Tenaya Therapeutics, Inc.
For the period ended Sep 30, 2026. Filed Nov 4, 2026.
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Sep 30, 2026 · Filed Nov 4, 2026
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Notes to Unaudited Condensed Financial Statements
Organization and Description of the Business
Description of the Business
Tenaya Therapeutics, Inc. (the Company) was incorporated in the state of Delaware in August 2016 and is headquartered in South San Francisco, California. The Company is a clinical-stage biotechnology company focused on discovering, developing and delivering curative therapies that address the underlying drivers of heart disease. The Company’s lead product candidates include TN-201, a gene therapy for myosin binding protein C3-associated hypertrophic cardiomyopathy, TN-401, a gene therapy for plakophilin 2-associated arrhythmogenic right ventricular cardiomyopathy, and TN-301, a small molecule with potential clinical utility in cardiac, metabolic and muscular conditions, including heart failure with preserved ejection fraction and Duchenne’s muscular dystrophy.
Liquidity
The Company has incurred net losses since inception and expects such losses to continue in the future as it conducts research and development activities. As of September 30, 2026, the Company had an accumulated deficit of $686.6 million. The Company incurred a net loss of $81.6 million and $70.4 million during the nine months ended September 30, 2026 and 2025, respectively. The Company had $66.8 million of cash and cash equivalents as of September 30, 2026.
Management recognizes the need to raise additional capital to fully implement its business plan. The Company may seek to raise capital through equity financings, debt financings, license agreements, collaborative agreements or other sources of financing. Management believes that its existing cash and cash equivalents as of September 30, 2026, will be sufficient to fund the Company’s operations for at least the next twelve months following the date these financial statements are filed with the Securities and Exchange Commission (SEC).
Summary of Significant Accounting Policies
Basis of Presentation
The accompanying condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) and follow the requirements of the SEC for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted.
The interim condensed balance sheet as of September 30, 2026, the interim condensed statements of operations and comprehensive loss, stockholders’ equity and cash flows for the nine months ended September 30, 2026 and 2025 are unaudited. These unaudited interim condensed financial statements have been prepared on the same basis as the Company’s annual financial statements and reflect all adjustments that are necessary for the fair statement of the Company’s financial position, results of operations and cash flows for the interim periods presented. The condensed results of operations for the nine months ended September 30, 2026, are not necessarily indicative of the results to be expected for the full year or for any other future annual or interim period. The condensed balance sheet as of December 31, 2025, included herein was derived from the audited financial statements as of that date. These condensed financial statements should be read in conjunction with the Company’s audited financial statements and the related notes thereto for the year ended December 31, 2025, included in the Company’s Annual Report on Form 10-K, filed with the SEC on March 11, 2026.
Use of Estimates
Thepreparation of condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and the disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying financial statements include, but are not limited to, accrued expenses related to research and development activities and revenue recognition related to collaboration agreements. The Company bases its estimates on historical experience, the current economic environment, and on various other assumptions that are believed to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions.
Significant Accounting Policies
There have been no material revisions to the Company’s significant accounting policies described in Note 2, Summary of Significant Accounting Policies, to the financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, except for the accounts receivable, revenue recognition and contract liability policies related to the collaboration agreements entered into during the nine months ended September 30, 2026, as described below.
Accounts Receivable
The Company's accounts receivable relates to licensing and collaboration arrangements. These accounts receivable are short-term in nature. The Company estimates expected credit losses over the life of the financial assets as of the reporting date based on relevant information about past events, current conditions, and reasonable and supportable forecasts. For the nine months ended September 30, 2026 and 2025, the Company hadno allowance for credit losses.
Revenue Recognition
Overview
The Company recognizes revenue in accordance with Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers(ASC 606). Revenue is recognized when promised goods or services are transferred to a customer in an amount that reflects the consideration to which the Company expects to be entitled. To determine the appropriate amount of revenue to be recognized for arrangements determined to be within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the promises and performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligations. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
Collaborative Frameworks and Assessment Under ASC 808 and ASC 606
The Company enters into arrangements that may include elements of collaboration with counterparties, such as joint steering committees or shared development activities. The Company evaluates each arrangement to determine whether the counterparty is acting in the capacity of a customer.
To the extent that the Company transfers goods or services to a counterparty in its capacity as a customer, the Company accounts for such transactions under ASC 606 and presents the related amounts as revenue. Amounts that do not represent transactions with a customer are accounted for under ASC Topic 808, Collaborative Arrangements(ASC 808), and presented within the appropriate operating expense line item.
