Quarterly Report for Quarter Ending September 30, 2026 (Form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report, and the audited financial information and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2025.

Our actual results and timing of certain events may differ materially from the results discussed, projected, anticipated, or indicated in any forward-looking statements. We caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Quarterly Report. In addition, even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with the forward-looking statements contained in this Quarterly Report, they may not be predictive of results or developments in future periods.

The following information and any forward-looking statements should be considered in light of factors discussed elsewhere in this Quarterly Report, including those risks identified under Part II, Item 1A. Risk Factors.

We caution readers against placing undue reliance upon any such forward-looking statements, which speak only as of the date they are made. We disclaim any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Overview

We are a global biopharmaceutical company dedicated to improving the lives of children and adults with spinal muscular atrophy ("SMA") and additional rare, severe and debilitating neuromuscular diseases. As a leader in the biology of transforming growth factor beta ("TGFβ") superfamily, our novel understanding of the molecular mechanisms of growth factor activation enabled the development of a proprietary platform for the discovery and development of monoclonal antibodies that locally and selectively target the precursor, or latent, forms of growth factors. Based on our innovative, proprietary, and scalable technology platform, we are building a world-leading anti-myostatin pipeline.

We have one product approved in the U.S., ISEMBYLD™ (apitegromab-mstn), for the treatment of SMA, and our lead product candidates include a subcutaneous formulation of apitegromab, and SRK-439.

Apitegromab is a fully human monoclonal antibody that inhibits myostatin activation by selectively binding the pro- and latent forms of myostatin in skeletal muscle. Myostatin is a catabolic agent that functions as a negative regulator of muscle mass; therefore, inhibition of myostatin results in increased muscle mass and strength. On September 11, 2026, the U.S. Food and Drug Administration (the "FDA") approved ISEMBYLD for the treatment of SMA in adults and children two years of age and older who are currently receiving a survival motor neuron 2 ("SMN2")-targeted treatment. ISEMBYLD is the first and only muscle-targeted treatment approved for patients with SMA currently receiving SMN2-targeted therapy, and we have initiated the U.S. commercial launch of ISEMBYLD. We plan to seek marketing authorizations for apitegromab for use in SMA in other jurisdictions. In October 2026, we resubmitted our Marketing Authorisation Application ("MAA") for apitegromab for the treatment of children and adults with SMA to the European Medicines Agency ("EMA"). In November 2026, we submitted our Japanese New Drug Application ("JNDA") for apitegromab for the treatment of children and adults with SMA to Japan's Pharmaceuticals and Medicines Devices Agency ("PMDA").

We continue to evaluate ISEMBYLD in SMA with its ongoing long-term extension ONYX trial and its Phase 2 OPAL trial in SMA patients under two years of age, which was initiated in the third quarter of 2025. Additionally, we are evaluating apitegromab for the treatment of patients with facioscapulohumeral muscular dystrophy ("FSHD") with our Phase 2 FORGE trial, which was initiated in the second quarter of 2026. We see potential for apitegromab broadly in additional rare, severe, and debilitating neuromuscular diseases where muscle atrophy is a key component of disease pathogenesis, and we are actively exploring indications beyond SMA and FSHD.

In addition to the current intravenous ("IV") formulation, we are developing a subcutaneous ("SC") formulation of apitegromab. A Phase 1 study in healthy volunteers has been completed and demonstrated that SC apitegromab has favorable bioavailability and a comparable pharmacodynamic profile relative to IV apitegromab. Further development activities are ongoing, including planned FDA and EMA regulatory engagements.

Our clinical-stage pipeline also includes SRK-439, a novel, investigational, subcutaneously administered fully human anti-pro/latent myostatin antibody that has high inhibitory potency while maintaining selectivity towards myostatin. SRK-439 is being developed for the treatment of patients with rare, severe, and debilitating neuromuscular diseases. A Phase 1 study of SRK-439 in healthy volunteers

is currently underway. The company expects to have topline data by year end 2026 and plans to share data from this study in the first quarter of 2027.

