays in site initiation, enrollment of participants in or completion of our clinical trials or the development of our product candidates.
Current report
Research and development expense was $22.0 million and $31.3 million for the three months ended June 30, 2026 and 2025, respectively. The $9.3 million decrease was primarily attributable to lower employee-related expenses and shared facilities and other costs due to lower headcount resulting from restructuring actions undertaken in 2025. The decrease was further attributable to reduced spend on VY7523 as enrollment in the clinical trial was completed as well as lower spend on other programs and platforms as a result of program prioritization.
Current report
General and administrative expense was $7.5 million and $10.5 million for the three months ended June 30, 2026 and 2025, respectively. The $3.0 million decrease was primarily attributable to reduced employee-related expenses due to lower headcount resulting from restructuring actions undertaken in 2025.
Current report
Other income, net was $1.9 million and $3.3 million for the three months ended June 30, 2026 and 2025, respectively. The $1.3 million decrease was primarily attributable to lower interest earned on our marketable securities as a result of lower average marketable securities balances during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025.
Current report
Comparison of the six months ended June 30, 2026 and 2025
Current report
Collaboration Revenue
Current report
Research and Development Expense
Current report
General and Administrative Expense
Current report
Other income, net was $4.3 million and $7.0 million for the six months ended June 30, 2026 and 2025, respectively. The $2.7 million decrease was primarily attributable to lower interest earned on our marketable securities as a result of lower average marketable securities balances during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025.
Current report
the scope, progress, results, and costs of product discovery, preclinical studies and clinical trials for our product candidates, including our ongoing Phase 1 clinical trial to evaluate VY7523 and our planned Phase 1 clinical trial to evaluate VY1706;
Current report
the scope, progress, results, costs, prioritization, and number of our research and development programs;
Current report
the progress and status of our strategic collaborations and option and license agreements and any similar arrangements we may enter into in the future, including any research and development costs for which we are responsible, future additional obligations that we may be committed to in connection with these agreements, including, for example, if we elect to exercise our rights for any of the three programs for which we retain opt-in rights, and our receipt of any expense reimbursements, future milestone payments and royalties from our collaboration partners or licensors;
Current report
the extent to which we are obligated to reimburse preclinical development and clinical trial costs, or the achievement of milestones or occurrence of other developments that trigger milestone and royalty payments, under any collaboration or license agreements to which we might become a party, such as the Touchlight License Agreement and the Transition Bio Agreement;
Showing the first 40 of 47 passages. Open the source sections for the rest.
Removed paragraphs (3)
Previous report
Other Income, Net
Previous report
Other Income, Net
Previous report
Other income, net decreased by $1.4 million from $3.7 million for the three months ended March 31, 2025 to $2.3 million for the three months ended March 31, 2026. The decrease was primarily due to decreased interest income on our marketable securities balances, as our marketable securities balance decreased during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025.
Reworded paragraphs (25)
Previous wording
ITEM 2. MANAGEMENT’S DISCUSSIO****N AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Current wording
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Previous wording
We are advancing our own proprietary pipeline of drug candidates for neurological diseases, with a focus on AD. Our wholly-owned prioritized pipeline includes two tau targeting programs: VY1706, a tau silencing gene therapy for AD, and VY7523, an anti-tau antibody for AD. VY1706 is a gene therapy that leverages an intravenously delivered TRACER Capsid containing a vectorized small interfering RNA specifically targeting tau mRNA. In a non-human primate, or NHP, study, a single 1.3E13 vector genomes per kilogram, or vg/kg, dose of VY1706 delivered intravenously resulted in reductions in tau mRNA levels of 50% to 73% across the cerebral cortex, including in areas of the brain where tau accumulates during the progression of AD. We completed investigational new drug-enabling good laboratory practices, or GLP, toxicology in the first quarter of 2026. Having had a Type C communication with the FDA in the first quarter of 2026, we anticipate completion of the investigational new drug, or IND, application process for the VY1706 program in the second quarter of 2026 and, subject to successful IND clearance, initiation of a clinical trial for the VY1706 program in the second half of 2026. VY7523 is an IV-administered, recombinant, humanized IgG4 monoclonal antibody developed to inhibit the spread of pathological tau, which is closely correlated with disease progression and cognitive decline in AD. The murine version of VY7523 reduced tau spread by approximately 70% in preclinical studies. VY7523 demonstrated an acceptable safety, tolerability, and immunogenicity profile as well as expected pharmacokinetic results in a Phase 1, single ascending dose clinical trial in healthy volunteers. In February 2025, we initiated a Phase 1 multiple ascending dose, or MAD, clinical trial of VY7523 in early AD patients. Enrollment in this MAD clinical trial was completed in the fourth quarter of 2025, and we expect initial tau positron emission tomography imaging efficacy data in the second half of 2026.
