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Aldeyra Therapeutics, Inc.

For the period ended Sep 30, 2026. Filed Nov 5, 2026.

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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2026 · Filed Nov 5, 2026

ALDX$0.63+2.9%Stored close · as of Nov 6, 2026

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Notes to Condensed Consolidated Financial Statements (unaudited)

NATURE OF BUSINESS

Aldeyra Therapeutics, Inc., together with its wholly owned subsidiaries (the “Company” or “Aldeyra”), a Delaware corporation, is a clinical-stage biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases.

The principal activities of the Company to date include research and development activities along with related general business planning.

BASIS OF PRESENTATION

The accompanying interim condensed consolidated financial statements and related disclosures are unaudited and have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and the instructions to Form 10-Q and Regulation S-X. Accordingly, the interim condensed consolidated financial statements do not include all the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the audited consolidated financial statements and related notes included in the Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the Securities and Exchange Commission on February 27, 2026 (2025 Annual Report).

In the opinion of management, all adjustments, consisting only of normal recurring adjustments considered necessary for the fair presentation of financial position, results of operations, and cash flows at the dates and for the periods presented, have been included. The balance sheet data as of December 31, 2025 was derived from audited consolidated financial statements. The results of the Company’s operations for any interim periods are not necessarily indicative of the results that may be expected for any other interim period or for a full fiscal year.

Based on the current operating plan of the Company, and excluding any potential licensing and product revenue, the Company believes that cash and cash equivalents will be sufficient to fund the currently projected operating expenses for at least the next 12 months from the date the financial statements are issued. The Company has based projections of operating capital requirements on the current operating plan, which includes assumptions that may prove to be incorrect, and the Company may use all available capital resources sooner than the Company expects. The Company will need to secure additional funding in the future, from one or more equity or debt financings, collaborations, or other sources, for the Company to carry out planned research and development activities and regulatory activities; commence or continue ongoing commercialization activities, including manufacturing, sales, marketing and distribution, for any product candidates for which the Company may receive marketing approval; or satisfy U.S. Food and Drug Administration (FDA) requirements for marketing approval. Additional funding may not be available to the Company on acceptable terms, or at all. Inability to secure additional funding could force the Company to delay, reduce, or eliminate research and development programs or commercialization efforts.

Curtailment of operations would cause significant delays in the efforts of the Company to develop and introduce products to market, which is critical to the realization of the business plan and the future operations of the Company.

Use of Estimates

Thepreparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions, including fair value estimates for investments that affect the reported amounts of assets and liabilities, and requires the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting periods. The Company’s management evaluates estimates and assumptions on an ongoing basis. Management’s most significant estimates in the Company’s condensed consolidated financial statements include, but are not limited to, deferred and accrued research and development costs, stock-based compensation, and accounting for income taxes and related valuation allowance. Although the estimates and assumptionsare based on the Company’s knowledge of current events and actions the Company may undertake in the future, actual results may ultimately materially differ from the estimates and assumptions.

Summary of Significant Accounting Policies

There were no changes to significant accounting policies during the nine months ended September 30, 2026, as compared to those identified in the 2025 Annual Report.

Recent Accounting Pronouncements

In November 2024, the FASB issued ASU No. 2024-03, Disaggregation of Income Statement Expenses (ASU 2024-03). ASU 2024-03 requires public business entities to disclose in the notes to the financial statements, among other things, specific information about certain costs and expenses including purchases of inventory; employee compensation; and depreciation, amortization, and depletion expenses for each caption on the income statement where such expenses are included. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted, and the amendments may be applied prospectively to reporting periods after the effective date or retrospectively to all periods presented in the financial statements. The Company is evaluating the disclosure requirements related to the new standard.