Using our innovative approach and proprietary platform, we are creating a pipeline of novel product candidates that selectively modulate growth factor activation implicated in rare, severe, and debilitating neuromuscular diseases.

As we focus our strategy on rare neuromuscular diseases, we are currently seeking partnerships for our non-neuromuscular disease programs. These programs include: SRK-181, a Phase 2-ready investigational inhibitor of latent TGFβ1 in development for the treatment of patients with solid tumors that are resistant to anti-PD-(L)1 antibody therapies; SRK-373, an investigational, highly selective inhibitor of the latent TGFβ1 isoform with selective activity in the fibrotic extracellular matrix, in nonclinical development for the treatment of fibrotic diseases; and SRK-256, an investigational inhibitor of RGMc, or hemojuvelin, in nonclinical development for the treatment of iron-restricted anemias. We are also seeking partners to further evaluate the potential for myostatin inhibition in combination with GLP-1 weight loss approaches following our positive Phase 2 EMBRAZE study, demonstrating proof-of-concept in the ability of apitegromab to drive statistically significant preservation of lean mass during tirzepatide-induced weight loss.

We have incurred significant operating losses since inception. Our net losses were $322.6 million for the nine months ended September 30, 2026. As of September 30, 2026, we had an accumulated deficit of $1.6 billion. We expect to continue to incur significant expenses and operating losses for the foreseeable future in performing our ongoing activities, as we:

In September 2026, we commenced commercialization of ISEMBYLD in the U.S. following FDA approval. As a result, we expect to generate product revenue from sales of ISEMBYLD while continuing to incur substantial expenses associated with commercialization activities, including sales, marketing, medical affairs, manufacturing, distribution and post-approval development activities. Although we have begun generating product revenue, we expect to continue to incur significant operating losses for the foreseeable future as we commercialize ISEMBYLD and advance our development pipeline.

Financial Operations Overview

Revenue

Product revenue, net

On September 11, 2026, the FDA approved ISEMBYLD for the treatment of SMA in adults and children two years of age and older who are currently receiving SMN2-targeted treatment. We began commercial shipments of ISEMBYLD in the U.S. during the third quarter of 2026 and therefore began recognizing product revenue during the quarter. We sell ISEMBYLD in the U.S. to a specialty distributor, which resells the ISEMBYLD to qualified health care providers, and to specialty pharmacies, which dispenses ISEMBYLD for administration to patients. We record product revenue net of estimated variable consideration, including chargebacks, government and commercial rebates, discounts, distributor and specialty pharmacy service fees, copay assistance and estimated product returns. Product revenue during the launch period reflects sales to our customers, including inventory build within the channel, and may not directly correspond to patient starts, infusions or underlying patient demand during the period.

Cost of product revenue

Cost of product revenue includes the cost of producing and distributing inventories that are related to product revenue and may also include costs related to excess or obsolete inventory adjustment charges, abnormal costs, unabsorbed manufacturing and overhead costs, or other reasons. Based on our policy to expense costs associated with the manufacturing of our products prior to regulatory approval, certain of the manufacturing costs associated with product shipments of ISEMBYLD recorded during the three months ended September 30, 2026 were expensed prior to FDA approval of ISEMBYLD. This inventory carries a lower cost basis, resulting in lower cost of product revenue and higher gross margin during the initial commercialization period. We had expensed $25.6 million for this inventory prior to receiving approval on September 11, 2026.

Operating Expenses

Research and Development

Research and development expenses consist primarily of costs incurred for our research and development activities, including our product candidate discovery efforts, nonclinical studies, manufacturing, and clinical trials under our research programs, which include:

Research and development costs are expensed as incurred. Costs for certain activities are recognized based on an evaluation of the progress to completion of specific tasks. Nonrefundable advance payments for research and development goods and services to be received in the future from third parties are deferred and capitalized. The capitalized amounts are expensed as the related services are performed.

