OCULAR THERAPEUTIX, INC
For the period ended Sep 30, 2026. Filed Nov 9, 2026.
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Sep 30, 2026 · Filed Nov 9, 2026
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Notes to the Condensed Consolidated Financial Statements
(Amounts in thousands, except share and per share data)
1. Nature of the Business
Ocular Therapeutix, Inc. (the “Company”) was incorporated on September 12, 2006 under the laws of the State of Delaware. The Company is an integrated biopharmaceutical company committed to redefining the retina experience. AXPAXLI (also known as OTX-TKI) is the Company’s investigational, bioresorbable, intravitreal hydrogel incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties. AXPAXLI is based on the Company’s proprietary ELUTYX hydrogel-based formulation technology. AXPAXLI is currently being evaluated in a Phase 3 registrational program for wet age-related macular degeneration (“wet AMD”), and a Phase 3 registrational program for diabetic retinal disease, including non-proliferative diabetic retinopathy (“NPDR”).
The Company also leverages the ELUTYX technology in its commercial product DEXTENZA, a corticosteroid approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients and for the treatment of ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged two years or older, and in its investigational product candidate OTX-TIC, which is a travoprost intracameral hydrogel for which the Company completed a Phase 2 clinical trial for the treatment of open-angle glaucoma (“OAG”) or ocular hypertension (“OHT”). The Company is evaluating next steps for the OTX-TIC program.
The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, dependence on specific programs, compliance with government regulations, regulatory approval and compliance, reimbursement, uncertainty of market acceptance of products and the need to obtain additional financing. 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. Approved products will require significant sales, marketing and distribution support. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval and adequate reimbursement or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapidly changing technology and substantial competition from pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees and consultants. The Company may not be able to generate significant revenue from sales of any product for several years, if at all. Accordingly, the Company will need to obtain additional capital to finance its operations.
The Company has incurred losses and negative cash flows from operations since its inception, and the Company expects to continue to generate operating losses and negative cash flows from operations in the foreseeable future. As of September 30, 2026, the Company had an accumulated deficit of $1,419,180. Based on its current operating plan which includes estimates of anticipated cash inflows from existing product sales and cash outflows from operating expenses and capital expenditures, the Company believes that its existing cash and cash equivalents of $530,612 as of September 30, 2026, will enable it to fund its planned operating expenses, debt service obligations and capital expenditures at least through the next 12 months from the issuance date of these unaudited condensed consolidated financial statements while the Company observes a minimum liquidity covenant of $20,000 in its credit facility (Note 7).
The future viability of the Company is dependent on the Company’s ability to generate cash flows from the sales of the Company’s product candidates, such as AXPAXLI, if and as approved, and the sales of DEXTENZA, and to raise additional capital to finance its operations. The Company will need to finance its operations through public or private securities offerings, debt financings, collaborations, strategic alliances, licensing agreements, royalty agreements, or marketing and distribution agreements. Although the Company has been successful in raising capital in the past, there is no assurance that it will be successful in obtaining such additional financing on terms acceptable to the Company, if at all. If the Company is unable to obtain funding on a timely basis, in sufficient amounts, or at all, the Company could be
forced to delay, reduce or eliminate some or all of its research and development programs for product candidates, product portfolio expansion or commercialization efforts, any of which could adversely affect its business prospects, or the Company may be unable to continue operations.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The significant accounting policies used in preparation of these unaudited condensed consolidated financial statements are consistent with those described in Note 2 — Summary of Significant Accounting Policies in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on February 5, 2026. The following information updates, and should be read in conjunction with, the significant accounting policies described in Note 2 — Summary of Significant Accounting Policies in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on February 5, 2026.
Use of Estimates
The preparation of these unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of these unaudited condensed consolidated financial statements, and the reported amounts of revenues and expenses during the reporting periods. Significant estimates and assumptions reflected in these unaudited condensed consolidated financial statements include, but are not limited to, the measurement and recognition of reserves for variable consideration related to product sales, revenue recognition related to a collaboration agreement that contains multiple promises, the fair value of derivatives, stock-based compensation, and realizability of net deferred tax assets. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from the Company’s estimates.
Unaudited Interim Financial Information
The balance sheet at December 31, 2025 was derived from the Company’s audited consolidated financial statements but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements as of September 30, 2026 and for the three and nine months ended September 30, 2026 and 2025 have been prepared by the Company, pursuant to the rules and regulations of the SEC for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December 31, 2025 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on February 5, 2026. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of September 30, 2026, the results of operations for the three and nine months ended September 30, 2026 and 2025, and cash flows for the nine months ended September 30, 2026 and 2025 have been made. The results of operations for the three and nine months ended September 30, 2026 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2026.