Helio Vision Acquisition

In connection with the January 2019 acquisition of Helio Vision, Inc. (Helio), the Company obtained the rights to develop ADX‑2191 for the treatment of proliferative vitreoretinopathy (the Helio Product Candidate) pursuant to an Agreement and Plan of Merger dated as of January 24, 2019 (the Merger Agreement). Under the Merger Agreement, the Company may be required to issue additional shares of common stock to the former securityholders and an advisor of Helio upon achievement of certain FDA regulatory milestones related to the Helio Product Candidate (the Milestone Shares), including FDA approval for proliferative vitreoretinopathy or a substantially similar indication prior to January 2029, or FDA approval for an indication other than proliferative vitreoretinopathy or a substantially similar indication prior to January 2031. During the year ended December 31, 2024, the Company ceased development of the Helio Product Candidate for the treatment of proliferative vitreoretinopathy. As a result, subject to the terms and conditions of the Merger Agreement, the Helio Product Candidate and related intellectual property rights may revert to an entity designated by the representative of the former Helio securityholders, if the agreement is terminated.

The Company accounts for the contingent obligation to issue the Milestone Shares under FASB ASC Topic 450, Contingencies. As of September 30, 2026, no remaining regulatory milestones were considered probable of being achieved and, accordingly, no liability has been recorded.

NET LOSS PER SHARE

For the three and nine months ended September 30, 2026 and 2025, diluted weighted average common shares outstanding are equal to basic weighted average common shares due to the net loss position of the Company.

The following potentially dilutive securities outstanding had an antidilutive impact and were therefore excluded from the computation of diluted weighted-average shares outstanding:

For the Three and Nine Months Ended September 30,
20262025
Options to purchase common stock8,886,6088,591,421
Nonvested restricted stock units59,688281,273
Total of common stock equivalents8,946,2968,872,694

CASH, CASH EQUIVALENTS, AND MARKETABLE SECURITIES

At September 30, 2026, cash and cash equivalents were comprised of:

CarryingAmountEstimatedFair ValueCash and CashEquivalents
Cash$2,431,925$2,431,925$2,431,925
Money market funds38,543,05438,543,05438,543,054
Total cash and cash equivalents$40,974,979$40,974,979$40,974,979

The contractual maturities of all cash equivalents and available for sale securities were less than one year at September 30, 2026.

At December 31, 2025, cash and cash equivalents were comprised of:

CarryingAmountEstimated FairValueCash and CashEquivalents
Cash$29,566,736$29,566,736$29,566,736
Money market funds40,474,51840,474,51840,474,518
Total cash and cash equivalents$70,041,254$70,041,254$70,041,254

There wereno marketable securities held at September 30, 2026 and December 31, 2025.

FAIR VALUE MEASUREMENTS

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value are performed in a manner to maximize the use of observable inputs and minimize the use of unobservable inputs. ASC 820, Fair Value Measurements, establishes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value, which are the following:

Level 1 – Quoted prices in active markets that are accessible at the market date for identical unrestricted assets or liabilities.

Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs for which all significant inputs are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

The following table presents information about the Company’s assets measured at fair value at September 30, 2026 and December 31, 2025:

Level 1Level 2Level 3Total
Assets:
Money market funds (a)$38,543,054$—$—$38,543,054
Total assets at fair value$38,543,054$—$—$38,543,054
Level 1Level 2Level 3Total
Assets:
Money market funds (a)$40,474,518$—$—$40,474,518
Total assets at fair value$40,474,518$—$—$40,474,518

(a)

Money market funds that are included in cash and cash equivalents in the consolidated balance sheets are valued at quoted market prices in active markets.

There wereno liabilities measured at fair value at September 30, 2026 or December 31, 2025, respectively.

Financial instruments, including clinical trial prepayments to contract research organizations and accounts payable, are carried in the condensed consolidated financial statements at amounts that approximate fair value based on the short maturities of the instruments.

PREPAID EXPENSES AND OTHER CURRENT ASSETS

Prepaid expenses and other current assets at September 30, 2026 and December 31, 2025 were:

September 30,December 31,
20262025
Deferred research and development expenses$616,318$1,043,086
Prepaid insurance expenses867,907407,194
Miscellaneous prepaid expenses and other current assets459,593291,922
Total prepaid expenses and other current assets$1,943,818$1,742,202

ACCRUED EXPENSES

Accrued expenses at September 30, 2026 and December 31, 2025 were:

September 30,December 31,
20262025
Accrued compensation$839,516$4,272,999
Accrued research and development expenses214,8081,288,423
Accrued other expenses502,232558,875
Total accrued expenses$1,556,556$6,120,297

CREDIT FACILITY

The Company previously maintained a Loan and Security Agreement with Hercules Capital, Inc. (the Loan and Security Agreement).

