Aldeyra Therapeutics, Inc.

Previous wording

the likelihood and timing of the FDA’s potential approval of the resubmitted new drug application (NDA) for reproxalap (the Reproxalap NDA);

Current wording

the likelihood and timing of a potential resubmission of a new drug application (NDA) for reproxalap (the Reproxalap NDA);

Previous wording

the adequacy of the data included in the Reproxalap NDA or supplemental responses to the FDA;

Current wording

the adequacy of the data included in potential resubmission of the Reproxalap NDA or supplemental responses to the FDA;

Previous wording

We encourage you to read “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors,” as well as our unaudited condensed consolidated financial statements contained in this Quarterly Report on Form 10‑Q. We also encourage you to read our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on February 28, 2025 (2024 Annual Report), and which contains a more complete discussion of the risks and uncertainties associated with our business. In addition to the risks described above and in our 2024 Annual Report, other unknown or unpredictable factors also could affect our results. Therefore, the information in this Quarterly Report on Form 10‑Q should be read together with other reports and documents that we file with the SEC from time to time, including Forms 10-Q, 8-K, and 10-K, which may supplement, modify, supersede, or update our risk factors. There can be no assurance that the actual results or developments anticipated by us will be realized or, even if substantially realized, that our results will materialize as expected. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

Current wording

We encourage you to read “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors,” as well as our unaudited condensed consolidated financial statements contained in this Quarterly Report on Form 10‑Q. We also encourage you to read our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on February 27, 2026 (2025 Annual Report), and which contains a more complete discussion of the risks and uncertainties associated with our business. In addition to the risks described above and in our 2025 Annual Report, other unknown or unpredictable factors also could affect our results. Therefore, the information in this Quarterly Report on Form 10‑Q should be read together with other reports and documents that we file with the SEC from time to time, including Forms 10-Q, 8-K, and 10-K, which may supplement, modify, supersede, or update those risk factors. There can be no assurance that the actual results or developments anticipated by us will be realized or, even if substantially realized, that our results will materialize as expected. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

Previous wording

Aldeyra Therapeutics, Inc., including our wholly owned subsidiaries (we, us, or the Company), is a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases. Our 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. Our 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. Our 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 and retinitis pigmentosa. Our development pipeline, as of the date of filing of this Quarterly Report on Form 10-Q is illustrated below.

Current wording

Aldeyra Therapeutics, Inc., including our wholly owned subsidiaries (we, us, or the Company), is a biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated diseases. Our 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. Our 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. Our 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 and retinitis pigmentosa. Our development pipeline, as of the date of filing of this Quarterly Report on Form 10-Q is illustrated below.

Previous wording

To date, substantially all of our research and development expenses have been incurred in connection with reproxalap and ADX‑2191, as well as proof of concept trials with ADX‑629, which was a signal-finding molecule no longer under development. We expect our research and development expenses to increase for the foreseeable future as we advance ADX‑248, ADX‑246, and other compounds through preclinical and clinical development. The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We are unable to estimate with any certainty the costs we will incur in the continued development of our product candidates. Clinical development timelines, the probability of success, and development costs can differ materially from expectations. We may never succeed in achieving marketing approval for our product candidates. The costs of clinical trials may vary significantly over the life of a project owing to, but not limited to, the following:

Current wording

To date, substantially all of our research and development expenses have been incurred in connection with reproxalap and ADX‑2191, as well as the proof of concept trials with ADX‑629, which was a signal-finding molecule no longer under development. We expect our research and development expenses to increase for the foreseeable future as we advance ADX‑248, ADX‑246, and other compounds through preclinical and clinical development. The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We are unable to estimate with any certainty the costs we will incur in the continued development of our product candidates. Clinical development timelines, the probability of success, and development costs can differ materially from expectations. We may never succeed in achieving marketing approval for our product candidates. The costs of clinical trials may vary significantly over the life of a project owing to, but not limited to, the following:

Previous wording

delays of, or other effects on, trials resulting from public health measures, and war or other military actions, or for other reasons;

Current wording

delays of, or other effects on, clinical trials resulting from public health measures, and war or other military actions, or for other reasons;

Previous wording

We do not expect reproxalap or any of our other product candidates to be commercially available, if at all, before at least the second half of 2025.