Recently Issued Accounting Pronouncements
In November 2024, the FASB issued ASU No. 2024-03Disaggregation of Income Statement Expenses. The new standard requires disclosures about specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses and is effective for annual reporting periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027. The Company is currently evaluating the impact of the amendment on its consolidated financial statements.
In September 2025, the FASB issued ASU No. 2025-06Intangibles – Goodwill and Other – Internal-Use Software. The amendments change (i) the criteria regarding the timing of the capitalization of costs for internal-use software and (ii) the accounting for website development costs. The amendments are effective for annual periods beginning after December 15, 2027. The Company is currently evaluating the impact of the amendments on its consolidated financial statements.
In September 2025, the FASB issued ASU No. 2025-07Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract(“ASU 2025-07”). The amendments provide for a new scope exception to the derivatives guidance for certain contracts with variables based on the operations or activities specific to one of the parties to the contract, and also clarify that share-based noncash consideration received from a customer as consideration for the transfer of goods or services in a revenue contract is subject to the revenue guidance and not the financial instruments guidance unless and until the company’s right to receive or retain the share-based noncash consideration is unconditional as defined in ASU 2025-07. The amendments are effective for annual reporting periods beginning after December 15, 2026, including interim periods within those fiscal years. Early adoption is permitted. The Company does not expect the adoption of the amendments to have a significant impact on its consolidated financial statements.
Recently Adopted Accounting Pronouncements
In July 2025, the FASB issued ASU No. 2025-05Financial Instruments – Credit Losses. For public business entities, the amendments provide for the election of a practical expedient to be used in developing reasonable and supportable forecasts as part of estimating future expected credit losses for current accounts receivable and current contract assets. The amendments are effective for annual reporting periods beginning after December 31, 2025, including interim periods within those fiscal years. The Company adopted ASU No. 2025-05 in the first quarter of 2026 with no significant impact on its consolidated financial statements.
3. Licensing Agreements and Deferred Revenue
Incept License Agreement (in-licensing)
On September 13, 2018, the Company entered into a second amended and restated license agreement with Incept, LLC (“Incept”) to use and develop certain intellectual property (the “Incept License Agreement”). Under the Incept License Agreement, as amended and restated, the Company was granted a worldwide, perpetual, exclusive license to use specific Incept technology to develop and commercialize products that are delivered to or around the human eye for diagnostic, therapeutic or prophylactic purposes relating to ophthalmic diseases or conditions. The Company is obligated to pay low single-digit royalties on net sales of commercial products developed using the licensed technology, commencing with the date of the first commercial sale of such products and until the expiration of the last to expire of the patents covered by the license.
The terms and conditions of the Incept License Agreement are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on February 5, 2026.
Royalties paid under the Incept License Agreement related to product sales (the “Incept Royalties”) were $404 and $1,125 for the three and nine months ended September 30, 2026, respectively, and $402 and $1,231 for the three and nine months ended September 30, 2025, respectively. The Incept Royalties are charged to cost of product revenue when accrued.
AffaMed License Agreement (out-licensing)
On October 29, 2020, the Company entered into a license agreement (“AffaMed License Agreement”) with AffaMed Therapeutics Limited (“AffaMed”) for the development and commercialization of the Company’s DEXTENZA product regarding ocular inflammation and pain following cataract surgery and allergic conjunctivitis and for the Company’s OTX-TIC product candidate (collectively, the “AffaMed Licensed Products”) regarding OAG or OHT, in each case in mainland China, Taiwan, Hong Kong, Macau, South Korea, and the countries of the Association of Southeast Asian Nations. The Company retains development and commercialization rights for the AffaMed Licensed Products in the rest of the world.
The terms and conditions of the AffaMed License Agreement are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on February 5, 2026.
As of September 30, 2026, the Company had recognized the full amount of the transaction price that was allocated to the performance obligation regarding the conduct of a Phase 2 clinical trial of OTX-TIC (the “Phase 2 Clinical Trial of OTX-TIC performance obligation”) as collaboration revenue, as this performance obligation was fully satisfied during the second quarter of 2025. The Company recognized collaboration revenue related to the Phase 2 Clinical Trial of OTX-TIC performance obligation of $0 and $128 for the three and nine months ended September 30, 2025.
Deferred revenue activity for the nine months ended September 30, 2026, was as follows:
| | | | |
|---|---|---|---|
| · · | |||
| Deferred revenue at December 31, 2025 | | $14,000 | |
| Amounts recognized into revenue | | | — |
| Deferred revenue at September 30, 2026 | | $14,000 | |
4. Cash Equivalents and Restricted Cash
The Company’s unaudited condensed consolidated statements of cash flows include restricted cash with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on such statements.
