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MapLight Therapeutics, Inc.

For the period ended Mar 31, 2026. Filed May 14, 2026.

View on SEC.gov

About 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.

Mar 31, 2026 · Filed May 14, 2026

MPLT$6.93+11.4%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-09-30; filed 2025-12-04.

0001193125-25-307453

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-03-31; filed 2026-05-14.

0001193125-26-224129

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

The 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 125 previous paragraphs and 116 current paragraphs.

63 unchanged; 35 reworded; 18 added; 24 removed; 3 previous and 0 current paragraphs rearranged.

Tables are not compared: 7 previous and 4 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 (18)

Current report

Our second clinical stage product candidate, ML-004, is a 5-HT 1B/1Dagonist that we are developing for the treatment of social communication deficit and/or irritability in autism spectrum disorder, or ASD. We are conducting IRIS, a Phase 2 trial evaluating the efficacy, safety and tolerability of ML-004 in adults and adolescents with ASD. 161 participants were randomized in this trial, and we expect to report topline results by mid-August 2026.

Current report

Research and development expenses were $53.7 million for the three months ended March 31, 2026, compared to $19.8 million for the three months ended March 31, 2025. The increase in research and development expenses of $33.9 million was primarily due to ongoing advancement of our product candidates, which included an increase of $22.9 million in clinical trial expenses and $8.9 million in employee-related expenses, including an increase in stock-based compensation expense of $5.3 million.

Current report

General and administrative expenses were $10.8 million for the three months ended March 31, 2026, compared to $3.8 million for the three months ended March 31, 2025. The increase in general and administrative expenses of $7.1 million was primarily due to an increase of $4.9 million in employee-related expenses, including an increase in stock-based compensation expense of $4.2 million, and an increase of $2.1 million in professional fees and other expenses, including expenses related to being a publicly-traded company.

Current report

During the three months ended March 31, 2026, net cash used in operating activities was $51.2 million, primarily resulting from our net loss of $60.7 million, which was primarily attributable to our research and development expenses, along with changes in our operating assets and liabilities of $0.3 million, partially offset by $9.2 million of non-cash items.

Current report

During the three months ended March 31, 2025, net cash used in operating activities was $25.6 million, primarily resulting from our net loss of $22.3 million, which was primarily attributable to our research and development expenses, along with changes in our operating assets and liabilities of $3.5 million, partially offset by $0.3 million of non-cash items.

Current report

Net cash used in financing activities was $6.9 million for the three months ended March 31, 2026, compared to net cash used in financing activities of a de minimis amount for the three months ended March 31, 2025. The increase in cash used in financing activities was due to the payment of employee tax obligations related to vesting of restricted stock units during the three months ended March 31, 2026.

Current report

the effectiveness of our platform in identifying additional targets and indications of interest;

Current report

our ability to address any potential supply chain interruptions or delays;
Removed paragraphs (24)

Previous report

In June 2020, we entered into an Asset Purchase Agreement, or the NeuroSolis Agreement, with NeuroSolis Inc., or NeuroSolis, to acquire NeuroSolis's proprietary M 1/M 4 agonist molecules and associated intellectual property.

Previous report

Pursuant to the NeuroSolis Agreement, NeuroSolis sold us its assets related to both its proprietary M 1/M 4 agonist molecules, and its program for the identification of molecules that modulate the activity of the muscarinic M 1 receptor or the muscarinic M 4 receptor. We did not assume any liabilities of NeuroSolis in connection with our purchase of these assets. We are obligated to use commercially reasonable efforts to achieve specified development and regulatory milestones by developing a product covered by a transferred patent, including ML-007C-MA.

Previous report

We have made upfront and development milestone payments of $150,000 in the aggregate to NeuroSolis. In addition, we agreed to issue NeuroSolis up to an aggregate of 62,083 shares of our common stock, contingent upon the occurrence of specified development and regulatory milestones, of which 26,607 were issued in June 2025.

Previous report

In October 2023, we entered into an Assignment and Assumption Agreement with Stellaromics, Inc., or Stellaromics, an entity focused on developing and commercializing a proprietary three-dimensional transcriptomic device inclusive of a confocal, probes, operating software and sample analysis software, pursuant to which we transferred all our rights and obligations to the licenses for STARmap and SNAIL-RCA technologies from Stanford University, or the Stellaromics Agreement. In exchange for the transfer of intellectual property, we received an equity investment in Stellaromics common stock and the right to continue using these technologies in devices already owned. See "—Loss from Equity Method Investment" below and the notes to our consolidated financial statements appearing elsewhere in this Quarterly Report for information regarding our equity method investment.