Current wording

We do not expect reproxalap or any of our other product candidates to be commercially available, if at all, before further discussions with the FDA.

Previous wording

During the nine months ended September 30, 2025 and 2024, our general and administrative expenses consisted primarily of employee-related expenses, including benefits and stock-based compensation for our full-time employees. Other general and administrative expenses include insurance premiums, consulting, and professional fees for auditing, tax, investor relations, and legal services, including patent-related costs. We expect that general and administrative expenses will increase in the future as we expand our operating activities, continue to incur additional costs associated with being a publicly traded company, and maintain compliance with exchange listing and SEC requirements. The general and administrative expense increases will likely include higher consulting costs, fees for commercializing our product candidates, legal fees, accounting fees, insurance premiums, and fees associated with investor relations.

Current wording

During the three months ended March 31, 2026 and 2025, our general and administrative expenses consisted primarily of employee-related expenses, including benefits and stock-based compensation for our full-time employees. Other general and administrative expenses include insurance premiums, consulting, and professional fees for auditing, tax, investor relations, and legal services, including patent-related costs. We expect that general and administrative expenses will increase in the future as we expand our operating activities, continue to incur additional costs associated with being a publicly traded company, and maintain compliance with exchange listing and SEC requirements. The general and administrative expense increases will likely include higher consulting costs, fees for commercializing our product candidates, legal fees, accounting fees, insurance premiums, and fees associated with investor relations.

Previous wording

Comprehensive loss is defined as the change in equity during a period from transactions and other events and/or circumstances from non-owner sources. For the nine months ended September 30, 2025, comprehensive loss is equal to our net loss of $27.4 million and our net unrealized loss on marketable securities of less than $0.1 million. For the nine months ended September 30, 2024, comprehensive loss is equal to our net loss of $40.0 million and our net unrealized gain on marketable securities of $0.1 million.

Current wording

Comprehensive loss is defined as the change in equity during a period from transactions and other events and/or circumstances from non-owner sources. For the three months ended March 31, 2026, comprehensive loss is equal to our net loss of $3.5 million. For the three months ended March 31, 2025, comprehensive loss is equal to our net loss of $9.9 million and our net unrealized loss on marketable securities of $36.0 thousand.

Previous wording

There were no material changes to our critical accounting estimates during the nine months ended September 30, 2025, as compared to those described in Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our 2024 Annual Report. It is important that the discussion of our operating results that follow be read in conjunction with the critical accounting policies disclosed in our 2024 Annual Report.

Current wording

There were no material changes to our critical accounting estimates during the three months ended March 31, 2026, as compared to those described in Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our 2025 Annual Report. It is important that the discussion of our operating results that follow be read in conjunction with the critical accounting policies disclosed in our 2025 Annual Report.

Previous wording

Research and development expenses. Research and development expenses were $5.4 million for the three months ended September 30, 2025, compared to $12.4 million for the three months ended September 30, 2024. The decrease of $7.0 million was related to a decrease of $4.4 million in external clinical development costs, $1.9 million in drug product manufacturing costs, $0.4 million in preclinical costs, and $0.3 million in personnel costs.

Current wording

Research and development expenses. Research and development expenses were $2.4 million for the three months ended March 31, 2026, compared to $7.4 million for the three months ended March 31, 2025. The decrease of $5.0 million was primarily related to a decrease of $1.9 million in personnel costs, $1.6 million in drug product manufacturing costs, and $1.5 million in external clinical development costs.

Previous wording

For three months ended September 30, 2025, approximately 10% of the total research and development expenses was related to the advancement of late-stage product candidates. The late-stage product candidate expense during the three months ended September 30, 2025 was primarily attributable to reproxalap. We do not track labor associated with each program and have allocated headcount costs on a pro-rated basis. Management believes the pro rata allocation results is a reasonable estimate of the headcount costs associated with each of the programs noted above.