Current wording
We are advancing our own proprietary pipeline of drug candidates for neurological diseases, with a focus on AD. Our wholly-owned prioritized pipeline includes two programs targeting tau, a protein associated with neurodegeneration and cognitive decline in AD as well as multiple other tauopathies. VY1706 is an investigational tau-silencing gene therapy product candidate for the treatment of AD, and VY7523 is an investigational anti-tau antibody product candidate for the treatment of AD.
Previous wording
In addition to our wholly-owned pipeline, we are advancing three programs with collaboration partners for which we retain options to participate in future development and commercialization. Two of these programs are in collaboration with Neurocrine: a frataxin (FXN) gene therapy program for FA, or the FA Program, and a glucosylceramidase beta 1 gene therapy program that will focus on Gaucher disease and PD, or the GBA1 Program. Neurocrine has stated that, pending successful FDA IND clearance, it intends to initiate a clinical trial with NBIB-’223 for FA in the second half of 2026. In preclinical studies, IV-administered NBIB-’223 resulted in protein expression in the brain and heart, and GLP toxicology studies for NBIB-’223 are now complete. In May 2026, FDA granted orphan drug designation to NBIB-’223 for the treatment of FA. Neurocrine has informed us that it continues to progress the GBA1 Program in addition to three gene therapy programs for which we do not have opt-in rights. We maintain options to co-develop and co-commercialize the FA Program, under which profits and losses of the program would be allocated 60% to Neurocrine and 40% to us, and the GBA1 Program, under which profits and losses of the program would be allocated 50% to Neurocrine and 50% to us, in each case in the U.S.
Current wording
In addition to our wholly-owned pipeline, we are advancing three programs with collaboration partners for which we retain options to participate in future development and commercialization. Two of these programs are in collaboration with Neurocrine: a frataxin (FXN) gene therapy program for FA, or the FA Program, and a glucosylceramidase beta 1 gene therapy program that will focus on Gaucher disease and PD, or the GBA1 Program. Neurocrine has stated that, pending successful FDA IND clearance, it intends to initiate a clinical trial with NBIB-’223 for the treatment of FA in the second half of 2026. In preclinical studies, IV-administered NBIB-’223 resulted in protein expression in the brain and heart, and GLP toxicology studies for NBIB-’223 are now complete. In May 2026, FDA granted orphan drug designation to NBIB-’223 for the treatment of FA. Neurocrine has informed us that it continues to progress the GBA1 Program in addition to three gene therapy programs for which we do not have opt-in rights. We maintain options to co-develop and co-commercialize the FA Program, under which profits and losses of the program would be allocated 60% to Neurocrine and 40% to us, and the GBA1 Program, under which profits and losses of the program would be allocated 50% to Neurocrine and 50% to us, in each case in the U.S.
Previous wording
We are collaborating with Neurocrine on three gene therapy programs against undisclosed targets. Two of these three programs have development candidates selected and are advancing through preclinical toxicology studies. In addition to the Neurocrine collaborations, we have partnered with Novartis on TRACER Capsid-based gene therapies for spinal muscular atrophy, or SMA, and Huntington’s disease, or HD. We have also licensed capsids to Novartis for one undisclosed CNS target and to Alexion for one undisclosed rare neurological disease target. In total, our partnerships have delivered more than $500.0 million in non-dilutive funding to us to date, including upfront fees, development milestone payments, option exercise fees, license fees, and research and development expense reimbursement. Looking forward, we have the potential to earn up to $6.8 billion in milestone payments across the partnered portfolio, including $2.4 billion in potential development milestone payments, as well as royalties.
Current wording
We are collaborating with Neurocrine on three gene therapy programs against undisclosed targets. Two of these three programs have development candidates selected and are advancing through preclinical toxicology studies. In addition to the Neurocrine collaborations, we have partnered with Novartis on TRACER Capsid-based gene therapy programs for spinal muscular atrophy, or SMA, and Huntington’s disease, or HD. We have also licensed capsids to Novartis for one undisclosed CNS target and to Alexion for one undisclosed rare neurological disease target. In total, our partnerships have delivered more than $500.0 million in non-dilutive funding to us to date, including upfront fees, development milestone payments, option exercise fees, license fees, and research and development expense reimbursement. Looking forward, we have the potential to earn up to $6.8 billion in milestone payments across the partnered portfolio, including $2.4 billion in potential development milestone payments, as well as royalties.
