Voyager Therapeutics, Inc.

Previous wording

We are advancing our own proprietary pipeline of drug candidates for neurological diseases, with a focus on AD, and particularly on tau, which we view as a critically important AD target. Our wholly-owned prioritized pipeline includes two tau targeting programs: VY7523 (which we formerly referred to as VY-TAU01), an anti-tau antibody for AD, and VY1706, a tau silencing gene therapy for AD. 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, or SAD, 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. We believe this trial has the potential to generate initial data in the second half of 2026. VY1706 is a gene therapy that leverages an intravenously delivered TRACER Capsid containing a vectorized small interfering RNA specifically targeting tau mRNA. VY1706 was selected as the development candidate for the tau silencing gene therapy program in November 2024. In a non-human primate, or NHP, study, a single 1.3E13 vector genomes per kilogram 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 progression of AD. We anticipate the submission of an investigational new drug, or IND, application for the VY1706 program in 2026. Our proprietary pipeline also includes early research initiatives to develop a vectorized anti-amyloid antibody for AD and a superoxide dismutase 1, or SOD1, gene therapy for SOD1 amyotrophic lateral sclerosis.

Current wording

We are advancing our own proprietary pipeline of drug candidates for neurological diseases, with a focus on AD, including programs against three critically important AD targets: tau, amyloid and apolipoprotein E (APOE). Our wholly-owned prioritized pipeline includes two tau targeting programs: VY7523 (which we formerly referred to as VY-TAU01), an anti-tau antibody for AD, and VY1706, a tau silencing gene therapy for AD. 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, or SAD, 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. We believe this trial has the potential to generate initial data in the second half of 2026. 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 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 progression of AD. We anticipate the submission of an investigational new drug, or IND, application and initiation of a clinical trial for the VY1706 program in 2026.

Previous wording

We are also working with our collaboration partners on multiple programs. We are advancing five gene therapy programs with Neurocrine. Development candidates were selected for three of these programs in 2024, resulting in milestone payments to us. We expect that Neurocrine will submit IND filings in 2025 for the two most advanced of these programs, a glucosylceramidase beta 1, or GBA1, gene therapy program, and a frataxin, or FXN, gene therapy program for FA, or the FA Program, provided the ongoing GLP toxicology studies support clinical development. These two programs are particularly significant to us for two reasons: thesubsequent clinical trials of these programs have the potential to establish human proof-of-concept for the TRACER Capsids, and we have the option to opt-in on co-development and co-commercialization in the United States for both products. Initiation of the first clinical trials for the FA and GBA1 programs are expected in 2026, and the associated regulatory and clinical milestones that we could potentially realize related to these indications in 2025-2026 total up to $35 million.

Current wording

programs, a glucosylceramidase beta 1, or GBA1, gene therapy program, and a frataxin, or FXN, gene therapy program for FA, or the FA Program, provided the ongoing GLP toxicology studies support clinical development. These two programs are particularly significant to us for two reasons: the subsequent clinical trials of these programs have the potential to establish human proof-of-concept for the TRACER Capsids, and we have the option to opt-in on co-development and co-commercialization in the United States for both products. Initiation of the first clinical trials for the FA and GBA1 programs are expected in 2026, and the associated regulatory and clinical milestones that we could potentially realize related to these indications in 2025-2026 total up to $35 million.

Previous wording

The GBA1 program, or the GBA1 Program, will focus on both Gaucher and Parkinson’s disease. Gaucher disease is a rare genetic disorder passed down from parents to children. People who have Gaucher disease are missing an enzyme that breaks down fatty substances called lipids. Lipids start to build up in certain organs such as the spleen and liver. In April 2025, Neurocrine deprioritized two discovery-stage programs against undisclosed targets which we had been developing under a collaboration and license agreement with Neurocrine for the research, development and commercialization of certain of our AAV gene therapy products, or the 2019 Neurocrine Collaboration Agreement. On April 30, 2025, the joint steering committee, or JSC, with Neurocrine agreed to discontinue these programs, so rights to these targets returned to us. The discontinuations were not due to any safety concerns. In addition to the Neurocrine collaborations, we have partnered with Novartis on TRACER Capsid-based gene therapies for spinal muscular atrophy and Huntington’s disease. We have also licensed capsids to Novartis for three undisclosed CNS targets and to Alexion for one undisclosed rare neurological disease target. In total, these 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 $7.4 billion in milestone payments across the partnered portfolio, including $2.6 billion in potential development milestone payments, as well as royalties.

