Stoke Therapeutics, Inc.
For the period ended Sep 30, 2026. Filed Nov 3, 2026.
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Sep 30, 2026 · Filed Nov 3, 2026
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Notes to unaudited condensed consolidated financial statements
Notes to condensed consolidated financial statements—(unaudited)
- Nature of the business
Organization
Stoke Therapeutics, Inc. (the "Company") was founded in June 2014 and was incorporated under the laws of the State of Delaware. The Company is a late-stage clinical company dedicated to addressing the underlying causes of severe diseases by upregulating protein expression with RNA-based medicines.
Shelf Registration
In July 2025, the Company filed a universal Shelf Registration statement on Form S-3 (the “2025 Registration Statement”) with the SEC. The 2025 Registration Statement was declared effective by the SEC on July 11, 2025, and contains two prospectuses: a base prospectus, which covers the offering, issuance and sale by the Company of up to a maximum aggregate offering price of $400.0 million of the Company’s common stock, preferred stock, debt securities, warrants to purchase common stock, preferred stock or debt securities, subscription rights to purchase common stock, preferred stock or debt securities and/or units consisting of some or all of these securities; and a sales agreement prospectus covering the offering, issuance and sale by the Company of up to a maximum aggregate offering price of $150.0 million of common stock that may be issued and sold under a Controlled Equity Offering Sales Agreement (the “Sales Agreement”). The Company does not intend to make any further offers or sales of its common stock pursuant to the Sales Agreement under the 2025 Registration Statement.
In March 2026, the Company filed an automatic universal Shelf Registration Statement on Form S-3 (the “2026 Registration Statement”) with the SEC. The 2026 Registration Statement originally contained two prospectuses: a base prospectus, which covers the offering, issuance and sale by the Company of its common stock, preferred stock, debt securities, warrants to purchase common stock, preferred stock or debt securities, subscription rights to purchase common stock, preferred stock or debt securities and/or units consisting of some or all of these securities; and a sales agreement prospectus (the “Initial Sales Agreement Prospectus”) which covered the offering, issuance and sale by the Company of up to a maximum aggregate offering price of $150.0 million of its common stock that may be issued and sold under the Sales Agreement. In August, 2026, the Company filed a prospectus supplement to the 2026 Registration Statement (the “August 2026 Sales Agreement Prospectus”), which superseded and replaced the Initial Sales Agreement Prospectus and covers the offering, issuance and sale by the Company of up to an additional maximum aggregate offering price of $200.0 million of its common stock that may be issued and sold under the Sales Agreement. The specific terms of any securities to be offered pursuant to the base prospectus will be specified in a prospectus supplement to the base prospectus. The Company intends to use the 2026 Registration Statement for any future issuances and sales of common stock.
As of December 31, 2025, the Company had issued approximately 3.2 million shares of common stock pursuant to the 2025 Registration Statement for net proceeds of $87.8 million. In addition, as of September 30, 2026, the Company issued approximately 4.6 million shares of common stock pursuant to the Sales Agreement and the Initial Sales Agreement Prospectus for net proceeds of $146.4 million. As of September 30, 2026, the Company had not sold any shares of common stock under the August 2026 Sales Agreement Prospectus. The Company may terminate this at-the-market program under the Sales Agreement at any time, pursuant to its terms.
Uncertainties
The Company is subject to risks and uncertainties common to late-stage clinical companies in the biotechnology industry including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
Liquidity
The Company expects that its operating losses and negative cash flows will continue for the foreseeable future. As of the issuance date of these unaudited condensed consolidated financial statements, the Company expects that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements through at least twelve months from the issuance date of these unaudited condensed consolidated financial statements.
- Summary of significant accounting policies and recent accounting pronouncements
Basis of presentation and consolidation
The accompanying condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standard Updates of the Financial Accounting Standards Board (“FASB”). All intercompany accounts and transactions have been eliminated in consolidation.
