Alto Neuroscience(ANRO) - 2025 Q1 - Quarterly Results

Recent Business Highlights Alto Neuroscience reported progress on its four clinical trials in Q1 2025, with key data readouts expected from 2025 through 2026, highlighting advancements in its biomarker platform and maintaining a strong cash position of $161.3 million, expected to fund operations into 2028 and through at least four upcoming clinical study readouts - Phase 2 proof-of-concept trial topline data for ALTO-203 in MDD is expected in Q2 2025, followed by ALTO-101 in schizophrenia in H2 2025[1] - Late-stage Phase 2b trial data for ALTO-300 in MDD is anticipated in mid-2026, and for ALTO-100 in bipolar depression in H2 2026[1] - The company possesses a strong cash position of approximately $161.3 million, which is projected to fund planned operations into 2028[1] - Alto continues to advance its biomarker platform, presenting new data on an EEG-based placebo response biomarker and dopamine-related biomarkers to support its precision psychiatry approach[2] Pipeline Highlights Alto Neuroscience is advancing four clinical-stage programs for various neuropsychiatric disorders, with ALTO-100 and ALTO-300 in Phase 2b trials for bipolar depression and MDD respectively, and ALTO-203 and ALTO-101 in Phase 2 proof-of-concept trials, all supported by a biomarker-driven approach to patient stratification ALTO-100 for Bipolar Depression (BPD) ALTO-100 is a first-in-class oral small molecule for BPD, currently in Phase 2b trials with data expected in H2 2026, utilizing an EEG-based biomarker - ALTO-100 is a first-in-class oral small molecule being developed for BPD in patients identified by a cognitive biomarker[3] - Enrollment is ongoing in the Phase 2b trial, with topline data from approximately 200 patients expected in the second half of 2026. The primary endpoint is the change from baseline on the MADRS[3] - The company is utilizing a prospectively validated EEG-based biomarker to account for potential placebo responders, which is expected to improve the detection of treatment response[3][4] ALTO-300 for Major Depressive Disorder (MDD) ALTO-300, an adjunctive treatment for MDD, is in a Phase 2b trial with topline data anticipated in mid-2026, showing a favorable safety profile - ALTO-300 (agomelatine 25mg) is being developed as an adjunctive treatment for MDD in patients characterized by an EEG biomarker[5] - Topline data from the Phase 2b trial, enrolling approximately 200 biomarker-positive patients, is expected in mid-2026[7] - The 25mg dose has demonstrated a favorable safety profile, with no liver enzyme elevations (≥ 3 times the upper limit of normal) observed in the completed 239-patient Phase 2a trial or the ongoing Phase 2b trial[7] ALTO-203 for Major Depressive Disorder (MDD) ALTO-203, a novel histamine H3 inverse agonist for MDD patients with anhedonia, has completed enrollment in its Phase 2 POC trial with data expected in Q2 2025 - ALTO-203 is a novel histamine H3 inverse agonist being developed for MDD patients with high levels of anhedonia[6] - Enrollment in the 69-patient Phase 2 proof-of-concept (POC) trial is complete, with topline data expected in the second quarter of 2025[6] - New preclinical data showed ALTO-203 effectively reversed anhedonia-like behavior, an effect not seen with pitolisant, the only FDA-approved H3R inverse agonist[11] ALTO-101 for Cognitive Impairment Associated with Schizophrenia (CIAS) ALTO-101, a transdermal PDE4 inhibitor for CIAS, is undergoing a Phase 2 POC trial with topline data anticipated in H2 2025, showing enhanced theta responses - ALTO-101 is a novel transdermal formulation of a PDE4 inhibitor being developed for CIAS[9] - Enrollment is ongoing in the Phase 2 POC trial, with topline data expected in the second half of 2025[11] - The primary outcome is the effect on theta band activity, an EEG measure associated with CIAS. Recent data demonstrated that ALTO-101 significantly enhanced theta responses in humans[11] Upcoming Milestones and Events Alto Neuroscience outlined a clear timeline of four major clinical trial data readouts scheduled from the second quarter of 2025 through the second half of 2026, with plans to present at four scientific and investor conferences in May and June 2025 Upcoming Clinical Trial Data Readouts | Expected Milestone | Timing | | :--- | :--- | | ALTO-203 Phase 2 POC MDD trial topline data | 2Q 2025 | | ALTO-101 Phase 2 POC CIAS trial topline data | 2H 2025 | | ALTO-300 Phase 2b MDD trial topline data | Mid-2026 | | ALTO-100 Phase 2b BPD trial topline data | 2H 2026 | - The company is scheduled to present at several upcoming conferences: American Society of Clinical Psychopharmacology (ASCP) Annual Meeting (May 27-30, 2025), Jefferies Healthcare Conference (June 3-5, 2025), H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference (June 16-17, 2025), and Biotechnology Innovation Organization (BIO) International Convention (June 16-19, 2025)[11] First Quarter 2025 Financial Highlights For the first quarter of 2025, Alto Neuroscience reported a net loss of $15.2 million, maintained a strong cash position of $161.3 million sufficient to fund operations into 2028, with research and development expenses remaining flat year-over-year while general and administrative expenses increased primarily due to higher headcount and public company costs Key Financial Metrics | Financial Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | R&D Expenses | $10.0 million | $10.0 million | | G&A Expenses | $5.7 million | $4.4 million | | Net Loss | $15.2 million | $13.4 million | - Cash, cash equivalents, and restricted cash was approximately $161.3 million as of March 31, 2025, compared to $168.7 million as of December 31, 2024[12] - The increase in G&A expenses was mainly due to higher headcount, expanded operational requirements, and public company operating costs, including $0.3 million in non-cash, stock-based compensation[14] Financial Statements The condensed consolidated financial statements for Q1 2025 show a net loss of $15.2 million, an increase from the $13.4 million loss in Q1 2024, with total assets at $171.9 million as of March 31, 2025, a slight decrease from $177.5 million at the end of 2024, and total liabilities increasing to $32.8 million Condensed Consolidated Statements of Operations and Comprehensive Loss The Condensed Consolidated Statements of Operations and Comprehensive Loss for Q1 2025 show a net loss of $15.2 million, an increase from $13.4 million in Q1 2024, with total operating expenses rising to $15.7 million | (in thousands, except per share) | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $9,974 | $9,952 | | General and administrative | $5,702 | $4,434 | | Total operating expenses | $15,676 | $14,386 | | Loss from operations | $(15,676) | $(14,386) | | Interest income | $1,827 | $1,558 | | Net loss | $(15,169) | $(13,417) | | Net loss per share, basic and diluted | $(0.56) | $(0.76) | | Weighted-average shares outstanding | 27,049 | 17,600 | Selected Condensed Consolidated Balance Sheet Data Selected Condensed Consolidated Balance Sheet Data as of March 31, 2025, indicates total assets of $171.9 million and total liabilities of $32.8 million, with cash decreasing from year-end 2024 | (in thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, and restricted cash | $161,254 | $168,729 | | Total assets | $171,915 | $177,542 | | Total liabilities | $32,819 | $26,082 | | Accumulated deficit | $(153,565) | $(138,396) |