Licensing and Collaboration Arrangements
The Company enters into licensing and collaboration arrangements that may include licenses to intellectual property, as well as research, development, or technical support services necessary to enable the licensee to utilize the underlying technology.
Identification of Performance Obligations
The Company evaluates the nature of its promises in these arrangements to determine whether they are distinct or should be combined. A license of intellectual property is combined with other promised services when the license is not distinct within the context of the contract, such as when the Company’s ongoing research or development activities significantly affect the utility of the licensed intellectual property. When a license and related services are not distinct, they are accounted for as a single combined performance obligation.
Recognition of Revenue
Revenue is recognized either at a point in time or over time, depending on the nature of the underlying performance obligations. Revenue is recognized at a point in time when control of a promised good or service transfers to the customer and the performance obligation is satisfied. Revenue is recognized over time when the Company satisfies a performance obligation over time, including when the Company’s performance does not create an asset with an alternative use and the Company has an enforceable right to payment for performance completed to date, or when the customer simultaneously receives and consumes the benefits of the Company’s performance.
For performance obligations satisfied over time, the Company measures progress using an appropriate method that faithfully depicts the transfer of control of the underlying services. Depending on the nature of the arrangement, the Company may use an input method, such as costs incurred relative to total estimated costs (cost-to-cost method), when such method best reflects the Company’s performance.
For arrangements that provide access to intellectual property or other rights over a defined period without additional performance obligations, revenue is recognized ratably over the contractual term.
Upfront License Fees
If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company will recognize revenue from upfront license fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company determines whether the combined performance obligation is satisfied over time or at a point in time.
Milestone Payments
Contingent milestones at contract inception are estimated at the amount which is not probable of a material reversal and included in the transaction price using the most likely amount method. Milestone payments that are not within the Company's control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received and therefore the variable consideration is constrained. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each reporting period, the Company re-evaluates the probability of achieving development, regulatory or sales-based milestone payments that may not be subject to a material reversal and, if necessary, adjusts the estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license and other revenue, as well as earnings, in the period of adjustment.
Sales-Based Royalties and Milestones
For arrangements that include sales-based royalties, including milestone payments based on the volume of sales, the Company will determine whether the license is deemed to be the predominant item to which the royalties or sales-based milestones relate and if such is the case, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Contract Liabilities
Contract liabilities consist primarily of upfront non-refundable payments received under collaboration agreements for which the related performance obligations have not yet been fully satisfied. The Company classifies amounts expected to be recognized as revenue within the next twelve months as contract liabilities, current, with the remainder classified as contract liabilities, noncurrent based on the estimated timing of revenue recognition.
Recently Adopted Accounting Standards
In July 2025, the Financial Accounting Standards Board (FASB) issued Accounting Standard Update (ASU) No. 2025-05 (ASU 2025-05), Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets(ASU 2025-05), which provides a practical expedient for entities to estimate expected credit losses on current accounts receivable and current contract assets arising from revenue transactions accounted for under ASC 606. ASU 2025-05 is effective for the Company for annual periods beginning after December 15, 2025, and interim periods within those annual periods. The Company adopted this ASU on a prospective basis during thefirst quarter of 2026. Theadoption didnot have a material impact on the Company's financial statements.
Recently Issued Accounting Pronouncements Not Yet Adopted
In December 2025, the FASB issued ASU No. 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements(ASU 2025-11), which clarifies the applicability of the interim reporting guidance, the types of interim reporting, and the form and content of interim financial statements in accordance with GAAP. Per the FASB, the amendment does not intend to change the fundamental nature of interim reporting or expand or reduce current interim disclosure requirements but rather provide clarity and improve navigability of the existing interim reporting requirements. ASU 2025-11 is effective for interim periods within annual reporting periods beginning after December 15, 2027, with early adoption permitted. ASU 2025-11 may be applied either prospectively or retrospectively for all prior periods presented. The Company is evaluating the impact of this standard on its financial statements and related disclosures.
In December 2025, the FASB issued ASU No. 2025-10, Government Grants (Topic 832): Accounting for Government Grants Received by Business Entities(ASU 2025-10), which adds guidance to Accounting Standards Codification (ASC) 832 on the recognition, measurement, and presentation of government grants. The guidance establishes a framework for accounting for government grants, including grants related to assets and grants related to income. ASU 2025-10 is effective for the Company for annual periods beginning after December 15, 2028, and interim periods within those annual periods. Early adoption is permitted. The Company is evaluating the impact of this standard on its financial statements and related disclosures.