Current wording

For three months ended March 31, 2026, approximately 15% of the total research and development expenses related to the advancement of late-stage product candidates. The late-stage product candidate spend during the three months ended March 31, 2026 was primarily attributable to reproxalap. We do not track labor associated with each program and have allocated headcount costs on a pro-rated basis. Management believes the pro rata allocation is a reasonable estimate of the headcount costs associated with each of the programs noted above.

Previous wording

General and administrative expenses. General and administrative expenses were $2.6 million for the three months ended September 30, 2025, compared to $3.7 million for the three months ended September 30, 2024. The decrease of $1.1 million was related to a decrease of $0.7 million in personnel costs, and $0.4 million in legal costs.

Current wording

General and administrative expenses. General and administrative expenses were $1.1 million for the three months ended March 31, 2026, compared to $3.0 million for the three months ended March 31, 2025. The decrease of $1.9 million was primarily related to a decrease of $1.6 million in personnel costs and $0.3 million in legal costs.

Previous wording

Other income (expense). Total other income (expense), net, was $0.3 million and $1.0 million for the three months ended September 30, 2025 and 2024, respectively. The decrease in net other income of $0.7 million was principally due to lower investment balances and a decrease in interest income as a result of decreased interest rates on our investments.

Current wording

Other income (expense). Total other income (expense), net, was $0.1 million and $0.5 million for the three months ended March 31, 2026 and 2025, respectively. The decrease in net other income of $0.4 million was principally due to a decrease in interest income as a result of a decrease in investments.

Previous wording

We have funded our operations primarily from the sale of equity securities, convertible equity securities, and borrowings under credit facilities. Since inception, we have incurred operating losses and negative cash flows from operating activities and have devoted substantially all our efforts to research and development. At September 30, 2025, we had total stockholders’ equity of approximately $49.2 million, and cash, cash equivalents, and marketable securities of $75.3 million. During the nine months ended September 30, 2025, we had a net loss of approximately $27.4 million. We expect to generate operating losses for the foreseeable future.

Current wording

We have funded our operations primarily from the sale of equity securities and convertible equity securities, as well as borrowings under credit facilities. Since inception, we have incurred operating losses and negative cash flows from operating activities and have devoted substantially all our efforts to research and development. At March 31, 2026, we had total stockholders’ equity of approximately $42.2 million , and cash and cash equivalents of $65.0 million. During the three months ended March 31, 2026, we had a net loss of approximately $3.5 million. We expect to generate operating losses for the foreseeable future.

Previous wording

The Hercules Credit Facility contains customary affirmative and negative covenants and events of default. Affirmative covenants include, among others, covenants requiring us to maintain our legal existence and governmental approvals, deliver certain financial reports, and maintain insurance coverage. Negative covenants include, in each case subject to customary exceptions, among others: restrictions on transferring any part of our business or intellectual property; incurring additional indebtedness; engaging in mergers or acquisitions; paying dividends or making other distributions; making investments; and creating other liens on our assets. The Hercules Credit Facility, as amended, is described in Note 9 to the notes to the condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q. As of September 30, 2025, $15.0 million was outstanding under the Hercules Credit Facility and no amounts remained available for borrowing.

Current wording

The Hercules Credit Facility contains customary affirmative and negative covenants and events of default. Affirmative covenants include, among others, covenants requiring us to maintain our legal existence and governmental approvals, deliver certain financial reports, and maintain insurance coverage. Negative covenants include, in each case subject to customary exceptions, among others: restrictions on transferring any part of our business or intellectual property; incurring additional indebtedness; engaging in mergers or acquisitions; paying dividends or making other distributions; making investments; and creating other liens on our assets. The Hercules Credit Facility, as amended, is described in Note 9 to the notes to the condensed consolidated financial statements contained in this Quarterly Report on 10-Q. As of March 31, 2026, $15.0 million was outstanding under the Hercules Credit Facility and no amounts remained available for borrowing.

