Here are a few analogies to describe Alto Neuroscience:

• Genentech for brain disorders. (Bringing precision medicine and targeted therapies to mental health, similar to how Genentech pioneered targeted oncology treatments.)
• Foundation Medicine for mental health treatments. (Using objective brain biomarkers like EEG and cognitive assessments to identify specific patient populations and match them to the right psychiatric drugs, much like Foundation Medicine uses genomic profiling to guide cancer therapies.)

• ALTO-100: A clinical-stage product candidate targeting major depressive disorder (MDD) in patients characterized by a cognitive biomarker.
• ALTO-300: A clinical-stage product candidate targeting major depressive disorder (MDD) in patients characterized by an electroencephalography (EEG) biomarker.
• ALTO-101: A clinical-stage product candidate being developed for patients with cognitive impairment associated with schizophrenia (CIAS).
• ALTO-203: A clinical-stage product candidate being developed for patients with major depressive disorder (MDD) and higher levels of anhedonia.
• ALTO-202: A novel, oral N-methyl-D-aspartate (NMDA) receptor antagonist planned for the treatment of patients with major depressive disorder (MDD).

Alto Neuroscience (ANRO) is a clinical-stage biopharmaceutical company focused on the development of novel treatment options for psychiatric disorders such as major depressive disorder (MDD) and schizophrenia. As a clinical-stage company, Alto Neuroscience is currently engaged in research and development, conducting clinical trials for its product candidates (e.g., ALTO-100, ALTO-300).

At its current stage, Alto Neuroscience does not have major customers, as it is not yet selling approved products or services. The company's primary focus is on advancing its drug candidates through clinical development and obtaining regulatory approvals.

Amit Etkin, MD, PhD - Founder, President, Chief Executive Officer, and Chairman of the Board

Dr. Amit Etkin founded Alto Neuroscience in 2019. Before establishing Alto, he served for over a decade as a tenured professor of psychiatry and behavioral sciences at Stanford University, where he directed a prominent laboratory. A trained psychiatrist and neuroscientist, Dr. Etkin received the highly competitive NIH Director's Pioneer Award, the first of its kind in clinical psychiatry. His entrepreneurial achievements were also recognized with an EY (Entrepreneur of the Year) award.

Nicholas Smith - Chief Financial Officer and Chief Business Officer

Nicholas Smith serves as Alto Neuroscience's Chief Financial Officer and Chief Business Officer. He joined the company as Director of Finance/CFO in October 2022.

Michael Hanley - Chief Operating Officer

Michael Hanley is the Chief Operating Officer at Alto Neuroscience, having taken on this role in 2024. Prior to joining Alto, he was the Chief Business Officer at Spyre Therapeutics, Inc. from 2022 to 2023 and also held a position at Horizon Therapeutics Ltd. (Ireland).

Erin R. McQuade - General Counsel and Chief Administrative Officer

Erin R. McQuade holds the titles of General Counsel and Chief Administrative Officer at Alto Neuroscience. She is also a co-founder of the company. Her background includes legal and administrative roles at various companies, such as SPSS, Inc., Assertio Therapeutics, Inc., Mead Johnson Nutrition Co., Hyatt Hotels Corp., and Levo Therapeutics, Inc.

Adam Savitz, MD, PhD - Chief Medical Officer

Dr. Adam Savitz is Alto Neuroscience's Chief Medical Officer, a position he assumed in 2021. Before joining Alto, he was the Senior Director of Clinical Research at Janssen Research & Development LLC from 2017 to 2021.

The key risks to Alto Neuroscience's business are:

1. The unproven nature of its novel Precision Psychiatry Platform and biomarker-driven approach for regulatory approval. The company explicitly states, "Our Platform is unproven and clinical evidence to support our approach is preliminary and limited at this time, and, as such, there can be no guarantee that our approach will result in an increased rate of approval for our therapeutic candidates."
2. The inherent risk of clinical trial failure for its novel product candidates. As a clinical-stage biopharmaceutical company, the success and commercial viability of Alto Neuroscience depend entirely on its drug candidates, such as ALTO-100 and ALTO-300, successfully completing ongoing and future clinical trials, demonstrating efficacy in biomarker-characterized populations, and receiving regulatory approvals.
3. The anticipated requirement to develop and obtain FDA approval for companion diagnostics alongside its product candidates. This adds a significant layer of complexity, cost, and regulatory uncertainty to the development and commercialization pathway for drugs utilizing their biomarker modalities.

• For Major Depressive Disorder (MDD), specifically the patient population characterized by Alto's cognitive or electroencephalography (EEG) biomarkers (targeted by ALTO-100 and ALTO-300), the estimated market size is approximately 15.75 million adults in the United States. This is based on an estimated 21 million adults in the U.S. experiencing at least one major depressive episode in 2021, and Alto's estimate that three-quarters of this population are characterized by one or both of their independent biomarkers.
• For schizophrenia, specifically cognitive impairment associated with schizophrenia (CIAS), which is targeted by ALTO-101, the overall market size for schizophrenia affects approximately 2.8 million adults in the United States as of 2020. While a specific sub-population size for CIAS is not provided, the company notes that CIAS is a core feature of schizophrenia that "severely impacts daily functioning and quality of life for millions of patients" and that there are currently no approved treatments for CIAS.