Previous report

In October 2023, we entered into the Stellaromics Agreement. As of September 30, 2025, we held approximately 3.7% of the outstanding capital stock of Stellaromics. Additionally, Christopher A. Kroeger, M.D., our Chief Executive Officer and a member of our board of directors, and George Pavlov, one of our directors, are members of Stellaromics' board of directors, and our largest stockholder, Catalyst4, Inc., holds greater than 30.0% of the outstanding capital stock of Stellaromics. We have significant influence over, but do not control, Stellaromics through our noncontrolling representation on Stellaromics' board of directors and our equity interest in Stellaromics. We determined that Stellaromics is a variable interest entity because it does not have sufficient equity at risk to finance its operations without additional subordinated financial support. We are not the primary beneficiary as we do not have the power to direct activities that most significantly impact Stellaromics' economic performance. Accordingly, we do not consolidate the financial statements of Stellaromics and account for this investment using the equity method of accounting.

Previous report

Under the equity method of accounting, our investments are initially recorded at fair value on our consolidated balance sheets. Upon recording an equity method investment, we evaluate whether there are basis differences between the carrying value and fair value of our proportionate share of the investee's underlying net assets. Typically, we amortize identified basis differences on a straight-line basis over the underlying asset's or liability's estimated useful life when calculating the attributable earnings or losses. If we are unable to attribute all of the basis difference to specific assets or liabilities of the investee, we consider the residual excess of the cost of the investment over the proportional fair value of the investee's assets and liabilities to be equity method goodwill, which is recognized within the equity investment balance. We subsequently record in the consolidated statements of operations and comprehensive loss our share of income or loss of the other entity within the equity method investment, net line item.

Previous report

We evaluate our equity method investments for impairment whenever events or changes in circumstances indicate that the carrying amounts of such investments may be impaired and consider qualitative and quantitative factors including the investee's financial metrics, product and commercial outlook and cash usage. If a decline in the value of an equity method investment is determined to be other than temporary, a loss is recorded in earnings in the current period and the investment is written down to fair value.

Previous report

Research and development expenses were $27.1 million for the three months ended September 30, 2025, compared to $16.8 million for the three months ended September 30, 2024. The increase in total research and development expenses of $10.3 million was primarily due to an increase of $8.0 million in clinical trial expenses, an increase of $1.4 million in employee-related expenses related to increased headcount associated with expanded clinical activities, and an increase of $0.8 million in formulation and chemistry, manufacturing and controls, or CMC, expenses, offset by a decrease of $0.7 million in preclinical program expenses. Research and development expenses were reduced as a result of grant earnings recognized of $1.2 million and $0.5 million for the three months ended September 30, 2025 and 2024, respectively.

Previous report

General and administrative expenses were $4.4 million for the three months ended September 30, 2025, compared to $4.1 million for the three months ended September 30, 2024. The increase in total general and administrative expenses of $0.3 million was primarily due to an increase of $0.5 million in professional fees driven by increased legal and consulting costs, partially offset by a decrease of $0.2 million in employee-related expenses.

Previous report

Comparison of the Nine Months Ended September 30, 2025 and 2024

Previous report

Research and development expenses were $73.7 million for the nine months ended September 30, 2025, compared to $47.8 million for the nine months ended September 30, 2024. The increase in total research and development expenses of $25.9 million was primarily due to an increase of $16.5 million in clinical trial expenses, an increase of $5.7 million in employee-related expenses related to increased headcount associated with expanded clinical activities, and an increase of $3.0 million in formulation and CMC expenses, offset by a decrease of $2.1 million in preclinical program expenses. Research and development expenses were reduced as a result of grant earnings recognized of $2.0 million and $1.0 million for the nine months ended September 30, 2025 and 2024, respectively.

Previous report

General and administrative expenses were $12.0 million for the nine months ended September 30, 2025, compared to $12.4 million for the nine months ended September 30, 2024. The decrease in total general and administrative expenses of $0.4 million was primarily due to a decrease of $0.7 million in professional fees driven by decreased consulting costs, partially offset by an increase of $0.3 million in employee-related expenses.

Previous report

Interest income was $3.0 million for the nine months ended September 30, 2025, compared to $3.6 million for the nine months ended September 30, 2024. The decrease in interest income of $0.6 million was due to the decreased short-term and long-term investments held at September 30, 2025 compared to September 30, 2024.

Previous report

The loss from equity method investment of $1.0 million recognized during the nine months ended September 30, 2024 was due to recognition of the loss from equity method investment related to our investment in Stellaromics. As of September 30, 2025, the carrying value of the equity method investment was $0, and no further losses will be recorded because we do not have any obligation to fund future losses.

