Aldeyra Therapeutics, Inc. reported a net loss of approximately $55.9 million for the year ended December 31, 2024, compared to a net loss of $37.5 million for the previous year, marking an increase of 48.8%. The company's total stockholders' equity stood at $71.0 million as of the end of 2024. The increase in losses was primarily attributed to heightened research and development expenses, which rose to $48.2 million from $29.5 million in 2023, driven by increased external clinical development and drug manufacturing costs. General and administrative expenses decreased by 10.8% to $11.9 million, reflecting reduced consulting and legal expenditures.

In a significant strategic development, Aldeyra entered into an exclusive option agreement with AbbVie Inc. on October 31, 2023, granting AbbVie the option to obtain a co-exclusive license for the development and commercialization of reproxalap, a RASP modulator aimed at treating dry eye disease and allergic conjunctivitis. AbbVie made an initial non-refundable payment of $1.0 million and subsequently extended the option period with an additional $5.0 million payment. If the collaboration agreement is executed, AbbVie would pay a $100 million upfront cash payment, with potential milestone payments of up to $300 million. The FDA accepted a resubmitted NDA for reproxalap on November 18, 2024, with a PDUFA date set for April 2, 2025.

Operationally, Aldeyra's employee count remained low, with only nine full-time employees as of December 31, 2024. The company continues to rely on third-party contract manufacturers for the production of its product candidates, which poses risks related to supply chain disruptions. The company has not yet generated revenue from product sales, as none of its product candidates have received regulatory approval. Aldeyra anticipates needing to raise additional capital to fund ongoing development and commercialization efforts, particularly if AbbVie does not exercise its option.

Looking ahead, Aldeyra's financial outlook remains uncertain, with the company acknowledging the need for substantial additional financing to support its operations and product development. The ongoing volatility in the capital markets and potential changes in healthcare regulations could further complicate its ability to secure necessary funding. The company is also subject to various risks, including the potential for delays in clinical trials and regulatory approvals, which could impact its ability to commercialize reproxalap and other product candidates.

About Aldeyra Therapeutics, Inc.

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