Previous wording
All of the gene therapies in our wholly-owned and collaborative pipeline are delivered intravenously leveraging TRACER capsids. TRACER is a broadly applicable, RNA-based screening platform that enables rapid discovery of AAV capsids with robust penetration of the blood-brain barrier, or BBB, and enhanced CNS tropism in multiple species, including NHPs. We subsequently utilized these BBB-penetrant capsids to identify the receptors by which the capsids enter the BBB. We have identified multiple receptors, including alkaline phosphatase, or ALPL, that are capable of transporting a large biologic molecule, such as a capsid, across the BBB.
Current wording
All of the gene therapy product candidates in our wholly-owned and collaborative pipeline are delivered intravenously leveraging TRACER Capsids. TRACER is a broadly applicable, RNA-based screening platform that enables rapid discovery of AAV capsids with robust penetration of the blood-brain barrier, or BBB, and enhanced CNS tropism in multiple species, including NHPs. We subsequently utilized these BBB-penetrant capsids to identify the receptors by which the capsids enter the BBB. We have identified multiple receptors, including ALPL, that are capable of transporting a large biologic molecule, such as a capsid, across the BBB.
Previous wording
We have leveraged our knowledge of BBB receptors, discovered using TRACER, to develop a second delivery platform called Voyager NeuroShuttle TM. Voyager NeuroShuttle is a non-viral delivery platform leveraging novel receptor-binding molecules to transport multiple modalities of neurotherapeutics across the BBB. The first NeuroShuttle within the platform leverages the ALPL receptor. During the third quarter of 2025, we shared the results of initial murine proof-of-concept studies of ALPL-VYGR-NeuroShuttle demonstrating in the study sustained brain expression over three weeks, compared to less than one week for transferrin receptor, or TfR, shuttles, with no impact on circulating reticulocytes or downstream measurements of anemia. In addition to the initial murine proof-of-concept data provided for the ALPL-VYGR-NeuroShuttle, a proof-of-concept study using anti-amyloid antibodies demonstrated that the ALPL-NeuroShuttle showed similar target engagement to a TfR shuttle. We initiated a discovery program using ALPL-VYGR-NeuroShuttle to target an undisclosed neurological disease.
Current wording
We have leveraged our knowledge of BBB receptors, discovered using TRACER, to develop a second delivery platform called Voyager NeuroShuttle TM. Voyager NeuroShuttle is a non-viral delivery platform leveraging novel receptor-binding molecules to transport multiple modalities of neurotherapeutics across the BBB. The first NeuroShuttle within the platform leverages the ALPL receptor. During the third quarter of 2025, we shared the results of initial murine proof-of-concept studies of ALPL-VYGR-NeuroShuttle demonstrating in the study sustained brain expression over three weeks, compared to less than one week for transferrin receptor, or TfR, shuttles, with no impact on circulating reticulocytes or downstream measurements of anemia. In addition to the initial murine proof-of-concept data provided for the ALPL-VYGR-NeuroShuttle, a proof-of-concept study using anti-amyloid antibodies demonstrated that the ALPL-VYGR-NeuroShuttle showed similar target engagement to a TfR shuttle. We have initiated a discovery program using ALPL-VYGR-NeuroShuttle to target an undisclosed neurological disease.
Previous wording
the Novartis License Options, to license TRACER Capsids, or the Novartis Licensed Capsids, for exclusive use in programs targeting three specified genes, or the Initial Novartis Targets, to develop and commercialize AAV gene therapy candidates comprised of Novartis Licensed Capsids and payloads directed to the Initial Novartis Targets, or the Novartis Initial Licensed Products. Effective as of March 1, 2023, Novartis exercised its Novartis License Options to license TRACER Capsids for use in gene therapy programs against two undisclosed Initial Novartis Targets. Upon Novartis’ exercise of the two Novartis License Options for Initial Novartis Targets, we granted Novartis a target-exclusive, worldwide license, with the right to sublicense, under certain of our intellectual property, the rights to develop and commercialize the applicable Novartis Licensed Capsid as incorporated into Novartis Initial Licensed Products. We also agreed to provide certain additional know-how to enable Novartis to exploit the Novartis Licensed Capsid and a payload directed to the applicable Initial Novartis Target for use in a Novartis Initial Licensed Product. Novartis elected not to license a capsid for one Initial Novartis Target prior to the expiration of the applicable Novartis License Option. As a result, the non-exclusive research license that we granted to Novartis in connection with this third Initial Novartis Target terminated, and all capsid rights with respect to that Initial Novartis Target returned to us.