In November 2024, the FASB issued ASU No. 2024-03, Income Statement (Topic 220): Reporting Comprehensive Income - Expense Disaggregation Disclosures, Disaggregation of Income Statement Expenses(ASU 2024-03), which requires public companies to disclose, in interim and annual reporting periods, additional information about certain expenses in the financial statements. The amendments in this ASU will be effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company is evaluating the impact of this standard on its financial statements and related disclosures.
Collaboration Revenue
Alnylam Collaboration Agreement
In March 2026, the Company entered into a collaboration agreement with Alnylam Pharmaceuticals, Inc. (Alnylam), pursuant to which both parties agreed to a research collaboration to discover and validate novel gene targets for the potential treatment of cardiovascular disease.
Under the agreement, both parties nominated and aligned on a set of collaboration targets to move forward into the collaboration. Following such alignment, the parties will conduct in vitro and in vivo validation activities under a mutually agreed research plan and budget for a period of twenty-four (24) months (which may be extended for completion of the work). The Company expects to take primary responsibility for the performance of all in vitro and in vivo validation activities throughout the validation term; Alnylam will reimburse the Company for full-time employees and out-of-pocket costs and expenses incurred by the Company in accordance with the agreed-upon research budget. After completion of the validation activities, Alnylam will be solely responsible, at its own expense, for all development, manufacture, regulatory and commercialization activities for any products directed to a collaboration target. The Company was also entitled to a non-refundable upfront platform access fee of up to $10.0 million. The upfront platform access fee was initially subject to variability based on the number of collaboration targets selected and became fixed at $10.0 million upon finalization of the collaboration target list. Reimbursement of research costs represents variable consideration and is excluded from the transaction price at contract inception as such amounts are fully constrained. These amounts are recognized as revenue as the related costs are incurred.
The Company concluded that the license and research activities represent a single performance obligation that is satisfied over time. Revenue is recognized using a cost-to-cost input method, which measures progress based on costs incurred relative to total estimated costs under the research plan. For the three and nine months ended September 30, 2026, the Company recognized collaboration revenue of $1.5 million and $2.4 million, respectively, related to the upfront platform access fee and reimbursable research costs incurred during the respective periods.
The Company may also receive future milestone payments of up to an aggregate of $1.1 billion under the agreement. Development and regulatory milestones will be recognized when the underlying milestone event is achieved, and it becomes probable that a significant reversal of cumulative revenue recognized will not occur. Sales-based milestones will be recognized when the related sales occur. As of September 30, 2026, the Company is unable to predict or reasonably estimate the amount or timing of such milestone payments.
As of September 30, 2026, the aggregate amount of the transaction price allocated to the remaining performance obligation under the collaboration agreement was approximately $8.5 million, which the Company expects to recognize over the remaining validation term of approximately 18 months. The transaction price allocated to the remaining performance obligation does not include variable consideration related to reimbursable research costs as they are contingent on actual qualifying costs incurred. Milestone payments were considered variable consideration and were also not included in the transaction price as they are fully constrained. The Company will reassess the transaction price at each reporting period as uncertainties are resolved.
The following table summarizes activity in the Company’s total contract liabilities for the three and nine months ended September 30, 2026. Additions to contract liabilities included $0.6 million of upfront payments from an additional immaterial collaboration arrangement.
| Contract Liabilities | |
|---|---|
| (In thousands) | |
| Balance as of December 31, 2025 | $— |
| Addition | 10,600 |
| Less: revenue recognized from contract liabilities | (198) |
| Balance as of March 31, 2026 | $10,402 |
| Less: revenue recognized from contract liabilities | (739) |
| Balance as of June 30, 2026 | $9,663 |
| Less: revenue recognized from contract liabilities | (1,124) |
| Balance as of September 30, 2026 | $8,539 |
Balance Sheet Components
Property and Equipment, Net
Property and equipment, net consists of the following:
| September 30, | December 31, | |
|---|---|---|
| 2026 | 2025 | |
| (In thousands) | ||
| Laboratory equipment | $12,060 | $19,014 |
| Leasehold improvements | 7,787 | 26,244 |
| Computer equipment and software | 1,293 | 1,893 |
| Furniture and fixtures | 519 | 902 |
| Manufacturing equipment | — | 19,485 |
| Construction in progress | — | 67 |
| Total property and equipment | $21,659 | $67,605 |
| Less: accumulated depreciation and amortization | (20,523) | (39,933) |
| Total property and equipment, net | $1,136 | $27,672 |
Depreciation and amortization expense for the three months ended September 30, 2026 and 2025 was $0.4 million and $1.9 million, respectively. Depreciation and amortization expense for the nine months ended September 30, 2026 and 2025 was $3.9 million and $6.6 million, respectively.
