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MOUNTAIN VIEW, Calif. - Alto Neuroscience, Inc. (NYSE: ANRO), currently trading at $3.11 and down nearly 26% over the past week, has announced the continuation of its Phase 2b clinical trial for ALTO-300, an adjunctive treatment for major depressive disorder (MDD), following a favorable interim analysis. The clinical-stage biopharmaceutical company, which specializes in precision medicines for neuropsychiatric disorders, expects topline results from the trial by mid-2026.
The decision to proceed comes after a planned interim analysis recommended expanding the study to include approximately 50 additional biomarker-positive patients, targeting a final analysis sample of around 200. The trial, which is double-blind and placebo-controlled, involves patients characterized by an electroencephalogram (EEG) biomarker signature. These patients are randomized to receive either ALTO-300 or a placebo in addition to their existing antidepressant treatment over six weeks, with the primary outcome being the change in their Montgomery-Åsberg Depression Rating Scale (MADRS) score. According to InvestingPro analysis, analysts maintain a strong buy consensus with price targets ranging from $4 to $18, suggesting significant upside potential if the trial succeeds.
ALTO-300, an oral small molecule, functions as a melatonin agonist and 5-HT2C antagonist. The drug candidate is being developed to improve treatment outcomes for patients with MDD who are identified using EEG biomarkers.
Alto Neuroscience’s CEO, Amit Etkin, M.D., Ph.D., expressed optimism about the trial’s interim results, which utilized insights from the previously completed ALTO-100 Phase 2b trial. The company’s Precision Psychiatry Platform™ aims to measure brain biomarkers to better predict patient response to its drug candidates, which are also being developed for conditions such as schizophrenia.
In addition to the trial update, Alto Neuroscience has reported an estimated preliminary year-end cash balance for 2024 of approximately $168 million, which is anticipated to sustain planned operations into 2028. The company maintains a strong liquidity position with a current ratio of 13.09, and InvestingPro data shows it holds more cash than debt on its balance sheet. However, the company has noted that its final financial results for 2024 are not yet available and may differ from preliminary estimates. InvestingPro analysis indicates the stock is currently undervalued, with 10 additional ProTips available to subscribers covering various aspects of the company’s financial health and market performance.
This news is based on a press release statement and does not constitute an endorsement of the company’s claims. The forward-looking statements in the press release are subject to various factors that could cause actual results to differ materially from current expectations.
In other recent news, Alto Neuroscience has announced a potential $75 million "at the market" offering program in collaboration with Leerink Partners LLC. This initiative allows the pharmaceutical company to sell shares directly on the market, with the flexibility to control the timing and amount of stock sold. However, Alto Neuroscience retains the right to suspend or terminate the offering at any time. Concurrently, the company disclosed preliminary financial data, reporting approximately $168 million in cash and cash equivalents as of December 31, 2024. The company cautions that these figures are preliminary and subject to change.
In related developments, Jones Trading has initiated coverage on Alto Neuroscience shares with a Buy rating and set a price target of $18.00. This rating reflects confidence in Alto Neuroscience’s strategic approach to drug development, particularly its biomarker platform aimed at improving the precision of treatment for patients suffering from central nervous system diseases. These are the latest developments for Alto Neuroscience, a company that continues to advance its clinical trials and research efforts.
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