Group 1: Fortune Future 50 List - U.S. tech companies, especially in software, dominate the 2025 Fortune Future 50 list, with Snowflake taking the top position [1][2] - The list highlights companies with strong prospects for above-average long-term growth, focusing on "corporate vitality" [3] Group 2: Snowflake's Position and Leadership - Snowflake is well-positioned for growth, with a new CFO, Brian Robins, set to take over on September 22, succeeding Mike Scarpelli [4] - Robins has a strong background in financial leadership, having served as CFO at multiple companies, including GitLab [4] - Snowflake reported earnings of 35 cents per share for the quarter ending July 31, nearly double from the previous year, with revenue climbing 32% to $1.1 billion, surpassing estimates [5][6] Group 3: AI and Business Trends - The rise of AI in business is a key driver for companies like Snowflake and Databricks, enabling organizations to leverage their data for AI applications [2] - A Gallup report indicates that trust in businesses to use AI responsibly has improved, with 31% of Americans expressing some level of trust in 2023, up from 21% the previous year [9][10]

Summary of Aldeyra Therapeutics FY Conference Call Company Overview - **Company**: Aldeyra Therapeutics (NasdaqCM: ALDX) - **Focus**: Development of reproxalap for dry eye disease and other RASP (reactive aldehyde species) pipeline candidates Key Points on Reproxalap - **PDUFA Date**: December 16, 2025, for reproxalap's approval [4] - **Commercial Partnership**: AbbVie has an option worth $194 million if they exercise post-approval within 10 business days [4] - **NDA Resubmission**: Resubmitted in June 2025, with a six-month review process [4] - **Trial Results**: New trial showed only a 2-point baseline imbalance between treatment arms, indicating a strong statistical significance [5] - **Efficacy**: Reproxalap aims to improve both ocular redness and discomfort, with a unique mechanism targeting RASP [10][12] - **Market Position**: If approved, reproxalap would be the only chronic-use drug for dry eye with redness data on the label, providing a commercial advantage [11] Market Dynamics - **Dry Eye Disease**: Increasing prevalence due to lifestyle factors (e.g., screen time) and environmental issues (e.g., pollution) [16][17] - **Current Treatments**: Existing options take weeks to show effects, while reproxalap aims for rapid relief [17][19] - **Patient Needs**: Emphasis on treating "bad days" rather than waiting for long-term relief [18] Pipeline Developments - **ADX-2191**: First intravitreal methotrexate candidate for ocular lymphoma, with a special protocol assessment agreement with the FDA [22][24] - **Other Candidates**: ADX-248 for atopic dermatitis and ADX-246 for dry age-related macular degeneration are in development [26][28] - **Clinical Trials**: Plans to initiate trials for lymphoma and other conditions, with data expected in the near future [29] Investor Considerations - **Key Questions**: Investors are focused on the likelihood of reproxalap's approval and AbbVie's decision to exercise their option [14] - **Future Catalysts**: Anticipated news flow from ongoing trials and potential approvals will keep investors engaged [29] Additional Insights - **RASP Mechanism**: Unique approach targeting multiple proteins simultaneously, potentially leading to broader therapeutic effects [12][13] - **Unmet Medical Needs**: Significant opportunities exist in treating conditions like ocular lymphoma and atopic dermatitis, which currently lack approved therapies [25][27] This summary encapsulates the critical aspects of Aldeyra Therapeutics' conference call, highlighting the company's strategic focus, market opportunities, and pipeline developments.

Summary of Aldeyra Therapeutics (ALDX) FY Conference Call Company Overview - **Company**: Aldeyra Therapeutics (ALDX) - **Focus**: Immunology with an emphasis on ophthalmology, particularly in the treatment of dry eye disease and other ocular conditions [3][4] Pipeline and Product Development - **Lead Product**: Reproxalap, a topical eye drop candidate for dry eye disease, is a RASP modulator targeting reactive aldehyde species [5][6][7] - **NDA Resubmission**: The company resubmitted the New Drug Application (NDA) for reproxalap, with a PDUFA date set for December 16, 2025. The last FDA feedback indicated the need for an additional symptom trial [5][8][10] - **Clinical Trials**: The company has conducted trials in dry eye chambers to demonstrate the drug's efficacy within minutes, addressing a significant gap in the current treatment landscape where existing therapies do not provide rapid relief [12][13][36] Market Opportunity - **Dry Eye Disease**: The prevalence of dry eye disease is expected to increase due to aging populations and increased screen time. Current treatments are limited and often ineffective for moderate to severe cases [11][12][14] - **Differentiation**: Reproxalap aims to be the first drug to address both symptoms and signs of dry eye disease, including redness and discomfort, which is not currently available in the market [16][46] Strategic Partnerships - **Collaboration with AbbVie**: AbbVie holds an option for reproxalap, which includes potential development for allergic conjunctivitis. The partnership is seen as advantageous given AbbVie's experience in the dry eye market [24][26][28] Additional Pipeline Products - **ADX-2191**: An intravitreal formulation of methotrexate for ocular lymphoma and retinitis pigmentosa. The company is preparing for pivotal trials in retinitis pigmentosa, a condition affecting peripheral vision [52][58] - **ADX-246**: A product targeting dry age-related macular degeneration (AMD), focusing on improving low-light vision and addressing early stages of the disease [66][70] Future Directions - **Focus on Mild to Moderate Diseases**: Aldeyra aims to address mild to moderate forms of diseases, which are often overlooked in the current treatment landscape. This approach is expected to meet the needs of a larger patient population [72][73] - **RASP Modulation Platform**: The RASP platform allows for the modulation of multiple proteins simultaneously, indicating a potential shift in treatment paradigms towards more comprehensive therapies [74] Key Takeaways - Aldeyra is positioned to potentially revolutionize the treatment of dry eye disease with reproxalap, focusing on rapid relief and addressing both symptoms and signs [16][46] - The collaboration with AbbVie enhances the company's market position and development capabilities [24][26] - The pipeline extends beyond dry eye disease, with promising developments in ocular lymphoma and retinitis pigmentosa, indicating a broad therapeutic focus [52][58]

