Alto Neuroscience Q2 2024 Financial Results and Business Highlights

Alto Neuroscience, Inc. (NYSE: ANRO) has announced its financial results for the second quarter ending June 30, 2024, alongside significant corporate advancements. The company is making strides in precision psychiatry with notable progress across its pipeline programs.

Amit Etkin, M.D., Ph.D., founder and CEO of Alto Neuroscience, highlighted the company's milestones, emphasizing the completion of patient enrollment in a Phase 2b study of ALTO-100. This study, which includes 301 patients, is groundbreaking as it uses a neurocognitive battery for patient selection. The results of this study are anticipated in October 2024. Additionally, a funding award from the Wellcome Trust has accelerated the development of ALTO-100 for bipolar depression, moving it directly into a Phase 2b study. The company aims to redefine neuropsychiatric treatment through its various studies.

Dr. Etkin also noted the progress across other programs, with five Phase 2 studies ongoing across four novel product candidates. The company expects to report topline data from these studies by the end of 2026. Their capital-efficient approach to clinical trials suggests that existing cash resources will support operations through 2027.

Key developments for Alto Neuroscience in the second quarter of 2024 and recent periods include:

ALTO-100: Progress in Studies for MDD and Bipolar Depression
ALTO-100 is an oral small molecule aimed at enhancing neural plasticity, under development for major depressive disorder (MDD) and bipolar depression (BPD). The company completed enrollment for a Phase 2b study in MDD patients, focusing on those with a memory-based cognitive biomarker. This six-week double-blind study is comparing ALTO-100 to a placebo, with the primary endpoint being the change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS).

Following a successful Type C meeting with the FDA in June 2024, Alto received feedback that the ongoing study would clarify the registrational path for ALTO-100. The company is set to report topline data in October 2024. Moreover, a Phase 2b study in BPD was initiated in July 2024, enrolling 200 patients using the same cognitive biomarker as the MDD study. This trial also aims to measure changes in MADRS scores, with results expected in 2026.

ALTO-300: Enrollment Progress
ALTO-300, or agomelatine, is being developed as an adjunctive treatment for MDD patients who do not respond adequately to antidepressants. This 200-patient Phase 2b study uses an EEG biomarker signature to evaluate ALTO-300 over six weeks. Topline data from this study are expected in the first half of 2025.

ALTO-101: Phase 2 Study for CIAS
ALTO-101, a novel brain-penetrant PDE4 inhibitor, is in a Phase 2 trial for cognitive impairment associated with schizophrenia (CIAS). This study follows positive Phase 1 results showing a favorable pharmacokinetic and tolerability profile for a transdermal formulation of ALTO-101. The ongoing Phase 2 study involves 70 adults with schizophrenia, aiming to assess the drug’s impact on EEG markers and cognitive performance. Results are expected in the second half of 2025.

ALTO-203: Study in MDD with Anhedonia
ALTO-203, a histamine H3 inverse agonist, is being tested in a Phase 2 proof-of-concept study for MDD patients with high levels of anhedonia. The study includes two double-blind treatment periods to evaluate the drug’s impact on positive emotion and overall safety. Enrollment is ongoing, with topline data anticipated in the first half of 2025.

ALTO-202: Development for Depression
ALTO-202, targeting the GluN2b subunit of NMDA receptors, is under development as a new treatment for depression.

Corporate Updates and Financials
Alto has strengthened its management team with Michael Hanley as Chief Operating Officer. The company plans an investor day on September 9, 2024, focusing on ALTO-100.

Financial highlights include a cash position of $193.6 million as of June 30, 2024, expected to fund operations into 2027. Research and development expenses increased to $13.2 million for the quarter, attributed to ongoing Phase 2b studies. General and administrative expenses also rose to support expanded clinical efforts and public company operations.

Alto Neuroscience continues to make significant progress in developing effective, personalized treatments for psychiatric conditions, leveraging neurobiology and innovative clinical approaches.

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