Previous wording

On November 15, 2024, we 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 we 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

Current wording

On November 15, 2024, we 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 we 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 our 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 we do not execute the Collaboration

Previous wording

Option and entry into the Collaboration Agreement, such that 60% of our 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 we do not execute the Collaboration Agreement, we 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 the date, if any, that we receive 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 us notice in case AbbVie determines that it will not exercise the AbbVie Option.

Current wording

Agreement, we 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 the date, if any, that we receive 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 us notice in case AbbVie determines that it will not exercise the AbbVie Option.

Previous wording

Based on our current operating plan, and excluding any potential licensing and product revenue, we believe that our cash, cash equivalents, and marketable securities as of September 30, 2025, will be sufficient to fund our currently projected operating expenses and debt obligations into the second half of 2027, including continued early and late-stage development of our product candidates in immune-mediated diseases. We base our projections of operating capital requirements on our current operating plan, which includes several assumptions that may prove incorrect, and we may use all of our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development, and commercialization (as applicable) of product candidates, we are unable to estimate the exact amount of our working capital requirements. We will need to secure additional funding in the future from one or more equity or debt financings, collaborations, or other sources in order to carry out all of our planned research and development and regulatory activities; commence or continue ongoing commercialization, including manufacturing, sales, marketing, and distribution for our product candidates; and conduct any substantial additional development requirements requested by the FDA. Due to the risks inherent in the drug development process, we are unable to estimate with any certainty the costs we will incur in the continued clinical development of reproxalap and our other product candidates. Trials initiated at a later date may be significantly more expensive, depending on the results of our prior clinical trials and feedback from the FDA or other third parties. Accordingly, we will continue to require substantial additional capital to continue our clinical development and potential commercialization activities. The amount and timing of our future funding requirements will depend on a variety of factors, including, but not limited to:

Current wording

Based on our current operating plan, and excluding any potential licensing and product revenue, we believe that our cash and cash equivalents as of March 31, 2026, will be sufficient to fund our currently projected operating expenses and debt obligations into the second half 2028, including continued early and late-stage development of our product candidates in ocular and systemic immune-mediated diseases. We base our projections of operating capital requirements on our current operating plan, which includes several assumptions that may prove to be incorrect, and we may use all of our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development, regulatory requirements, and commercialization (as applicable) of product candidates, we are unable to estimate the exact amount of our working capital requirements. We will need to secure additional funding in the future, from one or more equity or debt financings, collaborations, or other sources, in order to carry out all of our planned research, development activities, and regulatory activities; commence or continue ongoing commercialization, including manufacturing, sales, marketing and distribution for our product candidates; or fulfill additional development requirements requested by the FDA. At this time, due to the risks inherent in the drug development process, we are unable to estimate with any certainty the costs we will incur in the continued clinical development and regulatory requirements of reproxalap, and our other product candidates. Subsequent trials or regulatory activities initiated at a later date will cost considerably more, depending on the results of our prior clinical trials, and feedback from the FDA or other third parties. Accordingly, we will continue to require substantial additional capital to continue our clinical development, regulatory, and potential commercialization activities. The amount and timing of our future funding requirements will depend on many factors, including, but not limited to:

Previous wording

the costs, timing, and outcome of regulatory review of reproxalap, including any additional trials the FDA or other regulatory agencies may require for approval or label expansion;

Current wording

the costs, timing, and outcome of regulatory submission, procedures, and protocols, and review of reproxalap, including any additional trials the FDA or other regulatory agencies may require for approval or label expansion;

Previous wording

the costs of commercialization activities for reproxalap, if approved, and pre‑commercialization costs for reproxalap incurred prior to receiving any such marketing approval, including the costs and timing of establishing product sales, marketing, distribution, and outsourced manufacturing capabilities;

Current wording

the costs of commercialization activities for reproxalap, if we receive marketing approval, and pre commercialization costs for reproxalap incurred prior to receiving marketing approval, including the costs and timing of establishing product sales, marketing, distribution and outsourced manufacturing capabilities;

