We are a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. (Incorporated in Delaware)

Building on more than a decade of research by our founder, Dr. Amit Etkin, we aim to deeply understand brain function and match patients to the right medication more efficiently through the use of treatments that, if approved, are tailored to specific patient populations. As a result, we believe we can help patients avoid the often lengthy process of trying multiple ineffective treatments before finding one to which they respond, potentially helping patients get better faster. Through insights derived from our scalable and proprietary Precision Psychiatry Platform, or our Platform, which applies rigorous data science and robust analytics to data gathered by neurocognitive assessments, electroencephalography, and wearable devices, we aim to discover brain-based biomarkers to better identify which patients are more likely to respond to our novel product candidates. Our approach is designed to improve patient outcomes and increase the likelihood of clinical success and commercial impact of our product candidates by using neurobiological profiles to identify more homogeneous patient groups. We build upon and leverage vast data sets of longitudinal clinical and biomarker data from thousands of patients across central nervous system, or CNS, disorders, which we believe serves as a foundation for applying our approach across numerous patient populations. Ultimately, if we are successful, we believe our approach can substantially improve upon the traditional, all-comer approach to CNS drug development.

Our current pipeline consists of five clinical-stage assets initially targeting major depressive disorder, or MDD, and schizophrenia populations characterized by independent brain-based biomarkers. Each of our clinical-stage product candidates has been evaluated through at least initial Phase 1 clinical trials and observed to be well tolerated. Our most advanced programs, including our two product candidates being evaluated in ongoing late-stage (Phase 2b or later) trials, are supported by prospectively replicated evidence of clinical activity in biomarker-characterized populations.

We have successfully completed Phase 2a trials for our two most advanced product candidates, ALTO-100 and ALTO-300, in more than 200 patients each. In each of these trials, we identified patient populations more likely to respond based on objectively defined biomarker profiles, and then prospectively replicated these biomarker findings in independent datasets from within the same trial. We leveraged these biomarker findings to initiate a placebo-controlled, double-blind, randomized Phase 2b trial for each candidate in patients with MDD characterized by an objective biomarker. Specifically, in the ALTO-100 Phase 2b trial we are enrolling 266 patients with MDD characterized by a cognitive biomarker, and we expect to report topline data from this trial in the second half of 2024; and in the ALTO-300 Phase 2b trial we are enrolling 200 patients with MDD characterized by an electroencephalography, or EEG, biomarker, and we expect to report topline data from this trial in the first half of 2025. We estimate one or both of these two independent biomarkers are present in approximately three-quarters of the overall MDD population.

In addition to our two most advanced programs, we expect to initiate Phase 2 proof-of-concept, or POC, trials evaluating ALTO-101 and ALTO-203 in the first half of 2024. ALTO-101 is being developed for patients with cognitive impairment associated with schizophrenia, or CIAS, and ALTO-203 is being developed for patients with MDD and higher levels of anhedonia, or the lack of motivation or pleasure. We expect to report topline data from these trials in 2025 and the first half of 2025, respectively. We also plan to develop ALTO-202, our novel, oral N-methyl-D-aspartate, or NMDA, receptor antagonist, for the treatment of patients with MDD.

Note: Net loss and revenue figures are for the 12 months that ended Sept. 30, 2023.

(Note: Alto Neuroscience, Inc., priced its upsized IPO at $16.00 – the top of its $14.00-to-$16.00 range – and increased the number of shares to 8.04 million – up from 6.7 million shares in the prospectus – to raise $128.64 million. Background: Alto Neuroscience, Inc. filed its S-1/A on Jan. 29, 2024, and disclosed terms for its IPO: 6.7 million shares at a price range of $14.00 to $16.00 to raise $100.5 million. Background: Alto Neuroscience, Inc. filed its S-1 on Jan. 12, 2024, without disclosing terms for its IPO. The company submitted confidential IPO documents to the SEC in late 2023.)