The significant accounting policies used in preparation of these condensed consolidated financial statements for the three and nine months ended September 30, 2026 are consistent with those discussed in Note 2 to the consolidated financial statements included in the Company's 2025 Annual Report on Form 10-K, other than as noted below.
Unaudited interim condensed consolidated financial information
The accompanying interim unaudited condensed consolidated financial statements and related disclosures are unaudited and have been prepared in accordance with GAAP for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the Company’s condensed consolidated financial statements and related notes as of and for the year ended December 31, 2025, which was filed with the SEC on March 16, 2026. The Company’s financial information as of September 30, 2026 and for the three and nine months ended September 30, 2026 and 2025 is unaudited. In the opinion of management, all adjustments, consisting only of normal recurring adjustments, considered necessary for a fair presentation of the financial position, results of operations and cash flows at the dates and for the periods presented of the results of these interim periods have been included. The balance sheet information as of December 31, 2025 was derived from audited consolidated financial statements. The results of the Company’s operations for any interim period are not necessarily indicative of the results that may be expected for any other interim period or for a full fiscal year.
Cash, cash equivalents and restricted cash
The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents. The Company deposits its cash and cash equivalents in checking, sweep and money market accounts. Cash equivalents are carried at cost which approximates their fair market value.
At September 30, 2026, restricted cash consisted of money market accounts collateralizing letters of credit issued as security deposits in connection with the Company’s leases of its corporate facilities.
Cash and cash equivalents, and restricted cash in thecondensed consolidated statements of cash flows consists of the following (in thousands):
| As of September 30, | ||
|---|---|---|
| 2026 | 2025 | |
| Cash and cash equivalents | $107,271 | $83,394 |
| Restricted cash - current | 494 | — |
| Restricted cash - long-term | 3,227 | 721 |
| Total cash, cash equivalents and restricted cash | $110,992 | $84,115 |
- Fair value measurements
The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Cash equivalents: | ||||
| Money market funds | $98,507 | $— | $— | $98,507 |
| Total | $98,507 | $— | $— | $98,507 |
| Marketable Securities: | ||||
| Corporate bonds | $— | $58,775 | $— | $58,775 |
| Commercial paper | — | 28,156 | — | 28,156 |
| US Government and US Government agency debt securities | 161,482 | 3,105 | — | 164,587 |
| Total | $161,482 | $90,036 | $— | $251,518 |
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Cash equivalents: | ||||
| Money market funds | $72,890 | $— | $— | $72,890 |
| Total | $72,890 | $— | $— | $72,890 |
| Marketable Securities: | ||||
| Corporate bonds | $— | $84,750 | $— | $84,750 |
| Commercial paper | — | 23,961 | — | 23,961 |
| US Government and US Government agency debt securities | — | 197,999 | — | 197,999 |
| Total | $— | $306,710 | $— | $306,710 |
The Company’s cash equivalents and marketable securities are carried at fair value, determined according to the fair value hierarchy. The carrying value of the Company’s accounts payable and accrued expenses approximate their fair values due to the short-term nature of these liabilities.
The Company’s assets with fair value categorized as Level 1 within the fair value hierarchy include money market funds and certain marketable securities. Money market funds are publicly traded mutual funds and are presented as cash equivalents on the condensed consolidated balance sheets as of September 30, 2026 and December 31, 2025.
The Company measures its marketable securities at fair value on a recurring basis and classifies those instruments within Level 1 or Level 2 of the fair value hierarchy. Certain marketable securities are valued using models or other valuation methodologies that use Level 2 inputs. These models are primarily industry-standard models that consider various assumptions, including time value, yield curve, volatility factors, default rates, current market and contractual prices for the underlying financial instruments, as well as other economic measures. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace.
There wereno transfers into or out of Level 3 in the periods presented.