Prior to the regulatory approval of our drug candidates, we incurred expenses for the manufacture of drug product supplies to support clinical development that could potentially be available to support the commercial launch of those drugs. Until the date at which regulatory approval has been received or is otherwise considered probable, we record all such costs as research and development expenses.

A significant portion of our research and development costs have been external costs, which we track on a program-by-program basis after a clinical product candidate has been identified. However, we do not allocate our internal research and development expenses, consisting primarily of employee-related costs, depreciation and other indirect costs, on a program-by-program basis as they are deployed across multiple projects.

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials, as well as the associated clinical trial material requirements. We expect research and development costs for our product candidates to continue to be substantial for the foreseeable future as the development programs progress. However, we do not believe that it is possible at this time to accurately project total program-specific expenses through

commercialization. There are numerous factors associated with the successful commercialization of any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. Additionally, future commercial and regulatory factors beyond our control will impact our clinical development programs and plans.

The successful development of apitegromab for indications other than SMA, SRK-181, SRK-439, SRK-373, SRK-256 and any future product candidates is uncertain. Accordingly, 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 remainder of the development of apitegromab for indications other than SMA, SRK-181, SRK-439, SRK-373, SRK-256 and any future product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from the sale of our product candidates, if approved. This is due to the numerous risks and uncertainties associated with developing product candidates, including the uncertainty of:

Any of these variables, or other factors, with respect to the development of apitegromab in indications other than SMA, SRK-181, SRK-439, SRK-373, SRK-256 or any of our future product candidates could significantly change the costs and timing associated with the development of that product candidate.

Selling, General and Administrative

Selling, general and administrative expenses consist primarily of employee-related expenses, including salaries, benefits and equity-based compensation expenses for personnel in executive, finance, business development, investor relations, legal, information technology, human resources and commercial functions. Other significant selling, general and administrative expenses include facility costs not otherwise included in research and development expenses, legal fees relating to patent and corporate matters and fees for accounting, consulting services, professional services and corporate expenses. We expect selling, general and administrative expense to continue to increase as we support the commercial launch and ongoing commercialization of ISEMBYLD in the U.S. and continue to build infrastructure to support potential future launches in other jurisdictions, as well as in support of our research and development activities.

Other Income (Expense), Net

Other income (expense), net consists primarily of interest income earned on our cash, cash equivalents and marketable securities, offset by interest expense incurred on our debt facility, including amortization of debt discount and debt issuance costs.

Results of Operations

Comparison of the Three Months Ended September 30, 2026 and 2025

The following table summarizes our results of operations for the three months ended September 30, 2026 and 2025 (in thousands, except percentages):

NM - not meaningful

Product revenue, net

For the three months ended September 30, 2026, we recorded net product revenue of $0.6 million from sales of ISEMBYLD in the U.S. There was no net product revenue for the three months ended September 30, 2025.

Cost of product revenue

For the three months ended September 30, 2026, we recorded cost of product revenue of $8,000 related to sales of ISEMBYLD in the United States. Prior to the FDA approval of ISEMBYLD, product costs were expensed as research and development expense.

Operating Expenses

Research and Development

Research and development expense was $54.1 million and $50.5 million for the three months ended September 30, 2026 and 2025, respectively, an increase of $3.6 million or 7.2%. The following table summarizes our research and development expense for the three months ended September 30, 2026 and 2025 (in thousands, except percentages):

The increase in research and development expense was primarily attributable to the following:

Total research and development expenses are expected to continue to be substantial as we support post-approval development activities for ISEMBYLD, including post-marketing requirements from the FDA by ISEMBYLD, ONYX, and OPAL, continue development activities in FSHD through the FORGE trial, advance the development of a subcutaneous formulation of apitegromab and continue development of SRK-439 and our broader pipeline. We expect costs of our SRK-181 program to continue to decrease, as compared to the prior year, as we completed the Phase 1 DRAGON clinical trial in June 2025.