On April 1, 2026, the Company repaid in full the $15.0 million principal balance outstanding under the Loan and Security Agreement, together with accrued interest and all other amounts due under the Loan and Security Agreement. Upon repayment, the Loan and Security Agreement terminated in accordance with its terms, and all security interests granted thereunder were released.

As of September 30, 2026, the Company hadno debt obligations. Interest expense recognized during thenine months ended September 30, 2026 reflects amounts incurred under the Loan and Security Agreement through the repayment date, April 1, 2026.

STOCKHOLDERS’ EQUITY

In August 2024, the Company entered into an Open Market Sales Agreement SM with Jefferies, as sales agent (the 2024 Jefferies Sales Agreement), under which the Company has the ability to offer and sell, from time to time through Jefferies, shares of common stock providing for aggregate sales proceeds of up to $75.0 million. As of September 30, 2026, no shares of common stock were sold under the 2024 Jefferies Sales Agreement.

INCOME TAXES

Since the Company has incurred losses since inception for tax purposes, no current or deferred tax provision expenses for federal and state income taxes have been recorded. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes.

In assessing the realizability of net deferred taxes in accordance with Accounting Standards Codification (ASC) 740, Income Taxes (ASC 740), the Company considers the likelihood that some portion or all the deferred tax assets will not be realized. Based on the weight of available evidence, primarily the incurrence of net losses since inception, anticipated net losses in the near future, reversals of existing temporary differences, and expiration of various federal and state attributes, the Company does not believe that there is a reasonable likelihood that some or all of the net deferred taxes will be realized. Accordingly, a 100% valuation allowance has been applied against net deferred tax assets.

Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (Sections 382 and 383), a corporation that undergoes an “ownership change” is subject to limitations on the ability to utilize pre-change net operating losses (NOLs) and certain other tax assets (tax attributes) to offset future taxable income. In general, an ownership change occurs if the aggregate stock ownership of certain stockholders increases by more than 50 percentage points over such stockholders’ lowest percentage ownership during the testing period (generally three years). Transactions involving the Company’s common stock, within the testing period, even those outside the Company’s control, such as purchases or sales by investors, within the testing period could result in an ownership change. A limitation on the Company’s ability to utilize some or all NOLs or credits could have a material adverse effect on the Company’s results of operations and cash flows. Prior to December 31, 2021, the Company believes that four ownership changes have occurred. However, management believes that the aggregate Section 382 and 383 limitation (including the additional limitation for recognized “built-in-gains”) is sufficient so that no current impairment of pre-ownership change tax attributes is required. The Company does not believe an ownership change occurred from December 31, 2021 through September 30, 2026. Any future ownership changes, including those resulting from the Company’s future financing activities, may cause existing tax attributes to incur additional limitations.

As of September 30, 2026, the Company is subject to tax in the U.S. (Federal and Massachusetts). The Company is open to examination for the tax years ended December 31, 2025, 2024, 2023, and 2022. In addition, any loss years remain open to the extent that losses are available for carryover to future years.

The Company accounts for uncertain tax positions pursuant to ASC 740-10 which prescribes a recognition threshold and measurement process for financial statement recognition of uncertain tax positions taken or expected to be taken in a tax return. If the tax position meets the recognition threshold, the benefit to be recognized is measured as the tax benefit having the highest likelihood of being realized upon ultimate settlement with the taxing authority. Accordingly, in the provision for income taxes, the Company recognizes interest accrued related to unrecognized tax benefits and penalties. Because management is currently unaware of any uncertain tax positions, the Company has not recorded liabilities, including interest or penalties for uncertain tax positions.