- Marketable securities
The following table summarizes the Company’s marketable securities as of September 30, 2026 (in thousands):
| Amortized Cost | Unrealized Gain | Unrealized Loss | Fair Value | |
|---|---|---|---|---|
| Marketable securities: | ||||
| Corporate bonds | $58,972 | $2 | $(199) | $58,775 |
| Commercial paper | 28,201 | — | (45) | 28,156 |
| US Government and US Government agency debt securities | 165,396 | — | (809) | 164,587 |
| Total | $252,569 | $2 | $(1,053) | $251,518 |
The following table summarizes the Company’s marketable securities as of December 31, 2025 (in thousands):
| Amortized Cost | Unrealized Gain | Unrealized Loss | Fair Value | |
|---|---|---|---|---|
| Marketable securities: | ||||
| Corporate bonds | $84,568 | $183 | $(1) | $84,750 |
| Commercial paper | 23,959 | 7 | (5) | 23,961 |
| US Government and US Government agency debt securities | 197,638 | 365 | (4) | 197,999 |
| Total | $306,165 | $555 | $(10) | $306,710 |
As of September 30, 2026, the weighted average maturity of the Company’s short term marketable securities is 0.52 years and the weighted average maturity of the Company's long term marketable securities is 1.13 years.
The Company did recognize credit losses related to marketable securities and didnot record an allowance for credit losses as of September 30, 2026.
- Accrued and other current liabilities
Accrued and other current liabilities consisted of the following (in thousands):
| As of September 30, | As of December 31, | |
|---|---|---|
| 2026 | 2025 | |
| Accrued employee compensation costs | $10,173 | $13,975 |
| Accrued professional costs | 5,736 | 965 |
| Accrued research and development costs | 19,683 | 22,028 |
| Current portion of operating lease liabilities | 1,242 | 3,007 |
| Other current liabilities | 1,750 | 1,060 |
| $38,584 | $41,035 |
- Commitments and contingencies
Operating lease
The Company determines whether an arrangement is a lease at inception. The Company accounts for a lease when it has the right to control the leased asset for a period of time while obtaining substantially all of the assets’ economic benefits. Operating lease right-of-use assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the lease commencement date. The discount rate used to determine the present value of the lease payments is the Company’s incremental borrowing rate based on the information available at lease inception, as the Company did not have information to determine the rate implicit in the leases. Lease expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments (which include initial direct costs and lease incentives). Lease expense is included in operating expenses in the condensed consolidated statements of operations and comprehensive (loss) income.
The Company’s lease agreements also contain variable payments, primarily maintenance-related costs, which are expensed as incurred and not included in the measurement of the right-of-use assets and lease liabilities.
In August 2018, the Company entered into an agreement to lease approximately 23,000 square feet of space for a term ofthree years. Lease terms are triple net lease commencing at $0.9 million per year, then with 3% annual base rent increases plus operating expenses, real estate taxes, utilities and janitorial fees. The lease commencement date was December 10, 2018.
In September 2021, the Company entered into an agreement to extend the initial term of the 23,000 square foot lease for a period ofthree years commencing on December 15, 2021 and ending December 31, 2024. In addition, this lease provides for the lease of an additional 15,000 square feet of rentable space beginning on April 1, 2022 and ending on December 31, 2024. In December 2021, the Company recognized a right-of-use asset and operating lease liability of $3.5 million for the 23,000 square feet. On April 1, 2022, the Company recognized a right-of-use asset and operating lease liability of $1.8 million for the 15,000 square feet.
In December 2023, the Company entered into an agreement to extend the term of the 38,000 square foot lease for a period oftwo years commencing on January 1, 2025 and ending on December 31, 2026. In December 2023, the Company recognized a right-of-use asset and operating lease liability of $4.1 million. In August 2026, the Company further amended the term of the lease for a period of two months commencing on January 1, 2027, and ending on February 28, 2027.
