Alto Neuroscience Files for NYSE IPO to Advance Precision Psychiatry Platform Targeting Major Depressive Disorder and PTSD

Recently, Alto Neuroscience, a California-based biotechnology company focused on the field of neuroscience, has applied to be listed on the New York Stock Exchange. Alto Neuroscience is a provider of mental health treatment drugs, primarily engaged in the research and application of AI-predicted antidepressants. It measures patients' conditions by analyzing their EEG activity, behavioral performance, and health data. The products are suitable for depression, post-traumatic stress disorder, and other mental health conditions.

In November 2023, Alto Neuroscience disclosed its $45 million Series C financing. According to its S-1 filing, as of September 30 last year, the company had $51 million in cash and equivalents, and its R&D expenditure for the first nine months of 2023 was $20.6 million, an increase of approximately $3 million compared to the same period in 2022.

Alto was founded in 2019 by Stanford University psychiatrist Amit Etkin, who has been obsessed for decades with how to better define mental illnesses. He was frustrated by the lack of innovation in treating mental health conditions over the decades and suspected that traditional diagnoses did not actually address the core of what is happening in patients' brains.

In 2006, Etkin's research showed that some patients with different diagnostic outcomes, such as PTSD and depression, appeared very similar in brain imaging; in 2014, his research indicated that patients could be defined by observing individual discrete behaviors, such as attention or sleep. However, the major breakthrough came in 2017, when his team demonstrated that it was possible to predict the response of PTSD patients to treatment by observing brain waves.

In 2019, Etkin founded Alto Neuroscience around the predictive technology he developed. The company's primary focus is using biology to identify the right patients for each drug.

Alto's AI Platform Identifies Responsive Patients and Drives Drug Development Using Biomarkers. Alto identifies biomarkers in a manner similar to how it builds pipelines, with a close focus on core areas of mental function (cognition, emotion, and sleep) and their underlying brain circuits. By evaluating brain function metrics such as electroencephalograms (EEGs), along with behavioral assessments and computer tests using wearables, patients are stratified and matched with appropriate Alto drugs.

Currently, Alto has 7 pipelines in clinical stages, among which the 3 most advanced are ALTO-100, ALTO-202, and ALTO-300.

On December 4, 2023, Alto Neuroscience announced the Phase 2a clinical trial data of ALTO-300, which showed clinically meaningful improvement in patients with Major Depressive Disorder (MDD), as well as good safety and tolerability.

The digital display shows that, after administering ALTO-300, patients characterized by electroencephalogram (EEG) biomarkers exhibited strong clinical improvement and higher response rates in depressive symptoms compared to patients without EEG biomarkers, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS). These results support the potential of ALTO-300 as a new therapy for MDD. The company has initiated a Phase 2b study to evaluate the efficacy of ALTO-300 in 200 patients with MDD, with results expected to be announced in the first half of 2025.

On September 26, 2023, Alto Neuroscience announced the results of the Phase 2a study of ALTO-100 for post-traumatic stress disorder (PTSD), demonstrating clear evidence of the drug's efficacy and favorable safety in PTSD patients.

In this study, the subgroup of patients defined by a specific cognitive feature showed greater improvement in PTSD symptoms, as measured by CAPS-5 scores — Clinician-Administered PTSD Scale for DSM-5 — compared to those who did not exhibit the cognitive feature. This first-of-its-kind Phase 2 study for post-traumatic stress disorder (PTSD), utilizing Alto Neuroscience's Precision Psychiatry Platform™, identifies potential drug responders by matching unique neurobiological signatures with ALTO-100’s novel mechanism of action.

The results of the PTSD cohort build on the Major Depressive Disorder (MDD) dataset reported in January 2023 and continue to support the strong therapeutic potential of ALTO-100 in patients with comorbid mood and affective disorders as well as plasticity deficits.