STOCK-BASED COMPENSATION

The Company approved the 2013 Equity Incentive Plan in October 2013, which was amended in June 2016 and June 2018 (Amended 2013 Plan). The Amended 2013 Plan provided for the granting of stock options, restricted stock units (RSU), stock appreciation rights, and stock units to certain employees, members of the board of directors, and consultants of the Company.

In May 2023, the Company's Board of Directors approved the 2023 Equity Incentive Plan (the 2023 Equity Plan) to replace the Amended 2013 Plan. On June 30, 2023, the Company's stockholders approved the 2023 Equity Plan at the Company's 2023 annual meeting of stockholders. Pursuant to the 2023 Equity Plan, the Company cannot make any further grants under the Amended 2013 Plan, though awards previously granted under the Amended 2013 Plan still remain outstanding. The 2023 Equity Plan is effective for a period of ten years after June 30, 2023, and a total of 5,450,000 shares of the Company’s common stock, in addition to shares of the Company’s common stock that are subject to awards granted under the Amended 2013 Plan that are outstanding as of such date and that are subsequently forfeited, cancelled, or expire before being exercised or settled in full, are authorized for issuance under the 2023 Equity Plan. As of September 30, 2026, there were 2,439,770 shares of common stock available for grant under the 2023 Equity Plan.

In 2022, the Company granted performance cash settled bonus awards (CSBUs) under the Management Cash Incentive Plan, as amended (the Management Cash Incentive Plan). The performance criteria were met in February 2023, and the awards vested in four annual installments from the date of grant based on continued service. During the three months ended September 30, 2026, the Company settled the outstanding liability associated with the 2022 CSBUs through cash payments of approximately $1.2 million in accordance with the terms of the awards. As of September 30, 2026, no amounts remained payable related to the 2022 CSBUs.

In 2026, the Company granted additional CSBUs that are not subject to performance criteria and vest solely based on continued service over four years. The awards entitle employees to receive cash payments equal to the closing price per share of the Company's common stock on Nasdaq on the payment date, on the earlier of (i)four years from the date of grant or (ii) a change of control. As of September 30, 2026,$0.2 million was accrued as compensation expense for the outstanding CSBUs.

The Company recognizes stock-based compensation expense over the requisite service period. The Company's share-based awards are accounted for as equity instruments, except for cash awards and CSBUs, which are accounted for as liabilities. The amounts included in the consolidated statements of operations relating to stock-based compensation associated with the two equity incentive plans, cash awards, and CSBUs are as follows:

Three Months Ended September 30,Nine Months Ended September 30,
2026202520262025
Research and development expenses$690,763$1,466,469$1,276,615$2,965,376
General and administrative expenses423,3411,114,284492,935$2,035,956
Total stock-based compensation expense$1,114,104$2,580,753$1,769,550$5,001,332

Stock Options

The table below summarizes activity relating to stock options under the incentive plans for thenine months ended September 30, 2026:

Number ofShares · WeightedAverageExercise Price · WeightedAverageContractualTerm(Years) · AggregateIntrinsicValue(a)
Outstanding at December 31, 20258,582,483$5.506.18$6,607,251
Granted2,704,0901.77—
Exercised(20,009)3.5612,997
Forfeited(875,824)4.458,357
Expired(1,504,132)5.97—
Outstanding at September 30, 20268,886,608$4.396.77$—
Exercisable at September 30, 20265,528,379$5.405.38$—

(a)

The aggregate intrinsic value in the above table was calculated on the positive difference, if any, between the closing price per share of the Company’s common stock on September 30, 2026 of$1.23 and the per share exercise price of the underlying options.

As of September 30, 2026, unamortized stock-based compensation for stock options outstanding was$6.8 million and is expected to be recognized over a weighted average period of 2.34 years. Total unrecognized compensation cost will be adjusted for future forfeitures, if necessary.