A reconciliation of the cash, cash equivalents, and restricted cash reported within the balance sheets that sum to the total of the same amounts shown in the unaudited condensed consolidated statement of cash flows is as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · September 30, · · September 30, | ||||||
| · · 2026 · · 2025 | ||||||
| Cash and cash equivalents | | $530,612 | | $344,772 | ||
| Restricted cash (non-current) | | | 1,614 | | | 1,614 |
| Total cash, cash equivalents and restricted cash as shown on the statements of cash flows | | $532,226 | | $346,386 | ||
The Company's restricted cash as of September 30, 2026 and 2025 consisted of $1,500 in a collateral money market account and $114 for a letter of credit both established in connection with the Company’s real estate leases.
5. Inventory
Inventory consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · September 30, · · December 31, | ||||||
| · · 2026 · · 2025 | ||||||
| Raw materials | | $243 | | $202 | ||
| Work-in-process | | | 1,730 | | | 1,721 |
| Finished goods | | 2,287 | | 1,641 | ||
| | | $4,260 | | $3,564 | ||
6. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · September 30, · · December 31, | ||||||
| · · 2026 · · 2025 | ||||||
| Accrued research and development expenses | | $21,369 | | $14,726 | ||
| Accrued payroll and related expenses | | | 16,992 | | | 17,971 |
| Accrued rebates and programs | | | 6,707 | | | 6,245 |
| Accrued professional fees | | | 6,084 | | | 2,223 |
| Accrued other | | 2,571 | | 1,916 | ||
| Accrued interest payable on Barings Credit Facility (Note 9) | | 717 | | 754 | ||
| | | $54,440 | | $43,835 | ||
7. Financial Liabilities
Barings Credit Agreement
On August 2, 2023 (the “Closing Date”), the Company entered into a credit and security agreement (the “Barings Credit Agreement”) with Barings Finance LLC (“Barings”), as administrative agent, and the lenders party thereto, providing for a secured term loan facility for the Company (the “Barings Credit Facility”) in the aggregate principal amount of $82,474 (the “Total Credit Facility Amount”). The Company borrowed the full amount of $82,474 at closing and received proceeds of $77,290, after the application of an original issue discount and fees.
Indebtedness under the Barings Credit Facility matures on the six-year anniversary of the Closing Date. Indebtedness under the Barings Credit Facility incurs interest based on the Secured Overnight Financing Rate (“SOFR”), subject to a minimum 1.50% floor, plus 6.75%. The Company is obligated to make interest payments on its indebtedness under the Barings Credit Facility on a monthly basis, commencing on the Closing Date; to pay annual administration fees; and to pay, on the maturity date, any principal and accrued interest that remains outstanding as of such date. In addition, the Company is obligated to pay a fee in an amount equal to the Total Credit Facility Amount, which amount shall be reduced by the total amount of interest and principal prepayment fees paid under the Barings Credit Agreement (such fee, the “Barings Royalty Fee”).
The Company is required to pay the Barings Royalty Fee in installments to Barings, for the benefit of the lenders, on a quarterly basis in an amount equal to three and one-half percent (3.5%) of the net sales of DEXTENZA occurring during such quarter, subject to the terms, conditions and limitations specified in the Barings Credit Agreement, until the Barings Royalty Fee is paid in full. The Barings Royalty Fee is due and payable upon a change of control of the Company. The Company may, at its option, prepay any or all of the Barings Royalty Fee at any time without penalty. In connection with the Barings Credit Agreement, the Company granted the lenders thereto a first-priority security interest in all assets of the Company, including its intellectual property, subject to certain agreed-upon exceptions. The Barings Credit Agreement includes customary affirmative and negative covenants and requires the Company to maintain a minimum liquidity amount of $20,000.
The Company has determined that the embedded obligation to pay the Barings Royalty Fee (the “Barings Royalty Fee Obligation”) is required to be separated from the Barings Credit Facility and accounted for as a freestanding derivative instrument subject to derivative accounting. The allocation of proceeds to the Barings Royalty Fee Obligation resulted in a discount on the Barings Credit Facility. The Company is amortizing the discount to interest expense over the term of the Barings Credit Facility using the effective interest method. Accrued or paid Barings Royalty Fees are included in the change in fair value of derivative liabilities on the unaudited condensed consolidated statements of operations and comprehensive loss (Note 9).