Current wording
On March 4, 2022, we entered into an option and license agreement with Novartis, or the 2022 Novartis Option and License Agreement. Pursuant to the 2022 Novartis Option and License Agreement, we granted Novartis options, or the Novartis License Options, to license TRACER Capsids, or the Novartis Licensed Capsids, for exclusive use in programs targeting three specified genes, or the Initial Novartis Targets, to develop and commercialize AAV gene therapy candidates comprised of Novartis Licensed Capsids and payloads directed to the Initial Novartis Targets, or the Novartis Initial Licensed Products. Effective as of March 1, 2023, Novartis exercised its Novartis License Options to license TRACER Capsids for use in gene therapy programs against two undisclosed Initial Novartis Targets. Upon Novartis’ exercise of the two Novartis License Options for Initial Novartis Targets, we granted Novartis a target-exclusive, worldwide license, with the right to sublicense, under certain of our intellectual property, the rights to develop and commercialize the applicable Novartis Licensed Capsid as incorporated into Novartis Initial Licensed Products. We also agreed to provide certain additional know-how to enable Novartis to exploit the Novartis Licensed Capsid and a payload directed to the applicable Initial Novartis Target for use in a Novartis Initial Licensed Product. Novartis elected not to license a capsid for one Initial Novartis Target prior to the expiration of the applicable Novartis License Option. As a result, the non-exclusive research license that we granted to Novartis in connection with this third Initial Novartis Target terminated, and all capsid rights with respect to that Initial Novartis Target returned to us.
Previous wording
We are eligible to receive specified development, regulatory, and commercialization milestone payments of up to an aggregate of $125.0 million for the first Novartis Initial Licensed Product for the remaining Initial Novartis Target for which a Novartis License Option has been exercised to achieve the corresponding milestone. We are eligible to receive (a) specified sales milestone payments of up to an aggregate of $175.0 million per Novartis Licensed Product directed to the remaining Initial Novartis Target and (b) tiered, escalating royalties in the mid-to high-single-digit percentages based on annual net sales of each Novartis Licensed Product directed to the remaining Initial Novartis Target. The remaining Initial Novartis Target is distinct from targets in our wholly-owned and partnered pipeline. For a further description of the 2022 Novartis Option and License Agreement, refer to Note 9,Significant Agreements, to our
Current wording
We are eligible to receive specified development, regulatory, and commercialization milestone payments of up to an aggregate of $125.0 million for the first Novartis Initial Licensed Product for the remaining Initial Novartis Target for which a Novartis License Option has been exercised to achieve the corresponding milestone. We are eligible to receive (a) specified sales milestone payments of up to an aggregate of $175.0 million per Novartis Licensed Product directed to the remaining Initial Novartis Target and (b) tiered, escalating royalties in the mid-to high-single-digit percentages based on annual net sales of each Novartis Licensed Product directed to the remaining Initial Novartis Target. The remaining Initial Novartis Target is distinct from targets in our wholly-owned and partnered pipeline. For a further description of the 2022 Novartis Option and License Agreement, refer to Note 9, Significant Agreements, to our consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, under the caption “2022 Novartis Option and License Agreement.”
Previous wording
The 2019 Neurocrine Collaboration Agreement provides for aggregate development milestone payments from Neurocrine to us for the gene therapy products, or the 2019 Collaboration Products under the FA Program of up to $195.0 million. We may be entitled to receive aggregate commercial milestone payments for each 2019 Collaboration Product of up to $275.0 million, for a total of up to $550.0 million under the FA Program. Neurocrine has also agreed to pay us royalties, based on future net sales of the 2019 Collaboration Products. Such royalty percentages, for net sales in and outside the United States, as applicable, range from the low-teens to high-teens and high-single digits to mid-teens,
Current wording
The 2019 Neurocrine Collaboration Agreement provides for aggregate development milestone payments from Neurocrine to us for the gene therapy products, or the 2019 Collaboration Products, under the FA Program of up to $195.0 million. We may be entitled to receive aggregate commercial milestone payments for each 2019 Collaboration Product of up to $275.0 million, for a total of up to $550.0 million under the FA Program. Neurocrine has also agreed to pay us royalties, based on future net sales of the 2019 Collaboration Products. Such royalty percentages, for net sales in and outside the United States, as applicable, range from the low-teens to high-teens and high-single digits to mid-teens, for the FA Program. For a further description of the 2019 Neurocrine Collaboration Agreement, refer to Note 9, Significant Agreements, to our consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 under the caption “2019 Neurocrine Collaboration Agreement.”