PART I – FINANCIAL INFORMATION This section presents Aldeyra Therapeutics, Inc.'s unaudited condensed consolidated financial statements and management's discussion and analysis for the periods ended June 30, 2025, and December 31, 2024 [ITEM 1. Condensed Consolidated Financial Statements](index=4&type=section&id=ITEM%201.%20Condensed%20Consolidated%20Financial%20Statements) This section presents Aldeyra Therapeutics, Inc.'s unaudited condensed consolidated financial statements, including balance sheets, statements of operations, comprehensive loss, stockholders' equity, and cash flows, along with detailed notes for the periods ended June 30, 2025, and December 31, 2024 [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) The consolidated balance sheets provide a snapshot of the company's financial position, showing a decrease in total assets and stockholders' equity at June 30, 2025 | Metric | June 30, 2025 (Unaudited, USD) | December 31, 2024 (USD) | | :-------------------------------- | :-------------------------- | :------------------ | | Cash and cash equivalents | $41,241,269 | $54,527,092 | | Marketable securities | $40,678,370 | $46,624,180 | | Total current assets | $84,558,228 | $104,072,478 | | Total assets | $84,962,888 | $104,606,694 | | Total current liabilities | $29,531,299 | $18,601,823 | | Total liabilities | $29,674,746 | $33,601,823 | | Total stockholders' equity | $55,288,142 | $71,004,871 | - Total assets decreased from **$104.6 million** at December 31, 2024, to **$84.96 million** at June 30, 2025[8](index=8&type=chunk) - Total stockholders' equity decreased from **$71.0 million** at December 31, 2024, to **$55.3 million** at June 30, 2025[8](index=8&type=chunk) [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) The consolidated statements of operations show a reduced net loss for the three and six months ended June 30, 2025, due to decreased operating expenses | Metric | Three Months Ended June 30, 2025 (USD) | Three Months Ended June 30, 2024 (USD) | Six Months Ended June 30, 2025 (USD) | Six Months Ended June 30, 2024 (USD) | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $8,505,229 | $14,969,743 | $15,928,552 | $21,153,251 | | General and administrative | $1,663,503 | $3,038,064 | $4,667,639 | $6,248,420 | | Loss from operations | $(10,168,732) | $(18,007,807) | $(20,596,191) | $(27,401,671) | | Total other income, net | $401,420 | $1,160,235 | $899,378 | $2,471,977 | | Net loss | $(9,767,312) | $(16,847,572) | $(19,696,813) | $(24,929,694) | | Net loss per share (basic & diluted) | $(0.16) | $(0.28) | $(0.33) | $(0.42) | - Net loss decreased by **42.0%** for the three months ended June 30, 2025, compared to the same period in 2024[11](index=11&type=chunk) - Net loss decreased by **21.0%** for the six months ended June 30, 2025, compared to the same period in 2024[11](index=11&type=chunk) [Consolidated Statements of Comprehensive Loss](index=6&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) The consolidated statements of comprehensive loss detail total comprehensive loss, including net loss and unrealized loss on marketable securities | Metric | Three Months Ended June 30, 2025 (USD) | Three Months Ended June 30, 2024 (USD) | Six Months Ended June 30, 2025 (USD) | Six Months Ended June 30, 2024 (USD) | | :------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(9,767,312) | $(16,847,572) | $(19,696,813) | $(24,929,694) | | Net unrealized loss on marketable securities | $(12,593) | $(6,629) | $(48,437) | $(9,658) | | Total other comprehensive loss | $(12,593) | $(6,629) | $(48,437) | $(9,658) | | Comprehensive loss | $(9,779,905) | $(16,854,201) | $(19,745,250) | $(24,939,352) | [Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Equity) The consolidated statements of stockholders' equity detail changes in equity components, reflecting net losses and stock-based compensation | Metric (Six Months Ended June 30, 2025) | Shares | Common Stock Amount (USD) | Additional Paid-in Capital (USD) | Accumulated Other Comprehensive Income/(Loss) (USD) | Accumulated Deficit (USD) | Total Stockholders' Equity (USD) | | :-------------------------------------- | :----------- | :------------------ | :------------------------- | :-------------------------------------------- | :------------------ | :------------------------- | | Balance, December 31, 2024 | 59,648,278 | $59,648 | $521,018,373 | $37,442 | $(450,110,592) | $71,004,871 | | Stock-based compensation | — | — | $3,025,711 | — | — | $3,025,711 | | Issuance of common stock, exercise of stock options | 240,209 | $241 | $982,953 | — | — | $983,194 | | Issuance of common stock, employee stock purchase plan | 7,101 | $7 | $19,609 | — | — | $19,616 | | Issuance of common stock, vested restricted stock units | 149,942 | $150 | $(150) | — | — | — | | Other comprehensive loss | — | — | — | $(48,437) | — | $(48,437) | | Net loss | — | — | — | — | $(19,696,813) | $(19,696,813) | | Balance, June 30, 2025 | 60,045,530 | $60,046 | $525,046,496 | $(10,995) | $(469,807,405) | $55,288,142 | - Total stockholders' equity decreased from **$71.0 million** at December 31, 2024, to **$55.3 million** at June 30, 2025, primarily due to the net loss[16](index=16&type=chunk) - Stock-based compensation contributed **$3.0 million** to additional paid-in capital for the six months ended June 30, 2025[16](index=16&type=chunk) [Consolidated Statements of Cash Flows](index=9&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) The consolidated statements of cash flows show a net decrease in cash, driven by reduced operating cash use and positive investing activities | Cash Flow Activity | Six Months Ended June 30, 2025 (USD) | Six Months Ended June 30, 2024 (USD) | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(21,024,921) | $(23,196,985) | | Net cash provided by (used in) investing activities | $6,736,288 | $(48,614,499) | | Net cash provided by financing activities | $1,002,810 | $18,191 | | NET DECREASE IN CASH AND CASH EQUIVALENTS | $(13,285,823) | $(71,793,293) | | CASH AND CASH EQUIVALENTS, END OF PERIOD | $41,241,269 | $71,029,723 | - Net cash used in operating activities decreased by **$2.17 million (9.3%)** for the six months ended June 30, 2025, compared to the same period in 2024[19](index=19&type=chunk)[140](index=140&type=chunk) - Investing activities shifted from using **$48.6 million** in cash in 2024 to providing **$6.7 million** in 2025, primarily due to maturities of marketable securities[19](index=19&type=chunk)[141](index=141&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide essential context for the financial statements, covering business, accounting policies, and significant agreements [1. NATURE OF BUSINESS](index=10&type=section&id=1.%20NATURE%20OF%20BUSINESS) Aldeyra Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing therapies for immune-mediated and metabolic diseases - Aldeyra Therapeutics, Inc. is a clinical-stage biotechnology company[22](index=22&type=chunk) - The company focuses on discovering and developing therapies for immune-mediated and metabolic diseases[22](index=22&type=chunk) - Principal activities include research and development and related business planning[22](index=22&type=chunk) [2. BASIS OF PRESENTATION](index=10&type=section&id=2.