A summary of the Barings Credit Facility at September 30, 2026 and December 31, 2025 is as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · September 30, · · December 31, | ||||||
| · · 2026 · · 2025 | ||||||
| Barings Credit Facility | | $82,474 | | | 82,474 | |
| Less: unamortized discount | | | (8,939) | | | (11,138) |
| Total | | $73,535 | | | 71,336 | |
As of September 30, 2026, the full principal for the Barings Credit Facility of $82,474 was due for repayment in 2029.
8. Derivative Liability
Barings Credit Agreement
The Barings Credit Agreement (Note 7) contains the embedded Barings Royalty Fee Obligation, which meets the criteria to be bifurcated and accounted for separately from the Barings Credit Facility (the “Royalty Fee Derivative
Liability”). The Royalty Fee Derivative Liability was recorded at fair value upon entering into the Barings Credit Facility and is subsequently remeasured to fair value at each reporting period.
The Royalty Fee Derivative Liability was initially valued and is remeasured using a “with-and-without” method. The “with-and-without” methodology involves valuing the whole instrument on an as-is basis with the embedded Barings Royalty Fee Obligation and then valuing the instrument without the embedded Barings Royalty Fee Obligation. Royalty payments are estimated using a Monte Carlo simulation. Refer to Note 9 for details regarding the determination of fair value of the Royalty Fee Derivative Liability.
A roll-forward of the Royalty Fee Derivative Liability is as follows:
| | | | |
|---|---|---|---|
| · · Royalty Fee Derivative Liability | |||
| Balance at December 31, 2025 | | $13,903 | |
| Change in fair value | | | (4,356) |
| Balance at September 30, 2026 | | $9,547 | |
9. Risks and Fair Value
Concentration of Credit Risk and of Significant Suppliers and Customers
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable. The Company has its cash and cash equivalents balances atthree accredited financial institutions, in amounts that exceed federally insured limits. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
The Company is dependent on a small number of third-party manufacturers to supply products for research and development activities in its preclinical and clinical programs and for sales of its products. The Company’s development programs as well as revenue from future product sales could be adversely affected by a significant interruption in the supply of any of the components of these products.
Three specialty distributor customers accounted for the following percentages of the Company’s total revenue:
| | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Nine Months Ended · | |||||||||||||
| · · September 30, · · September 30, · | |||||||||||||
| · · 2026 · · 2025 · · 2026 · · 2025 · | |||||||||||||
| Customer 1 | | | 48% | | 46% | | 43% | | 43% | ||||
| Customer 2 | | | 24 | | | 23 | | | 26 | | | 25 | |
| Customer 3 | | | 8 | | | 9 | | | 7 | | | 9 | |
Three specialty distributor customers accounted for the following percentages of the Company’s accounts receivable, net:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · · · As of | |||||||
| · · · September 30, · · December 31, | |||||||
| · · · 2026 · · 2025 | |||||||
| Customer 1 | | | 46% | | 47% | ||
| Customer 2 | | | 28 | | | 25 | |
| Customer 3 | | | 8 | | | 10 | |
Change in Fair Value of Derivative Liabilities
Other income (expense) from the change in the fair values of derivative liabilities as presented on the Company’s unaudited condensed consolidated statements of operations and comprehensive loss includes the following:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Nine Months Ended | ||||||||||||
| · · September 30, · · September 30, | ||||||||||||
| · · 2026 · · 2025 · · 2026 · · 2025 | ||||||||||||
| Change in the fair value of Royalty Fee Derivative Liability | | $1,363 | | $(938) | | $4,356 | | $(1,716) | ||||
| Barings Royalty Fee | | | (451) | | | (509) | | | (1,300) | | | (1,350) |
| Total | | $912 | | $(1,447) | | $3,056 | | $(3,066) | ||||
Fair Value of Financial Assets and Liabilities
The following tables present information about the Company’s financial assets and liabilities that are measured at fair value on a recurring basis as of September 30, 2026 and December 31, 2025 and indicate the level of the fair value hierarchy utilized to determine such fair value:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Fair Value Measurements as of | ||||||||||||
| · · September 30, 2026 Using: | ||||||||||||
| · · Level 1 · · Level 2 · · Level 3 · · Total | ||||||||||||
| Assets: · · · · · · · · | ||||||||||||
| Cash equivalents: · · · · · · · · | ||||||||||||
| Money market funds | | $511,121 | | $— | | $— | | $511,121 | ||||
| | | | | | | | | | | | | |
| Liability: | | | | | | | | | | | | |
| Derivative liability | | $— | | $— | | $9,547 | | $9,547 | ||||
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Fair Value Measurements as of | ||||||||||||
| · · December 31, 2025 Using: | ||||||||||||
| · · Level 1 · · Level 2 · · Level 3 · · Total | ||||||||||||
| Assets: · · · · · · · · | ||||||||||||
| Cash equivalents: · · · · · · · · | ||||||||||||
| Money market funds | | $722,002 | | $— | | $— | | $722,002 | ||||
| | | | | | | | | | | | | |
| Liability: | | | | | | | | | ||||
| Derivative liability | | $— | | $— | | $13,903 | | $13,903 | ||||
Barings Credit Agreement and Royalty Fee Derivative Liability
At September 30, 2026, the Barings Credit Facility, net of the Royalty Fee Derivative Liability, was carried at amortized cost totaling $74,252, comprised of the $73,535 non-current liability (Note 7) and $717 accrued interest (Note 6). The estimated fair value of the Barings Credit Facility, without the Royalty Fee Derivative Liability, was $78,142 at September 30, 2026.