In connection with the early termination of the Union City lease for the Company's Genetic Medicine Manufacturing Center (the GMMC) (see Note 5, Commitments and Contingencies), the Company recorded an impairment loss of $21.8 million during the second quarter of 2026. The impairment loss primarily reflects the write-down tozero of leasehold improvements and certain manufacturing and laboratory equipment that, pursuant to the lease termination agreement, are required to remain at the GMMC and be surrendered to the landlord without consideration.
During the third quarter of 2026, the Company committed to a plan to sell certain laboratory equipment previously expected to be retained for continued use or repurposing following the closure of the GMMC. Upon meeting the criteria for classification as held for sale, the Company measured the equipment at the lower of its carrying amount or fair value less costs to sell and recognized an impairment loss of $0.7 million during the three months ended September 30, 2026. The Company sold substantially all of this equipment through an auction and separate sales arrangements and recognized a net loss on disposal of property and equipment of $0.1 million, which also included losses from the retirement of certain equipment. The impairment charges and net loss on disposal are presented separately within operating expenses in the accompanying condensed statements of operations and comprehensive loss.
Accrued and Other Current Liabilities
Accrued and other current liabilities consist of the following:
| September 30, | December 31, | |
|---|---|---|
| 2026 | 2025 | |
| (In thousands) | ||
| Accrued compensation and related expenses | $3,991 | $6,013 |
| Accrued research and development expenses | 2,524 | 1,651 |
| Accrued professional services | 341 | 718 |
| Accrued taxes | 45 | 277 |
| Other current liabilities | 160 | 176 |
| Total accrued and other current liabilities | $7,061 | $8,835 |
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consist of the following:
| September 30, | December 31, | |
|---|---|---|
| 2026 | 2025 | |
| (In thousands) | ||
| Prepaid expenses | $3,458 | $4,014 |
| Other current assets | 185 | 1,025 |
| Total prepaid expenses and other current assets | $3,643 | $5,039 |
Commitments and Contingencies
Facility Leases
In December 2016, the Company entered into a lease agreement for office and laboratory space in South San Francisco, California. The lease was initially set to expire in May 2025 with twofive-year renewal options. In June 2024, the Company amended the lease to extendthe term to November 2027. Pursuant to the terms of the amended lease, the Company hasone remaining five-year renewal option.
In February 2021, the Company entered into a lease agreement for office and manufacturing space in Union City, California. The lease commenced in May 2021 and has aten-year term withone five-year renewal option. On June 29, 2026, the Company entered into a lease termination agreement with the landlord. Pursuant to the agreement, the lease terminated on August 31, 2026, instead of its original expiration in July 2031. The Company is not required to remove tenant improvements or restore the premises and may surrender the facility in its existing condition. As consideration for the lease termination, the Company agreed to forfeit its $1.8 million security deposit and pay a one-time lease termination fee of $0.3 million. The Company accounted for the termination agreement as a lease modification under ASC 842 and remeasured the related operating lease liability and right-of-use asset duringthe second quarter of 2026. As a result of the lease modification, the Company recognized a net loss on lease termination of $1.4 million during the nine months ended September 30, 2026, consisting of the security deposit forfeiture and a brokerage commission incurred in connection with the lease termination, partially offset by the gains recognized upon remeasurement of the operating lease liability and right-of-use asset and the derecognition of the asset retirement obligation liability.
Information related to operating lease activity during the three and nine months ended September 30, 2026 was as follows (in thousands):
| Three Months Ended September 30, · Nine Months Ended September 30, | ||||||
|---|---|---|---|---|---|---|
| 2026 · 2025 · 2026 · 2025 | ||||||
| (In thousands) | ||||||
| Operating lease cost | $556 | $889 | $2,334 | $2,667 | ||
| Variable lease cost | 357 | 410 | 1,042 | 1,043 | ||
| Total lease cost | $913 | $1,299 | $3,376 | $3,710 | ||
| Cash paid for amounts included in the measurement of lease liabilities | $3,063 | $2,914 | ||||
As of September 30, 2026, the Company had one operating lease with a remaining lease term of 1.2 years and a discount rate of 7.8%. As of December 31, 2025, the Company’s operating leases had a weighted average remaining lease term of 4.1 years and a weighted average discount rate of 9.1%. Future minimum lease payments under the Company’s operating lease as of September 30, 2026 were as follows:
| Amount | |
|---|---|
| (In thousands) | |
| 2026 (three months remaining) | $628 |
| 2027 | 2,347 |
| 2028 | — |
| 2029 | — |
| 2030 | — |
| Thereafter | — |
| Total undiscounted future minimum lease payments | $2,975 |
| Imputed interest | (123) |
| Total operating lease liabilities | $2,852 |
Purchase Commitments
The Company enters into contractual agreements with various suppliers in the normal course of its business, including vendors that provide machinery and equipment. All contracts are terminable, with varying provisions regarding termination. In general, if a contract with a specific vendor were to be terminated, the Company would only be obligated for the products or services that the Company had received up to the time of termination.