%20BASIS%20OF%20PRESENTATION) Interim financial statements are unaudited, prepared under U.S. GAAP, and management expects sufficient funding for the next 12 months - Interim financial statements are unaudited and prepared under U.S. GAAP for interim reporting, not full annual disclosures[23](index=23&type=chunk) - Management believes current cash, cash equivalents, and marketable securities are sufficient to fund projected operating expenses and debt obligations for at least the next 12 months[25](index=25&type=chunk) - Additional funding will be needed for future research, development, regulatory activities, and potential commercialization efforts[25](index=25&type=chunk) [3. HELIO VISION ACQUISITION](index=11&type=section&id=3.%20HELIO%20VISION%20ACQUISITION) Aldeyra acquired Helio Vision for ADX-2191 rights, but ceased development, potentially reverting intellectual property rights - Aldeyra acquired Helio Vision, Inc. in January 2019, obtaining rights to develop ADX-2191[31](index=31&type=chunk) - Contingent payments included up to **$12.5 million** in common stock upon FDA approvals for specific indications[31](index=31&type=chunk) - The company ceased development of ADX-2191 for proliferative vitreoretinopathy in 2024, which may result in intellectual property rights reverting to former Helio stockholders[31](index=31&type=chunk) [4. NET LOSS PER SHARE](index=12&type=section&id=4.%20NET%20LOSS%20PER%20SHARE) Diluted weighted average common shares equal basic shares due to the company's net loss position, rendering dilutive securities antidilutive - Diluted weighted average common shares outstanding equal basic weighted average common shares due to net loss[33](index=33&type=chunk) Potentially Dilutive Securities | Potentially Dilutive Securities | For the Three and Six Months Ended June 30, 2025 (Shares) | For the Three and Six Months Ended June 30, 2024 (Shares) | | :------------------------------ | :----------------------------------------------- | :----------------------------------------------- | | Options to purchase common stock | 8,605,370 | 8,033,741 | | Nonvested restricted stock units | 364,567 | 732,056 | | Total of common stock equivalents | 8,969,937 | 8,765,797 | [5. CASH, CASH EQUIVALENTS, AND MARKETABLE SECURITIES](index=12&type=section&id=5.%20CASH%2C%20CASH%20EQUIVALENTS%2C%20AND%20MARKETABLE%20SECURITIES) Cash, cash equivalents, and marketable securities decreased to $81.9 million at June 30, 2025, with all maturities less than one year Asset Category Fair Value | Asset Category | June 30, 2025 (Fair Value, USD) | December 31, 2024 (Fair Value, USD) | | :--------------- | :------------------------- | :----------------------------- | | Cash | $17,502,858 | $23,734,013 | | Money market funds | $23,738,411 | $30,793,079 | | U.S. government agency securities | $40,678,370 | $46,624,180 | | Total | $81,919,639 | $101,151,272 | - Total cash, cash equivalents, and marketable securities decreased by approximately **$19.2 million** from December 31, 2024, to June 30, 2025[34](index=34&type=chunk)[36](index=36&type=chunk) - All contractual maturities of cash equivalents and available-for-sale securities were less than one year at June 30, 2025[35](index=35&type=chunk) [6. FAIR VALUE MEASUREMENTS](index=14&type=section&id=6.%20FAIR%20VALUE%20MEASUREMENTS) Assets are measured at fair value using a three-level hierarchy, with money market funds and U.S. government agency securities classified as Level 1 and Level 2 - Fair value measurements are categorized into Level 1 (quoted prices in active markets) and Level 2 (observable inputs other than Level 1)[38](index=38&type=chunk)[39](index=39&type=chunk) Assets at Fair Value | Asset Category | June 30, 2025 (Total Fair Value, USD) | December 31, 2024 (Total Fair Value, USD) | | :--------------- | :------------------------------- | :----------------------------------- | | Money market funds | $23,738,411 | $30,793,079 | | U.S. government agency securities | $40,678,370 | $46,624,180 | | Total assets at fair value | $64,416,781 | $77,417,259 | - Money market funds are valued at Level 1, and U.S. government agency securities are valued at Level 2[40](index=40&type=chunk)[41](index=41&type=chunk) [7. PREPAID EXPENSES AND OTHER CURRENT ASSETS](index=15&type=section&id=7.%20PREPAID%20EXPENSES%20AND%20OTHER%20CURRENT%20ASSETS) Prepaid expenses and other current assets decreased due to reduced deferred research and development expenses Prepaid Expenses and Other Current Assets | Category | June 30, 2025 (USD) | December 31, 2024 (USD) | | :---------------------------------------- | :------------ | :---------------- | | Deferred research and development expenses and deposits | $1,417,021 | $2,211,963 | | Prepaid insurance expenses | $1,028,081 | $408,091 | | Miscellaneous prepaid expenses and other current assets | $193,487 | $301,152 | | Total prepaid expenses and other current assets | $2,638,589 | $2,921,206 | - Deferred research and development expenses decreased by approximately **$0.8 million**[45](index=45&type=chunk) - Prepaid insurance expenses increased by approximately **$0.62 million**[45](index=45&type=chunk) [8. ACCRUED EXPENSES](index=15&type=section&id=8.%20ACCRUED%20EXPENSES) Accrued expenses significantly decreased due to reductions in accrued compensation and research and development expenses Accrued Expenses | Category | June 30, 2025 (USD) | December 31, 2024 (USD) | | :-------------------------------- | :------------ | :---------------- | | Accrued compensation | $3,160,622 | $4,333,216 | | Accrued research and development expenses | $2,976,949 | $7,228,922 | | Accrued other expenses | $526,009 | $556,229 | | Total accrued expenses | $6,663,580 | $12,118,367 | - Accrued research and development expenses decreased by approximately **$4.25 million**[46](index=46&type=chunk) - Accrued compensation decreased by approximately **$1.17 million**[46](index=46&type=chunk) [9. CREDIT FACILITY](index=15&type=section&id=9.%20CREDIT%20FACILITY) The company has a $60.0 million Hercules Credit Facility, with $15.0 million funded, and was in compliance with all covenants - The Hercules Credit Facility provides for a term loan of up to **$60.0 million**, with **$15.0 million** funded as of June 30, 2025[47](index=47&type=chunk)[53](index=53&type=chunk) - Amendments extended interest-only payments to April 1, 2026, and the Maturity Date to April 1, 2026[50](index=50&type=chunk) - The term loan interest rate is the greater of Prime Rate plus 3.10% or 11.10%, with an effective interest rate of **12.4%** at June 30, 2025[50](index=50&type=chunk)[52](index=52&type=chunk) Debt Components | Debt Component | June 30, 2025 (USD) | December 31, 2024 (USD) | | :------------------------------ | :------------ | :---------------- | | Term loan payable | $15,000,000 | $15,000,000 | | Second supplemental end of term charge | $150,000 | $33,333 | | Unamortized debt issuance costs | $(1,103) | $(1,961) | | Less: current portion | $(15,148,897) | $(31,372) | | Total long-term debt | $0 | $15,000,000 | [10. STOCKHOLDERS' EQUITY](index=19&type=section&id=10.%20STOCKHOLDERS'%20EQUITY) As of June 30, 2025, the company had an Open Market Sales Agreement for up to $75.0 million in common stock, with no shares sold - The company has an Open Market Sales Agreement with Jefferies for up to **$75.0 million** in common stock sales[55](index=55&type=chunk) - No shares of common stock were sold under the 2024 Jefferies Sales Agreement as of June 30, 2025[55](index=55&type=chunk) [11. INCOME TAXES](index=19&type=section&id=11.