Selling, General and Administrative

Selling, general and administrative expense was $52.5 million and $53.1 million for the three months ended September 30, 2026 and 2025, respectively, a decrease of $0.6 million or 1.1%. The total decrease was primarily driven by a decrease in professional fees of $3.2 million, partially offset by an increase of approximately $2.6 million in employee-related costs including salaries, bonus, benefits and payroll taxes related to increased headcount. We expect selling, general and administrative expenses to continue to increase as we continue to invest in building the global infrastructure to support the commercialization of apitegromab.

Other Income (Expense), Net

The change in other income (expense), net was primarily attributable to interest expense incurred on our debt facility, including amortization of debt discount and debt issuance costs, partially offset by an increase in interest income earned due to higher average balances in our cash, cash equivalents and marketable securities.

Comparison of the Nine Months Ended September 30, 2026 and 2025

The following table summarizes our results of operations for the nine months ended September 30, 2026 and 2025 (in thousands, except percentages):

NM - not meaningful

Product revenue, net

In September 2026, the U.S. Food and Drug Administration ("FDA") approved ISEMBYLD for the treatment of SMA in adults and

children two years of age and older who are currently receiving a survival motor neuron 2 ("SMN2")-targeted treatment. For the nine months ended September 30, 2026, we recorded net product revenue of $0.6 million from sales of ISEMBYLD in the U.S. There was no net product revenue for the nine months ended September 30, 2025.

Cost of product revenue

For the nine months ended September 30, 2026, we recorded cost of product revenue of $8,000 related to sales of ISEMBYLD in the U.S. Prior to the FDA approval of ISEMBYLD, product costs were expensed as research and development expense.

Operating Expenses

Research and Development

Research and development expense was $164.2 million and $161.6 million for the nine months ended September 30, 2026 and 2025, respectively, an increase of $2.6 million or 1.6%. The following table summarizes our research and development expense for the nine months ended September 30, 2026 and 2025 (in thousands, except percentages):

The increase in research and development expense was primarily attributable to the following:

Total research and development expenses are expected to continue to be substantial as we support post-approval development activities for ISEMBYLD, including ONYX and OPAL, continue development activities in FSHD through the FORGE trial, advance the development of a subcutaneous formulation of apitegromab and continue development of SRK-439 and our broader pipeline. We expect costs of our SRK-181 program to continue to decrease, as compared to the prior year, as we completed the Phase 1 DRAGON clinical trial in June 2025.

Selling, General and Administrative

Selling, general and administrative expense was $153.4 million and $131.2 million for the nine months ended September 30, 2026 and 2025, respectively, an increase of $22.2 million or 16.9%. The total increase was primarily driven by investments in infrastructure to support commercial launch readiness for apitegromab, including an increase of approximately $24.7 million in employee-related costs including salaries, bonus, benefits and payroll taxes related to increased headcount, an increase of $7.2 million in equity-based compensation expense, an increase of approximately $5.7 million in professional service fees and an increase of approximately $1.1 million in facility and other costs. The increase in headcount is partially associated with the hiring of our commercial and field-facing teams. These increases were partially offset by a decrease in costs associated with our leadership transition in 2025, including $12.6 million in non-cash equity-based compensation expense, a decrease of $2.0 million in bonuses, as well as an overall decrease of $1.9 million in severance related costs. We expect general and administrative expenses to continue to be substantial as we continue to invest in building the global infrastructure to support the commercialization of apitegromab.

Other Income (Expense), Net

The change in other income (expense), net was primarily attributable to our loss on extinguishment of debt and interest expense incurred on our debt facility, including amortization of debt discount and debt issuance costs.

Liquidity and Capital Resources

Sources of Liquidity

Since our inception, our funding primarily derived from equity financings, debt financings and collaboration arrangements. Following the FDA approval of ISEMBYLD in September 2026, we began generating product revenue in the U.S.; however, product revenue has not yet been sufficient to fund our operations and we have incurred significant operating losses and negative cash flows from our operations. We have funded our operations to date primarily with proceeds from the sale of our convertible preferred stock and units in private placements before our initial public offering ("IPO"), and issuance of our common stock through our IPO in 2018, to Gilead in an exempt private placement, through multiple secondary public offerings and through "at-the-market offerings" ("ATM") sales, as well as payments from our prior research collaborations, prior issuances of debt and the 2026 Loan Agreement (as defined below) entered into in February 2026 (see Note 13).