Contingencies
From time to time, the Company may become involved in litigation and other legal actions. The Company estimates the range of liability related to any pending litigation where the amount and range of loss can be estimated. The Company records its best estimate of a loss when the loss is considered probable. Where a liability is probable and there is a range of estimated loss with no best estimate in the range, the Company records a charge equal to at least the minimum estimated liability for a loss contingency when both of the following conditions are met: (i) information available prior to issuance of the financial statements indicates that it is probable that a liability had been incurred at the date of the financial statements and (ii) the range of loss can be reasonably estimated. The Company was not involved in any material litigation as of September 30, 2026.
Indemnification
In the normal course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend an indemnified party for losses suffered or incurred by the indemnified party. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amounts of future payments the Company could be required to make under these provisions is not determinable. In addition, the Company has entered into indemnification agreements with its directors and certain officers that may require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. As of September 30, 2026, the Company did not have any material indemnification claims that were probable or reasonably possible and, consequently, has not recorded any related liabilities.
Stock-Based Compensation
2024 Inducement Equity Incentive Plan
In September 2024, the Board of Directors (the Board) adopted the Company's 2024 Inducement Equity Incentive Plan (the Inducement Plan), and subject to the adjustment provisions of the Inducement Plan, reserved 1,200,000 shares of the Company’s common stock for issuance pursuant to equity awards granted under the Inducement Plan. The Inducement Plan allows the Company to make equity awards to prospective employees of the Company as an inducement to such individual’s commencement of employment with the Company. On January 26, 2026, the Board approved an increase of 2,161,000 shares to the number of shares reserved under the Inducement Plan.
Total shares reserved and available for grant under the Inducement Plan as of September 30, 2026, were 848,800.
Repricing
On January 22, 2025, the Compensation Committee of the Company's Board approved a repricing of certain outstanding vested and unvested stock option awards under the Amended and Restated 2016 Equity Incentive Plan (the 2016 Plan) and 2021 Plan for eligible employees and certain other service providers (the Repricing Participants). The per share exercise price of eligible stock option awards was reduced to $1.21, the closing price of the Company's common stock on January 24, 2025 (the Repricing Effective Date). To receive the benefit of the repricing, Repricing Participants were required to remain a Service Provider (as such term is defined in the 2016 Plan or 2021 Plan) through the period (the Retention Period) that began on the Repricing Effective Date and ended on July 24, 2025 (the Retention Date) and not exercise any of their repriced stock options prior to the Retention Date. Option holders who exercised their repriced stock options prior to the Retention Date were required to pay the original exercise price per share of such repriced options. No other changes were made to the terms and conditions of the eligible stock option awards. The stock option repricing impacted 4.1 million stock option awards and affected 89 employees and service providers.
On February 6, 2025, the Company's Board approved an option repricing applicable to Faraz Ali, the Company's Chief Executive Officer, with terms mirroring the aforementioned repricing approved on January 22, 2025, except that for Mr. Ali, the options eligible for repricing were limited to options with exercise prices higher than $5.25 per share. The total number of shares underlying Mr. Ali’s repriced options was 915,875 shares.
The repricing resulted in a total incremental stock-based compensation expense of $1.3 million, which was calculated using the Black-Scholes option pricing model, of which $1.0 million is associated with vested repriced options as of the Retention Date and were recognized on a straight-line basis over the Retention Period. The remaining $0.3 million of the incremental stock-based compensation expense is associated with unvested repriced options beyond the Retention Period and will be recognized on a straight-line basis over the remaining original vesting periods. For the nine months ended September 30, 2026 and 2025, the Company recognized an immaterial amount and $1.0 million, respectively, of incremental stock-based compensation expense.