%20INCOME%20TAXES) No current or deferred tax provision expenses were recorded due to accumulated losses, with a 100% valuation allowance against deferred tax assets - No current or deferred tax provision expenses have been recorded due to accumulated losses since inception[56](index=56&type=chunk) - A **100%** valuation allowance is applied against net deferred tax assets, as realization is not considered probable[57](index=57&type=chunk) - The company is assessing the implications of the 'One Big Beautiful Bill Act' enacted July 4, 2025, particularly regarding the restoration of immediate expensing for qualified R&D[59](index=59&type=chunk) [12. STOCK-BASED COMPENSATION](index=21&type=section&id=12.%20STOCK-BASED%20COMPENSATION) Stock-based compensation expense decreased for the six months ended June 30, 2025, with shares available under the 2023 Equity Incentive Plan Stock-Based Compensation Expense | Expense Category | Three Months Ended June 30, 2025 (USD) | Three Months Ended June 30, 2024 (USD) | Six Months Ended June 30, 2025 (USD) | Six Months Ended June 30, 2024 (USD) | | :------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development expenses | $177,819 | $1,034,174 | $1,498,906 | $1,898,358 | | General and administrative expenses | $18,745 | $901,355 | $921,672 | $1,586,008 | | Total stock-based compensation expense | $196,564 | $1,935,529 | $2,420,578 | $3,484,366 | - Total stock-based compensation expense decreased by approximately **$1.06 million (30.5%)** for the six months ended June 30, 2025, compared to the same period in 2024[66](index=66&type=chunk) - As of June 30, 2025, there were **2,721,787 shares** available for grant under the 2023 Equity Plan[63](index=63&type=chunk) [13. LEASES](index=23&type=section&id=13.%20LEASES) The company leases office space, with the lease term extended through December 2026, and an unamortized Right-Of-Use asset of approximately $0.4 million - The company's office lease was extended through December 2026 by exercising extension options[72](index=72&type=chunk) - As of June 30, 2025, the unamortized Right-Of-Use asset and operating lease liability were approximately **$0.4 million**[73](index=73&type=chunk) Lease Liability Components | Lease Liability Component | Amount (USD) | | :------------------------ | :----- | | 2025 remaining total lease payments | $437,159 | | Less: effect of discounting | $(30,161) | | Present value of lease liabilities | $406,998 | | Current operating lease liabilities | $263,551 | | Non-current operating lease liabilities | $143,447 | | Total | $406,998 | [14. COMMITMENTS AND CONTINGENCIES](index=24&type=section&id=14.%20COMMITMENTS%20AND%20CONTINGENCIES) The company indemnifies officers and directors and holds an exclusive license for ADX-2191, with no material legal proceedings expected - The company indemnifies officers and directors, with no material claims or losses as of June 30, 2025[74](index=74&type=chunk) - An exclusive worldwide license for ADX-2191 from MEEI involves annual license maintenance fees, future sales-dependent milestone payments (up to low seven figures), and low single-digit royalties on net sales[75](index=75&type=chunk)[77](index=77&type=chunk) - The company is not currently a party to any material legal proceedings expected to have a material adverse effect on its business[80](index=80&type=chunk) [15. SIGNIFICANT AGREEMENTS](index=26&type=section&id=15.%20SIGNIFICANT%20AGREEMENTS) Aldeyra has an exclusive option agreement with AbbVie for reproxalap, including a $6.0 million deferred collaboration revenue - Aldeyra granted AbbVie an exclusive option for reproxalap, including co-exclusive U.S. and exclusive ex-U.S. licenses[81](index=81&type=chunk) - AbbVie paid a non-refundable **$1.0 million** option payment and a **$5.0 million** option extension fee, which would be credited against a **$100.0 million** upfront payment if the option is exercised[81](index=81&type=chunk)[82](index=82&type=chunk)[84](index=84&type=chunk) - As of August 7, 2025, AbbVie has not exercised the option, and Aldeyra has recorded **$6.0 million** of deferred collaboration revenue[84](index=84&type=chunk)[85](index=85&type=chunk) [16. SEGMENT REPORTING](index=28&type=section&id=16.%20SEGMENT%20REPORTING) Aldeyra operates as a single operating segment, focusing on discovering and developing therapies for immune-mediated and metabolic diseases - The company operates through a single operating and reportable segment[86](index=86&type=chunk) - The focus is on discovering and developing therapies for immune-mediated and metabolic diseases, modulating protein systems[86](index=86&type=chunk) - The Chief Executive Officer is the Chief Operating Decision Maker (CODM), evaluating performance and allocating resources based on net income (loss)[87](index=87&type=chunk)[88](index=88&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, results of operations, liquidity, and capital resources, highlighting reduced net loss and product development [Cautionary Note Regarding Forward-Looking Statements](index=29&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This section warns that the report contains forward-looking statements subject to risks and uncertainties, and actual results may differ materially - The report contains forward-looking statements subject to substantial risks and uncertainties[90](index=90&type=chunk) - Actual results could differ materially from projections due to factors like regulatory approval delays, commercialization challenges, and financing availability[90](index=90&type=chunk) - Investors are cautioned not to place undue reliance on forward-looking statements, and the company undertakes no obligation to update them[90](index=90&type=chunk)[91](index=91&type=chunk) [Overview](index=30&type=section&id=Overview) Aldeyra is a clinical-stage biotechnology company developing RASP modulators like reproxalap and ADX-2191, with an unexercised AbbVie option - Aldeyra is a biotechnology company focused on immune-mediated and metabolic diseases, developing RASP modulators[93](index=93&type=chunk) - Late-stage product candidates include reproxalap for dry eye disease and allergic conjunctivitis, and ADX-2191 for retinitis pigmentosa[93](index=93&type=chunk) - The company has an exclusive option agreement with AbbVie for reproxalap, which includes potential upfront and milestone payments, but AbbVie has not exercised the option as of August 7, 2025[96](index=96&type=chunk)[99](index=99&type=chunk) [Research and development expenses](index=33&type=section&id=Research%20and%20development%20expenses) Research and development expenses decreased for both three and six months ended June 30, 2025, primarily due to lower external clinical development and manufacturing costs Research and Development Expenses | Period | 2025 (USD) | 2024 (USD) | Change (USD) | Change (%) | | :-------------------------- | :----------- | :----------- | :----------- | :--------- | | Three months ended June 30 | $8,505,229 | $14,969,743 | $(6,464,514) | (43.2%) | | Six