– Patent supports Alto’s precision approach to improve patient selection –

MOUNTAIN VIEW, Calif., February 19, 2025--(BUSINESS WIRE)--Alto Neuroscience, Inc. ("Alto") (NYSE: ANRO) a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today announced that the U.S. Patent and Trademark Office has granted U.S. Patent Number 12,226,375, with method claims pertaining to treatment of major depressive disorder (MDD) in patients with inadequate response to an antidepressant. The method includes treatment with ALTO-300 as an adjunctive therapy and patient selection using specific electroencephalogram (EEG) measures. As granted, not accounting for any potential patent term extensions, the patent is expected to cover the use of ALTO-300 in the EEG-defined patient population until 2044.

ALTO-300, also known agomelatine, is an oral, small molecule designed to act as a melatonin agonist and 5-HT2C antagonist and is being developed as an adjunctive treatment in the United States for biomarker-characterized patients with MDD who have had an inadequate response to current standard of care antidepressants.

"The granting of this patent underscores our novel approach to patient selection in neuropsychiatric treatment using objective biomarkers," said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. "We are dedicated to developing more effective, targeted treatments for patients with MDD and deepening our understanding of the patient phenotype that is most likely to benefit, based on our unique ALTO-300 biomarker."

About Alto Neuroscience

Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto’s Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. Alto’s clinical-stage pipeline includes novel drug candidates in depression, schizophrenia, and other mental health conditions. For more information, visit www.altoneuroscience.com or follow Alto on X.

Forward-Looking Statements

This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "expects," "plans," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Alto’s expectations about the potential benefits, activity, effectiveness and safety of its product candidates and Precision Psychiatry Platform ("Platform"); Alto’s expectations with regard to the design and results of its clinical trials and other statements that are not historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including uncertainties inherent in the progress and completion of clinical trials and clinical development of Alto’s product candidates and other important factors, any of which could cause Alto’s actual results to differ from those contained in the forward-looking statements, which are described in greater detail in the section titled "Risk Factors" in Alto’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2024 filed with the Securities and Exchange Commission ("SEC") as well as in other filings Alto may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alto expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as required by law.

Availability of Information on Alto’s Website

Alto routinely uses its investor relations website to post presentations to investors and other important information, including information that may be material. Accordingly, Alto encourages investors and others interested in Alto to review the information it makes public on its investor relations website.

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Contacts

Investor Contact:
Nick Smith
investors@altoneuroscience.com

Media Contact:
Mari Purpura
media@altoneuroscience.com