Previous report

Other income, net was $1.1 million for the nine months ended September 30, 2025, compared to $1.2 million for the nine months ended September 30, 2024. The decrease of $0.1 million was primarily due to decreased amortization of premiums and accretion of discounts on investments held during the nine months ended September 30, 2025.

Previous report

Net cash used in operating activities was $91.3 million for the nine months ended September 30, 2025, reflecting a net loss of $81.6 million and a net change in our net operating assets and liabilities of $11.1 million, partially offset by non-cash charges of $1.4 million. The change in our net operating assets and liabilities was primarily due to a $10.8 million increase in prepaid expenses and other assets, a $2.0 million decrease in deferred grant earnings and a $0.6 million decrease in operating lease liability, offset by a $1.8 million increase in accrued expenses and a $0.5 million increase in accounts payable. Non-cash charges primarily consisted of $0.6 million of non-cash lease expense, $0.5 million of common stock issued to NeuroSolis, $0.5 million of stock-based compensation expense, and $0.4 million of depreciation, offset by $0.7 million of net amortization of premiums and accretion of discounts on investments.

Previous report

Net cash used in operating activities was $57.3 million for the nine months ended September 30, 2024, reflecting a net loss of $56.4 million and a net change in our net operating assets and liabilities of $2.5 million, partially offset by non-cash charges of $1.6 million. The change in our net operating assets and liabilities was primarily due to a $1.2 million decrease in accounts payable, a $1.0 million decrease in deferred grant earnings, a $0.9 million increase in prepaid expenses and other assets and a $0.5 million decrease in operating lease liability, offset by a $1.0 million increase in accrued expenses. Non-cash charges primarily consisted of $1.0 million of loss from equity method investment, $0.9 million of stock-based compensation expense, $0.5 million of non-cash lease expense and $0.5 million of depreciation, offset by $1.3 million of net amortization of premiums and accretion of discounts on investments.

Previous report

Net cash provided by financing activities was $197.9 million for the nine months ended September 30, 2025, compared to net cash provided by financing activities of $118.1 million for the nine months ended September 30, 2024. The increase in cash provided by financing activities was primarily due to proceeds received from the issuance and sale of shares of our Series D Preferred Stock, net of issuance costs during the nine months ended September 30, 2025.

Previous report

Our agreements to license intellectual property include potential milestone payments that are dependent upon the development of products using the licensed intellectual property and contingent upon the achievement of development, regulatory, and commercial milestones. As of September 30, 2025, we were unable to estimate the timing or likelihood of these milestones.
Reworded paragraphs (35)

Previous wording

You should read the following discussion and analysis of our financial condition and results of operations together with our audited consolidated financial statements and related notes as of and for the year ended December 31, 2024 included in our final prospectus filed with the Securities and Exchange Commission on October 27, 2025 pursuant to Rule 424(b)(3) under the Securities Act for our IPO, our unaudited condensed financial statements and related notes included elsewhere in this Quarterly Report and other financial information included elsewhere in this Quarterly Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, future results of operations and financial position, and our objectives for future operations, includes forward-looking statements that involve risks and uncertainties. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "might," "intend," "target," "ongoing," "project," "estimate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions intended to identify statements about the future. As a result of many factors, including those factors set forth in the section entitled "Risk Factors" of this Quarterly Report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis or set forth elsewhere in this Quarterly Report.

Current wording

You should read the following discussion and analysis of our financial condition and results of operations together with our audited consolidated financial statements and related notes and other financial information included elsewhere in this Quarterly Report and with the audited consolidated financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2025. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, future results of operations and financial position, and our objectives for future operations, includes forward-looking statements that involve risks and uncertainties. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "might," "intend," "target," "ongoing," "project," "estimate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions intended to identify statements about the future. As a result of many factors, including those factors set forth in the section entitled "Risk Factors" of this Quarterly Report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis or set forth elsewhere in this Quarterly Report.

Previous wording

Our lead product candidate, ML-007C-MA, is a fixed-dose combination of an M 1/M 4 muscarinic agonist, ML-007, co-formulated with a peripherally acting anticholinergic, or PAC, which we are initially developing for the treatment of schizophrenia and Alzheimer's disease psychosis, or ADP. ML-007C-MA is designed to activate both M 1 and M 4 muscarinic receptors centrally to drive efficacy, while synchronizing the pharmacokinetics of the agonist and antagonist components to mitigate peripheral cholinergic side effects. ML-007 alone, co-administered or co-formulated with the PAC has been evaluated in four Phase 1 trials, with a total of 270 healthy participants enrolled and more than 1,500 doses of ML-007 administered. Based on our clinical and preclinical data, we believe that ML-007C-MA has demonstrated the potential to be a well-tolerated treatment option with convenient dosing, while achieving or exceeding cerebrospinal fluid, or CSF, exposures expected to result in improvement across key symptom domains. We are currently conducting ZEPHYR, a Phase 2 trial evaluating ML-007C-MA for the treatment of acute schizophrenia, and expect topline results in the second half of 2026. We are also conducting VISTA, a Phase 2 trial evaluating ML-007C-MA for the treatment of ADP, and expect topline results in the second half of 2027.