months ended June 30 | $15,928,552 | $21,153,251 | $(5,224,699) | (24.7%) | - The decrease in R&D expenses for the three months was primarily due to reductions in external clinical development (**$3.3 million**), drug product manufacturing (**$1.9 million**), personnel (**$0.9 million**), and preclinical costs (**$0.4 million**)[118](index=118&type=chunk) - Approximately **40%** of total R&D expenses for both periods were related to late-stage product candidates, primarily reproxalap[119](index=119&type=chunk)[123](index=123&type=chunk) [General and administrative expenses](index=35&type=section&id=General%20and%20administrative%20expenses) General and administrative expenses decreased for both three and six months ended June 30, 2025, mainly due to lower personnel and legal costs General and Administrative Expenses | Period | 2025 (USD) | 2024 (USD) | Change (USD) | Change (%) | | :-------------------------- | :----------- | :----------- | :----------- | :--------- | | Three months ended June 30 | $1,663,503 | $3,038,064 | $(1,374,561) | (45.2%) | | Six months ended June 30 | $4,667,639 | $6,248,420 | $(1,580,781) | (25.3%) | - The decrease in G&A expenses for the three months was primarily due to lower personnel costs (**$1.0 million**) and legal costs (**$0.3 million**)[120](index=120&type=chunk) - G&A expenses are expected to increase in the future due to expanded operating activities and costs associated with being a publicly traded company[110](index=110&type=chunk) [Other income (expense)](index=35&type=section&id=Other%20income%20(expense)) Total other income, net, decreased for both three and six months ended June 30, 2025, due to lower investment balances and interest rates Other Income (Expense) | Period | 2025 (USD) | 2024 (USD) | Change (USD) | Change (%) | | :-------------------------- | :--------- | :--------- | :----------- | :--------- | | Three months ended June 30 | $401,420 | $1,160,235 | $(758,815) | (65.4%) | | Six months ended June 30 | $899,378 | $2,471,977 | $(1,572,599) | (63.6%) | - The decrease in net other income was principally due to lower investment balances and decreased interest rates[121](index=121&type=chunk)[125](index=125&type=chunk) [Comprehensive loss](index=35&type=section&id=Comprehensive%20loss) Comprehensive loss for the six months ended June 30, 2025, was $19.7 million, including net loss and unrealized loss on marketable securities - Comprehensive loss for the six months ended June 30, 2025, was **$19.7 million**[112](index=112&type=chunk) - This includes a net loss of **$19.7 million** and a net unrealized loss on marketable securities of **$48.4 thousand**[112](index=112&type=chunk) - For the six months ended June 30, 2024, comprehensive loss was **$24.9 million**, including a net unrealized loss of **$9.7 thousand**[112](index=112&type=chunk) [Critical Accounting Estimates](index=35&type=section&id=Critical%20Accounting%20Estimates) Management's financial statements rely on estimates for R&D costs, stock-based compensation, and income taxes, with no material changes reported - Financial statements require management estimates and assumptions for assets, liabilities, and expenses[113](index=113&type=chunk) - Significant estimates include deferred and accrued R&D costs, stock-based compensation, and income taxes[27](index=27&type=chunk) - No material changes to critical accounting estimates occurred during the six months ended June 30, 2025[114](index=114&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) Operating results are expected to fluctuate, with net loss decreasing by 42.0% and 21.0% for the three and six months ended June 30, 2025, respectively - Operating results are expected to fluctuate due to R&D efforts, clinical trials, regulatory submissions, and the AbbVie option[117](index=117&type=chunk) Net Loss - Three Months Ended June 30 | Metric | Three Months Ended June 30, 2025 (USD) | Three Months Ended June 30, 2024 (USD) | Change Amount (USD) | Change Percent | | :----- | :------------------------------- | :------------------------------- | :------------ | :------------- | | Net loss | $(9,767,312) | $(16,847,572) | $7,080,260 | (42.0%) | Net Loss - Six Months Ended June 30 | Metric | Six Months Ended June 30, 2025 (USD) | Six Months Ended June 30, 2024 (USD) | Change Amount (USD) | Change Percent | | :----- | :----------------------------- | :----------------------------- | :------------ | :------------- | | Net loss | $(19,696,813) | $(24,929,694) | $5,232,881 | (21.0%) | [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) The company has $81.9 million in cash and marketable securities, expected to fund operations into 2027, but requires substantial additional financing - Operations are funded primarily by equity sales and debt, with significant accumulated operating losses[126](index=126&type=chunk) - As of June 30, 2025, cash, cash equivalents, and marketable securities totaled **$81.9 million**, projected to fund operations into 2027[126](index=126&type=chunk)[136](index=136&type=chunk) - Substantial additional funding is required for planned R&D, regulatory activities, and commercialization, with no guarantee of availability on acceptable terms[136](index=136&type=chunk)[137](index=137&type=chunk) [Cash Flows](index=43&type=section&id=Cash%20Flows) Net cash used in operating activities decreased, while investing activities shifted to providing cash, and financing activities provided $1.0 million Cash Flow Activities | Cash Flow Activity | Six Months Ended June 30, 2025 (USD) | Six Months Ended June 30, 2024 (USD) | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(21,024,921) | $(23,196,985) | | Net cash provided by (used in) investing activities | $6,736,288 | $(48,614,499) | | Net cash provided by financing activities | $1,002,810 | $18,191 | | Net decrease in cash and cash equivalents | $(13,285,823) | $(71,793,293) | - The decrease in cash used in operating activities was primarily due to a decrease in net loss[140](index=140&type=chunk) - Net cash provided by investing activities in 2025 was mainly from maturities of marketable securities, contrasting with net cash used in 2024 for purchases[141](index=141&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures about Market Risk](index=43&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a 'smaller reporting company,' Aldeyra Therapeutics, Inc. is not required to provide market risk disclosures in this Quarterly Report - The company is a 'smaller reporting company' and is exempt from providing quantitative and qualitative disclosures about market risk[143](index=143&type=chunk) [ITEM 4. Controls and Procedures](index=43&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes in internal control over financial reporting - Disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025[144](index=144&type=chunk) - No material changes in internal control over financial reporting occurred during the three months ended June 30, 2025[145](index=145&type=chunk) PART II – OTHER INFORMATION This section provides additional information, including legal proceedings, risk factors, equity sales, and exhibits [ITEM 1. Legal Proceedings](index=44&type=section&id=ITEM%201.