The following table provides information regarding our total cash, cash equivalents and marketable securities at September 30, 2026 and December 31, 2025 (in thousands):

During the nine months ended September 30, 2026, our cash, cash equivalents and marketable securities balance increased by $46.0 million. The change was primarily due to proceeds from our debt facility, sales under our ATM program and the exercises of stock options and warrants, partially offset by cash used to operate our business, including payments related to, among other things, research and development and general and administrative expenses as we continued to invest in our product candidates and supported our internal research and development efforts, invested in building the infrastructure to support the commercialization of apitegromab and made interest payments on our debt.

Our current sales agreement with Jefferies, entered into in November 2022, allows for the sale of shares of our common stock from time to time in ATM offerings through Jefferies as the Company's sales agent. During the nine months ended September 30, 2026, we sold 3,543,692 shares of our common stock under the ATM program, generating net proceeds of $160.8 million.

In February 2025, we entered into an Amended and Restated Loan and Security Agreement with Oxford Finance LLC ("Oxford") and Silicon Valley Bank ("SVB") (such agreement, as amended, the "Oxford Loan Agreement") for up to $200 million of which $25.0 million from Tranche 1 was received in October 2020, $25.0 million from Tranche 2 was received in December 2021 and $50.0

million from Tranche 3 was received in September 2025, bringing the total outstanding balance under the Term Loans to $100.0 million. This debt facility was paid off in February 2026 (see Note 13).

In February 2026, we entered into a Financing Agreement (the "Financing Agreement") and a Pledge and Security Agreement (the "Security Agreement," together with the Financing Agreement, the "2026 Loan Agreement") with certain funds managed by Blue Owl Capital Corporation ("Blue Owl") for up to $350.0 million, of which $100.0 million of the initial term loan (the "Initial Term Loan") was received in February 2026. In addition, the Financing Agreement includes an uncommitted incremental term loan facility that requires the consent of Blue Owl in an aggregate principal amount not to exceed $200.0 million. We used the proceeds of the Initial Term Loan upon the closing under the 2026 Loan Agreement to repay all outstanding obligations, totaling $103.7 million, under the Oxford Loan Agreement with Oxford and upon such repayment, terminated the Oxford Loan Agreement. The amount repaid by the Company included $100.0 million of outstanding indebtedness plus accrued and unpaid interest as of February 27, 2026 and fees. We recognized a loss on extinguishment of debt of $3.3 million in connection with the termination of the Oxford Loan Agreement. As a result of the termination, all credit commitments under the Oxford Loan Agreement were terminated and all security interests and guarantees executed in connection with the Oxford Loan Agreement were released. On March 31, 2026, the Company received $100.0 million from the next available tranche under the 2026 Loan Agreement, bringing the outstanding balance to $200.0 million (see Note 13). The additional delayed draw term loan commitment in an aggregate principal amount not to exceed $150.0 million became available on September 11, 2026, on the date of the FDA's approval for ISEMBYLD in SMA. The additional loan will be available until the date that is the earliest of the full usage thereof, termination thereof and September 30, 2027, which may be borrowed by the Company at its sole option upon satisfying certain customary conditions, including satisfaction of the minimum cash covenant (if applicable).

During the nine months ended September 30, 2026, 6,804,082 of the Company's pre-funded warrants were exercised. As of September 30, 2026, the Company had 10,558,065 pre-funded warrants outstanding.

During the nine months ended September 30, 2026, 250,000 of the Company's common warrants were exercised. As of September 30, 2026, the Company did not have any common warrants outstanding.