2021 Equity Incentive Plan
Under the Company’s 2021 Equity Incentive Plan (the 2021 Plan),4,000,000 shares of the Company’s common stock were initially reserved for issuance of equity awards to employees, directors, and consultants, under terms and provisions established by the Board. Prior to May 27, 2026, the number of shares of common stock available for issuance under the 2021 Plan automatically increased on the first day of January for a period often years, commencing on January 1, 2022, in an amount equal to the lesser of:4,000,000 shares;4%of the outstanding sharesof the Company’s common stock as of the last day of the immediately preceding year; or such other amount as the board of directors may determine.
On May 27, 2026, the Company’s stockholders approved the Amended and Restated 2021 Equity Incentive Plan (the Restated 2021 Plan). The Restated 2021 Plan increased the number of shares of the Company’s common stock reserved for issuance by 6,509,966 shares. In addition, beginning on January 1, 2027, the annual automatic increase provision was amended such that the number of shares available for issuance under the Restated 2021 Plan will increase on the first day of each fiscal year through 2031 in an amount equal to 4% of the outstanding shares of the Company’s common stock as of the last day of the immediately preceding year, or such lesser amount as the Board or the Compensation Committee may determine, without the previous annual cap of 4,000,000 shares. The Restated 2021 Plan also provides that no more than 15,000,000 shares may be issued pursuant to incentive stock options.
The total number of shares reserved and available for grant under the Restated 2021 Plan as of September 30, 2026 was 4,215,105.
Stock Option Activity
The following table summarizes stock option activity:
| Shares | Weighted AverageExercisePrice | |
|---|---|---|
| (in dollars) | ||
| Outstanding as of December 31, 2025 | 12,050,796 | $1.90 |
| Granted | 8,581,923 | $0.81 |
| Exercised | — | $— |
| Cancelled | (487,809) | $1.88 |
| Outstanding as of September 30, 2026 | 20,144,910 | $1.46 |
Stock option awards granted to employees generally vest over afour-year period. The contractual term of stock option awards is generally 10 years from the grant date.
Stock Option Valuation
The fair value of the Company’s stock option awards is estimated on the date of grant using the Black-Scholes option pricing model using the following assumptions:
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Expected term (in years) | 6.0 – 6.1 | 6.1 | 5.5 – 6.1 | 5.5 – 6.1 |
| Expected volatility | 82% – 83% | 90% | 82% – 85% | 87% – 91% |
| Risk-free interest rate | 4.4% – 4.8% | 3.7% | 3.9% – 4.8% | 3.7% – 4.5% |
| Expected dividend yield | —% | —% | —% | —% |
Restricted Stock Units
Restricted stock units (RSUs) are awards that entitle the holder to receive freely tradable shares of the Company’s common stock upon the completion of a specific period of continued service. RSUs generally vest over atwo- tofour-year periodand are subject to forfeiture if employment terminates prior to the release of vesting restrictions. RSUs are valued at the market price of the underlying common stock on the date of grant. The Company recognizes noncash compensation expense for the fair value of RSUs on a straight-line basis over the requisite service period of the awards. The following table summarizes activity of RSUs granted to employees with service-based vesting under the 2021 Plan.
| Shares | Weighted Average Grant DateFair Value per Share | |
|---|---|---|
| (in dollars) | ||
| Unvested as of December 31, 2025 | 1,536,234 | $2.39 |
| Granted | 2,162,667 | $0.80 |
| Vested | (796,450) | $2.30 |
| Forfeited | (123,653) | $2.03 |
| Unvested as of September 30, 2026 | 2,778,798 | $1.20 |
2021 Employee Stock Purchase Plan
Under the Company's 2021 Employee Stock Purchase Plan (the ESPP), the Company initially reserved 800,000 shares for future issuance. The number of shares of common stock available for issuance under the ESPP automatically increases on the first day of each fiscal year for a period often years beginning with 2022 in an amount equal to the lesser of:800,000 shares;1% of the outstanding shares of the Company’s common stock as of the last day of the immediately preceding year; or such other amount as the Board may determine. As of September 30, 2026,2,999,814 shares were reserved for future issuance under the ESPP. Under the Company’s ESPP, employees are generally eligible to participate and can purchase shares on each purchase date established semi-annually through payroll deductions at the lower of 85% of the fair market value of the Company’s stock at the commencement of the offering period or each purchase date of the offering period. Each offering period spanssix months. The ESPP permits eligible employees to purchase common stock through payroll deductions for up to 15% of qualified compensation, up to an annual limit of $25,000 per the Internal Revenue Service. For the nine months ended September 30, 2026 and 2025, the stock-based compensation expense for ESPP was not material.
