Company Overview - Avalo Therapeutics, Inc. is a clinical stage biotechnology company focused on the treatment of immune dysregulation [3] - The company's lead asset is AVTX-009, an anti-IL-1β monoclonal antibody targeting inflammatory diseases [3] Leadership Appointment - Dr. Rita Jain has been appointed to Avalo's Board of Directors, bringing over two decades of leadership experience in biopharmaceutical development [2] - Dr. Jain's previous roles include Executive Vice President and Chief Medical Officer at ChemoCentryx, where she advanced the development of Tavneos® [2] - Her expertise spans clinical development, regulatory strategy, and executive leadership across multiple therapeutic areas, including immunology and inflammation [2] Product Development - AVTX-009 is currently in a Phase 2 trial for hidradenitis suppurativa (HS), with results expected in the middle of next year [2] - The drug is a humanized monoclonal antibody that binds to interleukin-1β (IL-1β), a key driver in the inflammatory process, and is implicated in various autoimmune and inflammatory diseases [4] - Inhibition of IL-1β is considered a validated target for therapeutic intervention in multiple inflammatory diseases [4]

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]

Company Overview - Avalo Therapeutics, Inc. is a clinical stage biotechnology company focused on the treatment of immune dysregulation [3] - The company's lead asset is AVTX-009, an anti-IL-1β monoclonal antibody targeting inflammatory diseases [3] Product Information - AVTX-009 is a humanized monoclonal antibody (IgG4) that binds to interleukin-1β (IL-1β) with high affinity and neutralizes its activity [4] - IL-1β is a central driver in the inflammatory process, and its overproduction is implicated in many autoimmune and inflammatory diseases [4] - Inhibition of IL-1β could be effective in treating conditions such as hidradenitis suppurativa and various inflammatory diseases in dermatology, gastroenterology, and rheumatology [4] Upcoming Events - Dr. Garry Neil, CEO of Avalo, will present at the Citizens Life Sciences Conference in New York on May 8, 2025, at 3:00 pm ET [1]

Leiden, the Netherlands, April 25, 2025: Pharming Group N.V. ("Pharming" or "the Company") (NASDAQ:PHAR) announces the following presentations by the Company or its collaborators at the 2025 Annual Meeting of the Clinical Immunology Society (CIS), taking place May 1-4, 2025 in Philadelphia, PA. These presentations include Phase III clinical data for leniolisib for pediatric patients aged 4-11 years with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) and insights into APDS and additional p ...