In connection with the approval of ISEMBYLD, we were issued a Rare Pediatric Disease priority review voucher ("PRV") by the FDA. The PRV can be used to obtain priority review of a subsequent marketing application or sold or transferred to another sponsor. In November 2026, we entered into an asset purchase agreement with BioNTech US Inc., pursuant to which we agreed to sell our PRV for $205.0 million in cash upon the closing of the sale. The transaction remains subject to customary closing conditions. See Note 16, "Subsequent Events," to our condensed consolidated financial statements.

Cash Flows

The following table provides information regarding our cash flows for the nine months ended September 30, 2026 and 2025 (in thousands):

Net Cash Used in Operating Activities

Net cash used in operating activities was $234.2 million for the nine months ended September 30, 2026, and consisted of our net loss of $322.6 million, partially offset by changes in our assets and liabilities of $22.5 million and non-cash adjustments of $65.9 million. The non-cash adjustments are primarily from equity-based compensation.

Net cash used in operating activities was $224.5 million for the nine months ended September 30, 2025, and consisted of our net loss of $287.0 million, partially offset by changes in our assets and liabilities of $4.6 million and non-cash adjustments of $57.8 million. The non-cash adjustments are primarily from equity-based compensation.

Net Cash Provided by Investing Activities

Net cash used in investing activities was $2.9 million for the nine months ended September 30, 2026 compared to net cash provided by investing activities of $179.7 million for the nine months ended September 30, 2025.

Net cash provided by and used in investing activities for both periods was primarily associated with transactions involving our marketable securities.

Net Cash Provided by Financing Activities

Net cash provided by financing activities was $280.0 million for the nine months ended September 30, 2026 compared to $155.1 million for the nine months ended September 30, 2025. Net cash provided by financing activities for the nine months ended September 30, 2026 was primarily attributable to $160.8 million in proceeds from the sale of common shares under our ATM program, $197.7 million in proceeds from our debt facility and $20.6 million from the exercise of stock options, $7.1 million from the exercise of warrants, partially offset by $103.1 million from the repayment of our Oxford Loan Agreement with Oxford and $3.1 million of debt issuance costs related to our Financing Agreement with Blue Owl.

Net cash provided by financing activities for the nine months ended September 30, 2025 was primarily attributable to $91.7 million in proceeds from the sale of common shares under our ATM program, $50.0 million in proceeds from our debt facility and $3.4 million from the exercise of common warrants and $10.9 million from the exercise of stock options, partially offset by the net impact of our debt refinancing.

Funding Requirements

We expect our expenses to be substantial as we continue the research and development of apitegromab in indications, other than SMA and invest in our pipeline, as well as funding our ongoing commercialization of ISEMBYLD in the United States. We continue to pursue regulatory approvals for apitegromab in jurisdictions outside the U.S., including Europe. We expect to incur significant expenses related to commercial operations, manufacturing, supply chain, medical affairs, distribution and potential future launches outside the U.S. We expect to continue to incur apitegromab development costs as we invest in trials to support other SMA patient populations, such as our Phase 2 OPAL clinical trial, and for programs in multiple other diseases beyond SMA where selective inhibition of myostatin activation may offer therapeutic benefit, such as our Phase 2 FORGE trial. We expect to incur costs to support our anti-myostatin program, and our Phase 1 trial for SRK-439. Additionally, we will support the development of our pipeline and any other nonclinical programs. Furthermore, we expect to continue to incur costs associated with operating as a public company.

Based on our current operating model, we expect that our existing cash, cash equivalents and marketable securities, together with the cash available under our debt facility and our anticipated product revenues will enable us to fund our operating expenses and capital expenditure requirements into 2028. However, we will require additional capital in order to complete clinical development and commercialization for each of our current programs. We have based this estimate on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Our future capital requirements will depend on many factors, including:

Identifying potential product candidates and conducting nonclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales for additional product candidates. In addition, commercialization of ISEMBYLD may not be successful, and any future approved products may not achieve commercial success. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all.

Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, common stockholder ownership interests may be diluted, and the terms of these securities may include liquidation or other preferences that could adversely affect the rights of a common stockholder. Additional debt financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business.