In January 2025, the Company entered into an agreement to lease 7,581 square feet of space for an initial term ofthree years and three months. The lease includestwo renewal options for an additional three years each. Lease terms commence at $0.7 million per annum, with 2.0% annual base rent increases plus operating expenses, real estate taxes, and utilities. The lease commencement date was July 8, 2025. In July 2025, the Company recognized a right-of-use asset and operating lease liability of $1.8 million. In September 2025, the Company entered into a sublease agreement for the 7,581 square feet of space for a term equal to the initial term of the original lease. Sublease terms commence at $0.4 million per annum with 2% annual rent increases. As a result of this sublease, the Company recognized a right of use asset impairment of $0.7 million.
On January 21, 2026, the Company entered into a new lease for its corporate headquarters and laboratory space with NWALP PHOP Property Owner LLC, located at 245 Fifth Avenue, Waltham, Massachusetts (the “Lease Agreement”), in order to expand its office and laboratory space. The Lease Agreement premises include approximately 98,500 square feet. The Lease Agreement will expire on March 31, 2038, and includestwo options to further extendthe Lease Agreement for an additional five years at the then-prevailing market rate. The aggregate estimated base rent payments due over the term of the Lease Agreement is approximately $86.6 million. The Company paid a security deposit of $3.0 million in the form of an irrevocable standby letter of credit, which may be reduced over time in accordance with the terms of the Lease Agreement. The Company expects to occupy the space late in 2026 and has evaluated build to suit considerations as of September 30, 2026.
Future minimum lease payments under non-cancellable leases as of September 30, 2026 were as follows (in thousands):
| 2026 | 815 |
| 2027 | 699 |
| 2028 | 532 |
| Total lease payments | 2,046 |
| Less imputed interest | (124) |
| Present value of lease liabilities | $1,922 |
Lease balances as of September 30, 2026 were as follows (in thousands):
| Operating right-of-use assets | $1,233 |
|---|---|
| Current portion of operating lease liabilities | $1,242 |
| Non-current portion of operating lease liabilities | 680 |
| Total operating lease liabilities | $1,922 |
The weighted average remaining lease term and weighted average discount rate of the Company’s operating leases as of September 30, 2026 were as follows:
| Weighted average remaining lease term in years | 1.5 |
|---|---|
| Weighted average discount rate | 9.97% |
Lease expense incurred under operating leases was $0.6 million and $0.7 million for the three months ended September 30, 2026 and 2025, respectively, and was $1.8 million and $2.1 million for the nine months ended September 30, 2026 and 2025, respectively.
License and research agreements
In April 2016, the Company entered into an exclusive, worldwide license agreement with the University of Southampton (the “Southampton Agreement”), whereby the Company acquired rights to foundational technologies related to the Company’s proprietary protein upregulation platform technology. Under the Southampton Agreement, the Company receives an exclusive, worldwide license under certain licensed patents and applications relating to the Company's proprietary protein upregulation platform. Under the Southampton Agreement, the Company may be obligated to make additional payments that are contingent upon certain milestones being achieved, as well as royalties on future product sales. These royalty obligations survive until the latest of (i) the expiration of the last valid claim of a licensed patent covering a subject product or (ii) the expiration of any regulatory exclusivity for the subject product in a country. In addition, if the Company sublicenses its rights under the Southampton Agreement, the Company is required to pay a mid-single digit percentage of the sublicense revenue to the University of Southampton. As of September 30, 2026, the Company had paid $8.9 million under the Southampton Agreement as a result of the Acadia license and collaboration agreementand the Biogen license and collaboration agreement. Additionally, certain licenses under the Southampton Agreement require the Company to reimburse the University of Southampton for certain past and ongoing patent related expenses. For the three and nine months ended September 30, 2026 and September 30, 2025 these expenses were immaterial.
Litigation
The Company may periodically become subject to legal proceedings and claims arising in connection with ongoing business activities, including claims or disputes related to patents that have been issued or that are pending in the field of research on which it is focused. As of September 30, 2026 and December 31, 2025, the Company was not subject to any legal proceedings and no legal proceedings are currently pending or threatened to which it was a party or to which its property was subject that, in the opinion of management, would have a material adverse effect on its business.
