Aldeyra Therapeutics, Inc.

Previous wording

delay in or failure to obtain regulatory approval of reproxalap or any of our other product candidates, including as a result of the U.S. Food and Drug Administration (FDA) not accepting our regulatory filings or requiring additional clinical trials or data prior to review or approval of such filings;

Current wording

delay in or failure to obtain regulatory approval of reproxalap or any of our other product candidates, including as a result of the U.S. Food and Drug Administration (FDA) not accepting our regulatory filings, including an unsuccessful formal dispute resolution request (FDRR), or requiring additional clinical trials or data prior to review or approval of such filings;

Previous 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.

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.

Previous wording

All of our development plans and timelines are subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, funding, and other factors that could delay the initiation, completion, or reporting of clinical trials. Regulatory review timelines are flexible and subject to change based on the regulator’s workload and other potential review issues. The timing of ongoing clinical trials depends, in part, on the availability of clinical research facilities and staffing, and the ability to recruit patients.

Current wording

All of our development plans and timelines are subject to adjustment depending on recruitment rate, regulatory review, including the FDRR process, preclinical and clinical results, funding, and other factors that could delay the initiation, completion, or reporting of clinical trials. Regulatory review timelines are flexible and subject to change based on the regulator’s workload and other potential review issues. The timing of ongoing clinical trials depends, in part, on the availability of clinical research facilities and staffing, and the ability to recruit patients.

Previous wording

To date, substantially all 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:

Current wording

To date, substantially all 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 obtaining 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 associated with clinical development and regulatory activities, including FDRR and related regulatory interactions, may vary significantly over the life of a project owing to, but not limited to, the following:

Previous wording

Included in research and development are expenses associated with asset acquisitions. Assets purchased in an asset acquisition transaction are expensed as in-process research and development unless the assets acquired are deemed to have an alternative future use. Acquired in-process research and development payments are immediately expensed, and include upfront payments, as well as transaction fees and subsequent milestone payments. Development costs incurred after the asset acquisition are expensed as incurred.

Current wording

Research and development expenses may include costs associated with asset acquisitions. Assets purchased in an asset acquisition transaction are expensed as in-process research and development unless the assets acquired are deemed to have an alternative future use. Acquired in-process research and development payments are immediately expensed, and include upfront payments, as well as transaction fees and subsequent milestone payments. Development costs incurred after the asset acquisition are expensed as incurred.

Previous 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.

Current wording

We do not expect reproxalap or any of our other product candidates to be commercially available, if at all, before further discussions including as part of the FDRR process, with the FDA, timing and outcome of which are unpredictable.

Previous wording

During the six months ended June 30, 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.

Current wording

During the nine months ended September 30, 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 and certain regulatory matters. 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

Total other income (expense) consists primarily of interest income earned on our interest-bearing accounts and interest expense incurred on our outstanding debt.

Current wording

Total other income (expense) consists primarily of interest income earned on our interest-bearing accounts and interest expense incurred on our previously outstanding debt.

Previous wording

Comprehensive loss is defined as the change in equity from transactions and other events from non-owner sources. For the six months ended June 30, 2026, comprehensive loss is equal to our net loss of $8.9 million. For the six months ended June 30, 2025, comprehensive loss is equal to our net loss of $19.7 million inclusive of an immaterial amount of unrealized loss on marketable securities.

Current wording

Comprehensive loss is defined as the change in equity from transactions and other events from non-owner sources. For the nine months ended September 30, 2026, comprehensive loss is equal to our net loss of $12.7 million. For the nine months ended September 30, 2025, comprehensive loss is equal to our net loss of $27.4 million inclusive of an immaterial amount of unrealized loss on marketable securities.

Previous wording

There were no material changes to our critical accounting estimates during the six months ended June 30, 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.

Current wording

There were no material changes to our critical accounting estimates during the nine months ended September 30, 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

We anticipate that our results of operations will fluctuate for the foreseeable future due to several factors, including the progress of our research and development efforts, the timing and outcome of clinical trials, the timing and outcome of regulatory submissions, regulatory requirements, and the exercise, if any, of the AbbVie Option, including any related commercialization costs. Our limited operating history makes predictions of future operations difficult or impossible. Since our inception, we have incurred significant losses.

