Alto Neuroscienc Stock Price, News & Analysis

Alto Neuroscience (NYSE: ANRO) reported Q2 2024 financial results and business highlights. Key points include:

• Completed enrollment of 301 patients in Phase 2b MDD study for ALTO-100; topline data expected in October 2024
• Initiated Phase 2 studies for ALTO-101 in schizophrenia, ALTO-203 in MDD with anhedonia, and ALTO-100 in bipolar depression
• Reported positive Phase 1 data on transdermal formulation of ALTO-101
• Strong cash position of $194 million expected to fund operations into 2027
• Q2 2024 R&D expenses increased to $13.2 million from $7.1 million in Q2 2023
• Net loss for Q2 2024 was $16.0 million compared to $8.7 million in Q2 2023

The company has five Phase 2 studies ongoing across four novel product candidates, with topline data expected before the end of 2026.

Alto Neuroscience (NYSE: ANRO) has received an $11.7 million funding award from Wellcome Trust to advance ALTO-100, a first-in-class small molecule, in a 200-patient Phase 2b study for bipolar depression. The study will leverage a cognitive biomarker previously identified in MDD and PTSD patients. This marks the first precision psychiatry trial in bipolar depression, an area of high unmet need.

ALTO-100 is believed to enhance neural plasticity and is currently in Phase 2b development for MDD, with results expected in October 2024. The new study for bipolar depression will use the same memory biomarker and design as the ongoing MDD study. The primary endpoint is the change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS) over a six-week treatment period.

Alto Neuroscience (NYSE: ANRO) has completed enrollment in its Phase 2b study of ALTO-100 for major depressive disorder (MDD). The study includes 300 adult patients with and without a specific cognitive biomarker. Topline results are expected in October 2024. The randomized, double-blind, placebo-controlled study aims to determine ALTO-100's efficacy in MDD patients defined by an objective cognitive biomarker. The primary endpoint is the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) over a 6-week treatment period. Alto plans to host an investor day on September 9, 2024, focusing on ALTO-100 and providing information on study participants, mechanistic rationale, and the predictive cognitive test used for patient selection.

Alto Neuroscience announced the initiation of a Phase 2 trial for ALTO-101, a PDE4 inhibitor aimed at treating cognitive impairment in schizophrenia. The study, expected to conclude by the second half of 2025, will involve 70 adults and compare a transdermal formulation of ALTO-101 against a placebo. Previous Phase 1 trials showed positive cognitive effects and fewer adverse events compared to oral administration. CEO Amit Etkin highlighted the potential of ALTO-101 to improve cognitive function across various psychiatric disorders.

The primary outcome will measure the effect on theta band activity using EEG. This follows promising data presented at the SOBP Annual Meeting, affirming the relevance of EEG measures in assessing cognitive function in schizophrenia.

Amit Etkin, M.D., Ph.D., founder and CEO of Alto Neuroscience, was named an EY Entrepreneur Of The Year 2024 Bay Area Award winner. Dr. Etkin was selected from a pool of 26 finalists by an independent panel of judges. The award celebrates innovative leaders across various industries. Alto Neuroscience, under Dr. Etkin's leadership, has been recognized for its mission to advance precision psychiatry. The winners were evaluated based on entrepreneurial spirit, purpose, growth, and impact. Regional winners, announced on June 14, 2024, will now compete for the National Awards in November.

Alto Neuroscience (NYSE: ANRO) announced its participation in the Jefferies Global Healthcare Conference in New York from June 5-6, 2024. Founder and CEO Amit Etkin, M.D., Ph.D., will engage in a fireside chat on June 6, 2024, at 2:30 p.m. ET. Additionally, the company's management will hold one-on-one meetings with investors. A live webcast of the discussion will be available on Alto's investor relations webpage, with a replay accessible afterward.

Alto Neuroscience (NYSE: ANRO) has appointed Michael Hanley as its new Chief Operating Officer (COO). Hanley brings over 25 years of expertise in the life sciences industry, particularly in neuropsychiatric conditions like major depressive disorder and schizophrenia. His role will involve new product planning, portfolio strategy, and cross-functional leadership to enhance Alto's clinical-stage programs and biomarker platform. Hanley's extensive background includes leadership positions at Aeglea BioTherapeutics and Horizon Therapeutics. He holds a Bachelor of Business Administration from the University of Notre Dame and an MBA from Kellogg School of Management.

Alto Neuroscience (NYSE: ANRO) announced its Q1 2024 financial results and recent business updates. The company initiated a Phase 2 study of ALTO-203 for MDD and anhedonia, and reported positive Phase 1 data for the transdermal formulation of ALTO-101, showing improved drug exposure and tolerability. Patient enrollment for ALTO-100 and ALTO-300 Phase 2b MDD studies is progressing well. The company has a strong cash position of approximately $206 million, expected to support operations into 2027.

Alto's ongoing studies include ALTO-100 and ALTO-300, both targeting MDD, and ALTO-101 for CIAS. The company also announced the initiation of a Phase 2 proof-of-concept study for ALTO-203 in patients with MDD and high levels of anhedonia. Financial highlights include a net loss of $13.4 million, an increase in R&D expenses to $10 million, and higher G&A expenses reaching $4.4 million. Alto completed an upsized IPO in February 2024, netting $133 million in proceeds.

Alto Neuroscience, Inc. ('Alto') (ANRO) announced upcoming data presentations at the Society of Biological Psychiatry and American Society of Clinical Psychopharmacology Annual Meetings, showcasing its precision psychiatry pipeline. The company highlighted neurobiological markers linked to cognitive impairment in schizophrenia and the development of novel compounds for depression and schizophrenia. The ALTO-100 study identified memory-based cognitive markers predicting antidepressant response, while ALTO-101 showed significant effects on electrophysiological measures relevant to cognitive processing. ALTO-300 demonstrated EEG-based cognitive markers predicting greater response. The presentations aim to contribute to the scientific community and further develop treatment options for patients.