- License and collaboration agreements
Acadia Pharmaceuticals Inc.
In January 2022, the Company entered into a License and Collaboration Agreement (the “Acadia Agreement”) with Acadia Pharmaceuticals Inc. (“Acadia”) for the discovery, development and commercialization of novel RNA-based medicines for the treatment of severe and rare genetic neurodevelopmental diseases of the central nervous system. The Acadia Agreement focused on the targets SYNGAP1, MECP2 (Rett syndrome), and an undisclosed neurodevelopmental target of mutual interest. In connection with each target, the Company agreed to collaborate with Acadia to identify potential treatments for further development and commercialization as licensed products. With respect to SYNGAP1, the Company agreed with Acadia to co-develop and co-commercialize licensed products for such target globally, and in connection therewith the Company granted to Acadia worldwide, co-exclusive (with the Company) licenses for such licensed products. With respect to MECP2 and the neurodevelopmental target, the Company granted Acadia worldwide, exclusive licenses to develop and commercialize licensed products for such targets. In September 2025, Acadia terminated the MECP2 and the undisclosed neurodevelopmental programs under the Acadia Agreement (the “Discontinued Acadia Programs”) and rights to these targets returned to the Company. The collaboration with Acadia with respect to SYNGAP1 remains ongoing.
Pursuant to the terms of the Acadia Agreement, the Company received an upfront payment of $60.0 million from Acadia. Acadia agreed to fund the research for the Discontinued Acadia Programs, and the Company will equally fund with Acadia the research to identify potential licensed products for SYNGAP1. The Company is eligible to receive up to $245.0 million in potential total milestone payments based upon the achievement of certain development, regulatory, first commercial sales and sales milestone events for the SYNGAP1 program, assuming each milestone were achieved at least once. For SYNGAP1 licensed products that the Company is co-developing and co-commercializing, the Company will be responsible for 50% of the development and commercialization costs and will receive 50% of the profits from global commercialization. The Company is provided with a co-development and co-commercialization opt out option relating to the SYNGAP1 target indication at the Company’s discretion. Such opt-out would reduce development and commercialization milestones but would provide the Company with royalties on an escalating basis attributable to net sales milestones. As a result of the termination of the Discontinued Acadia Programs, the Company is no longer eligible to receive the milestones for those programs of up to $662.5 million or any royalties related thereto.
Acadia Agreement accounting
At the commencement of the Acadia Agreement, the Company identified three performance obligations consisting of pre-clinical research activities for each of the three targets, SYNGAP1, MECP2, and the undisclosed neurodevelopmental target. The exclusive or co-exclusive licenses granted to Acadia to conduct pre-clinical research activities on each of the three targets, and participation on each of the respective joint research committees were identified as promised services. However, the licenses granted to Acadia and the research activities were determined to be not distinct from each other, and therefore are considered a combined performance obligation for each of the three targets. Participation on each of the joint research committees was determined to be quantitatively and qualitatively immaterial in the context of the arrangement with Acadia.
The Company is recognizing the transaction price for the pre-clinical research activities for the remaining target over time as the research services are provided. The transfer of control to Acadia occurs over this time period, and in management’s judgment, is the best measure of progress towards satisfying the performance obligation. An input method is used that measures the cost incurred to date in satisfying each of the three research activities in relation to the estimated total projected cost of each of the research activities to fulfill the respective obligations. The cumulative effect of revisions to estimated costs and/or the transaction price to complete the research performance obligations will be recorded in the period in which changes are identified and amounts can be reasonably estimated.
Milestone payments that are not within the control of the Company, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. For other milestones, the Company evaluated factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone in making this assessment. Milestones that are outside of the Company’s or Acadia’s control will not be recognized until such milestones are achieved. As to the other milestones, to date, no milestone payments have been included in the transaction price due to the uncertainty as to whether these milestones will be achieved. The Company will at the end of each reporting period reevaluate the probability of achievement of all milestones subject to constraint and, if necessary, adjust its estimate of the overall transaction price for each of the research activities on the three targets. Any such adjustments will be recorded on a cumulative catch-up basis.