Current wording

Our lead product candidate, ML-007C-MA, is a fixed-dose combination of an M 1/M 4 muscarinic agonist, ML-007, co-formulated with a peripherally acting anticholinergic, or PAC, which we are initially developing for the treatment of schizophrenia and Alzheimer's disease psychosis, or ADP. ML-007C-MA is designed to activate both M 1 and M 4 muscarinic receptors centrally to drive efficacy, while synchronizing the pharmacokinetics of the agonist and antagonist components to mitigate peripheral cholinergic side effects. ML-007 alone, co-administered or co-formulated with the PAC has been evaluated in four Phase 1 trials, with a total of 270 healthy participants enrolled and more than 1,500 doses of ML-007 administered. Based on our clinical and preclinical data, we believe that ML-007C-MA has demonstrated the potential to be a well-tolerated treatment option with convenient dosing, while achieving or exceeding cerebrospinal fluid, or CSF, exposures expected to result in improvement across key symptom domains. We are conducting ZEPHYR, a Phase 2 trial evaluating ML-007C-MA for the treatment of schizophrenia. We have completed enrollment in the ZEPHYR trial with 307 participants enrolled, and we expect to report topline results by mid-August 2026. We are also conducting VISTA, a Phase 2 trial evaluating ML-007C-MA for the treatment of ADP, and we expect to report topline results in the second half of 2027. In December 2025, ML-007C-MA was granted Fast Track designation by the FDA for the treatment of hallucinations and delusions associated with ADP.

Previous wording

Since our inception in 2018, we have devoted substantially all of our time and efforts to performing research and development activities, raising capital and recruiting management and technical staff to support our operations. To date, we have financed our operations primarily with proceeds from the sales of our redeemable convertible preferred stock and research and development grants received and most recently, with net proceeds from our initial public offering, or IPO, and concurrent private placement, or the Concurrent Private Placement.

Current wording

Since our inception in 2018, we have devoted substantially all of our time and efforts to performing research and development activities, raising capital and recruiting management and technical staff to support our operations. To date, we have financed our operations primarily with proceeds from the sales of our redeemable convertible preferred stock and research and development grants received and most recently, with net proceeds from our initial public offering, or IPO, and our concurrent private placement, or Concurrent Private Placement.

Previous wording

We have incurred significant net losses since inception. Our net losses for the nine months ended September 30, 2025 and 2024 were $81.6 million and $56.4 million, respectively. As of September 30, 2025, we had an accumulated deficit of $281.0 million. We expect to continue to incur significant and increasing expenses and net losses for the foreseeable future as we advance our current and future product candidates through preclinical and clinical development, seek regulatory approval for such product candidates, maintain and expand our intellectual property portfolio, hire additional research and development and business personnel, expand our infrastructure and operate as a public company.

Current wording

We have incurred significant net losses since inception. Our net losses for the three months ended March 31, 2026 and 2025 were $60.7 million and $22.3 million, respectively. As of March 31, 2026, we had an accumulated deficit of $421.2 million. We expect to continue to incur significant and increasing expenses and net losses for the foreseeable future as we advance our current and future product candidates through preclinical and clinical development, seek regulatory approval for such product candidates, maintain and expand our intellectual property portfolio, hire additional research and development and business personnel, expand our infrastructure and operate as a public company.

Previous wording

Following the closing of our IPO, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting, insurance, investor relations and other expenses that we did not incur as a private company. We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates. In addition, if we obtain regulatory approval for our product candidates, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, manufacturing and distribution activities initially in the United States.

Current wording

We expect to incur additional costs associated with operating as a public company, including significant legal, accounting, insurance, investor relations and other expenses that we did not incur as a private company. We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates. In addition, if we obtain regulatory approval for our product candidates, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, manufacturing and distribution activities, initially in the United States.

Previous wording

At this time, due to the inherently unpredictable nature of clinical and preclinical development and given the current stage of our product candidates, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval and commercialize our current product candidates or any future product candidates, if at all. For the same reasons, we are also unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. If we fail to become profitable or sustain profitability on a continuing basis, then we may be unable to raise additional capital, maintain our research and development efforts, expand our business or continue our operations at planned levels, and as a result we may be forced to substantially reduce or terminate our operations.

