ATAI Life Sciences N.V. reported a net loss attributable to its stockholders of $149.3 million for the fiscal year ended December 31, 2024, a significant increase from the $40.2 million net loss in 2023. License revenue decreased slightly to $0.3 million in 2024 from $0.3 million in 2023, reflecting the termination of the Otsuka Agreement in January 2025. Total operating expenses decreased by 18% to $103.0 million in 2024, primarily due to reductions in research and development and general and administrative expenses. The decrease in research and development expenses was partially offset by increased direct costs in core psychedelic and non-psychedelic programs.

Significant changes in other income (expense) contributed to the overall net loss increase. A $135.4 million decrease in the change in fair value of assets and liabilities, primarily driven by losses related to investments in COMPASS Pathways plc and IntelGenx Technologies Corp., significantly impacted the results. Conversely, a $5.6 million gain on the settlement of a pre-existing contract following the acquisition of IntelGenx Corp. partially offset these losses. The company also reported a benefit from research and development tax credits of $0.5 million in 2024, down from $2.4 million in 2023.

During 2024, ATAI Life Sciences completed the acquisition of IntelGenx Corp. through a credit bid, discharging its senior secured debt in exchange for IGX shares. The company also made a strategic investment in Beckley Psytech, acquiring approximately one-third ownership. The company initiated a Phase 2 study of EMP-01 for social anxiety disorder and dosed the first patient in the Elumina trial for VLS-01 in treatment-resistant depression. ATAI Life Sciences also announced positive topline results from the Phase 1b trial of VLS-01. The company's employee headcount was 54 full-time employees and nine contractors as of December 31, 2024.

Key operational developments included positive topline results from the Phase 1b trial of VLS-01, demonstrating a favorable safety profile and dose-dependent subjective effects. The company initiated a Phase 2 study of EMP-01 for social anxiety disorder and dosed the first patient in the Elumina trial for VLS-01 in treatment-resistant depression. Beckley Psytech, in which ATAI Life Sciences holds a significant investment, also reported positive topline results from Phase 2a studies of BPL-003 for treatment-resistant depression and alcohol use disorder, and from a Phase 2a study of ELE-101 for major depressive disorder. Recognify Life Sciences, another strategic investment, is conducting a Phase 2b trial for RL-007 in cognitive impairment associated with schizophrenia.

ATAI Life Sciences projects that its existing cash resources will be sufficient to fund operations into 2027. However, the company anticipates incurring losses for the foreseeable future and may need to raise additional capital through equity or debt financings, or strategic collaborations. The company's future success depends on the successful development and commercialization of its product candidates, obtaining regulatory approvals, and achieving market acceptance. The company also highlighted numerous risk factors, including those related to clinical development, regulatory approvals, commercialization, intellectual property, and financial position.

About ATAI Life Sciences N.V.

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