Restricted Stock Units

The table below summarizes activity relating to restricted stock units (RSUs) for thenine months ended September 30, 2026:

Numberof SharesWeighted-Average Grant Date Fair Value
Outstanding at December 31, 2025274,496$5.55
Released(151,392)5.42
Cancelled / Forfeited(46,402)4.72
Vested(17,014)4.72
Outstanding at September 30, 202659,688$6.76

There wereno RSUs granted during thenine months ended September 30, 2026. The total grant date fair value of RSUs vested was$0.9 million for the nine months ended September 30, 2026. As of September 30, 2026, the outstanding RSUs had unamortized stock-based compensation of$0.1 million with a weighted-average remaining recognition period of 0.25 years and an aggregate intrinsic value of$0.1 million.

Employee Stock Purchase Plan

At September 30, 2026, the Company had 4,106,821 shares available for issuance under the 2016 Employee Stock Purchase Plan (2016 ESPP). A summary of the weighted-average grant-date fair value, and total stock-based compensation expense recognized related to the 2016 ESPP are as follows:

Nine Months Ended September 30,
20262025
Weighted-average grant-date fair value per share$2.06$—
Total stock-based compensation expense$11,006$—

LEASES

The Company currently leases office space to conduct business operations. Lease renewal options are regularly evaluated, and when the exercise of an option is reasonably certain, the Company includes the renewal period in the lease term. The rates implicit in the Company's operating leases are not readily determinable. Accordingly, the Company uses its incremental borrowing rate at the respective lease commencement dates to determine the present value of lease payments.

The Company leases office space in Lexington, Massachusetts (Lexington Lease), under an operating lease agreement that is scheduled to expire in December 2026. In September 2026, the Company relocated its operations to Concord, Massachusetts, and wrote off the remaining right-of-use asset associated with the Lexington Lease in connection with the planned abandonment of the premises. The Company remains obligated to make lease payments through the expiration of the Lexington Lease.

On July 28, 2026, the Company entered into a new operating lease agreement for approximately 4,067 square feet of office space in Concord, Massachusetts (Concord Lease), to serve as its corporate headquarters. The Concord Lease commenced in September 2026, when the Company obtained access to and occupied the premises, and expires on September 30, 2029. The Company recognized a right-of-use asset and corresponding operating lease liability upon commencement of the Concord Lease in September 2026.

As of September 30, 2026, the Company maintained an unamortized Right-Of-Use asset of approximately$0.4 million related to the Concord Lease and aggregate operating lease liabilities of approximately$0.5 million related to the Lexington Lease and Concord Lease, based on the present value of the minimum rental payments in accordance with ASC Topic 842, Leases. The weighted average discount rate used for leases as of September 30, 2026 is 8.8%. The weighted average remaining lease term as of September 30, 2026 was 2.57 years. The operating lease expense for the nine months ended September 30, 2026 was$0.3 million.

Maturities and balance sheet presentation of the Company’s operating lease liabilities as of September 30, 2026 is as follows:

Remaining total lease payments$513,108
Less: effect of discounting(54,410)
Present value of lease liabilities$458,698
Current operating lease liabilities$178,577
Non-current operating lease liabilities$280,121
Total$458,698

The Company’s gross future minimum payments under all non-cancelable operating leases as of September 30, 2026, are:

Total2026202720282029
Operating Lease Obligations$513,108$98,949$147,090$151,158$115,911

COMMITMENTS AND CONTINGENCIES

Guarantees and Indemnifications

As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while the officer or director is, or was, serving at the Company’s request in such capacity. The term of the indemnification is for the officer’s or director’s lifetime. Through September 30, 2026, the Company had not incurred any material losses related to these indemnification obligations. Although claims for indemnification may arise in the ordinary course of business, the Company does not expect any such claims to have a material adverse effect on the consolidated financial statements. Accordingly, the Company concluded that the fair value of these obligations is negligible, andno related reserves have been established.

In-License Agreements

MEEI Agreement

The Company assumed an Exclusive License Agreement with Massachusetts Eye and Ear Infirmary (MEEI), originally entered into in July 2016 between MEEI and Helio, as amended, (the MEEI Agreement), in connection with the 2019 acquisition of Helio. Pursuant to the MEEI Agreement, the Company obtained an exclusive worldwide license from MEEI to develop and commercialize ADX‑2191 under certain patents, patent applications, and other licenses to intellectual property rights licensed by MEEI (the MEEI Patent Rights).