At December 31, 2025, the Barings Credit Facility, net of the Royalty Fee Derivative Liability, was carried at amortized cost totaling $72,090, comprised of the $71,336 non-current liability (Note 7) and $754 accrued interest (Note 6). The estimated fair value of the Barings Credit Facility, without the Royalty Fee Derivative Liability, was $78,940 at December 31, 2025.
The Barings Credit Facility is categorized as a Level 3 measurement in the fair value hierarchy as it incorporates significant unobservable inputs, including assumptions regarding the timing and probability of repayment and the Company’s credit risk.
The fair value of the Royalty Fee Derivative Liability is estimated using a Monte Carlo simulation. The use of this approach requires the use of Level 3 unobservable inputs. The main inputs when determining the fair value of the
Royalty Fee Derivative Liability are the amount and timing of the expected future revenue of the Company, the estimated volatility of these revenues, and the discount rate corresponding to the risk of revenue. The estimated fair value presented is not necessarily indicative of an amount that could be realized in a current market exchange. The use of alternative inputs and estimation methodologies could have a material effect on these estimates of fair value.
The main inputs to valuing the Royalty Fee Derivative Liability are as follows:
| · · · · · · · | |||||
|---|---|---|---|---|---|
| · · As of | |||||
| | | September 30, | | December 31, | |
| | | 2026 | | 2025 | |
| Revenue volatility | | | 58.2% | | 62.0% |
| Revenue discount rate | | | 15.6% | | 14.0% |
10. Equity
In February 2024, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain institutional accredited investors (the “Investors”), pursuant to which the Company issued and sold to the Investors in a private placement an aggregate of 32,413,560 shares of the Company’s common stock, par value $0.0001 per share (the “Shares”), at a price of $7.52 per share, and, to certain Investors in lieu of Shares, pre-funded warrants to purchase 10,805,957 shares of the Company’s common stock (the “Pre-Funded Warrants”), at a price of $7.519 per Pre-Funded Warrant (the “2024 Private Placement”). Each Pre-Funded Warrant issued in the 2024 Private Placement that remains outstanding has an exercise price of $0.001 per share, is currently exercisable and will remain exercisable until the Pre-Funded Warrant is exercised in full.
During the three and nine months ended September 30, 2026, Pre-Funded Warrants to purchase zero and 1,749,453 shares of the Company’s common stock, respectively, were exercised via cashless exercise forzero and 1,749,300 shares of the Company’s common stock, respectively.
There wereno exercises of Pre-Funded Warrants during the three months ended September 30, 2025. During the nine months ended September 30, 2025, Pre-Funded Warrants to purchase 1,092,273 shares of the Company’s common stock were exercised via cashless exercise for 1,092,148 shares of the Company’s common stock.
As of September 30, 2026,5,818,592 Pre-Funded Warrants remained outstanding.
In August 2021, the Company and Jefferies LLC (“Jefferies”) entered into an Open Market Sale Agreement (the “2021 Sales Agreement”) under which the Company may offer and sell shares of its common stock from time to time through Jefferies, acting as agent. In November 2023, the Company filed a prospectus in connection with the 2021 Sales Agreement for the issuance and sale of common stock having an aggregate offering price of up to $100,000 thereunder. The offering of securities under the registration statement pursuant to which the prospectus was filed was terminated in September 2025. The Company did not offer or sell shares of its common stock under the 2021 Sales Agreement during the three and nine months ended September 30, 2026. The Company didnot offer or sell shares of its common stock under the 2021 Sales Agreement during the three months ended September 30, 2025. During the nine months ended September 30, 2025, the Company sold 11,548,364 shares of common stock under the 2021 Sales Agreement, resulting in gross proceeds to the Company of $96,775, and net proceeds, after accounting for issuance costs, of $94,025.