Previous wording
DNA Preparation Process, and to authorize the prospective exploitation of TRACER Capsids created with the use of the Subject DNA Preparation Process. The terms of the Touchlight License Agreement include future milestone payments and low single-digit royalties payable to Touchlight by us if we or our program collaborators or licensees choose to utilize in a therapeutic product certain TRACER Capsids that were created with the historical use of the Subject DNA Preparation Process. Additionally, we are obligated to pay low single-digit royalties to Touchlight on future payments we receive in connection with licensing of certain TRACER Capsids that were created with the historical use of the Subject DNA Preparation Process, excluding the licensing of or collaboration on any of our therapeutic programs. For a further description of the TouchLight License Agreement, refer to Note 9,Significant Agreements, to our consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, under the caption “Other Agreements.”
Current wording
In November 2022, we and Touchlight IP Limited, or Touchlight, entered into a license agreement, or the Touchlight License Agreement, to authorize historical use by us of a certain DNA preparation process, or the Subject DNA Preparation Process, and to authorize the prospective exploitation of TRACER Capsids created with the use of the Subject DNA Preparation Process. The terms of the Touchlight License Agreement include future milestone payments and low single-digit royalties payable to Touchlight by us if we or our program collaborators or licensees choose to utilize in a therapeutic product certain TRACER Capsids that were created with the historical use of the Subject DNA Preparation Process. Additionally, we are obligated to pay low single-digit royalties to Touchlight on future payments we receive in connection with licensing of certain TRACER Capsids that were created with the historical use of the Subject DNA Preparation Process, excluding the licensing of or collaboration on any of our therapeutic programs. For a further description of the Touchlight License Agreement, refer to Note 9, Significant Agreements, to our consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, under the caption “Other Agreements.”
Previous wording
We have a history of incurring significant losses. We reported a net loss of $27.9 million for the three months ended March 31, 2026, and a net loss of $119.7 million for the fiscal year ended December 31, 2025. As of March 31, 2026, we had an accumulated deficit of $473.8 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future in connection with our ongoing activities, if and as we:
Current wording
We have a history of incurring significant losses. We reported a net loss of $52.4 million for the six months ended June 30, 2026, and a net loss of $119.7 million for the fiscal year ended December 31, 2025. As of June 30, 2026, we had an accumulated deficit of $498.3 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future in connection with our ongoing activities, if and as we:
Previous wording
To date, we have not generated any revenue from product sales and do not expect to generate any revenue from product sales for the foreseeable future. For the three months ended March 31, 2026, we recognized $1.3 million of collaboration revenue from the 2023 Neurocrine Collaboration Agreement, $0.1 million of collaboration revenue from the 2019 Neurocrine Collaboration Agreement, and $1.2 million of collaboration revenue in connection with the 2023 Novartis Collaboration Agreement. For the three months ended March 31, 2025, we recognized $4.5 million of collaboration revenue from the 2023 Neurocrine Collaboration Agreement, $0.5 million of collaboration revenue from the 2019 Neurocrine Collaboration Agreement, $1.2 million of collaboration revenue in connection with the 2023 Novartis Collaboration Agreement, and $0.3 million of other collaboration revenue.
Current wording
To date, we have not generated any revenue from product sales and do not expect to generate any revenue from product sales for the foreseeable future. For the three months ended June 30, 2026, we recognized $0.4 million of collaboration revenue from the 2019 Neurocrine Collaboration Agreement and $2.8 million of collaboration revenue in connection with the 2023 Novartis Collaboration Agreement. For the six months ended June 30, 2026, we recognized $1.3 million of collaboration revenue from the 2023 Neurocrine Collaboration Agreement, $0.5 million of collaboration revenue from the 2019 Neurocrine Collaboration Agreement, and $4.0 million of collaboration revenue in connection with the 2023 Novartis Collaboration Agreement.
Previous wording
and estimates about matters that are uncertain at the time we make the estimate. There were no changes to our critical accounting policies during the three months ended March 31, 2026, as compared to those identified in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025. It is important that the discussion of our operating results that follow be read in conjunction with the critical accounting policies disclosed in Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations –Critical Accounting Policies and Estimates” in our Annual Report on Form 10-K, as filed with the SEC on March 9, 2026.
Current wording
We believe that several accounting policies are important to understanding our historical and future performance. We refer to these policies as critical because these specific areas generally require us to make judgments and estimates about matters that are uncertain at the time we make the estimate. There were no changes to our critical accounting policies during the three months ended June 30, 2026, as compared to those identified in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025. It is important that the discussion of our operating results that follow be read in conjunction with the critical accounting policies disclosed in Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations –Critical Accounting Policies and Estimates” in our Annual Report on Form 10-K, as filed with the SEC on March 9, 2026.