Stock-Based Compensation
The following table summarizes stock-based compensation recognized in the Company’s condensed statements of operations and comprehensive loss:
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Research and development | $768 | $1,485 | $2,853 | $5,405 |
| General and administrative | 911 | 1,449 | 2,723 | 4,896 |
| Total stock-based compensation | $1,679 | $2,934 | $5,576 | $10,301 |
Stockholders' Equity
Lender Warrant
On August 6, 2024, the Company entered into a Loan and Security Agreement (the Loan Agreement) with Silicon Valley Bank (SVB). In connection with the Loan Agreement, the Company issued to SVB a warrant which isexercisable for up to 73,649 shares of common stockat an exercise price of $2.55 per share (the Lender Warrant). The Lender Warrant was classified as equity and its fair value was recorded in the stockholders’ equity section of the balance sheet. The Lender Warrant expires on August 6, 2034. As of September 30, 2026, all borrowing commitments under the Loan Agreement had expired, and no term loans were outstanding.
“At-the-Market” Equity Offering
On August 10, 2022, the Company entered into a sales agreement (the Sales Agreement) with Leerink Partners LLC to establish an “at-the-market” (ATM) offering defined in Rule 415 under the Securities Act. Pursuant to the Sales Agreement, the Company is permitted to offer and sell, from time to time, shares of its common stock havinga maximum aggregate offering price of up to $75.0 million. In January 2025, the Company sold 822,566 shares of common stock under the ATM offering for net proceeds of $0.9 million, after deducting commissions and offering costs of $0.3 million. During the third quarter of 2026, the Company sold 3,341,727 shares of common stock under the ATM offering for net proceeds of $2.4 million, after deducting commissions of $0.1 million. As of September 30, 2026, the Company may issue and sell up to approximately $67.4 million of common stock under the ATM offering.
Follow-On Offering
On December 15, 2025, the Company completed an underwritten public offering of 50,000,000 units, priced at a public offering price of $1.20 per unit, with each unit consisting ofone share of its common stock and a warrant to purchaseone share of its common stock at an exercise price of $1.50 per share, which were immediately exercisable and expire five years from the date of issuance (December 2025 Warrants), under its registration statement on Form S-3 (File No. 333-286005). The Company received net proceeds of $55.8 million, after deducting underwriting discounts and commissions of $3.6 million and other offering expenses of $0.6 million.
On March 5, 2025, the Company completed an underwritten public offering of 75,000,000 units, priced at a public offering price of $0.70 per unit, with each unit consisting ofone share of its common stock, a warrant to purchaseone share of its common stock at an exercise price of $0.80 per share, which were immediately exercisable and expire five years from the date of issuance (a Series A Warrant) and a warrant to purchaseone-half of a share of its common stock at an exercise price of $0.70 per share, which were immediately exercisable and expired on June 30, 2026 (a Series B Warrant), under its registration statement on Form S-3 (File No. 333-266741). The Company received net proceeds of approximately $48.8 million, after deducting underwriting discounts and commissions of approximately $3.2 million and other offering expenses of approximately $0.5 million. During the second quarter of 2026, certain holders exercised Series B Warrants to purchase 6,955,000 shares of common stock for an aggregate exercise price of $4.9 million. From issuance through their expiration on June 30, 2026, Series B Warrants to purchase 10,211,250 shares of our common stock were exercised, and the remaining Series B Warrants to purchase 27,288,750 shares of our common stock expired.
The Company analyzed the December 2025, Series A, and Series B Warrants under ASC 480, Distinguishing Liabilities from Equity, and ASC 815-40, Derivatives and Hedging - Contracts in Entity's Own Equity, and concluded that they were not liabilities, were indexed to its own stock and met all other conditions for equity classification. Accordingly, the Company has classified them as permanent equity.
As of September 30, 2026, total shares of common stock reserved for issuance, on an as-if converted basis, are as follows:
| Outstanding stock options and restricted stock units | 22,923,708 |
|---|---|
| Outstanding Lender Warrant | 73,649 |
| Outstanding Series A Warrants | 74,987,500 |
| Outstanding December 2025 Warrants | 50,000,000 |
| Shares available for further issuance under the 2024 Inducement Equity Incentive Plan | 848,800 |
| Shares available for further issuance under the 2021 Equity Incentive Plan | 4,215,105 |
| Shares available for further issuance under the 2021 Employee Stock Purchase Plan | 2,999,814 |
| Total | 156,048,576 |
Fair Value Measurements
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows:
Level 1 - Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.
Level 2 - Inputs other than quoted market prices included in Level 1 are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life.