11. Stock-Based Awards
For the three and nine months ended September 30, 2026, the Company hadthree stock-based compensation plans under which it was able to grant stock-based awards, the 2021 Stock Incentive Plan, as amended (the “2021 Plan”), the 2019 Inducement Stock Incentive Plan, as amended (the “2019 Inducement Plan”), and the Amended and Restated 2014 Employee Stock Purchase Plan (the “ESPP”) (collectively, the “Stock Plans”). The 2021 Plan and the 2019 Inducement Plan provide for the grant of non-statutory stock options, restricted stock awards, restricted stock units (“RSUs”), performance stock units (“PSUs”), stock appreciation rights and other stock-based awards. The 2021 Plan also provides for the grant of incentive stock options.
The terms and conditions of the Stock Plans are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on February 5, 2026. Subsequent updates to the Stock Plans during the nine months ended September 30, 2026 are as follows:
2019 Plan — On February 4, 2026, the Company's board of directors amended the 2019 Inducement Plan to increase the aggregate number of shares issuable thereunder from 6,054,000 to 7,028,000 shares of common stock.
2021 Plan — On June 10, 2026, the Company’s stockholders approved an amendment to the 2021 Plan to increase the aggregate number of shares of common stock issuable thereunder by 10,000,000 shares of common stock.
As of September 30, 2026,11,812,763,222,315, and 2,075,397 shares of common stock remained available for issuance under the 2021 Plan, the 2019 Inducement Plan, and the ESPP, respectively.
Stock options, RSUs and PSUs
During the three and nine months ended September 30, 2026, the Company granted options to purchase 424,100 and 6,351,203 shares of common stock, respectively, at a weighted exercise price of $9.50 and $11.12 per share, respectively. Of these, options to purchase 185,575 and 4,952,828 shares of common stock, respectively, were granted under the 2021 Plan, and options to purchase 238,525 and 1,398,375 shares of common stock, respectively, were granted under the 2019 Inducement Plan.
During the three and nine months ended September 30, 2026, the Company granted 139,250 and 2,266,134 RSUs, respectively. Of these,61,075 and 1,805,859 RSUs, respectively, were granted under the 2021 Plan and 78,175 and 460,275 RSUs, respectively, were granted under the 2019 Inducement Plan. Each RSU is settleable forone share of common stock upon vesting.
On February 11, 2025, the Company granted 1,500,000 PSUs to its Executive Chairman, President and Chief Executive Officer under the 2021 Plan. Each PSU is settleable forone share of common stock upon vesting. The PSUs are allocated equally across four tranches, which can be earned during afive-year performance period commencing on the grant date (the “PSU Performance Period”), if the Company’s consecutive 60-day closing stock price average meets or exceeds per share price hurdles of $15.00, $20.00, $25.00 and $30.00, as applicable. All PSUs are subject to a service condition. The PSUs earned during the first three years of the PSU Performance Period are subject to additional service-based vesting requirements through February 11, 2028.
On February 11, 2025, the Company granted 2,750,000 performance stock options to the Company’s Executive Chairman, President and Chief Executive Officer under the 2021 Plan (the “Performance Option Award”). The Performance Option Award was contingent upon the approval by the Company’s stockholders of Amendment No. 4 to the 2021 Plan. The stockholders of the Company approved Amendment No. 4 to the 2021 Plan on June 11, 2025. In accordance with the guidance of Accounting Standards Codification Topic 718Compensation—Stock Compensation, the Performance Option Award was deemed granted for financial accounting purposes as of June 11, 2025 when shareholder approval was obtained. The Performance Option Award is allocated equally across four tranches, which can be earned during afive-year performance period commencing on February 11, 2025 (the “Option Award Performance Period”), if the Company’s consecutive 60-day closing stock price average meets or exceeds per share price hurdles of $15.00, $20.00, $25.00 and $30.00, as applicable. All performance stock options are subject to a service condition. The performance stock options earned during the first three years of the Option Award Performance Period are subject to additional service-based vesting requirements through February 11, 2028.
The fair value of each tranche of the PSUs and each tranche of the Performance Option Award was estimated using a Monte Carlo simulation. The main inputs to valuing each tranche include the risk-free interest rate, expected volatility, the contractual term offive years, andno expected dividend yield. The requisite service period for each tranche was derived from the Monte Carlo simulation, taking into account thethree-year minimum service requirement.
During the three and nine months ended September 30, 2026,181,187 and 2,084,365 stock options, respectively, and 30,058 and 218,380 RSUs, respectively, expired or were forfeited.