Current wording

The GBA1 program, or the GBA1 Program, will focus on both Gaucher and Parkinson’s disease. In addition to the FA and GBA1 Programs, we are collaborating with Neurocrine on three gene therapy programs against undisclosed targets. In addition to the Neurocrine collaborations, we have partnered with Novartis on TRACER Capsid-based gene therapies for spinal muscular atrophy and Huntington’s disease. We have also licensed capsids to Novartis for three undisclosed CNS targets 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 $7.4 billion in milestone payments across the partnered portfolio, including $2.6 billion in potential development milestone payments, as well as royalties.

Previous wording

All of the gene therapies in our wholly-owned and collaborative pipeline leverage TRACER. 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 are also developing a second, non-viral therapeutics platform focused on non-viral receptor-mediated transport across the BBB.

Current 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 are also developing a second, non-viral therapeutics platform focused on non-viral receptor-mediated transport across the BBB.

Previous wording

In January 2023, we entered into a collaboration agreement with Neurocrine for the research, development, manufacture and commercialization of certain of our AAV gene therapy products, or the 2023 Neurocrine Collaboration Agreement. Under the 2023 Neurocrine Collaboration Agreement, we agreed to collaborate on the conduct of four collaboration programs, which we refer to collectively as the 2023 Neurocrine Programs: the GBA1 Program, and three new programs focused on the research, development, manufacture and commercialization of gene therapies designed to address central nervous system diseases or conditions associated with rare genetic targets, or the 2023 Discovery Programs. Neurocrine has agreed to be responsible for all costs we incur in conducting preclinical development activities for each 2023 Neurocrine Program, in accordance with workplans and budgets agreed upon by a JSC.

Current wording

In January 2023, we entered into a collaboration agreement with Neurocrine for the research, development, manufacture and commercialization of certain of our AAV gene therapy products, or the 2023 Neurocrine Collaboration Agreement. Under the 2023 Neurocrine Collaboration Agreement, we agreed to collaborate on the conduct of four collaboration programs, which we refer to collectively as the 2023 Neurocrine Programs: the GBA1 Program, and three new programs focused on the research, development, manufacture and commercialization of gene therapies designed to address central nervous system diseases or conditions associated with rare genetic targets, or the 2023 Discovery Programs. Neurocrine has agreed to be responsible for all costs we incur in conducting preclinical development activities for each 2023 Neurocrine Program, in accordance with workplans and budgets agreed upon by a Joint Steering Committee, or JSC.

Previous wording

The 2019 Neurocrine Collaboration Agreement provides for aggregate development milestone payments from Neurocrine to us for the research, development, manufacture, and commercialization of 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, subject to an aggregate cap on commercial milestone payments across all 2019 Neurocrine Programs of $1.1 billion. We are no longer eligible to receive milestone or royalty payments for the VY-AADC Program in light of the partial termination of the 2019 Neurocrine Collaboration Agreement with respect to the VY-AADC Program. The JSC’s selection of a lead development candidate for the FA Program in February 2024 triggered a $5.0 million milestone payment to us, which we received in March 2024. In April 2025, Neurocrine deprioritized both 2019 Discovery Programs. On April 30, 2025, the JSC agreed to discontinue these programs, so rights to these targets returned to us. The discontinuations were not due to any safety concerns. As a result, such programs are deemed terminated, and we are no longer eligible to receive the milestones for either of the two 2019 Discovery Programs of up to $130.0 million per 2019 Discovery Program or any commercial milestones or royalties related thereto.