Current wording

We anticipate that our results of operations will fluctuate for the foreseeable future due to several factors, including the progress of our research and development efforts, the timing and outcome of clinical trials, the timing and outcome of regulatory submissions and the FDRR, regulatory requirements, and the exercise, if any, of the AbbVie Option, including any related commercialization costs. Our limited operating history makes predictions of future operations difficult or impossible. Since our inception, we have incurred significant losses.

Previous wording

Research and development expenses. Research and development expenses were $5.9 million for the six months ended June 30, 2026, compared to $15.9 million for the six months ended June 30, 2025. The decrease of approximately $10.0 million was primarily related to a decrease of $5.4 million in external clinical development costs, $3.1 million in drug product manufacturing costs, $1.2 million in personnel costs, $0.2 million in preclinical expenditures, and $0.1 million in consulting expenditures.

Current wording

Research and development expenses. Research and development expenses were $1.8 million for the three months ended September 30, 2026, compared to $5.4 million for the three months ended September 30, 2025. The decrease of $3.6 million was primarily related to a decrease of $1.6 million in external clinical development costs, $1.1 million in personnel costs, $0.5 million in drug product manufacturing costs, $0.2 million in preclinical expenditures, and $0.2 million in consulting expenditures. The decrease is reflective of our shift in focus from clinical development activities to regulatory activities associated with its development programs, including reproxalap.

Previous wording

For three months ended June 30, 2026, approximately 20% 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 June 30, 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.

Current wording

For three months ended September 30, 2026, approximately 30% 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 September 30, 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 $2.4 million for the three months ended June 30, 2026, compared to $1.7 million for the three months ended June 30, 2025. The increase of $0.7 million was primarily related to an increase of $0.4 million in personnel costs and $0.3 million in legal costs.

Current wording

General and administrative expenses. General and administrative expenses were $2.3 million for the three months ended September 30, 2026, compared to $2.6 million for the three months ended September 30, 2025. The decrease of $0.3 million was primarily related to a decrease of $0.8 million in personnel costs, offset by an increase of $0.4 million in legal costs and $0.1 million in consulting expenditures.

Previous wording

Other income (expense). Total other income (expense), net, was $0.4 million for each of the three months ended June 30, 2026 and 2025. Net other income primarily related to lower interest income resulting from decreased investment balances, substantially offset by lower interest expense following the repayment of the Loan and Security Agreement.

Current wording

Other income (expense). Total other income (expense), net, was $0.4 million and $0.3 million for the three months ended September 30, 2026 and 2025, respectively. The increase in net other income was primarily due to lower interest expense following the repayment of the Loan and Security Agreement, substantially offset by lower interest income resulting from decreased investment balances.

Previous wording

Research and development expenses. Research and development expenses were $3.5 million for the three months ended June 30, 2026, compared to $8.5 million for the three months ended June 30, 2025. The decrease of $5.0 million was primarily related to a decrease of $3.8 million in external clinical development costs and $1.6 million in drug product manufacturing costs.

Current wording

Research and development expenses. Research and development expenses were $7.7 million for the nine months ended September 30, 2026, compared to $21.4 million for the nine months ended September 30, 2025. The decrease of approximately $13.7 million was primarily related to a decrease of $7.0 million in external clinical development costs, $3.6 million in drug product manufacturing costs, $2.3 million in personnel costs, $0.4 million in preclinical expenditures, and $0.4 million in consulting expenditures. The decrease is reflective of our shift in focus from clinical development activities to regulatory activities associated with its development programs, including reproxalap.

Previous wording

For the six months ended June 30, 2026, approximately 15% 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 six months ended June 30, 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 results is a reasonable estimate of the headcount costs associated with each of the programs noted above.

Current wording

For the nine months ended September 30, 2026, approximately 25% 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 nine months ended September 30, 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 results 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 $3.5 million for the six months ended June 30, 2026, compared to $4.7 million for the six months ended June 30, 2025. The decrease of approximately $1.2 million was primarily related to a decrease of $1.2 million in personnel costs.

