Alto Neuroscience(US:ANRO)2025-05-14 20:32Part I - Financial Information Financial Statements (Unaudited) The unaudited condensed consolidated financial statements for Q1 2025 reflect a net loss of $15.2 million, a decrease in total assets, and an increase in total liabilities, with $160.8 million in cash Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $160,754 | $168,229 | | Total assets | $171,915 | $177,542 | | Total liabilities | $32,819 | $26,082 | | Total stockholders' equity | $139,096 | $151,460 | Condensed Consolidated Statement of Operations Highlights (in thousands) | Account | 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 | | Loss from operations | $(15,676) | $(14,386) | | Net loss | $(15,169) | $(13,417) | | Net loss per share, basic and diluted | $(0.56) | $(0.76) | Condensed Consolidated Statement of Cash Flows Highlights (in thousands) | Activity | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(16,556) | $(10,983) | | Net cash used in investing activities | $(24) | $(224) | | Net cash provided by financing activities | $9,127 | $134,559 | Notes to Condensed Consolidated Financial Statements The notes detail the company's clinical-stage biopharmaceutical business, its accumulated deficit of $153.6 million, and key financing activities including an amended $75.0 million loan and an $11.7 million convertible grant - The company is a clinical-stage biopharmaceutical firm developing personalized psychiatry treatments with five clinical-stage assets in its pipeline28 - As of March 31, 2025, the company reported an accumulated deficit of approximately $153.6 million, primarily funded through equity financings including $133.0 million net proceeds from its February 2024 IPO2930 - In January 2025, the company amended its loan agreement with K2 HealthVentures, increasing the total term loan facility to $75.0 million and drawing $20.0 million4648 - A convertible grant agreement with The Wellcome Trust Limited, signed in July 2024, provides up to $11.7 million for ALTO-100 development, with $1.3 million drawn as of March 31, 202564 - The company holds multiple license and asset purchase agreements requiring potential future milestone and royalty payments upon achieving development, regulatory, and commercial targets7377838992 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's clinical-stage biopharmaceutical operations, reporting a net loss of $15.2 million for Q1 2025, and projects sufficient cash resources of $161.3 million to fund operations into 2028 - The company's pipeline includes five clinical-stage assets: ALTO-100 (BPD), ALTO-300 (MDD), ALTO-203 (MDD with anhedonia), ALTO-101 (CIAS), and ALTO-202 (MDD)140 Key Clinical Trial Updates and Expected Data Readouts | Product Candidate | Indication | Status | Expected Topline Data | | :--- | :--- | :--- | :--- | | ALTO-100 | BPD | Phase 2b Enrollment Ongoing | H2 2026 | | ALTO-300 | MDD | Phase 2b Enrollment Ongoing | Mid-2026 | | ALTO-203 | MDD | Phase 2 POC Enrollment Complete | Q2 2025 | | ALTO-101 | CIAS | Phase 2 POC | H2 2025 | - The company held $161.3 million in cash, cash equivalents, and restricted cash as of March 31, 2025, projected to fund operations into 2028160199 - Net loss for Q1 2025 was $15.2 million, an increase from $13.4 million in Q1 2024, primarily due to higher G&A costs and a $0.7 million loss on debt extinguishment155173176 Results of Operations Total operating expenses increased to $15.7 million in Q1 2025, driven by a $1.3 million rise in general and administrative expenses and a $0.7 million loss on debt extinguishment, while research and development costs remained stable Research and Development Expenses by Program (in thousands) | Program | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | ALTO-100 | $1,124 | $2,207 | $(1,083) | | ALTO-300 | $922 | $1,116 | $(194) | | ALTO-101 | $969 | $406 | $563 | | ALTO-203 | $737 | $620 | $117 | | Personnel-related costs | $5,093 | $4,353 | $740 | | Total R&D | $9,974 | $9,952 | $22 | - General and administrative expenses increased by $1.3 million, from $4.4 million in Q1 2024 to $5.7 million in Q1 2025, primarily due to higher personnel costs and professional fees associated with public company operations175 - Other income, net, decreased by $0.5 million, mainly due to a $0.7 million loss on debt extinguishment in Q1 2025176 Liquidity and Capital Resources As of March 31, 2025, the company held $161.3 million in cash, cash equivalents, and restricted cash, with operations funded by IPO proceeds and debt facilities, projected to be sufficient into 2028 - The company held $161.3 million in cash, cash equivalents, and restricted cash as of March 31, 2025178 - In January 2025, the company amended its loan agreement, increasing the total facility to $75.0 million and drawing $20.0 million, with approximately $10.0 million used for refinancing179182 - In July 2024, the company secured a convertible grant agreement with Wellcome for up to approximately $11.7 million to fund ALTO-100 development190 - Net cash used in operating activities increased to $16.6 million in Q1 2025 from $11.0 million in Q1 2024, mainly due to timing of bonus payments and higher operational spending195 - Net cash from financing activities was $9.1 million in Q1 2025 from new loan proceeds, compared to $134.6 million in Q1 2024 from the IPO197198 - Management projects current cash and equivalents will sufficiently fund operating expenses and capital requirements into 2028199 Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, the company is exempt from providing quantitative and qualitative disclosures about market risk - As a smaller reporting company, Alto Neuroscience, Inc. is not required to provide quantitative and qualitative disclosures about market risk220 Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - The Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2025221222 - No material changes occurred in internal control over financial reporting during Q1 2025223 Part II - Other Information Legal Proceedings The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business - As of the report date, the company is not involved in any legal proceedings expected to have a material adverse effect on the business227 Risk Factors No material changes have occurred to the risk factors previously disclosed in the company's Annual Report on Form 10-K - No material changes have occurred to the risk factors previously disclosed in the company's Annual Report228 Unregistered Sales of Equity Securities and Use of Proceeds The company reports no unregistered sales of equity securities and no material change in the planned use of $133.0 million net proceeds from its February 2024 IPO - The company's IPO closed on February 6, 2024, generating $133.0 million in net proceeds from the sale of 9,246,000 shares at $16.00 per share230231 - No material change has occurred in the planned use of IPO proceeds231 Defaults Upon Senior Securities Not applicable Mine Safety Disclosures Not applicable Other Information Not applicable Exhibits This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, financial agreements, and officer certifications