Previous wording

the amount of revenue received from commercial sales of reproxalap or any other product candidates, if approved;

Current wording

assuming receipt of marketing approval, the amount of revenue received from commercial sales of reproxalap or any other product candidates;

Previous wording

costs associated with any other product candidates that we may develop, in-license, or acquire, including potential milestone or royalty payments for product candidates that we may in-license or acquire;

Current wording

costs associated with any other product candidates that we may develop, in-license, or acquire, including potential milestone or royalty payments;

Previous wording

We will continue to incur costs as a public company, including, but not limited to, costs and expenses for directors' fees; increased directors' and officers' insurance; investor relations fees; expenses for compliance with the Sarbanes-Oxley Act of 2002 and related to rules implemented by the SEC and Nasdaq, on which our common stock is listed; and various other costs. The Sarbanes-Oxley Act of 2002 requires that we maintain effective disclosure controls and procedures and internal controls.

Current wording

We will continue to incur costs as a public company, including, but not limited to, costs and expenses for directors' fees; increased directors' and officers' insurance; investor relations fees; expenses for compliance with the Sarbanes-Oxley Act of 2002 and related rules implemented by the SEC and Nasdaq, on which our common stock is listed; and various other costs. The Sarbanes-Oxley Act of 2002 requires that we maintain effective disclosure controls and procedures and internal controls.

Previous wording

The following table summarizes our cash flows for the nine months ended September 30, 2025 and 2024:

Current wording

The following table summarizes our cash flows for the three months ended March 31, 2026 and 2025:

Previous wording

Operating Activities. Net cash used in operating activities was $28.0 million for the nine months ended September 30, 2025, compared to net cash used in operating activities of $31.2 million for the same period in 2024. The primary use of cash was to fund our operations. The decrease in the amount of cash used in operating activities for the nine months ended September 30, 2025 as compared to 2024 was principally due to a decrease in net loss, primarily from research and development activities; changes in accrued expenses, due to the amount and timing of payments for research and development activities; changes in prepayments, due to timing of payment; and collection of a receivable for the nine months ended September 30, 2025 compared to the same period in 2024.

Current wording

Operating Activities. Net cash used in operating activities was $5.1 million for the three months ended March 31, 2026, compared to net cash used in operating activities of $12.5 million for the same period in 2025. The primary use of cash was to fund our operations. The decrease in the amount of cash used in operating activities for the three months ended March 31, 2026 as compared to 2025 was principally due to decreases in research and development activities, a reduction in the value of stock-based cash awards, and decreases in accrued expenses due to the amount and timing of payments for research and development activities for the three months ended March 31, 2026 compared to the same period in 2025.

Previous wording

Investing Activities. Net cash provided by investing activities was $31.7 million for the nine months ended September 30, 2025, and net cash used in investing activities was $43.4 million for the nine months ended September 30, 2024. Net cash provided by investing activities related to maturities of marketable securities offset by purchases of marketable securities for the nine months ended September 30, 2025. Net cash used in investing activities related to purchases of marketable securities for the nine months ended September 30, 2024.

Current wording

Investing Activities. There were no investing activities for the three months ended March 31, 2026, compared to $7.3 million provided by investing activities for the three months ended March 31, 2025, resulting from maturities of marketable securities offset by purchases of marketable securities.

Previous wording

Financing Activities. Net cash provided by financing activities was $1.1 million for the nine months ended September 30, 2025, compared to $0.2 million used in the nine months ended September 30, 2024. The net cash provided by financing activities for the nine months ended September 30, 2025 consisted primarily of exercises of options. The net cash used in financing activities for the nine months ended September 30, 2024 consisted of stock purchases under the employee stock purchase plan.

Current wording

Financing Activities. Net cash provided by financing activities was $0.1 million for the three months ended March 31, 2026, compared to $1.0 million for the three months ended March 31, 2025. The net cash provided by financing activities for the three months ended March 31, 2026 and March 31, 2025 consisted primarily of exercises of options.