Current wording

At this time, due to the inherently unpredictable nature of clinical and preclinical development and given the current stage of our product candidates, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval and commercialize our current or future product candidates, if at all. For the same reasons, we are also unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. If we fail to become profitable or sustain profitability on a continuing basis, then we may be unable to raise additional capital, maintain our research and development efforts, expand our business or continue our operations at planned levels, and as a result we may be forced to substantially reduce or terminate our operations.

Previous wording

As of September 30, 2025, we had cash, cash equivalents and short-term investments of $227.2 million. Based on our current operational plans and assumptions, we expect that the $269.8 million of estimated net proceeds from the IPO and the Concurrent Private Placement, after deducting underwriting discounts and commissions, the placement agent fee and offering expenses, together with our existing cash, cash equivalents and short-term investments, will be sufficient to fund our operations through 2027. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we expect. If we are unable to raise sufficient funding, we may be unable to continue to operate in the long term. See "—Liquidity and Capital Resources—Plan of Operation and Future Funding Requirements" below.

Current wording

As of March 31, 2026, we had cash, cash equivalents and investments of $395.2 million. Based on our current operational plans and assumptions, we expect that our existing cash, cash equivalents and investments will be sufficient to fund our operations through 2027. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we expect. If we are unable to raise sufficient funding, we may be unable to continue to operate in the long term. See "—Liquidity and Capital Resources—Plan of Operation and Future Funding Requirements" below.

Previous wording

salaries, benefits and other employee-related costs, including stock-based compensation expense, for personnel engaged in research and development functions;

Current wording

the salaries, benefits and other employee-related costs, including stock-based compensation expense, for personnel engaged in research and development functions;

Previous wording

expenses incurred under agreements with contract research organizations, or CROs;

Current wording

the expenses incurred under agreements with contract research organizations, or CROs;

Previous wording

costs of outside consultants, including their fees and travel expenses;

Current wording

the costs of outside consultants, including their fees and travel expenses;

Current wording

the costs associated with clinical trials and preclinical studies; and

Previous wording

We expense research and development costs as incurred. Costs for external development activities are recognized based on an evaluation of the progress to completion of specific activities. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our consolidated financial statements as prepaid or accrued research and development expenses.

Current wording

We expense research and development costs as incurred. Costs for external development activities are recognized based on an evaluation of the progress to completion of specific activities. Payments for these activities are based on the terms of the individual agreements, which may differ from the timing of costs incurred, and are reflected in our consolidated financial statements as prepaid or accrued research and development expenses.

Previous wording

Research and development activities are central to our business model. We expect that our research and development expenses will continue to increase substantially for the foreseeable future as we continue conducting clinical trials, advance our preclinical programs into the clinic and continue to discover and develop additional product candidates.

Current wording

Research and development activities are central to our business model. We expect that our research and development expenses will continue to increase substantially for the foreseeable future as we initiate and conduct clinical trials, advance our preclinical programs and continue to discover and develop additional product candidates.

Previous wording

our ability to demonstrate to the satisfaction of the FDA or any comparable foreign regulatory authority that the applicable product candidate is safe and effective as for its intended uses;

Current wording

our ability to demonstrate to the satisfaction of the FDA or any comparable foreign regulatory authority that the applicable product candidate is safe and effective for its intended uses;

Previous wording

our ability to demonstrate to the satisfaction of the FDA or any comparable foreign regulatory authority that the applicable product candidate's risk-benefit ratio for its proposed indication is acceptable;

Current wording

our ability to demonstrate to the satisfaction of the FDA or any comparable foreign regulatory authority that the applicable product candidate's benefit risk assessment for its proposed indication is acceptable;

Previous wording

Since our inception, we have not recorded income tax benefits for the net operating losses, or NOLs, incurred or the research and development tax credits generated in each year due to the uncertainty of realizing a benefit from those items. As of December 31, 2024, we had U.S. federal and state net operating loss carryforwards of $58.6 million and $10.5 million, respectively, which may be available to offset future taxable income. The federal net operating loss carryforwards do not expire, but may only be used to offset 80% of annual taxable income. The state net operating loss carryforwards expire beginning in 2039. As of December 31, 2024, we also had federal and state research and development tax credit carryforwards of $8.0 million and $0.1 million, respectively, which may be available to offset future tax liabilities and expire at various dates beginning in 2039.

Current wording

Since our inception, we have not recorded income tax benefits for the net operating losses, or NOLs, incurred or the research and development tax credits generated in each year due to the uncertainty of realizing a benefit from those items. As of December 31, 2025, we had U.S. federal and state net operating loss carryforwards of $96.6 million and $13.1 million, respectively, which may be available to offset future taxable income. The federal net operating loss carryforwards do not expire, but may only be used to offset 80% of annual taxable income. The state net operating loss carryforwards expire beginning in 2039. As of December 31, 2025, we also had federal and state research and development tax credit carryforwards of $13.3 million and $0.2 million, respectively.