%20Legal%20Proceedings) Aldeyra Therapeutics, Inc. is not currently a party to any material legal proceedings expected to adversely affect its business - The company is not currently involved in any material legal proceedings expected to adversely affect its business[147](index=147&type=chunk) [ITEM 1A. Risk Factors](index=44&type=section&id=ITEM%201A.%20Risk%20Factors) This section outlines numerous risks that could materially affect Aldeyra's business, financial condition, and future results, including product development, financial position, and intellectual property [Summary of Risks Related to our Business](index=44&type=section&id=Summary%20of%20Risks%20Related%20to%20our%20Business) Investment in Aldeyra's common stock is speculative due to dependence on reproxalap, need for capital, and a history of significant operating losses - Business success is largely dependent on the successful commercialization and FDA approval of reproxalap[150](index=150&type=chunk) - The company requires substantial additional financing and may face delays or termination of development if capital is not obtained[150](index=150&type=chunk) - Significant operating losses have been incurred since inception, with expectations of continued losses[150](index=150&type=chunk) [Risks Related to the Potential Development and Commercialization of Reproxalap and our Product Candidates](index=46&type=section&id=Risks%20Related%20to%20the%20Potential%20Development%20and%20Commercialization%20of%20Reproxalap%20and%20our%20Product%20Candidates) The company faces significant risks in developing and commercializing product candidates, including regulatory approval failures, clinical trial delays, and intense competition - Success is highly dependent on regulatory approval and commercialization of reproxalap, which is uncertain[152](index=152&type=chunk)[153](index=153&type=chunk) - The FDA has issued Complete Response Letters for reproxalap, requiring additional studies to demonstrate efficacy in treating dry eye symptoms, leading to delays[156](index=156&type=chunk) - Clinical trials may be delayed or unsuccessful due to various factors, including patient enrollment, safety concerns, manufacturing issues, and regulatory changes[164](index=164&type=chunk)[166](index=166&type=chunk) [Risks Related to our Financial Position and Capital Requirements](index=62&type=section&id=Risks%20Related%20to%20our%20Financial%20Position%20and%20Capital%20Requirements) Aldeyra has a history of operating losses, requires substantial additional financing, and faces uncertainties regarding market acceptance and reimbursement - The company has incurred significant operating losses since inception and expects to continue doing so, with an accumulated deficit of **$469.8 million** as of June 30, 2025[238](index=238&type=chunk) - Substantial additional financing is required for ongoing operations and commercialization efforts; failure to obtain it could force delays or termination of product development[245](index=245&type=chunk)[246](index=246&type=chunk) - Market acceptance and sales of product candidates depend on adequate insurance coverage and reimbursement, which are uncertain and subject to government and third-party payor policies, including potential price controls and healthcare reform[200](index=200&type=chunk)[201](index=201&type=chunk)[263](index=263&type=chunk) [Risks Related to our Reliance on Third Parties](index=85&type=section&id=Risks%20Related%20to%20our%20Reliance%20on%20Third%20Parties) Aldeyra heavily relies on third parties for clinical development, manufacturing, and commercial readiness, with limited control over their performance - The company relies extensively on outsourcing for clinical development, manufacturing, and commercial readiness, with only **8 full-time employees** as of June 30, 2025[271](index=271&type=chunk) - Dependence on third-party CROs and investigators means the timing and success of clinical trials are largely outside the company's direct control[274](index=274&type=chunk) - Reliance on third-party suppliers for drug substance and product manufacturing poses risks of supply interruptions, quality issues, and regulatory non-compliance, which could delay development and commercialization[277](index=277&type=chunk)[279](index=279&type=chunk) [Risks Relating to Our Intellectual Property](index=90&type=section&id=Risks%20Relating%20to%20Our%20Intellectual%20Property) Aldeyra's success depends on protecting intellectual property, which is subject to risks like patent challenges, infringement claims, and changes in patent law - Commercial success depends on obtaining and maintaining patent and trade secret protection for product candidates and technologies[288](index=288&type=chunk) - Patent applications may not result in issued patents, and issued patents may be challenged, invalidated, or circumvented[290](index=290&type=chunk) - Claims by third parties of patent infringement could lead to costly litigation, development delays, or the need for unfavorable licensing agreements[291](index=291&type=chunk) [Risks Related to Employee Matters and Managing Growth](index=98&type=section&id=Risks%20Related%20to%20Employee%20Matters%20and%20Managing%20Growth) The company is highly dependent on senior management and key consultants, and future growth requires significant organizational expansion - The company is highly dependent on its senior management team and key consultants; their loss could delay or prevent product development[310](index=310&type=chunk) - As of June 30, 2025, the company had only **8 full-time employees**, necessitating substantial growth for future commercialization and public company functions[314](index=314&type=chunk) - Failure to attract, retain, and integrate qualified personnel could impede business strategy and growth[311](index=311&type=chunk)[314](index=314&type=chunk) [Risks Related to Other Legal or Regulatory Matters](index=100&type=section&id=Risks%20Related%20to%20Other%20Legal%20or%20Regulatory%20Matters) Aldeyra faces political, economic, legal, and social risks, including evolving data privacy laws, anti-corruption regulations, and potential product liability lawsuits - The company is exposed to political, economic, legal, and social risks, including global conflicts, trade policies, and compliance with diverse national and local laws[315](index=315&type=chunk) - Stringent and evolving data privacy laws (e.g., EU GDPR, UK GDPR, CPRA) pose risks of regulatory investigations, litigation, significant fines, and business disruptions if not complied with[322](index=322&type=chunk)[323](index=323&type=chunk)[324](index=324&type=chunk) - Operations are subject to anti-corruption, fraud and abuse, and other healthcare laws, which could lead to civil/criminal penalties, exclusion from government programs, and reputational harm if violated[336](index=336&type=chunk)[338](index=338&type=chunk)[342](index=342&type=chunk) [Risks Related to Our Common Stock](index=114&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) The trading price of common stock is highly volatile, and