ADDED
Management's Discussion and Analysis of Financial Condition and Results of Operations 115 Item 7A.
Form 10-K Summary 163 Signatures 164 Unless context otherwise requires, the terms the Company, Alto, we, us, our, and similar references in this Annual Report on Form 10-K refer to Alto Neuroscience, Inc.
Our current pipeline consists of seven clinical-stage assets addressing high-need therapeutic areas, including major depressive disorder, or MDD, bipolar depression, or BPD, treatment resistant depression, or TRD, schizophrenia, and Parkinson s disease.
Each of our programs, including our most advanced program ALTO-207, are supported by robust clinical data in the respective patient populations in which we are developing them.
In 2025, we identified and prospectively replicated an EEG biomarker that captures brain activity patterns in people with MDD that are more likely to elicit a larger response to placebo.
We believe this biomarker can be used throughout the development of novel medicines for depression to reduce the signal-to-noise ratio and improve the detection of true therapeutic response.
Discover and prospectively replicate objective biomarkers for patient selection Our proprietary approach relies on rigorous analytics using patient-derived data to discover, and prospectively replicate, biomarker signatures for likely drug responders.
Expand our pipeline by strategically evaluating in-licensing and acquisition opportunities We plan to seek opportunities to in-license, acquire, or partner on new product candidates in clinical indications where we are able to offer unique expertise to potentially enhance the product candidate s value and potentially streamline development through targeted patient selection.
As a fixed-dose combination, ALTO-207 is designed to enable rapid titration and higher dosing by mitigating the dose-limiting adverse events typically experienced with pramipexole.
ALTO-207 is being developed to address the significant unmet need for patients with TRD.
REMOVED
Management's Discussion and Analysis of Financial Condition and Results of Operations 108 Item 7A.
Our current pipeline consists of five clinical-stage assets addressing high-need therapeutic areas, including major depressive disorder, or MDD, bipolar depression, or BPD, and schizophrenia.
Our most advanced programs are supported by prospectively replicated evidence of clinical activity in biomarker-characterized populations.
Our Strategy We are building a leading precision psychiatry company with a mission to redefine neuropsychiatric care with personalized and highly effective treatment opti ons.
Expand our pipeline by strategically evaluating in-licensing and acquisition opportunities.
We plan to seek opportunities to in-license, acquire, or partner on new product candidates in clinical indications where we are able to offer unique expertise to potentially enhance the product candidate s value and potentially streamline development through targeted patient selection.
Selectively partner our product candidates to maximize their value to patients and our stockholders.
In July 2024 we reported that this Phase 2b study is supported in part by a funding award from The Wellcome Trust Limited, or Wellcome.
We have granted patents and pending patent applications that we believe provide protection of ALTO-100 to at least 2043.
In particular, our development of ALTO-100 in the United States is protected by granted patents covering methods of treating BPD and MDD in patients having objectively determined impaired learning and/or memory with 40-240 mg of ALTO-100.