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Alto Neuroscience Inc. (NYSE: ANRO) is a clinical-stage biopharmaceutical company dedicated to redefining psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. The company's innovative Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to identify which patients are more likely to respond to their product candidates.
Alto's clinical-stage pipeline includes several promising drug candidates targeting various neuropsychiatric disorders such as depression, PTSD, schizophrenia, and cognitive impairments. Some of the key assets in their pipeline include ALTO-100, ALTO-202, ALTO-101, and ALTO-300, initially focusing on depressive disorders and schizophrenia populations as identified by brain-based biomarkers.
In recent news, Alto Neuroscience announced the pricing and closing of its upsized initial public offering (IPO) of over 9 million shares of common stock, generating approximately $147.9 million in gross proceeds. The company's stock began trading on the New York Stock Exchange on February 2, 2024, under the ticker symbol 'ANRO'.
Alto’s lead product candidates, ALTO-100 and ALTO-300, have shown positive Phase 2a results in major depressive disorder (MDD) trials. Enrollment is on track for Phase 2b studies, with expected data readouts in the second half of 2024 for ALTO-100 and the first half of 2025 for ALTO-300. Additionally, ALTO-101, a novel PDE4 inhibitor, has demonstrated favorable results in Phase 1, with plans to initiate a proof-of-concept study for cognitive impairment associated with schizophrenia (CIAS) in 2024.
With a robust cash position of approximately $206 million as of March 31, 2024, Alto Neuroscience is well-positioned to support its planned operations into 2027. The company is committed to advancing its mission of providing personalized treatment options for patients with neuropsychiatric conditions and delivering value to shareholders.
Alto Neuroscience (NYSE: ANRO) has been granted U.S. Patent Number 12,226,375 for its precision medicine approach in treating Major Depressive Disorder (MDD). The patent covers the use of ALTO-300 (agomelatine) as an adjunctive therapy for patients who have shown inadequate response to antidepressants, specifically using electroencephalogram (EEG) measures for patient selection.
ALTO-300 is an oral, small molecule designed to function as a melatonin agonist and 5-HT2C antagonist. The patent protection extends until 2044, not accounting for potential extensions. The treatment is being developed as an adjunctive therapy for biomarker-characterized MDD patients in the United States who haven't responded adequately to standard antidepressant treatments.
Alto Neuroscience (NYSE: ANRO) announced favorable interim analysis results for its Phase 2b trial of ALTO-300, an adjunctive treatment for major depressive disorder (MDD). The trial will continue with an increased target of approximately 200 biomarker-positive patients in the final analysis sample, up from the current 87 patients.
The double-blind, placebo-controlled study is enrolling patients characterized by an EEG biomarker signature. ALTO-300, an oral small molecule acting as a melatonin agonist and 5-HT2C antagonist, is being tested as an addition to background antidepressant therapy in patients with inadequate response. The primary outcome measure is the change in Montgomery-Åsberg Depression Rating Scale (MADRS) score.
The company reported an estimated preliminary 2024 year-end cash balance of $168 million, expected to support planned operations into 2028. Topline results are anticipated in mid-2026.
Alto Neuroscience (NYSE: ANRO) presented multiple studies at the 63rd ACNP annual meeting, showcasing progress in their precision psychiatry platform. The company highlighted new mechanistic findings supporting the ALTO-300 biomarker, which measures reduced neural signal stability and is linked to 5-HT2C receptor activity.
Key presentations included data on neural mechanisms of the ALTO-300 biomarker, validation of reward processing assessments for ALTO-203 trials, and findings on cognitive impairment in depression. The company announced plans for an interim analysis of the ongoing ALTO-300 Phase 2b trial in Q1 2025, with complete topline data expected in H1 2025.
Alto Neuroscience reported Q3 2024 financial results with a cash position of $182 million, expected to fund operations into 2027. The company announced topline data expectations from two MDD trials in H1 2025 for ALTO-300 and ALTO-203. While the ALTO-100 Phase 2b study in MDD did not meet its primary endpoint, it showed promising results in adjunctive treatment. R&D expenses increased to $13.1 million from $8.0 million YoY, while G&A expenses rose to $5.8 million from $1.8 million. Net loss widened to $16.8 million compared to $9.1 million in Q3 2023.
Alto Neuroscience (NYSE: ANRO), a clinical-stage biopharmaceutical company developing precision medicines for neuropsychiatric disorders, has announced its participation in two major investor conferences in November 2024. The company will present at the Stifel 2024 Healthcare Conference in New York on November 18 at 3:00 pm ET, and the Jefferies London Healthcare Conference on November 20 at 3:00 pm GMT. Both events will feature fireside chats and one-on-one investor meetings. Presentations will be available via webcast on Alto's website with replay options available.
Alto Neuroscience (NYSE: ANRO) reported that its Phase 2b study of ALTO-100 for major depressive disorder (MDD) did not meet its primary endpoint. The treatment failed to show significant improvement in depressive symptoms compared to placebo in patients with a memory-based cognitive biomarker. However, ALTO-100 maintained a favorable safety and tolerability profile.
The study, involving 301 adults with MDD across 34 U.S. sites, used the Montgomery-Åsberg Depression Rating Scale (MADRS) to assess changes in depressive symptoms. Despite the disappointing results, Alto Neuroscience remains committed to its mission and expects its strong cash position to support operations through 2027 and multiple near-term clinical milestones.
The company is also evaluating ALTO-100 in a Phase 2b study for bipolar depression and anticipates additional readouts for ALTO-203 and ALTO-300 in MDD in the first half of 2025.
Alto Neuroscience (NYSE: ANRO) has published a peer-reviewed analysis in The Journal of Clinical Psychiatry, revealing that baseline cognitive performance does not moderate response to standard antidepressants in major depressive disorder (MDD) patients. The study, involving 1,812 participants across four placebo-controlled trials, found that vortioxetine, despite its cognitive benefits, does not show greater efficacy in MDD patients with cognitive impairment.
This underscores the unmet need for effective treatments for MDD patients with cognitive impairment, who comprise up to 50% of the MDD population. Alto Neuroscience is developing ALTO-100, a first-in-class oral small molecule designed to enhance neural plasticity, as a potential treatment for this subgroup. Topline data from the Phase 2b MDD study of ALTO-100 is expected in October 2024.
Alto Neuroscience (NYSE: ANRO), a clinical-stage biopharmaceutical company developing precision medicines for neuropsychiatric disorders, has announced its participation in several upcoming investor conferences in September 2024. The company will host an Investor Day on September 9, focusing on ALTO-100 for Major Depressive Disorder, ahead of expected topline data in October 2024.
Alto will also present at the Baird Global Healthcare Conference (September 10-11), the Cantor Global Healthcare Conference (September 17-19), and the TD Cowen 4th Annual Novel Mechanisms in Neuropsychiatry Summit (September 26). These events will feature presentations, one-on-one investor meetings, and a fireside chat, providing insights into Alto's progress and strategies.
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.
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