Alto Neuroscience, Inc. (NYSE: ANRO) reported financial results for the full year ending December 31, 2024, highlighting recent progress across its pipeline of clinical-stage product candidates. The company also provided upcoming milestones it expects to reach and assured investors about its financial stability.
Alto Neuroscience had a successful IPO in 2024 that gave the company a cash cushion that it said would fund the company through 2028. At the end of 2024, Alto had cash, cash equivalents, and restricted cash of approximately $169 million, compared to approximately $83 million at the end of 2023. The company reported a net loss of $61.4 million for 2024 versus a net loss of $36.3 million for 2023. The company ahs no revenues to report at this time.
“In 2024 we continued to advance our mission to change the way medicines are developed for neuropsychiatric conditions,” said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. “Using our proprietary platform we have evaluated brain-based biomarkers in over 2,000 participants and have completed six clinical studies across our pipeline programs since our founding. Further, we believe the outcome of the recent interim analysis of the ongoing ALTO-300 trial is suggestive of antidepressant activity, and we believe the sample re-estimation improves the overall probability of success in that trial.”
Expenses
The company reported that its research and development expenses for the full year were $47.0 million versus 2023’s $30.3 million. The company attributed the change to increased personnel costs; including $1.5 million of non-cash, stock-based compensation; as well as costs associated with the Phase 2b clinical study for ALTO-300, and the Phase 2 POC studies for ALTO-203 and ALTO-101.
General and administrative expenses were $21.6 million, also higher than 2023’s $7.5 million. The increase was due to costs associated with higher headcount to support expanded clinical development efforts, growing operational requirements, and costs associated with operating as a public company. $3.3 million of the increase is reflective of non-cash, stock-based compensation.
Pipeline
ALTO-100 is in development for the treatment of bipolar depression (BPD). The company had reported in October that its Phase2b study didn’t deliver the desired results. Alto said that upon further discovery, it learned that the patients had a lower rate of medication compliance. the company said it reviewed the results of the patients who had complied and found the results worth continuing the study. The company said enrollment in the randomized, double-blind, placebo-controlled Phase 2b trial remains ongoing with topline data expected in the second half of 2026.
ALTO-300 is being developed as an adjunctive treatment in the United States for patients with MDD (major depressive disorder). The company said topline data from the double-blind, placebo-controlled, randomized Phase 2b trial is expected in mid-2026.
ALTO-203 is being developed for the treatment of MDD associated with increased levels of anhedonia. In February, Alto reported it completed enrollment in the Phase 2 proof-of-concept (POC) trial in MDD patients with higher levels of anhedonia. The company said it expects to report topline data in the second quarter of 2025.
ALTO-101 is being developed for the treatment of Cognitive Impairment Associated with Schizophrenia (CIAS). The company reported that enrollment is ongoing in the Phase 2 POC (proof of concept) trial in CIAS, with topline data expected in the second half of 2025.
Dr. Etkin added, “Successfully completing our IPO in 2024 has provided us with a strong balance sheet to support several key clinical milestones in the coming years. As a scientific founder with a sincere passion to move the field forward, I am very proud of all our team has accomplished and I look forward to building on this momentum.”
[[{“value”:”The company said it is expecting to reach some important milestones in 2025.
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