Previous wording

Interest income was $1.5 million for the three months ended September 30, 2025, compared to $1.1 million for the three months ended September 30, 2024. The increase in interest income of $0.4 million was due to the increased short-term and long-term investments held at September 30, 2025 compared to September 30, 2024.

Current wording

Interest income was $2.5 million for the three months ended March 31, 2026, compared to $0.8 million for the three months ended March 31, 2025. The increase in interest income of $1.7 million was due to an increase in investments held during the three months ended March 31, 2026 compared to the three months ended March 31, 2025.

Previous wording

Other income, net was $0.5 million for the three months ended September 30, 2025, compared to $0.8 million for the three months ended September 30, 2024. The decrease of $0.3 million was primarily due to decreased amortization of premiums and accretion of discounts on investments held during the three months ended September 30, 2025.

Current wording

Other income, net was $1.4 million for the three months ended March 31, 2026, compared to $0.4 million for the three months ended March 31, 2025. The increase of $1.0 million was primarily due to amortization of premiums and accretion of discounts on investments held during the three months ended March 31, 2026.

Previous wording

We have incurred significant net losses since inception. We expect to continue to incur significant and increasing expenses and net losses for the foreseeable future, as we advance our current and future product candidates through preclinical and clinical development, seek regulatory approval for our current and future product candidates through clinical and preclinical development, maintain and expand our intellectual property portfolio, hire additional research and development and business personnel, scale-up of our production capabilities and operate as a public company. As of September 30, 2025, we had cash, cash equivalents and short-term investments of $227.2 million and an accumulated deficit of $281.0 million. Historically, we have financed our operations primarily through issuances of our redeemable convertible preferred stock and research and development grants received, and more recently, with proceeds from our IPO and Concurrent Private Placement.

Current wording

We have incurred significant net losses since inception. We expect to continue to incur significant and increasing expenses and net losses for the foreseeable future as we advance our current and future product candidates through preclinical and clinical development, seek regulatory approval for our current and future product candidates through clinical and preclinical development, maintain and expand our intellectual property portfolio, hire additional research and development and business personnel, scale-up our production capabilities and operate as a public company. As of March 31, 2026, we had cash, cash equivalents and investments of $395.2 million and an accumulated deficit of $421.2 million. Historically, we have financed our operations primarily through issuances of our redeemable convertible preferred stock and research and development grants, and more recently, with proceeds from our IPO and our Concurrent Private Placement.

Previous wording

In October 2025, we closed our IPO, pursuant to which we issued and sold an aggregate of 16,962,500 shares of our common stock (inclusive of 2,212,500 shares pursuant to the exercise of the underwriters' overallotment option in full) at a public offering price of $17.00 per share for gross proceeds of $288.4 million. We estimate the aggregate net proceeds from our IPO, including the exercise by the underwriters of their option to purchase additional shares, to be approximately $262.3 million, after deducting underwriting discounts and commissions and estimated offering expenses. Concurrent with our IPO, we also closed our Concurrent Private Placement, in which we issued and sold 476,707 shares of our common stock at a price of $17.00 per share. We received aggregate net proceeds of $7.5 million from our Concurrent Private Placement, after deducting placement agent fees and estimated private placement expenses.

Current wording

In October 2025, we closed our IPO, pursuant to which we issued and sold an aggregate of 16,962,500 shares of our common stock at a public offering price of $17.00 per share for net proceeds of $261.6 million, after deducting underwriting discounts and commissions and offering expenses. Concurrent with our IPO, we also closed our Concurrent Private Placement, in which we issued and sold 476,707 shares of our common stock at a price of $17.00 per share for net proceeds of $7.5 million, after deducting placement agent fees and private placement expenses.

Previous wording

Our cash flows from operating activities are heavily influenced by our use of cash for operating expenses and working capital required to support our business. We have historically generated negative cash flows from operating activities due to expenses incurred in our clinical trials, preclinical studies, and research and development initiatives.

Current wording

Our cash flows from operating activities are primarily driven by our use of cash for operating expenses and working capital required to support our business. We have historically generated negative cash flows from operating activities due to expenses incurred for our clinical trials, preclinical studies, and research and development initiatives.

Previous wording

Net cash used in investing activities was $80.7 million for the nine months ended September 30, 2025, compared to net cash used in investing activities of $113.2 million for the nine months ended September 30, 2024. The decrease in cash used by investing activities during the nine months ended September 30, 2025 was driven by the maturities of short-term investments.