Current wording

The 2019 Neurocrine Collaboration Agreement provides for aggregate development milestone payments from Neurocrine to us for the research, development, manufacture, and commercialization of 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, subject to an aggregate cap on commercial milestone payments across all 2019 Neurocrine Programs of $1.1 billion. We are no longer eligible to receive milestone or royalty payments for the VY-AADC Program in light of the partial termination of the 2019 Neurocrine Collaboration Agreement with respect to the VY-AADC Program. The JSC’s selection of a lead development candidate for the FA Program in February 2024 triggered a $5.0 million milestone payment to us, which we received in March 2024. In April 2025, Neurocrine deprioritized both 2019 Discovery Programs. On April 30, 2025, the JSC agreed to discontinue these programs, so rights to these targets returned to us. The discontinuations were not due to any safety concerns. As a result, such programs are deemed terminated, and we are no longer eligible to receive the

Previous wording

We have a history of incurring significant losses. We reported a net loss of $31.0 million for the three months ended March 31, 2025 and a net loss of $65.0 million for the fiscal year ended December 31, 2024. As of March 31, 2025, we had an accumulated deficit of $357.2 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase substantially in connection with our ongoing activities, as we:

Current wording

We have a history of incurring significant losses. We reported a net loss of $64.4 million for the six months ended June 30, 2025 and a net loss of $65.0 million for the fiscal year ended December 31, 2024. As of June 30, 2025, we had an accumulated deficit of $390.6 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase substantially in connection with our ongoing activities, 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, 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. For the three months ended March 31, 2024, we recognized $11.5 million of collaboration revenue from the 2023 Neurocrine Collaboration Agreement, $6.5 million of collaboration revenue from the 2019 Neurocrine Collaboration Agreement, $0.8 million of collaboration revenue in connection with the 2023 Novartis Collaboration Agreement, and $0.7 million of collaboration revenue in connection with the premium on the issuance of the Novartis Shares to Novartis pursuant to the 2023 Novartis Stock Purchase Agreement.

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, 2025, we recognized $2.4 million of collaboration revenue from the 2019 Neurocrine Collaboration Agreement, $1.4 million of collaboration revenue in connection with the 2023 Novartis Collaboration Agreement, $1.3 million of collaboration revenue from the 2023 Neurocrine Collaboration Agreement, and $0.1 million of other collaboration revenue. For the six months ended June 30, 2025, we recognized $5.8 million of collaboration revenue from the 2023 Neurocrine Collaboration Agreement, $2.8 million of collaboration revenue from the 2019 Neurocrine Collaboration Agreement, $2.7 million of collaboration revenue in connection with the 2023 Novartis Collaboration Agreement, and $0.4 million of other collaboration revenue.

Previous wording

Research and development activities are central to our business model. We are in the early stages of development of our product candidates. During the three months ended March 31, 2025, our research and development expenses have increased as compared to the amounts recorded in the same period in the prior year. As our research and development programs progress and as we identify product candidates and initiate preclinical studies and clinical trials, including our SAD and MAD clinical trials to evaluate VY7523, we expect research and development costs to continue to increase. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of our product candidates.

Current wording

Research and development activities are central to our business model. We are in the early stages of development of our product candidates. During the six months ended June 30, 2025, our research and development expenses have increased as compared to the amounts recorded in the same period in the prior year. As our research and development programs progress and as we identify product candidates and initiate preclinical studies and clinical trials, including our MAD clinical trial to evaluate VY7523, we expect research and development costs to continue to increase. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of our product candidates.

Previous wording

General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in executive, finance, accounting, information technology, business development, legal and human resource functions. Other significant costs include corporate facility costs not otherwise included in research and development expenses, legal fees related to patent and corporate matters and fees for accounting and consulting services.

Current wording

General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in executive, finance, accounting, information technology, business development, legal and human resource functions. Other significant costs include corporate facility costs not otherwise included in research and development expenses, legal fees related to patent and corporate matters and fees for accounting, consulting services, and one-time severance benefits, including cash severance, temporary health care coverage, and transition support services related to a reduction in force recorded in the second quarter of 2025.

Previous wording

During the three months ended March 31, 2025, our general and administrative expenses have increased as compared to the amount recorded in the same period in prior year primarily due to additional professional services used in the quarter compared to the three months ended March 31, 2024.