As of September 30, 2026, the Company had $1.3 million in receivables and $2.2 million recorded as current deferred revenue under the Acadia Agreement, related to performance obligations that were either unsatisfied or partially unsatisfied. Revenue recognized under the Acadia collaboration was $2.5 million and $3.9 million for the three months ended September 30, 2026 and 2025, respectively. For the nine months ended September 30, 2026 and 2025, the Company recognized $7.5 million and $20.7 million, respectively, in revenue related to the Acadia Agreement.
Biogen International GmbH License and Collaboration Agreement
On February 14, 2025, the Company entered into a License and Collaboration Agreement (the “Biogen Agreement”) with Biogen International GmbH (“Biogen”) for the joint development and commercialization of zorevunersen and other compounds targeting the SCN1A gene (the “Licensed Product”).
Under the terms of the Biogen Agreement, the Company granted Biogen an exclusive, royalty bearing license to develop, manufacture and commercialize licensed products outside the United States, Canada and Mexico (the “Biogen Territory”). Biogen also has an option to exercise an exclusive, royalty-bearing, sublicensable and transferable license to certain future follow on antisense oligonucleotides (“ASOs”) directed to SCN1A controlled by the Company. The parties are jointly developing zorevunersen, with the Company leading global development, and development costs are shared pursuant to an agreed budget, with the Company responsible for 70% and Biogen responsible for 30%.
The Company received an upfront payment of $165.0 million and is eligible to receive development and commercial milestones that could total up to approximately $50.0 million and $335.0 million, respectively if all the specified milestones set forth in the collaboration arrangement are achieved. The Company is also eligible to receive tiered, double-digit royalties ranging from the low double digits to the high teen percentages on future net sales in the Licensed Product territory. As of September 30, 2026, no milestones have been achieved.
Biogen Agreement accounting
The Company determined that the Biogen Agreement represents a contract with a customer under ASC 606 and identified two performance obligations:
the license granted to Biogen (the “IP License”); and
development services, that are expected to generate data necessary for regulatory approval in the Biogen Territory for the Licensed Product (“Global Development Activities”).
The initial transaction price was $243.4 million, consisting of the non-refundable upfront payment of $165.0 million and $78.4 million estimated variable consideration related to development cost reimbursements for Global Development Activities. Sales-based royalties and milestone payments were excluded from the transaction price as they were either subject to the sales- or usage-based royalty exception or fully constrained due to uncertainty.
The transaction price was allocated to the performance obligations based on their relative standalone selling prices. Revenue allocated to the IP License was recognized upon transfer of the license in February 2025. Revenue related to Global Development Activities is recognized over time using a cost-based measure of progress, which is considered by the Company to be appropriate as there is a direct relationship between the costs incurred and satisfaction of the performance obligation. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
The following table provides a summary of the transaction price allocated to each performance obligation, in addition to revenue activity for the nine months ended September 30, 2026 and September 30, 2025 (in thousands):
| 2026 | 2025 | |||
|---|---|---|---|---|
| Transaction Price Allocated | Revenue Recognized | Transaction Price Allocated | Revenue Recognized | |
| Performance obligations | ||||
| IP License | $— | $— | $150,779 | $150,779 |
| Global Development Activity | — | 19,322 | 92,644 | 11,524 |
| $— | $19,322 | $243,423 | $162,303 | |
As of September 30, 2026, the Company had $7.3 million of receivables and $8.6 million of deferred contract consideration related to the Biogen Agreement, of which $4.1 million was classified as current deferred revenue. For the three months ended September 30, 2026 and 2025, the Company recognized revenue of $8.8 million and $6.7 million, respectively, and for the nine months ended September 30, 2026 and 2025, the Company recognized $19.3 million and $162.3 million, respectively, under the Biogen Agreement. The Company expects to fully recognize the deferred contract consideration in December 2028.