If we raise funds through collaborations, strategic alliances 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 to grant licenses on terms that may not be favorable to us. Market volatility or other factors could also adversely impact our ability to access capital as and when needed. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Critical Accounting Estimates

This management's discussion and analysis is based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these condensed consolidated financial statements requires us to make judgments and estimates that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgements about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts and experience. The effects of material revisions in estimates, if any, will be reflected in the condensed consolidated financial statements prospectively from the date of change in estimates. Our actual results may differ from these estimates under different assumptions or conditions.

There have been no material changes to our critical accounting estimates from those described in Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations" included in our Annual Report on Form 10-K for the year ended December 31, 2025.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under applicable SEC rules.

Recent Accounting Pronouncements

We have reviewed all recently issued standards and have determined that, other than as disclosed in Note 2 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report, they will not have a material impact on our financial statements or do not otherwise apply to our operations.

Smaller Reporting Company and Non-Accelerated Filer Status

Based on the market value of our common stock held by our non-affiliates as of June 30, 2025, we are no longer a smaller reporting company. Accordingly, we ceased to be eligible to use the requirements for a smaller reporting company beginning with our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, and are thus subject to additional disclosure and compliance requirements. Because we remained eligible to use the requirements for smaller reporting companies through December 31, 2025, we will remain a "non-accelerated filer" through December 31, 2026.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Interest Rate Risk

As of September 30, 2026 and December 31, 2025, we had cash, cash equivalents, and marketable securities totaling $413.6 million and $367.6 million, respectively, which included bank deposits, money market funds, U.S. treasury obligations and government agency securities. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates, particularly because our investments are in short-term marketable securities. Such interest-earning instruments carry a degree of interest rate risk; however, historical fluctuations in interest income have not been significant for us. Due to the short-term duration of our cash equivalents and marketable securities, we do not believe an immediate one percent change in interest rates would have a material effect on the fair value of our cash equivalents and marketable securities.

Foreign Currency Risk

Our operations include activities in countries outside the U.S. As a result, our financial results are impacted by factors such as changes in foreign currency exchange rates or weak economic conditions in the foreign markets where we operate. We do not currently hedge our foreign currency exchange rate risk. Our monetary exposures on our condensed consolidated balance sheet were immaterial to our financial position as of September 30, 2026 and December 31, 2025.

Inflation

Inflation generally affects us by increasing our cost of labor, research, manufacturing and development costs, and clinical trial costs. We have not seen a significant impact from inflation on our business, financial condition or results of operations as of September 30, 2026. However, a significant or prolonged period of high inflation could adversely impact our results if the increase in costs outpaces the growth in our revenues.

Item 4. Controls and Procedures

Management's Evaluation of our Disclosure Controls and Procedures

We maintain "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission's rules and forms and (2) accumulated and communicated to our management, including our principal executive officer and principal financial and accounting officer, as appropriate to allow timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our disclosure controls and procedures are designed to provide reasonable assurance of achieving their control objectives.

Our management, with the participation of our chief executive officer (principal executive officer) and chief financial officer (principal financial and accounting officer) have evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2026, the end of the period covered by this Quarterly Report on Form 10-Q. Based upon such evaluation, our chief

executive officer and chief financial officer have concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of such date. We continue to review and document our disclosure controls and procedures, including our internal controls and procedures for financial reporting, and may from time to time make changes aimed at enhancing their effectiveness and to ensure that our systems evolve with our business.

Changes in Internal Controls Over Financial Reporting

No change in our internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the nine months ended September 30, 2026 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Part II. OTHER INFORMATION

Item 1. Legal Proceedings

From time to time, we are subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Although the results of litigation and claims cannot be predicted with certainty, as of the date of this Quarterly Report, we do not believe we are party to any claim or litigation the outcome of which, if determined adversely to us, would individually or in the aggregate be reasonably expected to have a material adverse effect on our business. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.