Alto Neuroscience Q1 2024 Financial Results and Business Highlights

Alto Neuroscience, Inc., based in Los Altos, California, recently disclosed its financial results for the first quarter ending March 31, 2024, alongside significant advancements within their corporate framework. Dr. Amit Etkin, the founder and CEO, highlighted the company’s dedication to creating individualized brain therapies, marking the initiation of five Phase 2 clinical studies since the company's inception. The pipeline includes studies on ALTO-100, ALTO-300, and ALTO-203, focusing on treating depression over the next year.

The company commenced a Phase 2 study of ALTO-203 in patients with major depressive disorder (MDD) and anhedonia. Additionally, positive Phase 1 data were reported for the transdermal formulation of ALTO-101, showing enhanced drug exposure and tolerability compared to oral administration. Patient enrollment is on schedule for Phase 2b MDD studies for ALTO-100 and ALTO-300, and the company maintains a robust cash position of approximately $206 million to fund operations until 2027.

ALTO-100 is an innovative oral small molecule under Phase 2b evaluation for MDD patients marked by a memory-based cognitive biomarker. The 266-patient study is comparing ALTO-100 to a placebo over six weeks, with changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) as the primary endpoint. Results are anticipated in the latter half of 2024.

ALTO-300, believed to act as a melatonin agonist and 5HT2C antagonist, is also in Phase 2b development for patients with MDD who didn’t respond well to antidepressants. Currently enrolling 200 patients with an EEG biomarker signature, the study will evaluate the efficacy of ALTO-300 over six weeks, with top-line data expected in the first half of 2025.

ALTO-101, a novel PDE4 inhibitor, is in Phase 1 development targeting cognitive impairment in schizophrenia (CIAS). The recent Phase 1 study in healthy volunteers indicated positive impacts on brain pharmacodynamic markers relevant to cognition. The transdermal formulation of ALTO-101, developed with MedRx Co., Ltd., demonstrated improved pharmacokinetics and tolerability. A Phase 2 proof-of-concept study in CIAS is set to begin in the first half of 2024.

ALTO-203, an oral small molecule acting as a histamine H3 inverse agonist, is being developed for MDD with anhedonia. Initiated in April 2024, the Phase 2 proof-of-concept study will assess ALTO-203’s effects on dopamine release and positive emotional measures in patients with MDD. The study involves two double-blind, placebo-controlled treatment periods with about 60 participants, expecting top-line data in the first half of 2025.

ALTO-202, targeting the GluN2b subunit of NMDA receptors, is under development for depression, with plans to advance clinical trials for patients with this condition.

Corporate achievements include completing an upsized initial public offering in February 2024, yielding net proceeds of $133 million. Upcoming milestones include the initiation of the ALTO-101 proof-of-concept CIAS study in the first half of 2024 and reporting top-line data for ALTO-100, ALTO-300, and ALTO-203 studies from 2024 to 2025.

Financially, Alto Neuroscience reported a cash position of $205.9 million as of March 31, 2024, expected to sustain operations into 2027. Research and development expenses increased to $10.0 million from $5.6 million in the same period of 2023, mainly due to costs associated with the ALTO-100 and ALTO-300 clinical studies. General and administrative expenses rose to $4.4 million from $1.6 million, reflecting costs related to higher personnel requirements and public company operations. The net loss for the quarter was $13.4 million, compared to $7.3 million in the previous year.