MOUNTAIN VIEW, Calif. - Alto Neuroscience, Inc. (NYSE: ANRO), a biopharmaceutical company specializing in neuropsychiatric treatments, has received an $11.7 million grant from the Wellcome Trust. This funding will support a Phase 2b clinical trial for ALTO-100, a novel drug candidate for bipolar depression, a condition with significant unmet medical needs.
The company announced the initiation of the placebo-controlled, double-blind, randomized study, aiming to enroll around 200 patients. The trial will use a cognitive biomarker previously utilized in major depressive disorder (MDD) and post-traumatic stress disorder (PTSD) studies. The primary goal is to measure the change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS), with results expected in 2026.
Amit Etkin, M.D., Ph.D., founder and CEO of Alto Neuroscience, highlighted the limitations of current antipsychotic treatments for bipolar depression and expressed gratitude to Wellcome for accelerating their late-stage clinical program. ALTO-100, an oral small molecule, has shown potential in enhancing neural plasticity and has demonstrated favorable safety and tolerability in earlier Phase 2a trials.
Dr. Lynsey Bilsland from Wellcome emphasized the importance of funding research for early intervention in mental health and expressed encouragement for the drug candidate's potential impact on bipolar depression and other mental health conditions.
ALTO-100 is also in Phase 2b development for MDD, with outcomes expected in October 2024. Alto Neuroscience's approach focuses on leveraging brain biomarkers to develop personalized treatments for mental health conditions, including depression, PTSD, schizophrenia, and others.
The company's Precision Psychiatry Platform™ identifies brain-based biomarkers to predict medication response, with ALTO-100 targeting patients with a specific verbal memory biomarker, indicative of hippocampal neuroplasticity.
This announcement is based on a press release statement. The forward-looking statements within the press release are subject to various factors, including the risk of delays in enrollment and the availability of study results.
In other recent news, Alto Neuroscience has appointed Michael Hanley as its new Chief Operating Officer. Hanley, a seasoned professional with over 25 years of experience in the life sciences industry, is set to play a crucial role in the company's product planning and portfolio strategy, particularly in the central nervous system and neuroscience sectors.
His previous roles have included strategic planning, development, and commercialization in CNS and psychiatry, including leadership positions at Aeglea BioTherapeutics, Horizon Therapeutics (NASDAQ:HZNP), and Lundbeck's psychiatry business unit.
Alto's founder and CEO, Amit Etkin, has expressed confidence in Hanley's expertise as the company moves into late-stage clinical development. Hanley's role will be instrumental in advancing Alto Neuroscience's mission to provide targeted treatments for mental health conditions. This is a recent development that underscores the company's commitment to enhancing its leadership team and boosting its strategic planning capabilities.
Alto Neuroscience's Precision Psychiatry Platform™, which incorporates brain biomarkers, EEG activity, and other data to improve patient response to the company's drug candidates, is a key component of its strategy. The company's pipeline includes treatments for a range of mental health conditions, including depression, PTSD, and schizophrenia. This information is based on recent press releases and company announcements.
InvestingPro Insights
As Alto Neuroscience, Inc. (NYSE: ANRO) embarks on its Phase 2b clinical trial for ALTO-100, investors are closely monitoring the company's financial health and market performance. According to real-time data from InvestingPro, ANRO currently holds a market capitalization of $396.95 million USD, reflecting investor valuation of the company's potential in the neuropsychiatric space. Despite recent challenges, ANRO has exhibited a strong return over the last month with a 50.1% price total return, which could signal growing investor confidence in the company's prospects.
InvestingPro Tips suggest a mixed financial picture for ANRO. On the one hand, the company maintains a positive liquidity position, holding more cash than debt and having liquid assets that exceed short-term obligations. This could provide a cushion for the company as it continues to invest in its clinical trials and research endeavors. On the other hand, ANRO is not currently profitable, with a negative P/E ratio of -1.88, and it suffers from weak gross profit margins, which could be a concern for potential investors.
For those interested in a deeper analysis, InvestingPro offers additional insights on ANRO, including the company's adjusted operating income at -$44.99 million USD for the last twelve months as of Q1 2024. It is also noteworthy that ANRO does not pay a dividend to shareholders, which is typical for biopharmaceutical companies in the growth phase focusing on reinvestment.
Investors looking to make an informed decision on ANRO can find further InvestingPro Tips by visiting https://www.investing.com/pro/ANRO. For access to these valuable insights, use coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription. With 5 additional tips available on InvestingPro, investors can gain comprehensive guidance tailored to their investment strategy.
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