Aldeyra Therapeutics(ALDX) - 2025 Q1 - Quarterly Report

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]