Current wording

During the six months ended June 30, 2025, general and administrative expenses have increased as compared to the amount recorded in the same period in prior year primarily due to increased employee related costs including amounts associated with the reduction in force completed during the three months ended June 30, 2025.

Previous 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 March 31, 2025, as compared to those identified in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024. 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 11, 2025.

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 six months ended June 30, 2025, as compared to those identified in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024. 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 11, 2025.

Previous wording

Collaboration revenue was $6.5 million and $19.5 million for the three months ended March 31,2025 and 2024, respectively. During the three months ended March 31, 2025, we recognized collaboration revenue in connection with the following agreements:

Current wording

Collaboration revenue was $5.2 million and $29.6 million for the three months ended June 30, 2025 and 2024, respectively. This decrease was primarily due to the recognition of revenue under the percent complete model for up front work related to the 2023 Neurocrine Collaboration Agreement during the second quarter of 2024. During the three months ended June 30, 2025, we recognized collaboration revenue in connection with the following agreements:

Previous wording

Research and development expense increased by $4.4 million from $27.1 million for the three months ended March 31, 2024 to $31.5 million for the three months ended March 31, 2025. The following table summarizes our research and development expenses for the three months ended March 31, 2025 and 2024. All amounts for the three months ended March 31, 2024 have been reclassified to conform to the current year’s presentation.

Current wording

and development expenses for the three months ended June 30, 2025 and 2024. All amounts for the three months ended June 30, 2024 have been reclassified to conform to the current year’s presentation.

Previous wording

The increase in research and development expense for the three months ended March 31, 2025 was primarily attributable to the following:

Current wording

The decrease in research and development expense for the three months ended June 30, 2025 was primarily attributable to the following:

Previous wording

During the three months ended March 31, 2024, we completed an underwritten public offering which resulted in net proceeds to us of approximately $93.5 million after deducting underwriting discounts and commissions and offering expenses.

Current wording

During the six months ended June 30, 2024, we completed an underwritten public offering which resulted in net proceeds to us of approximately $93.5 million after deducting underwriting discounts and commissions and offering expenses.

Previous wording

We and Novartis entered into the 2023 Novartis Stock Purchase Agreement, on December 28, 2023, for the sale and issuance of the Novartis Shares to Novartis at a price of $9.324 per share, for an aggregate purchase price of approximately $20.0 million. In accordance with the terms and conditions of the 2023 Novartis Stock Purchase Agreement, we issued and sold these shares to Novartis on January 3, 2024.

Current wording

We and Novartis entered into the 2023 Novartis Stock Purchase Agreement, on December 28, 2023, for the sale and issuance of the Novartis Shares to Novartis at a price of $9.324 per share, for an aggregate purchase price of

Previous wording

The following table provides information regarding our cash flows for the three months ended March 31, 2025, and 2024:

Current wording

The following table provides information regarding our cash flows for the six months ended June 30, 2025 and 2024:

Previous wording

The net cash provided by operating activities during the three months ended March 31, 2024 was primarily due to a decrease in accounts receivable from the cash receipt under the 2023 Novartis Collaboration Agreement during the first quarter of 2024, offset by the net loss of $11.3 million, combined with changes in our working capital accounts, including a decrease in deferred revenue and a decrease in accrued expenses during the three months ended March 31, 2024.

Current wording

Net cash used in operating activities was $71.2 million during the six months ended June 30, 2025, compared to $27.2 million of net cash provided by operating activities during the six months ended June 30, 2024. The change was primarily due to a decrease in accounts receivable of $78.4 million during the 2024 period primarily from the receipt of the $80.0 million upfront payment under the 2023 Novartis Collaboration Agreement during the first quarter of 2024.

Previous wording

Net cash provided by investing activities was $41.2 million during the three months ended March 31, 2025 compared to $96.1 million of net cash used in investing activities during the three months ended March 31, 2024. The change was primarily due to a decrease of $126.9 million of purchases of marketable securities during the three months ended March 31, 2025 as compared to March 31, 2024. Further, proceeds from sales and maturities of marketable securities increased by $8.9 million during the three months ended March 31, 2025 compared to March 31, 2024.