investors' returns depend solely on stock price appreciation, with no dividends intended - The trading price of common stock is highly volatile, influenced by regulatory developments, clinical trial results, and market conditions[363](index=363&type=chunk)[365](index=365&type=chunk) - Failure to meet Nasdaq listing requirements could result in delisting, negatively affecting stock price and liquidity[368](index=368&type=chunk) - The company does not intend to pay dividends, meaning investor returns depend solely on stock price appreciation[371](index=371&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=122&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report for the period - No unregistered sales of equity securities or use of proceeds were reported[387](index=387&type=chunk) [ITEM 3. Defaults Upon Senior Securities](index=122&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report for the period - No defaults upon senior securities were reported[388](index=388&type=chunk) [ITEM 4. Mine Safety Disclosures](index=122&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to Aldeyra Therapeutics, Inc.'s operations - Mine safety disclosures are not applicable[389](index=389&type=chunk) [ITEM 5. Other Information](index=122&type=section&id=ITEM%205.%20Other%20Information) There is no other information to report for the period - No other information was reported[390](index=390&type=chunk) [ITEM 6. Exhibits](index=123&type=section&id=ITEM%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate documents and Sarbanes-Oxley Act certifications - Key exhibits include the Restated Certificate of Incorporation, Amended and Restated Bylaws, and a Sixth Amendment to Lease[392](index=392&type=chunk) - Certifications from the Principal Executive Officer and Principal Financial and Accounting Officer, as required by the Sarbanes-Oxley Act, are also filed[392](index=392&type=chunk) [Signatures](index=124&type=section&id=Signatures) The report is signed on behalf of Aldeyra Therapeutics, Inc. by its Chief Executive Officer and Head of Finance on August 7, 2025 - The report was signed by Todd C. Brady, M.D., Ph.D., Chief Executive Officer[397](index=397&type=chunk) - The report was also signed by Michael Alfieri, Head of Finance (Principal Financial and Principal Accounting Officer)[398](index=398&type=chunk) - The signing date was August 7, 2025[397](index=397&type=chunk)[398](index=398&type=chunk)

Industry Overview - The uncertainty surrounding tariffs and trade measures has impacted economic growth, with President Trump threatening to impose tariffs as high as 200% on pharmaceutical imports to encourage domestic production [1] - Despite these threats, the biotech sector has remained stable, with many global pharmaceutical companies already investing in domestic manufacturing [1] Current Trends - The Zacks Medical-Drugs industry is showing promising trends due to positive pipeline and regulatory developments [2] - Key areas of innovation include rare diseases, next-generation oncology treatments, obesity, immunology, and neuroscience, attracting significant investor interest [3] M&A Activity - M&A activity in the sector remains healthy, indicating growth potential for companies like Catalyst Pharmaceuticals, Zevra Therapeutics, Theravance Biopharma, Aldeyra Therapeutics, and Larimar Therapeutics [3] Industry Characteristics - The Zacks Medical-Drugs industry consists of small to medium-sized drug companies that produce medicines for human and veterinary use, often relying on collaboration payments for revenue [4] Factors Influencing Future Growth - The success of key pipeline candidates in clinical studies can significantly impact stock prices, with successful innovations acting as catalysts [5] - Strong collaboration with larger drugmakers is a positive indicator for small pharma companies, especially when equity investments are involved [6] - Investment in technology and personalized medicine is crucial for smaller companies to thrive in a changing healthcare landscape [7] Performance Metrics - The Zacks Medical-Drugs industry currently holds a Zacks Industry Rank of 96, placing it in the top 39% of 245 Zacks industries, indicating strong prospects [9] - Year-to-date, the industry has risen 5.6%, outperforming the Zacks Medical sector, which has decreased by 2.9%, while slightly underperforming the S&P 500, which has risen by 6.9% [11] Valuation - The industry is currently trading at a trailing 12-month price-to-sales ratio of 2.32, compared to the S&P 500's 5.66 and the Zacks Medical sector's 2.37 [12] Company Highlights - **Catalyst Pharmaceuticals**: Lead drug Firdapse shows strong demand; stock has risen 0.4% this year; earnings estimate for 2025 increased from $2.23 to $2.25 [16][17] - **Theravance Biopharma**: Strong sales from Yupelri; stock has risen 22.6% this year; earnings estimate for 2025 declined from 3 cents to 1 cent [20][21] - **Larimar Therapeutics**: Developing nomlabofusp for Friedreich's ataxia; stock has declined 18.3% this year; loss estimate for 2025 narrowed from $1.90 to $1.89 [24][25] - **Zevra Therapeutics**: Early adoption of Miplyffa exceeds expectations; stock has risen 53.4% this year; earnings estimate for 2025 increased from 31 cents to 76 cents [28][29] - **Aldeyra Therapeutics**: Focused on RASP modulators; stock has declined 0.4% this year; loss estimate for 2025 narrowed from $1.03 to 90 cents [31][32]

Core Viewpoint - Aldeyra Therapeutics, Inc. (ALDX) has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive outlook based on rising earnings estimates, which are a significant factor influencing stock prices [1][4][6]. Earnings Estimates and Ratings - The Zacks rating system is primarily driven by changes in a company's earnings picture, with the Zacks Consensus Estimate reflecting EPS estimates from sell-side analysts [2][3]. - The recent upgrade for Aldeyra Therapeutics suggests an improvement in its underlying business, which is expected to positively impact its stock price [4][6]. Impact of Earnings Estimate Revisions - There is a strong correlation between earnings estimate revisions and near-term stock price movements, making the tracking of these revisions crucial for investment decisions [5][7]. - The Zacks Rank system, which categorizes stocks based on earnings estimates, has shown a historical average annual return of +25% for Zacks Rank 1 stocks since 1988 [8]. Current Earnings Estimates for Aldeyra Therapeutics - Aldeyra Therapeutics is projected to earn -$0.90 per share for the fiscal year ending December 2025, with no year-over-year change [9]. - Over the past three months, the Zacks Consensus Estimate for Aldeyra has increased by 12.2%, indicating a positive trend in earnings expectations [9]. Zacks Rating System Overview - The Zacks rating system maintains a balanced distribution of "buy" and "sell" ratings across its universe of over 4,000 stocks, with only the top 5% receiving a "Strong Buy" rating [10][11]. - The upgrade of Aldeyra Therapeutics to Zacks Rank 1 places it in the top 5% of stocks based on estimate revisions, suggesting potential for market-beating returns in the near term [11].

