Alto Neuroscience Reports $61.4 Million Net Loss for 2024, Highlights IPO and Clinical Developments

Alto Neuroscience, Inc., a clinical-stage biopharmaceutical company, reported a net loss of $61.4 million for the year ended December 31, 2024, compared to a net loss of $36.3 million in 2023. This increase is primarily attributable to a rise in research and development expenses, from $30.3 million to $47.0 million, and general and administrative expenses, which increased from $7.5 million to $21.6 million. The increase in research and development expenses reflects higher costs associated with ongoing and new Phase 2b and Phase 2 proof-of-concept clinical trials for its product candidates ALTO-100, ALTO-300, ALTO-101, and ALTO-203, as well as milestone payments under licensing agreements. The rise in general and administrative expenses is largely due to increased personnel costs and expenses related to operating as a public company.

The company's cash, cash equivalents, and restricted cash totaled $168.7 million as of December 31, 2024, a significant increase from $82.5 million at the end of 2023. This increase is largely due to net proceeds of $133 million from its initial public offering (IPO) in February 2024. Alto anticipates incurring substantial losses for the foreseeable future and will require additional funding to complete clinical development and potential commercialization of its product candidates. The company projects that its current cash resources will fund operations into 2028, based on its current operating plan.

Significant developments during the year included the completion of its IPO, raising $133 million in net proceeds. Alto also entered into a convertible loan agreement with The Wellcome Trust Limited for up to $11.7 million to support the development of ALTO-100 in bipolar depression. Furthermore, the company amended its loan agreement with K2 HealthVentures, increasing the maximum available term loan amount to $75 million. Alto also initiated a joint development and license agreement with MedRx Co., Ltd. for the development of a transdermal formulation of ALTO-101. As of December 31, 2024, Alto employed 76 individuals, with 18 holding Ph.D. and/or M.D. degrees.

The company's product candidates are in various stages of clinical development, with ALTO-100 currently in a Phase 2b trial for bipolar depression and ALTO-300 in a Phase 2b trial for major depressive disorder. ALTO-101 is in a Phase 2 proof-of-concept trial for cognitive impairment associated with schizophrenia, and ALTO-203 is in a Phase 2 proof-of-concept trial for major depressive disorder with anhedonia. ALTO-202 is currently in the planning stages for its next phase of clinical development. The company's financial performance and future prospects are subject to various risks and uncertainties, including the success of its clinical trials, regulatory approvals, market acceptance of its products, and securing additional funding. The 10-K filing details these risks extensively.

Alto's outlook is contingent upon the successful completion of its ongoing clinical trials and the subsequent regulatory approval of its product candidates. The company's ability to secure additional funding and successfully commercialize its products will be crucial to its future financial performance and achieving profitability. The company's reliance on third-party manufacturers and collaborators also presents significant risks to its operations and timelines.