Stock-based Compensation
The Company recorded stock-based compensation expense related to stock options, RSUs and PSUs in the following expense categories of its unaudited condensed consolidated statements of operations and comprehensive loss:
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Nine Months Ended | ||||||||
| · · September 30, · · September 30, | ||||||||
| | | 2026 | | 2025 | | 2026 | | 2025 |
| Research and development | | $5,406 | | $3,451 | | $16,028 | | $9,819 |
| Selling and marketing | | 1,988 | | 1,205 | | 6,151 | | 3,450 |
| General and administrative | | 7,672 | | 7,035 | | 23,118 | | 18,556 |
| | | $15,066 | | $11,691 | | $45,297 | | $31,825 |
As of September 30, 2026, the Company had an aggregate of $93,251 of unrecognized stock-based compensation cost, which is expected to be recognized over a weighted average period of 2.24 years.
12. Net Loss Per Share
Basic net loss per share was calculated as follows for the three and nine months ended September 30, 2026 and 2025:
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Nine Months Ended | ||||||||
| · · September 30, · · September 30, | ||||||||
| | | 2026 | | 2025 | | 2026 | | 2025 |
| Numerator: · · · · · · · · · · | ||||||||
| Net loss attributable to common stockholders | | $(94,782) | | $(69,418) | | $(262,157) | | $(201,285) |
| Denominator: | | | | | | | | |
| Weighted average common shares outstanding, basic | | 225,515,234 | | 183,919,808 | | 224,860,835 | | 175,356,729 |
| Net loss per share - basic | | $(0.42) | | $(0.38) | | $(1.17) | | $(1.15) |
For the three and nine months ended September 30, 2026 and 2025, respectively, there wasno dilutive impact from potentially issuable common shares. Therefore, diluted net loss per share was the same as basic net loss per share. As of September 30, 2026 and September 30, 2025,5,818,592 and 9,713,684, respectively, outstanding Pre-Funded Warrants (Note 10) are included in the calculation of basic and diluted net loss per share.
The Company excluded the following potentially issuable common shares, outstanding as of September 30, 2026 and 2025, respectively, from the computation of diluted net loss per share for the three and nine months ended September 30, 2026 and 2025, respectively, because they had an anti-dilutive impact:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Nine Months Ended | ||||||||||||
| · · September 30, · · September 30, | ||||||||||||
| · · 2026 · · 2025 · · 2026 · · 2025 | ||||||||||||
| Options to purchase common stock | | | 25,689,428 | | | 21,936,593 | | | 25,689,428 | | | 21,936,593 |
| RSUs | | | 4,772,277 | | | 4,641,629 | | | 4,772,277 | | | 4,641,629 |
| PSUs | | | 1,500,000 | | | 1,500,000 | | | 1,500,000 | | | 1,500,000 |
| | | | 31,961,705 | | | 28,078,222 | | | 31,961,705 | | | 28,078,222 |
13. Segment Reporting
The Company operates as a single operating segment. Its operations consist of developing and commercializing innovative therapies for retinal diseases and other eye conditions based on its ELUTYX proprietary bioresorbable hydrogel-based formulation technology.
Resources are allocated and performance is assessed by the Company’s Chief Executive Officer and the Company’s Chief Operating Officer, who the Company has determined to be, collectively, the Company’s Chief Operating Decision Maker (“CODM”).
The accounting policies for the Company’sone segment are the same as those described in Note 2. The CODM evaluates the performance of itsone segment and allocates resources based on Net Loss.