Current wording

Net cash provided by investing activities was $67.0 million for the three months ended March 31, 2026, compared to net cash provided by investing activities of $37.5 million for the three months ended March 31, 2025. The increase in cash provided by investing activities during the three months ended March 31, 2026 was driven by the maturities of investments.

Previous wording

We use our capital resources mainly to fund operating expenses, including research and development expenditures. We plan to increase our research and development expenses for the foreseeable future as we continue clinical trial activities, advance our preclinical programs into the clinic and continue to discover and develop additional product candidates. At this time, due to the inherently unpredictable nature of clinical and preclinical development and given the early stage of our product candidates, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval and commercialize our current product candidates or any future product candidates, if at all. For the same reasons, we are also unable to predict when, if ever, we will generate revenue from product sales or whether, or when, if ever, we may achieve profitability. Clinical and preclinical development timelines, the probability of success, and development costs can differ materially from expectations. In addition, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

Current wording

We use our capital resources mainly to fund operating expenses, including research and development expenditures. We plan to increase our research and development expenses for the foreseeable future as we continue clinical trial activities, advance our preclinical programs into the clinic and continue to discover and develop additional product candidates. At this time, due to the inherently unpredictable nature of clinical and preclinical development and given the early stage of our product candidates, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval and commercialize our current product candidates or any future product candidates, if any. For the same reasons, we are also unable to predict when, if ever, we will generate revenue from product sales or whether, or when, if ever, we may achieve profitability. Clinical and preclinical development timelines, the probability of success, and development costs can differ materially from expectations. In addition, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

Previous wording

As of September 30, 2025, we had cash, cash equivalents and short-term investments of $227.2 million. Based on our current operational plans and assumptions, we expect that the $269.8 million of estimated net proceeds from our IPO and Concurrent Private Placement, after deducting underwriting discounts and commissions, the placement agent fee and offering expenses, together with our existing cash, cash equivalents and investments, will be sufficient to fund our operations through 2027. We have based this estimate on assumptions that may prove to be wrong, however, and we could use our capital resources sooner than we expect.

Current wording

As of March 31, 2026, we had cash, cash equivalents and investments of $395.2 million. Based on our current operational plans and assumptions, we expect that our existing cash, cash equivalents and investments, will be sufficient to fund our operations through 2027. We have based this estimate on assumptions that may prove to be wrong, however, and we could use our capital resources sooner than we expect.

Previous wording

the scope, timing, progress, costs and results of discovery, preclinical development and clinical trials for our current or future product candidates;

Current wording

the scope, timing, progress, costs and results of discovery efforts, preclinical development and clinical trials for our current or future product candidates;

Previous wording

our ability to enter into and maintain new, strategic collaborations or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement;

Current wording

our ability to maintain existing and establish new, strategic collaborations or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement;

Previous wording

our ability to mitigate the impact of adverse macroeconomic conditions or geopolitical events, including the ongoing conflicts between Ukraine and Russia and in the Middle East, bank failures, inflation and increased interest rates or other factors on our preclinical and clinical development or operations;

Current wording

our ability to mitigate the impact of adverse macroeconomic or geopolitical conditions, including the ongoing conflicts between Ukraine and Russia and in the Middle East, inflation, tariffs and fluctuations in increased interest rates or other factors, on our preclinical and clinical development or operations;

Previous wording

Our existing cash, cash equivalents and short-term investments, will not be sufficient to complete development of any product candidate. Accordingly, we will be required to obtain further funding to achieve our business objectives.

Current wording

Our existing cash, cash equivalents and investments will not be sufficient to complete development of any product candidate. Accordingly, we will be required to obtain further funding to achieve our business objectives.

Previous wording

Until we can generate substantial revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings. We may also consider entering into collaborations, strategic alliances and licensing arrangements or selectively partnering for clinical development and commercialization as well as funding through other sources. The sale of additional equity may result in additional dilution to our stockholders. The incurrence of debt financing would result in debt service obligations, and the instruments governing such debt could provide for operating and financial covenants that could restrict our operations or our ability to incur additional indebtedness or pay dividends, among other things. If we raise additional funds through governmental funding, collaborations, strategic partnerships and alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are not able to secure adequate additional funding, we may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible and/or suspend or curtail planned programs or cease operations. Any of these actions could materially and adversely affect our business, financial condition, results of operations and prospects.

