Core Insights - Avalo Therapeutics, Inc. is making significant progress in its Phase 2 LOTUS trial for AVTX-009, targeting hidradenitis suppurativa (HS), with topline data expected in 2026 [2][5] - The company has sufficient capital, approximately $125 million as of March 31, 2025, to fund operations into at least 2027, with potential to extend into 2028 [5][6] - The company is evaluating additional development activities beyond the LOTUS trial, considering current market conditions [2][5] Financial Performance - Cash and cash equivalents were reported at $125.0 million as of March 31, 2025, down from $134.5 million at the end of 2024 [7] - Net cash used in operating activities for Q1 2025 was $9.5 million, with research and development expenses increasing to $9.1 million, up from $2.1 million in Q1 2024 [6][9] - The net loss for Q1 2025 was $13.1 million, a significant decrease from $121.3 million in Q1 2024, primarily due to a reduction in other expenses related to prior period warrants [6][9] Trial and Development Updates - The LOTUS trial involves approximately 180 adults with HS, evaluating the efficacy and safety of AVTX-009 with expected topline data in 2026 [6][12] - The primary efficacy endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16 [12] - Avalo is also exploring AVTX-009 for additional immune-mediated diseases and plans to announce a second indication [6][12] Corporate Highlights - Mike Heffernan has been appointed as Chairman of the Board [5] - The company continues to focus on its lead asset, AVTX-009, which targets inflammatory diseases by neutralizing interleukin-1β [10][11]
Avalo Reports First Quarter 2025 Financial Results and Recent Business Updates