- Equity incentive plans
As of September 30, 2026, there wereno shares available for future issuance under the 2014 Plan,2,285,901 shares were available under the 2019 Plan and 1,767,006 shares were available under the 2023 Plan.
During the three months ended September 30, 2026, the Company granted options to purchase 531,869 shares of common stock to certain of its employees and directors. The options vest over a period of up tofour years and are exercisable at a per share price equal to the fair value of the common stock on the grant date. During the three months ended September 30, 2026, the Company granted 26,000 RSUs and didnot grant any performance stock units (“PSUs”) to its employees. The RSUs vest over a period of up tofour years.
Stock-based compensation
As of September 30, 2026, there was $83.4 million of unrecognized compensation cost related to unvested stock options granted under the 2019 and 2023 Plans. Compensation expense is expected to be recognized over a weighted average period of 2.8 years as of September 30, 2026. As of September 30, 2026, there was $35.8 million of unrecognized stock-based compensation related to RSUs. The compensation expense for RSUs is expected to be recognized over a weighted average period of 2.8 years.
Stock-based compensation expense recorded as research and development and sales, general and administrative expenses in the accompanying condensed consolidated statements of operations and comprehensive (loss) income is as follows (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Research and development | $4,753 | $3,200 | $12,512 | $8,688 |
| Sales, general and administrative | 6,280 | 4,839 | 18,076 | 13,702 |
| Total | $11,033 | $8,039 | $30,588 | $22,390 |
2019 Employee stock purchase plan
In June 2019, the Company adopted the 2019 Employee Stock Purchase Plan (the “ESPP”), which became effective on June 18, 2019. The Company initially reserved 315,000 shares of common stock for sale under the ESPP. At September 30, 2026, the Company had 2,572,303 shares available for issuance under the ESPP. The average grant date fair value per share under the ESPP was $31.81 for 2026. The total ESPP stock-based compensation expense for the three and nine months ended September 30, 2026 was $0.2 million and $0.7 million, respectively, and for the three and nine months ended September 30, 2025 was $0.1 million and $0.4 million, respectively. Thenumber of shares reserved for issuance under the ESPP will increase automatically on January 1 of each of the first tencalendar years following the first offering date by the number of shares equal to the lesser of 1% of the total outstanding shares of the Company’s common stock as of the immediately preceding December 31 or a lower amount determined by the Company’s board of directors. The aggregate number of shares issued over the term of the ESPP will not exceed 3,150,000 shares of the Company’s common stock.
- Net (loss) income per share
The following table summarizes the computation of basic and diluted net (loss) income per share of the Company (in thousands except share and per share amounts):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Numerator: | ||||
| Net (loss) income | $(73,644) | $(38,347) | $(185,265) | $51,049 |
| Denominator: | ||||
| Weighted-average number of common shares, basic | 68,362,880 | 58,611,677 | 65,834,172 | 58,278,812 |
| Weighted-average number of common shares, diluted | 68,362,880 | 58,611,677 | 65,834,172 | 60,397,681 |
| Net (loss) income per share, basic | $(1.08) | $(0.65) | $(2.81) | $0.88 |
| Net (loss) income per share, diluted | $(1.08) | $(0.65) | $(2.81) | $0.85 |
As the Company had net income during the nine months ended September 30, 2025, the Company’s potential dilutive securities, which include stock options, RSUs and PSUs, were included in the calculation of diluted net income per share attributable to common stockholders.
For the three and nine months ended September 30, 2026 and the three months ended September 30, 2025, the Company incurred a net loss. Weighted-average shares outstanding used to calculate basic net loss per share includes 3,703,730 warrants outstanding during the period. The Company’s potential dilutive securities, which include stock options, restricted stock units and performance stock units have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same for the three and nine months ended September 30, 2026 and the three months ended September 30, 2025.