Under the MEEI Agreement, the Company is obligated to pay annual license maintenance fees; certain development, regulatory, and commercial milestone payments upon the achievement of specified events; royalties on net sales of products incorporating the MEEI Patent Rights; and a portion of certain sublicense revenue. The MEEI Agreement remains in effect until the expiration of the last patent licensed under the MEEI Agreement, unless earlier terminated in accordance with the MEEI Agreement. Upon an early termination of the MEEI Agreement, the licensed rights and related intellectual property developed under the MEEI Agreement revert to MEEI.

Other In-License Agreements

Additionally, the Company has other in-license agreements with third parties that require the Company to make future development, regulatory and commercial milestone payments, as well as royalty payments on net sales of specified products, if and when such milestones are achieved or sales occur. As of September 30, 2026, none of the related milestones had been achieved andno royalties were due. The amount and timing of any future payments are uncertain and depend on the successful development and commercialization of the related products.

Legal Proceedings

On March 30, 2026, a purported stockholder filed a putative class action lawsuit (the Securities Class Action) in the U.S. District Court for the District of Massachusetts, against us and certain current and former officers. On October 9, 2026, the lead plaintiff filed an amended complaint. The amended complaint asserts violations by the defendants of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5. The amended complaint alleges that the defendants made false or misleading statements or failed to disclose certain information concerning the new drug application (NDA) for and the prospects of reproxalap for the treatment of dry eye disease. The lawsuit seeks, among other things, compensatory damages on behalf of all persons and entities that purchased or otherwise acquired our securities between November 28, 2023, and March 16, 2026, as well as attorneys’ fees and costs. At this time, we cannot reasonably predict the outcome or estimate potential losses, if any, that could result from this matter.

In addition, from time to time, the Company may become subject to litigation and claims arising in the ordinary course of business. Other than the Securities Class Action, the Company is not currently a party to any material legal proceedings that we expect to have any material adverse effect on our business, financial condition, or results of operation.

SIGNIFICANT AGREEMENTS

AbbVie Option Agreement

On October 31, 2023 (the AbbVie Option Agreement Effective Date), the Company entered into an exclusive option agreement (the AbbVie Option Agreement) with AbbVie Inc. (AbbVie), pursuant to which the Company granted AbbVie an exclusive option (the AbbVie Option) to obtain (a) a co-exclusive license in the United States to facilitate a collaboration with the Company to develop, manufacture, and commercialize reproxalap in the United States, (b) an exclusive license to develop, manufacture, and commercialize reproxalap outside the United States, (c) a right of first negotiation for compounds that are owned or otherwise controlled by the Company in the field of ophthalmology relating to treating conditions of the ocular surface, and (d) a right to review data for any other compounds that are owned or otherwise controlled by the Company in the fields of ophthalmology and immunology before such data is shared with any other third party (the Collaboration Agreement). AbbVie paid the Company a non-refundable payment of $1.0 million in consideration of the AbbVie Option (the AbbVie Option Payment).

On December 21, 2023, pursuant to the AbbVie Option Agreement, AbbVie extended the period during which it may exercise the AbbVie Option (the Exercise Period Extension) by paying the Company a non-refundable payment of $5.0 million (the AbbVie Option Extension Fee). If the Collaboration Agreement is entered into, the AbbVie Option Payment and the AbbVie Option Extension Fee will be credited against the upfront cash payment payable by AbbVie.