Previous wording
Collaboration revenue was $2.6 million and $6.5 million for the three months ended March 31, 2026 and 2025, respectively. During the three months ended March 31, 2026, we recognized $1.3 million of collaboration revenue under the 2023 Neurocrine Collaboration Agreement, $0.1 million of collaboration revenue under the 2019 Neurocrine Collaboration Agreement, and $1.2 million of collaboration revenue under the 2023 Novartis Collaboration Agreement. During the three months ended March 31, 2025, we recognized $4.5 million of collaboration revenue under the 2023 Neurocrine Collaboration Agreement, $0.5 million of collaboration revenue under the 2019 Neurocrine Collaboration Agreement, $1.2 million of collaboration revenue under the 2023 Novartis Collaboration Agreement, and $0.3 million in other collaboration revenue.
Current wording
Collaboration revenue was $5.8 million and $11.7 million for the six months ended June 30, 2026 and 2025, respectively. During the six months ended June 30, 2026, we recognized $1.3 million of collaboration revenue under the 2023 Neurocrine Collaboration Agreement, $0.5 million of collaboration revenue under the 2019 Neurocrine Collaboration Agreement, and $4.0 million of collaboration revenue under the 2023 Novartis Collaboration Agreement. During the six months ended June 30, 2025, we recognized $5.8 million of collaboration revenue under the 2023 Neurocrine Collaboration Agreement, $2.8 million of collaboration revenue under the 2019 Neurocrine Collaboration Agreement, $2.7 million of collaboration revenue under the 2023 Novartis Collaboration Agreement, and $0.4 million in other collaboration revenue.
Previous wording
Research and development expense was $24.6 million and $31.5 million for the three months ended March 31, 2026 and March 31, 2025, respectively. The $6.9 million decrease was primarily due to the discontinuation of the SOD1 program, reduced spend on the anti-tau antibody program (VY7523) as enrollment in planned clinical trials was completed, and lower employee-related expenses as we had lower headcount due to cost-cutting initiatives. The decrease was partially offset by an increase in the tau silencing gene therapy program (VY1706) in preparation for the planned clinical trial initiation.
Current wording
Research and development expense was $46.6 million and $62.9 million for the six months ended June 30, 2026 and 2025, respectively. The $16.2 million decrease was primarily attributable to lower employee-related expenses and shared facilities and other costs due to lower headcount resulting from restructuring actions undertaken in 2025. The decrease was further attributable to reduced spend on VY7523 as enrollment in the clinical trial was completed, the discontinuation of the SOD1 program, and reduced spend on other programs and platforms as a result of program prioritization. The decrease was partially offset by increased spend on VY1706 in preparation for the planned clinical trial initiation.
Previous wording
General and administrative expense decreased by $1.4 million from $9.6 million for the three months ended March 31, 2025 to $8.3 million for the three months ended March 31, 2026. The decrease in general and administrative expense was primarily attributable to lower legal fees and reduced employee-related expenses as a result of lower headcount year-over-year due to cost-cutting and efficiency initiatives.
Current wording
General and administrative expense was $15.8 million and $20.1 million for the six months ended June 30, 2026 and 2025, respectively. The $4.4 million decrease was primarily attributable to lower legal fees and reduced employee-related expenses due to lower headcount resulting from restructuring actions undertaken in 2025.
Previous wording
In November 2025, we entered into a sales agreement with TD Securities (USA) LLC, as the sales agent, pursuant to which we may from time to time, issue and sell common stock with an aggregate value of up to $100.0 million in an at-the-market offering, or the ATM Facility. We sold 630,570 shares of our common stock under the ATM Facility during the three months ended March 31, 2026. These shares were sold at a weighted average price per share of
Current wording
In November 2025, we entered into a sales agreement with TD Securities (USA) LLC, as the sales agent, pursuant to which we may, from time to time, issue and sell shares of common stock having an aggregate offering price of up to $100.0 million through an at-the-market program, or the ATM Facility. During the six months ended June 30, 2026, we sold 1,358,566 shares of our common stock under the ATM Facility at a weighted average price of $4.31 per share for net proceeds of $5.7 million, after deducting commissions and offering costs. As of June 30, 2026, $94.1 million remained available to be sold under the ATM Facility.
Previous wording
The following table provides information regarding our cash flows for the three months ended March 31, 2026, and 2025:
Current wording
The following table provides information regarding our cash flows for the six months ended June 30, 2026 and 2025:
Previous wording
Net cash used in operating activities was $33.4 million during the three months ended March 31, 2026, compared to $37.9 million during the three months ended March 31, 2025. The decrease in net cash used in operating activities is primarily attributed to a lower net loss. Net cash used in operating activities during the three months ended March 31, 2026, was primarily due to our net loss of $27.9 million, combined with changes in our working capital accounts, including decreases in accrued expenses and accounts payable and deferred revenue during the three months ended March 31, 2026.