The Company excluded the following potential common stock, presented based on amounts outstanding at September 30, 2026 and 2025 from the computation of diluted net (loss) income per share attributable to common stockholders because including them would have had an anti-dilutive effect.
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Outstanding options to purchase common stock | 11,561,874 | 9,552,776 | 11,561,874 | 6,759,812 |
| Restricted stock units | 2,002,214 | 1,588,510 | 2,002,214 | 119,730 |
| Performance stock units | — | 201,000 | — | — |
| Total | 13,564,088 | 11,342,286 | 13,564,088 | 6,879,542 |
- Income taxes
For the nine months ended September 30, 2026, the Company didnot have any income tax expense recorded in its condensed consolidated statements of operations and comprehensive (loss) income. In 2025, the Company recorded federal and state tax expense of $1.1 million and $0.1 million, respectively due to recognizing income from the Biogen collaboration, offset by net operating loss carryforwards that were able to be utilized to the extent allowable by tax law. In the three months ended September 30, 2025, prior recorded income tax expense of $1.1 million and $0.1 million for federal and state, respectively, were reversed due to the passage on July 4, 2025 of the One Big Beautiful Bill Act. The Company has provided a valuation allowance for the full amount of its net deferred tax assets as of September 30, 2026 and December 31, 2025, as management has determined it is more likely than not that any future benefit from deductible temporary differences and net operating loss and tax credit carryforwards would not be realized.
- Segment Information
The Company comprisesone reportable segment, Stoke. As of September 30, 2026, this segment has not generated any product revenue since inception, as it does not yet have approved products for sale.
The Company primarily generates revenue in North America, with its long-lived assets also concentrated in this region, and manages its business activities on a consolidated basis. Decisions concerning the allocation of the Company’s resources are made by the Company’s Chief Operating Decision Maker (“CODM”), which is the Company’s Chief Executive Officer. The CODM views the Company’s operations as a single operating segment which is the business of discovering and developing RNA-based medicines, using the Company's proprietary protein upregulation platform and developing ASOs to selectively restore protein levels.
The CODM assesses performance for the Company's operations segment and decides how to allocate resources based on net income or loss that is also reported on the income statement as consolidated net income or loss and the measure of segment assets as reported on the balance sheet as total consolidated assets. Net income or loss is used to monitor budget versus actual results as well as assess the general performance of the segment in a given period.
The following table reconciles segment net (loss) income to the Company’scondensed consolidated results (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Revenue | $11,255 | $10,632 | $26,808 | $183,018 |
| Zorevunersen(1) | 35,496 | 21,087 | 83,593 | 50,143 |
| ADOA(1) | 3,697 | 1,607 | 8,252 | 3,747 |
| SYNGAP1(1) | 337 | 917 | 2,156 | 2,075 |
| MECP2(1) | — | 16 | — | (38) |
| Other external program costs | 4,524 | 2,221 | 11,692 | 5,891 |
| Payroll and other personnel costs - R&D (2) | 19,668 | 12,627 | 54,004 | 35,256 |
| Payroll and other personnel costs - SG&A (2) | 14,342 | 8,941 | 38,716 | 26,849 |
| Other non-program costs - R&D (3) | 3,125 | 1,713 | 6,433 | 4,738 |
| Other non-program costs - SG&A (3) | 7,382 | 4,594 | 18,124 | 13,508 |
| Interest expense | (20) | (3) | (61) | (6) |
| Interest income | 3,686 | 3,466 | 10,625 | 10,147 |
| Other income | 6 | 3 | 333 | 59 |
| Provision for income taxes | — | (1,278) | — | — |
| Segment net (loss) income | $(73,644) | $(38,347) | $(185,265) | $51,049 |
(1)Includes external research and development andsales, general and administrative expenses associated with programs.
(2)Includes salaries, benefits and other personnel related expenses, including stock based compensation expense, of relevant personnel.
(3)Includes costs incurred for conducting non-program activities related to Company activities.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.