Current wording

General and administrative expenses. General and administrative expenses were $5.8 million for the nine months ended September 30, 2026, compared to $7.2 million for the nine months ended September 30, 2025. The decrease of approximately $1.4 million was primarily related to a decrease of $1.9 million in personnel costs, offset by an increase of $0.4 million in legal costs and $0.1 million in consulting expenditures.

Previous wording

Other income (expense). Total other income (expense), net, was $0.5 million and $0.9 million for the six months ended June 30, 2026 and 2025, respectively. The decrease in net other income of $0.4 million was principally due a decrease in interest income as a result of a decrease in investments, substantially offset by lower interest expense following the repayment of the Loan and Security Agreement.

Current wording

Other income (expense). Total other income (expense), net, was $0.9 million and $1.2 million for the nine months ended September 30, 2026 and 2025, respectively. The decrease in net other income of $0.3 million was principally due to a decrease in interest income as a result of a decrease in investments, substantially offset by lower interest expense following the repayment of the Loan and Security Agreement.

Previous 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 June 30, 2026, we had total stockholders’ equity of approximately $37.9 million, and cash and cash equivalents of $45.1 million. During the six months ended June 30, 2026, we had a net loss of approximately $8.9 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 September 30, 2026, we had total stockholders’ equity of approximately $35.2 million, and cash and cash equivalents of $41.0 million. During the nine months ended September 30, 2026, we had a net loss of approximately $12.7 million. We expect to generate operating losses for the foreseeable future.

Previous 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 June 30, 2026, will be sufficient to fund our currently projected operating expenses 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 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:

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 September 30, 2026, will be sufficient to fund our currently projected operating expenses into 2029, including continued development and regulatory activities associated with our product candidates in ocular and systemic immune-mediated diseases, including the FDRR process. We base our projections of operating capital requirements on our current operating plan, which includes 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 and regulatory review processes, we are unable to estimate with any certainty the costs we will incur in the continued clinical development and regulatory requirements of reproxalap, including the FDRR process, 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 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;

Current wording

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

Previous wording

The following table summarizes our cash flows for the six months ended June 30, 2026 and 2025:

Current wording

The following table summarizes our cash flows for the nine months ended September 30, 2026 and 2025:

Previous wording

Operating Activities. Net cash used in operating activities was $9.7 million for the six months ended June 30, 2026, compared to net cash used in operating activities of $21.0 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 six months ended June 30, 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 six months ended June 30, 2026 compared to the same period in 2025.

Current wording

Operating Activities. Net cash used in operating activities was $13.8 million for the nine months ended September 30, 2026, compared to net cash used in operating activities of $28.0 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 nine months ended September 30, 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 nine months ended September 30, 2026 compared to the same period in 2025.

Previous wording

Investing Activities. Investing activities were immaterial for the six months ended June 30, 2026. For the six months ended June 30, 2025, net cash provided by investing activities was $6.7 million, primarily reflecting maturities of marketable securities offset by purchases of marketable securities.

Current wording

Investing Activities. Investing activities were immaterial for the nine months ended September 30, 2026. For the nine months ended September 30, 2025, net cash provided by investing activities was $31.7 million, primarily reflecting maturities of marketable securities offset by purchases of marketable securities.

Previous wording

Financing Activities. Net cash used in financing activities was $15.2 million for the six months ended June 30, 2026, compared to net cash provided by financing activities was $1.0 million for the six months ended June 30, 2025. The net cash used in financing activities for the six months ended June 30, 2026 consisted primarily of the repayment of the outstanding Loan and Security Agreement. The net cash provided by financing activities for the six months ended June 30, 2025 consisted primarily of exercises of options.

Current wording

Financing Activities. Net cash used in financing activities was $15.2 million for the nine months ended September 30, 2026, compared to net cash provided by financing activities of $1.1 million for the nine months ended September 30, 2025. The net cash used in financing activities for the nine months ended September 30, 2026 consisted primarily of the repayment of the outstanding Loan and Security Agreement. The net cash provided by financing activities for the nine months ended September 30, 2025 consisted primarily of exercises of options.