Current wording
Net cash used in operating activities was $59.3 million during the six months ended June 30, 2026, compared to $71.2 million during the six months ended June 30, 2025. The decrease in net cash used in operating activities is primarily attributed to a lower net loss. Net cash used in operating activities during the six months ended June 30, 2026, was primarily due to our net loss of $52.4 million, combined with changes in our working capital accounts, including decreases in accounts payable, accrued expenses and operating lease liabilities during the six months ended June 30, 2026.
Previous wording
Net cash used in operating activities during the three months ended March 31, 2025, was primarily due to our net loss of $31.0 million, combined with changes in our working capital accounts, including a decrease in accrued expenses and deferred revenue during the three months ended March 31, 2025.
Current wording
Net cash used in operating activities during the six months ended June 30, 2025, was primarily due to our net loss of $64.4 million, combined with changes in our working capital accounts, including decreases in accounts payable, accrued expenses, operating lease liabilities and deferred revenue during the six months ended June 30, 2025.
Previous wording
Net cash provided by investing activities was $8.1 million during the three months ended March 31, 2026, compared to $41.2 million during the three months ended March 31, 2025. The decrease was primarily due to a decrease in proceeds from sales and maturities of marketable securities of $67.2 million, partially offset by decreases in purchases of marketable securities of $33.5 million during the three months ended March 31, 2026.
Current wording
Net cash provided by investing activities was $23.5 million during the six months ended June 30, 2026, compared to $43.1 million during the six months ended June 30, 2025. The decrease was primarily due to a decrease in proceeds from sales and maturities of marketable securities which was $94.4 million during the six months ended June 30, 2026, partially offset by decreases in purchases of marketable securities, which was $70.9 million during the six months ended June 30, 2026.
Previous wording
Net cash provided by financing activities was $3.3 million during the three months ended March 31, 2026, compared to $0.1 million during the three months ended March 31, 2025. The increase was primarily due to $3.0 million in proceeds during the three months ended March 31, 2026, from the issuance of common stock from the ATM Facility.
Current wording
Net cash provided by financing activities was $6.2 million during the six months ended June 30, 2026, compared to $0.6 million during the six months ended June 30, 2025. The increase was primarily due to $5.7 million in net proceeds during the six months ended June 30, 2026, from the issuance of common stock from the ATM Facility.
Previous wording
Our expenses decreased during the three months ended March 31, 2026, as compared with the three months ended March 31, 2025, as a result of continued portfolio prioritization and alignment of operating expenditures with our current capital resources. We expect we will continue to incur research and development expensesas we continue our research and development activities, conduct clinical trials, including completing the Phase 1 MAD clinical trial for VY7523 and initiating the clinical trial for VY1706, pending successful IND clearance, and seek marketing approval of our product candidates, and as we continue to enter into or conduct activities in connection with our collaboration agreements. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant expenses related to program sales, marketing, manufacturing and distribution to the extent that such sales, marketing and distribution are not the responsibility of potential collaborators. Furthermore, we expect to continue to
Current wording
Our expenses decreased during the six months ended June 30, 2026, as compared with the six months ended June 30, 2025, as a result of continued portfolio prioritization and alignment of operating expenditures with our current capital resources. We expect we will continue to incur research and development expenses as we continue our research and development activities, conduct clinical trials, including completing the Phase 1 MAD clinical trial for VY7523 and initiating the clinical trial for VY1706, and seek marketing approval of our product candidates, and as we continue to enter into or conduct activities in connection with our collaboration agreements. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant expenses related to program sales, marketing, manufacturing and distribution to the extent that such sales, marketing and distribution are not the responsibility of potential collaborators. Furthermore, we expect to continue to incur costs associated with operating as a public company, including executing financial statement controls, satisfying regulatory and quality standards, fulfilling healthcare compliance requirements, and maintaining product, clinical trial and directors’ and officers’ liability insurance coverage. We also anticipate the cost of goods and services and the levels of compensation paid to employees will increase due to inflationary conditions existing in the general economy. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital or enter into business development transactions when needed or on acceptable terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts.