Current wording

Until we can generate substantial revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings. We may also consider entering into collaborations, strategic alliances and licensing arrangements or selectively partnering for clinical development and commercialization as well as funding through other sources. The sale of additional equity or convertible debt may result in additional dilution to our stockholders. The incurrence of debt financing would result in debt service obligations, and the instruments governing such debt could provide for operating and financial covenants that could restrict our operations or our ability to incur additional indebtedness or pay dividends, among other things. If we raise additional funds through governmental funding, collaborations, strategic partnerships and alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are not able to secure adequate additional funding, we may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible and/or suspend or curtail planned programs or cease operations. Any of these actions could materially and adversely affect our business, financial condition, results of operations and prospects.

Previous wording

In August 2020, we entered into a lab and office lease agreement in Redwood City, California. We rented additional space under amendments to the lease agreement in August 2022 and August 2023. We currently lease a total of 13,734 square feet, and the term of the lease extends to June 2031. The lease provides for escalating annualized base rent payments starting at $0.8 million and increasing to $1.2 million in the final year of the lease. Remaining lease payments from January 1, 2025 through the end of the lease term total $7.0 million.

Current wording

We have a lease for laboratory and office space located in Redwood City, California, with a term that extends to June 2031. We and the lessor have the ability to terminate the lease with 15 months' notice. The lease provides for escalating annualized base rent payments starting at $0.8 million and increasing to $1.2 million in the final year of the lease. Remaining lease payments from April 1, 2026 through the end of the lease term total $5.8 million.

Previous wording

In September 2023, we entered into a lease agreement for office space located in Burlington, Massachusetts. This lease commenced in April 2024 and has an initial term of approximately five years, with an option to extend the term for an additional five years. Cash that is required as security deposit to be held in accordance with the lease is $0.2 million. Remaining lease payments from January 1, 2025 through the end of the lease term total $1.4 million.

Current wording

We have a lease for office space located in Burlington, Massachusetts, with a term that extends to May 2029, and with an option to extend the term for an additional five years. Remaining lease payments from April 1, 2026 through the end of the lease term total $1.0 million.

Previous wording

We enter into contracts in the normal course of business with CROs and other vendors to assist in the performance of our clinical trials, CMC, research and development and other services and products for operating purposes. These contracts typically do not contain minimum purchase commitments and generally provide for termination on notice. Payments due upon cancellation consist of payments for services provided or expenses incurred to date, including payment of noncancelable obligations of our service providers, up to the date of cancellation, and may also include termination penalties. As of September 30, 2025, the timing, the amount or likelihood of such payments are not known.

Current wording

We enter into contracts in the normal course of business with CROs and other vendors to assist in the performance of our clinical trials, CMC, research and development and other services and products for operating purposes. These contracts typically do not contain minimum purchase commitments and generally provide for termination on notice. Payments due upon cancellation consist of payments for services provided or expenses incurred to date, including payment of noncancelable obligations of our service providers, up to the date of cancellation, and may also include termination penalties. As of March 31, 2026, the timing, amount or likelihood of such payments are not known.

Previous wording

We are also party to certain grant agreements with the Michael J. Fox Foundation and license and collaboration agreements with NeuroSolis, Stanford University, Vanderbilt University and other universities. We may be obligated to make certain future payments under these agreements that are contingent upon future events such as our achievement of specified regulatory and commercial milestones or royalties on net product sales under these agreements. As of September 30, 2025, we were unable to estimate the timing or likelihood of achieving these milestones or generating future product sales.

Current wording

We are party to certain grant agreements with the Michael J. Fox Foundation and license and collaboration agreements with NeuroSolis, Stanford University, Vanderbilt University and other third parties. We may be obligated to make certain future payments under these agreements that are contingent upon future events such as our achievement of specified preclinical, clinical, regulatory and commercial milestones or royalties on net product sales under these agreements. As of March 31, 2026, we were unable to estimate the timing or likelihood of achieving these milestones or generating future product sales.

Previous wording

A summary of our critical accounting policies is presented in Note 2 to our audited consolidated financial statements as of and for the year ended December 31, 2024 included in our final prospectus filed with the SEC on October 27, 2025 pursuant to Rule 424(b)(3) under the Securities Act for our IPO. There were no material changes to our critical accounting policies during the three months ended September 30, 2025.

Current wording

A summary of our critical accounting policies is presented in Note 2 to our audited consolidated financial statements as of and for the year ended December 31, 2025 included in our Annual Report on Form 10-K. There were no material changes to our critical accounting policies during the three months ended March 31, 2026.
Rearranged previous paragraphs (3)

Previous report — wording carried elsewhere

The following table summarizes our results of operations for the periods indicated (in thousands):

Previous report — wording carried elsewhere

The following table summarizes our research and development expenses for the periods indicated (in thousands):

Previous report — wording carried elsewhere

The following table summarizes our general and administrative expenses for the periods indicated (in thousands):