Level 3 - Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.
The following tables summarize the Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy:
| ValuationHierarchy | AmortizedCost | UnrealizedGain | UnrealizedLoss | Fair Value | |
|---|---|---|---|---|---|
| (In thousands) | |||||
| Assets: | |||||
| Cash equivalents: | |||||
| Money market funds | Level 1 | $63,071 | $— | $— | $63,071 |
| Total financial assets | $63,071 | $— | $— | $63,071 | |
| ValuationHierarchy | AmortizedCost | UnrealizedGain | UnrealizedLoss | Fair Value | |
|---|---|---|---|---|---|
| (In thousands) | |||||
| Assets: | |||||
| Cash equivalents: | |||||
| Money market funds | Level 1 | $98,424 | $— | $— | $98,424 |
| Total financial assets | $98,424 | $— | $— | $98,424 | |
Money market funds are classified as Level 1 because they are valued using quoted market prices in active markets for identical assets.
The carrying amount of the Company’s remaining financial assets and liabilities, which include cash, receivables and payables, approximate their fair values due to their short-term nature.
Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains a significant majority of its cash balances with a single financial institution, with the remainder held at other financial institutions. The Company’s cash balances exceed federally insured limits. The Company has not experienced any losses on its cash balances and management monitors the creditworthiness of these institutions and believes the Company is not exposed to significant credit risk related to these balances.
Income Taxes
For the three and nine months ended September 30, 2026 and 2025, the Company didnot record any income tax expense or benefit. The Company has recorded a full valuation allowance against its U.S. federal and state deferred tax assets as the Company believes it is more likely than not that the benefit will not be realized.
Net Loss Per Share
Basic and diluted loss per share are computed by dividing net loss by the weighted-average number of common shares outstanding during the reporting period. The following potentially dilutive securities were not included in the calculation of diluted net loss per share as of the periods presented because the effect would have been anti-dilutive:
| September 30, | ||
|---|---|---|
| 2026 | 2025 | |
| Outstanding stock options and restricted stock units | 22,923,708 | 13,986,181 |
| Outstanding Lender Warrant | 73,649 | 122,749 |
| Outstanding Series A and Series B Warrants | 74,987,500 | 111,992,500 |
| Outstanding December 2025 Warrants | 50,000,000 | — |
| Total | 147,984,857 | 126,101,430 |
Segment Reporting
The Company is a clinical-stage biotechnology company focused on discovering, developing and delivering curative therapies that address the underlying drivers of heart disease and hasone operating and reportable segment. The Company’s chief operating decision maker (CODM) is thechief executive officer.
The statement of operations includes research and development expenses, general and administrative costs, interest income, and income taxes; the Company has not generated any product revenue. In addition to reviewing the expenses in the Company’s statement of operations, the CODM is regularly provided with operating expenses by function. The CODM does not review assets at a different asset level or category than the amounts disclosed in the Company’s balance sheet. The Company’s long-lived assets are located in the United States.
The following table provides information about the Company’s operating expenses by function and includes a reconciliation to net loss.
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Revenue | ||||
| Collaboration revenue | $1,697 | $— | $3,032 | $— |
| Operating expenses: | ||||
| Research and development | ||||
| Clinical | 6,174 | 4,065 | 16,752 | 15,410 |
| Manufacturing (pre-commercial) | 1,487 | 4,107 | 8,804 | 13,631 |
| Research | 5,034 | 3,579 | 11,812 | 13,681 |
| Other | 2,171 | 3,612 | 8,945 | 11,087 |
| Total research and development | $14,866 | $15,363 | $46,313 | $53,809 |
| General and administrative | 5,648 | 5,573 | 16,501 | 18,747 |
| Impairment loss | 666 | — | 22,487 | — |
| Loss on lease termination, net | — | — | 1,368 | — |
| Loss on disposal of property and equipment | 89 | — | 89 | — |
| Total operating expenses | 21,269 | 20,936 | 86,758 | 72,556 |
| Loss from operations | (19,572) | (20,936) | (83,726) | (72,556) |
| Other income, net: | ||||
| Interest income | 635 | 658 | 2,126 | 2,107 |
| Other (loss) income, net | (1) | 3 | (3) | 27 |
| Total other income, net | 634 | 661 | 2,123 | 2,134 |
| Net loss before income tax expense | (18,938) | (20,275) | (81,603) | (70,422) |
| Income tax expense | — | — | — | — |
| Net loss | $(18,938) | $(20,275) | $(81,603) | $(70,422) |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.