Previous wording
As of March 31, 2026, we had cash, cash equivalents, and marketable securities of $171.7 million. Based upon our current operating plan, we expect that our existing cash, cash equivalents, and marketable securities at March 31, 2026, along with amounts expected to be received as reimbursement for development costs under our collaboration and license agreements with Neurocrine and Novartisand interest income, to be sufficientto meet our planned operating expenses and capital expenditure requirements into 2028. Our future capital requirements will depend on many factors, including:
Current wording
As of June 30, 2026, we had cash, cash equivalents, and marketable securities of $148.8 million. Based upon our current operating plan, we expect that our existing cash, cash equivalents, and marketable securities at June 30, 2026, along with amounts expected to be received as reimbursement for development costs under our collaboration and license agreements with Neurocrine and Novartis and interest income, to be sufficient to meet our planned operating expenses and capital expenditure requirements into 2028. Our future capital requirements will depend on many factors, including:
Previous wording
incur costs associated with operating as a public company, including executing financial statement controls, satisfying regulatory and quality standards, fulfilling healthcare compliance requirements, and maintaining product, clinical trial and directors’ and officers’ liability insurance coverage. We also anticipate the cost of goods and services and the levels of compensation paid to employees will increase due to inflationary conditions existing in the general economy. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital or enter into business development transactions when needed or on acceptable terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts.
Current wording
the costs of operating as a public company and maintaining adequate product, clinical trial, and directors’ and officers’ liability insurance coverage; and
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
VY7523 is an IV-administered, recombinant, humanized IgG4 monoclonal antibody developed to inhibit the spread of extracellular tau, which is closely correlated with disease progression and cognitive decline in AD. VY7523 targets an epitope in the C-terminal region and is specific for pathological tau. The murine version of VY7523 reduced tau spread by approximately 70% in preclinical studies. VY7523 demonstrated an acceptable safety, tolerability, and immunogenicity profile as well as expected pharmacokinetic results in a Phase 1, single ascending dose clinical trial in healthy volunteers. In February 2025, we initiated a Phase 1 multiple ascending dose, or MAD, clinical trial of VY7523 in early AD patients. Enrollment in this MAD clinical trial was completed in the fourth quarter of 2025, and we expect initial tau PET imaging efficacy data in the fourth quarter of 2026.
Current report — wording carried from elsewhere
continue investing in NeuroShuttle, our proprietary non-viral delivery platform leveraging novel receptor-binding molecules to transport multiple modalities of neurotherapeutics across the BBB;
Current report — wording carried from elsewhere
continue investing in our collaboration with Transition Bio to advance small molecules targeting TDP-43 to treat ALS and frontotemporal dementia with TDP-43 pathology;
Current report — wording carried from elsewhere
Collaboration revenue was $3.2 million and $5.2 million for the three months ended June 30, 2026 and 2025, respectively. During the three months ended June 30, 2026, we recognized $0.4 million of collaboration revenue under the 2019 Neurocrine Collaboration Agreement and $2.8 million of collaboration revenue under the 2023 Novartis Collaboration Agreement. During the three months ended June 30, 2025, we recognized $1.3 million of collaboration revenue under the 2023 Neurocrine Collaboration Agreement, $2.4 million of collaboration revenue under the 2019 Neurocrine Collaboration Agreement, $1.4 million of collaboration revenue under the 2023 Novartis Collaboration Agreement, and $0.1 million in other collaboration revenue.
Current report — wording carried from elsewhere
The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025:
Current report — wording carried from elsewhere
The following table summarizes our research and development expenses for the six months ended June 30, 2026 and 2025:
Rearranged previous paragraphs (6)
Previous report — wording carried elsewhere
On March 4, 2022, we entered into an option and license agreement with Novartis, or the 2022 Novartis Option and License Agreement. Pursuant to the 2022 Novartis Option and License Agreement, we granted Novartis options, or
Previous report — wording carried elsewhere
consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, under the caption “2022 Novartis Option and License Agreement.”
Previous report — wording carried elsewhere
for the FA Program. For a further description of the 2019 Neurocrine Collaboration Agreement, refer to Note 9,Significant Agreements, to our consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 under the caption “2019 Neurocrine Collaboration Agreement.”
Previous report — wording carried elsewhere
In November 2022, we and Touchlight IP Limited, or Touchlight, entered into a license agreement, or the Touchlight License Agreement, to authorize historical use by us of a certain DNA preparation process, or the Subject
Previous report — wording carried elsewhere
We believe that several accounting policies are important to understanding our historical and future performance. We refer to these policies as critical because these specific areas generally require us to make judgments
Previous report — wording carried elsewhere
$4.92 for aggregate net proceeds of $3.0 million, after deducting commissions and offering costs. As of March 31, 2026, $96.9 million remained available to be sold under the ATM Facility.