Aldeyra Therapeutics(ALDX) - 2025 Q3 - Quarterly Report

Collaboration and Licensing Agreements - The company has entered into an exclusive option agreement with AbbVie Inc., granting AbbVie the option to obtain a co-exclusive license for reproxalap in the U.S. and an exclusive license outside the U.S., with an initial non-refundable payment of $1.0 million[97]. - AbbVie extended the option period by paying an additional non-refundable fee of $5.0 million, which will be credited against the upfront cash payment if the collaboration agreement is executed[98]. - Upon execution of the collaboration agreement, AbbVie will pay a $100.0 million upfront cash payment, with potential additional milestone payments of up to approximately $300.0 million[100]. - The company entered into an exclusive option agreement with AbbVie, granting them an option to obtain a co-exclusive license for reproxalap, with an initial non-refundable payment of $1.0 million[130]. - If the collaboration agreement is executed, AbbVie will pay a $100.0 million upfront cash payment, with potential additional milestone payments of up to $300.0 million[134]. Financial Performance and Expenses - Comprehensive loss for the nine months ended September 30, 2025, was $27.4 million, compared to $40.0 million for the same period in 2024, reflecting a decrease of 31.6%[113][116]. - Research and development expenses for the three months ended September 30, 2025, were $5.4 million, down 56.3% from $12.4 million in 2024, primarily due to a $4.4 million decrease in external clinical development costs[118][119]. - General and administrative expenses for the nine months ended September 30, 2025, were $7.2 million, a decrease of 27.2% from $9.9 million in 2024, attributed to lower personnel and legal costs[122][124]. - Net loss for the three months ended September 30, 2025, was $7.7 million, a reduction of 49.1% compared to $15.1 million in 2024[118]. - Total other income, net, for the nine months ended September 30, 2025, was $1.2 million, down 65.3% from $3.5 million in 2024, mainly due to lower investment balances[125]. Cash and Funding - As of September 30, 2025, the company had total stockholders' equity of approximately $49.2 million and cash, cash equivalents, and marketable securities of $75.3 million[126]. - The Hercules Credit Facility provides for a term loan of up to $60.0 million, with $15.0 million funded as of September 30, 2025, and interest-only payments until April 1, 2026[105]. - The Hercules Credit Facility has $15.0 million outstanding as of September 30, 2025, with interest-only payments until April 1, 2026[128][129]. - As of September 30, 2025, the company believes its cash, cash equivalents, and marketable securities will be sufficient to fund projected operating expenses and debt obligations into the second half of 2027[135]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $28.0 million, a decrease from $31.2 million in the same period in 2024, primarily due to a decrease in net loss from research and development activities[138]. - Net cash provided by investing activities was $31.7 million for the nine months ended September 30, 2025, compared to net cash used of $43.4 million in the same period in 2024, indicating a significant improvement[139]. - Net cash provided by financing activities was $1.1 million for the nine months ended September 30, 2025, compared to a net cash outflow of $0.2 million in the same period in 2024, primarily from exercises of options[140]. - The company may need to secure additional funding in the future through equity or debt financings, collaborations, or other sources to support ongoing research and development activities[136]. - The company anticipates needing substantial additional capital for continued clinical development and potential commercialization activities[135]. Research and Development Outlook - The company expects research and development expenses to increase as it advances product candidates ADX-248, ADX-246, and others through preclinical and clinical development[106]. - The company does not expect reproxalap or any other product candidates to be commercially available before at least the second half of 2025[110]. - Approximately 40% of the total research and development expenses for the nine months ended September 30, 2025, were related to late-stage product candidates, primarily reproxalap[123]. - The company may license or acquire new immune-modulating approaches to expand its product candidate pipeline[102]. Regulatory and Compliance Considerations - The company will continue to incur costs related to compliance with the Sarbanes-Oxley Act and other regulatory requirements as a public company[137]. - Future funding requirements will depend on various factors, including the costs and outcomes of regulatory reviews and clinical trials for product candidates[135]. - The company faces economic uncertainties, including inflation and geopolitical instability, which could impact its ability to obtain financing on commercially reasonable terms[136].