The following table provides information about the Company’s single segment:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Nine Months Ended | ||||||||||||
| · · September 30, · · September 30, | ||||||||||||
| · · 2026 · · 2025 · · 2026 · · 2025 | ||||||||||||
| Revenue | | $12,874 | | $14,544 | | $37,134 | | $38,701 | ||||
| Cost of product revenue | | | 1,455 | | | 1,774 | | | 4,795 | | | 4,980 |
| Research and development (a) | | | | | | | | | | | | |
| Direct program expenses | | | | | | | | | | | | |
| AXPAXLI | | | 48,750 | | | 34,707 | | | 119,966 | | | 92,893 |
| Other clinical and preclinical programs | | | 627 | | | 1,224 | | | 2,101 | | | 3,307 |
| Unallocated expenses | | | | | | | | | | | | |
| Personnel costs | | | 13,114 | | | 9,136 | | | 39,628 | | | 27,825 |
| All other costs | | | 2,661 | | | 1,632 | | | 6,551 | | | 5,986 |
| Selling and marketing (a) | | | 13,537 | | | 11,721 | | | 42,691 | | | 36,972 |
| General and administrative (a) | | | 11,018 | | | 8,563 | | | 37,040 | | | 26,864 |
| Facilities (b) | | | 2,051 | | | 1,722 | | | 6,808 | | | 5,230 |
| Stock-based compensation | | | 15,066 | | | 11,691 | | | 45,297 | | | 31,825 |
| Depreciation | | | 2,453 | | | 1,072 | | | 5,565 | | | 3,076 |
| Interest income | | | 4,978 | | | 3,729 | | | 16,478 | | | 11,012 |
| Interest expense | | | (2,814) | | | (3,002) | | | (8,383) | | | (9,003) |
| Other non-operating items | | | 912 | | | (1,447) | | | 3,056 | | | (3,037) |
| Net loss | | $(94,782) | | $(69,418) | | $(262,157) | | $(201,285) | ||||
| (a) | excluding stock-based compensation, depreciation, and facilities expenses |
| (b) | excluding stock-based compensation and depreciation |
14. Commitments and Contingencies
Legal Proceedings
EyePoint Litigation
On March 20, 2026, plaintiff EyePoint, Inc. (“EyePoint”) filed a lawsuit against the Company in Middlesex County Superior Court of Massachusetts. The plaintiff alleged that the Company had made certain false and defamatory statements about EyePoint and its DURAVYU product candidate. The complaint asserted counts of (1) defamation; (2) commercial disparagement; (3) unfair or deceptive practices in violation of Massachusetts General Laws c. 93A, §§ 2, 11; and (4) tortious interference with advantageous business relations. The plaintiff sought, among other things, injunctive relief, damages, and attorneys’ fees.
On March 23, 2026, EyePoint filed a Motion for Temporary Restraining Order and Preliminary Injunction, seeking, among other things, to enjoin the Company from disseminating allegedly false and misleading statements. On April 13, 2026, the court denied the plaintiff’s motion for temporary restraining order. Hearings on the plaintiff’s motion for preliminary injunction were held on May 5, 2026, and July 7, 2026. On August 21, 2026, the court issued an order denying EyePoint’s motion for preliminary injunction.
On October 30, 2026, the Company and EyePoint entered into a settlement agreement that fully resolved EyePoint’s claims (the “Settlement Agreement”). The Settlement Agreement contains a mutual release of claims and no financial obligation on behalf of either party other than to pay its own attorney’s fees and costs. Pursuant to the terms of the Settlement Agreement, on October 30, 2026, EyePoint filed a Joint Stipulation of Dismissal with Prejudice with the
Middlesex County Superior Court of Massachusetts, dismissing the action and all claims with prejudice and with each party bearing its own attorneys’ fees, costs, and expenses, and with all rights of appeal waived.
The Company has assessed and evaluated the matter under ASC 450, Contingencies, and, based on its current assessment, has determinedno accrual associated with the matter has been incurred as of September 30, 2026.
Indemnification Agreements
In the ordinary 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 indemnified parties for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third-party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable.
To date, the Company has not incurred any material costs as a result of such indemnifications.
15. Related Party Transactions
The Company has engaged Boston Image Reading Center LLC (“BIRC”) to provide certain clinical development-related services. Nadia Waheed, M.D., M.P.H., the Company’s Chief Medical Officer, is a Director of BIRC. For the three and nine months ended September 30, 2026, the Company incurred fees for clinical development-related services rendered by BIRC of $109 and $288, respectively. For the three and nine months ended September 30, 2025, the Company incurred fees for clinical development-related services rendered by BIRC of $23 and $48, respectively. As of September 30, 2026 and December 31, 2025, there was $0 and $126 recorded in accounts payable for BIRC, respectively. As of September 30, 2026 and December 31, 2025, there was $86 and $590 recorded in accrued expenses for BIRC, respectively. The Company engages BIRC in the ordinary course of business on an arm’s length basis.
Jeffrey Heier, M.D., the Company’s Chief Scientific Officer, and Peter Kaiser, M.D., the Company’s Chief Development Officer, are each a shareholder of i2Vision, Inc. The Company had engaged i2Vision to provide services with respect to the clinical advancement of AXPAXLI. For the three and nine months ended September 30, 2026, no costs for services rendered by i2Vision were incurred. For the three months ended September 30, 2025, i2Vision did not provide any services to the Company. For the nine months ended September 30, 2025, the Company recorded a net credit for fees and expenses related to services rendered by i2Vision that were previously recorded as expense of $(121).
16. Subsequent Events
On November 6, 2026, the Company’s board of directors amended the 2019 Inducement Plan to increase the aggregate number of shares issuable thereunder from 7,028,000 to 8,028,000 shares of common stock.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.