Current wording

Net cash provided by investing activities was $43.1 million during the six months ended June 30, 2025, compared to $132.0 million in cash used in investing activities during the six months ended June 30, 2024. The change was primarily due to decreased purchases of marketable securities during the six months ended June 30, 2025 as compared to the six months ended June 30, 2024.

Previous wording

Net cash provided by financing activities was $0.1 million during the three months ended March 31, 2025 compared to $112.9 million during the three months ended March 31, 2024. The decrease was primarily due to $93.5 million in net proceeds from the issuance of common stock and pre-funded warrants in connection with the public offering in 2024, and $19.3 million in proceeds from the issuance of common stock in connection with the 2023 Novartis Stock Purchase Agreement, during the three months ended March 31, 2024.

Current wording

Net cash provided by financing activities was $0.6 million during the six months ended June 30, 2025, compared to $113.4 million during the six months ended June 30, 2024. The change was primarily due to proceeds from the issuance of common stock and pre-funded warrants in connection with the underwritten public offering and the issuance of common stock in connection with the 2023 Novartis Stock Purchase Agreement during the first quarter of 2024.

Previous wording

Our expenses during the three months ended March 31, 2025, increased as compared with the three months ended March 31, 2024, as we progressed our research and development programs, advanced VY7523 into clinical development, and increased headcount. We expect our expenses to continue to increase as we continue the research and development of, conduct clinical trials of, and seek marketing approval for our product candidates, including in our ongoing Phase 1 MAD clinical trial to evaluate VY7523 in 2025, 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 incur increasing costs associated with operating as a public company, 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 the current 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

Our expenses increased duringthe six months ended June 30, 2025, as compared withthe six months ended June 30, 2024, as our development programs progressed, we advanced VY7523 into clinical development, and due to charges related to our reduction in force. We expect our expenses to continue to increase as we continue the research and development of, conduct clinical trials of, and seek marketing approval for our product candidates, including in our ongoing Phase 1 MAD clinical trial to evaluate VY7523 in 2025, 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 incur increasing costs associated with operating as a public company, 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.

Previous wording

As of March 31, 2025 we had cash, cash equivalents, and marketable securities of $295.1 million. Based upon our current operating plans, we expect that our existing cash, cash equivalents, and marketable securities at March 31, 2025 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 mid-2027. Our future capital requirements will depend on many factors, including:

Current wording

As of June 30, 2025, we had cash, cash equivalents, and marketable securities of $262.0 million. Based upon our current operating plans, we expect that our existing cash, cash equivalents, and marketable securities at June 30, 2025, 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

Identifying potential product candidates and conducting preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete. We may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success. Our product revenues, if any, and any commercial milestone payments or royalty payments under our collaboration agreements, will be derived from sales of products that may not be commercially available for many years, if at all. Accordingly, we will need to continue to rely on additional financing and business development transactions to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all.

Current wording

Identifying potential product candidates and conducting preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete. We may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success. Our product revenues, if any, and any commercial milestone payments or royalty

Previous wording

Our agreements to license intellectual property include potential milestone payments that are dependent upon the development of products using the intellectual property licensed under the agreements and contingent upon the achievement of clinical trial or regulatory approval milestones. We may also be required to pay annual maintenance fees or minimum amounts payable ranging from low-four digits to low five-digits depending upon the terms of the applicable agreement. In certain instances, we are also obligated to pay our licensors royalties based on sales of products, if approved, using the intellectual property licensed under the applicable agreement.

Current wording

Our agreements to license intellectual property generally include potential milestone payments that are dependent upon the development of products using the intellectual property licensed under the agreements and contingent upon the achievement of clinical trial or regulatory approval milestones. We may also be required to pay annual maintenance fees or minimum amounts payable ranging from low-four digits to low five-digits depending upon the terms of the applicable agreement. In certain instances, we are also obligated to pay our licensors royalties based on sales of products, if approved, using the intellectual property licensed under the applicable agreement.