On November 15, 2024, the Company entered into the Expansion Side Letter (the Expansion Letter) with AbbVie. The Expansion Letter makes certain changes to the AbbVie Option Agreement, among other things, providing that the Company will conduct certain launch activities, which costs shall not exceed mid-single-digit millions of dollars without AbbVie’s approval, and which costs will be considered allowable expenses pursuant to the Collaboration Agreement upon the delivery of AbbVie’s written notice of exercising the AbbVie Option and entry into the Collaboration Agreement, such that 60% of the Company's allowable expenses will be reimbursed by AbbVie in the event of exercise. If AbbVie does not deliver a written notice of exercising the AbbVie Option and the Company and AbbVie do not execute the Collaboration Agreement, the Company will remain solely responsible for such costs. AbbVie has also independently initiated pre-commercialization planning activities. In addition, the Exercise Period (as defined in the AbbVie Option Agreement) was restricted to ten (10) business days following approval from the U.S. Food and Drug Administration of the NDA for reproxalap in dry eye disease (the FDA Decision), provided that AbbVie shall provide the Company notice in case AbbVie determines that it will not exercise the AbbVie Option. The Company did not conduct any launch activities or incur related expenses during thenine months ended September 30, 2026 and September 30, 2025.

Upon AbbVie’s delivery of the agreement execution notice and the parties entering into the Collaboration Agreement, AbbVie would pay the Company a $100.0 million upfront cash payment, less the AbbVie Option Payment and the AbbVie Option Extension Fee. In addition, the Company would be eligible to receive up to approximately $300.0 million in regulatory and commercial milestone payments, inclusive of a $100.0 million milestone payment payable if the FDA Decision is received prior to or after the execution. In the United States, the Company would share profits and losses with AbbVie from the commercialization of reproxalap according to a split of 60% for AbbVie and 40% for the Company. Outside of the United States, the Company would be eligible to receive tiered royalties on net sales of reproxalap. As of November 5, 2026, AbbVie has not exercised the AbbVie Option.

As of September 30, 2026, the Company recorded $6.0 million of deferred collaboration revenue related to the AbbVie Option Agreement and Exercise Period Extension, which was classified as a current liability as AbbVie may exercise the option at any time. Although the AbbVie Option Agreement was not considered to be a vendor-customer relationship, the Company used ASC 606 to conclude that the $6.0 million liability would be considered the transaction price (the Transaction Price) and all other amounts due to the Company under the Collaboration Agreement would be excluded from the Transaction Price, since such amounts relate to fees that can only be achieved subsequent to the exercise of the AbbVie Option. Because the AbbVie Option Extension Fee and the AbbVie Option Payment are creditable against the Collaboration Agreement payments due to the Company, the Transaction Price was allocated to a single unit of account and was considered the option to enter into a future collaboration agreement, which is considered a material right. The Company concluded that all other performance obligations were immaterial promises in the context of the AbbVie Option Agreement and did not represent additional units of account. The Company will begin to recognize revenue if the AbbVie Option is exercised or when the AbbVie Option expires.

SEGMENT REPORTING

The Company operates through asingle operating and reportable segment focused on the discovery and development of innovative therapies designed to treat immune-mediated diseases. The segment's approach is to develop pharmaceuticals that modulate protein systems, instead of directly inhibiting or activating single protein targets, with the goal of optimizing multiple pathways at once while minimizing toxicity. The Company's product candidates include RASP (reactive aldehyde species) modulators ADX‑248, ADX‑246, and chemically related molecules for the potential treatment of systemic and retinal immune-mediated diseases. The Company's late-stage product candidates are reproxalap, a RASP modulator for the potential treatment of dry eye disease and allergic conjunctivitis, and ADX‑2191, a novel formulation of intravitreal methotrexate for the potential treatment of primary vitreoretinal lymphoma. The Company's tangible assets are held in the United States. The Company manages all business activities on a consolidated basis. The Company's Chief Operating Decision Maker (CODM) is the Chief Executive Officer.

The accounting policies of the operating segment are the same as those described in Note 2, Summary of Significant Accounting Policies contained within the notes included in the Annual Report on Form 10-K for the year ended December 31, 2025. The CODM evaluates the performance of the operating segment and allocates resources based on net income (loss) that also is reported on the consolidated income statement as net loss. The measure of the operating segment assets is reported on the consolidated balance sheet as total assets.

The CODM uses net income (loss) to monitor budget versus actual results and to analyze cash flows in assessing performance of the segment and allocating resources. The significant expenses are presented on the Company’s Consolidated Statements of Operations.

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