Company Overview - Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) is a biotechnology company focused on developing medicines using a novel anti-inflammatory approach through its proprietary Reactive Aldehyde Species (RASP) platform [1] Lead Asset - The company's lead asset is Reproxalap, which targets Dry Eye Disease (DED) and Allergic Conjunctivitis (AC) [1]

Summary of Aldeyra Therapeutics Conference Call Company Overview - Aldeyra Therapeutics is an immunology company focused on developing treatments for eye diseases, particularly dry eye disease and allergic conjunctivitis [6][7][8] Core Product: Reproxalap - Reproxalap is in development for dry eye disease and allergic conjunctivitis, targeting conditions that currently lack effective acute treatments [7][8] - The company is preparing to resubmit a New Drug Application (NDA) to the FDA for reproxalap after receiving a complete response letter in April 2023, which requested an additional trial [8][19][20] - The FDA's approval process for dry eye disease requires both symptom and sign assessments, focusing on redness and discomfort [11][12][18] Regulatory Developments - The first NDA submission was in 2022, but the FDA requested another trial due to a failed co-primary endpoint [20][22] - A successful chamber trial has been completed, which is expected to support the resubmission of the NDA [21][23] - The company is awaiting feedback from the FDA regarding the recent trial data and plans to resubmit the NDA soon [24][25][29] Market Opportunity - Approximately 40 million people in the U.S. suffer from dry eye disease, with a significant portion untreated due to the ineffectiveness of current therapies [43][44] - The unmet need is particularly pronounced for about 5 million patients who do not respond to artificial tears [44][46] - Reproxalap aims to differentiate itself by providing rapid relief, with the potential for symptom improvement in minutes rather than weeks [17][42] Allergic Conjunctivitis - Reproxalap is also being studied for allergic conjunctivitis, a condition affecting a significant portion of the population, with many patients not adequately responding to current treatments [49][50] - The company has conducted two phase three trials in a chamber setting to assess the drug's efficacy in this area [51] Pipeline Developments - Aldeyra is exploring other programs, including retinitis pigmentosa, where methotrexate is being tested as a potential treatment [53][56] - The company is also developing ADX-248, an oral RASP inhibitor for atopic dermatitis, currently in phase one clinical testing [59][60] - Updates on the alcoholic hepatitis program are expected, focusing on the role of acetaldehyde in the disease [62][63] Key Milestones - Investors are particularly focused on the timeline for NDA submission, acceptance, and approval, which are anticipated within the year, pending positive discussions with the FDA [64][65]

Collaboration with AbbVie - The company has entered into an exclusive option agreement with AbbVie Inc., granting AbbVie the option to obtain a co-exclusive license for the development and commercialization of reproxalap in the U.S. and an exclusive license outside the U.S.[95] - AbbVie has made a non-refundable payment of $1.0 million for the option and extended the exercise period by paying an additional $5.0 million[96] - Upon execution of the collaboration agreement, AbbVie will pay a $100.0 million upfront cash payment, with potential for up to $300.0 million in regulatory and commercial milestone payments[98] - The collaboration with AbbVie includes a profit-sharing model of 60% for AbbVie and 40% for the company from the commercialization of reproxalap in the U.S.[98] - The profit-sharing arrangement with AbbVie for the commercialization of reproxalap is set at 60% for AbbVie and 40% for the company in the U.S.[127] Financial Position and Funding - The company has no products approved for sale and has primarily funded operations through the sale of common stock and debt, indicating a need for additional capital to fund product development[101] - The Hercules Credit Facility allows for a term loan of up to $60.0 million, with $15.0 million funded as of March 31, 2025, and various amendments extending payment terms and conditions[103] - As of March 31, 2025, total stockholders' equity was approximately $63.6 million, with cash, cash equivalents, and marketable securities totaling $90.1 million[119] - As of March 31, 2025, the company expects its cash, cash equivalents, and marketable securities to fund operations into 2027, excluding potential licensing and product revenue[128] - The company anticipates needing additional funding for ongoing research and development activities, regulatory activities, and commercialization efforts[128] - The company may seek additional capital through debt, equity, or partnerships, amid economic uncertainties and market disruptions[129] Research and Development - The company is developing multiple product candidates, including reproxalap for dry eye disease and ADX-2191 for retinitis pigmentosa, with ongoing clinical trials and regulatory submissions[93] - Research and development expenses increased to $7.4 million for the three months ended March 31, 2025, up 20.1% from $6.2 million in the same period of 2024[115] - Approximately 40% of total research and development expenses for the three months ended March 31, 2025, were related to late-stage product candidates, primarily reproxalap[116] - The company expects research and development expenses to increase as it advances ADX-246, ADX-248, and other compounds through preclinical and clinical development[104] - The company does not expect reproxalap or any other product candidates to be commercially available before at least the second half of 2025[107] Operational Results - Net loss for the three months ended March 31, 2025, was approximately $9.9 million, representing a 22.9% increase from a net loss of $8.1 million in the same period of 2024[115] - Total other income (expense), net, decreased to $0.5 million for the three months ended March 31, 2025, down 62.0% from $1.3 million in the same period of 2024[118] - General and administrative expenses decreased to $3.0 million for the three months ended March 31, 2025, down 6.4% from $3.2 million in the same period of 2024[117] - Net cash used in operating activities for Q1 2025 was $12.5 million, an increase from $10.0 million in Q1 2024, primarily due to higher research and development expenses[131] - Net cash provided by investing activities was $7.3 million for Q1 2025, compared to a net cash outflow of $30.4 million in Q1 2024[132] - Net cash provided by financing activities was $1.0 million for Q1 2025, significantly higher than $18.2 thousand in Q1 2024[133] Regulatory and Compliance Risks - The company is subject to various risks and uncertainties that could impact its financial position and operational results, including regulatory approvals and market acceptance of its product candidates[94] - The company will incur ongoing costs related to compliance with the Sarbanes-Oxley Act and other regulatory requirements as a public entity[130]

Core Viewpoint - Aldeyra Therapeutics, Inc. is under investigation for potential violations of federal securities laws following the failure of its Phase III clinical trial for reproxalap, which was intended to treat dry eye disease [1][4]. Group 1: Company Overview - Aldeyra Therapeutics is a biotechnology company focused on developing therapies for immune-mediated and metabolic diseases, with reproxalap as its lead drug candidate for dry eye disease [2]. Group 2: Clinical Trial Results - The company announced the success of its Phase III dry eye chamber clinical trial, claiming the results were "uniquely supportive" and met FDA requirements for New Drug Application resubmission [3]. - However, the trial ultimately failed to demonstrate the efficacy of reproxalap in treating ocular symptoms associated with dry eyes, with methodological issues identified in the data [4]. Group 3: Stock Market Reaction - Following the FDA's Complete Response Letter on April 3, 2025, which stated that the NDA for reproxalap did not demonstrate efficacy, Aldeyra's stock price plummeted nearly 75%, dropping from $5.33 per share on April 2, 2025 [5].