WAYNE, Pa. and ROCKVILLE, Md., March 26, 2025 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (NASDAQ:AVTX), a clinical-stage biotechnology company dedicated to treating immune dysregulation, today announced the appointment of Michael Heffernan as Chairman of the Board of Directors ("Board"). Mr. Heffernan will succeed Dr. Garry Neil as Chairman of the Board. Dr. Neil will continue as a Board member and Chief Executive Officer (CEO) of the Company. "We are thrilled to welcome Michael to Avalo's Board of Direct ...

On Monday, Stifel initiated coverage on Avalo Therapeutics, Inc. AVTX. Avalo’s lead asset is AVTX-009, an anti-IL-1β mAb targeting inflammatory diseases.The company initiated a Phase 2 LOTUS trial, which will include approximately 180 adults with hidradenitis suppurativa (HS), to evaluate the efficacy and safety of subcutaneous bi-weekly and monthly dosing regimens compared to placebo. Topline data is expected in 2026.Avalo continues to evaluate AVTX-009 for additional immune-mediated diseases with plans to ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______to______ Commission File No. 001-37590 AVALO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) 540 Gaither Road, Su ...

Financial Performance - Avalo Therapeutics reported a net loss of $35.1 million for 2024, an increase of 11.4% from the net loss of $31.5 million in 2023[8]. - Basic net loss per share was $7.94 for 2024, compared to $113.58 for 2023, reflecting a significant increase in the number of shares outstanding[8]. Cash Position - Cash and cash equivalents were approximately $134.5 million as of December 31, 2024, supported by $185 million in gross proceeds from a private placement in 2024[8]. - Total assets increased to $150.7 million as of December 31, 2024, compared to $21.0 million in 2023[9]. Research and Development - Research and development expenses increased to $24.4 million in 2024, up 78% from $13.7 million in 2023, primarily due to costs associated with the Phase 2 LOTUS trial[8]. - The Phase 2 LOTUS trial for AVTX-009 is expected to enroll approximately 180 adults, with topline data anticipated in 2026[5]. - The company plans to explore additional indications for AVTX-009 beyond hidradenitis suppurativa[5]. Administrative Expenses - General and administrative expenses rose to $17.2 million in 2024, an increase of 67% from $10.3 million in 2023, driven by higher employee compensation and professional fees[8]. Strategic Appointments and Focus - The company appointed Jennifer Riley as Chief Strategy Officer, effective January 1, 2025, to guide strategy and pipeline planning[5]. - Avalo's primary focus for 2025 is executing the LOTUS trial and releasing data in 2026[2].

Topline data from Phase 2 LOTUS Trial of AVTX-009 for the treatment of hidradenitis suppurativa expected in 2026 Appointed Jennifer Riley as Chief Strategy Officer Cash on hand of approximately $135 million as of December 31, 2024 expected to provide runway into at least 2027 WAYNE, Pa. and ROCKVILLE, Md., March 20, 2025 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company focused on the treatment of immune dysregulation, today announced business updates and ye ...

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] - Avalo has two additional drug candidates: quisovalimab (anti-LIGHT monoclonal antibody) and AVTX-008 (BTLA agonist fusion protein) [3] Product Details - 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 is implicated in many autoimmune and inflammatory diseases [4] - Evidence suggests that 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 - Management will participate in the TD Cowen 45th Annual Health Care Conference in Boston on March 3, 2025, at 3:10 pm ET [2] - The company will also engage in 1x1 and small group meetings at the Leerink Partners Global Healthcare Conference in Miami on March 12, 2025 [2] - Live webcasts and replays of these events will be available on the Avalo Therapeutics website [2]

WAYNE, Pa. and ROCKVILLE, Md. , Feb. 04, 2025 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (NASDAQ:AVTX), a clinical stage biotechnology company focused on the treatment of immune dysregulation, today announced that Garry A. Neil, M.D., Chief Executive Officer and Chairman of the Board, will present at the virtual Oppenheimer 35th Annual Healthcare Life Sciences Conference on Tuesday, February 11, 2025 at 10:00 a.m ET. Live webcast and replay can be found under "News / Events" in the Investors section of th ...

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] - Avalo has two additional drug candidates: quisovalimab (anti-LIGHT monoclonal antibody) and AVTX-008 (BTLA agonist fusion protein) [3] Product Details - 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] - Evidence suggests that inhibition of IL-1β could be effective in treating hidradenitis suppurativa and various inflammatory diseases in dermatology, gastroenterology, and rheumatology [4] Upcoming Events - Garry A. Neil, M.D., CEO and Chairman of the Board, will present at the virtual Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 11, 2025, at 10:00 a.m. ET [1] - A live webcast and replay of the presentation will be available on the Avalo Therapeutics website for at least 30 days [2]

Core Insights - Avalo Therapeutics has successfully raised a total of $185 million from a private placement, with $69.4 million coming from the full exercise of warrants issued in March 2024 [1][2] - The company is focused on advancing its Phase 2 LOTUS trial for AVTX-009, an anti-IL-1β monoclonal antibody, while also exploring additional inflammatory indications [2][4] Financial Overview - The gross proceeds from the warrant exercise amount to $69.4 million, with an exercise price of $5.796933 per share [2] - The total gross proceeds from the private placement transaction now stand at $185 million, ensuring a cash runway expected to last until at least 2027 [1][2] Company Profile - Avalo Therapeutics is a clinical-stage biotechnology company specializing in treatments for immune dysregulation, with its lead asset being AVTX-009 [3] - The company also has two additional drug candidates: quisovalimab and AVTX-008 [3] Product Information - AVTX-009 is a humanized monoclonal antibody targeting interleukin-1β (IL-1β), which plays a significant role in inflammatory diseases [4] - The drug is being evaluated for its efficacy in treating hidradenitis suppurativa and other inflammatory conditions [4][6] Clinical Trial Details - The LOTUS Trial is a Phase 2, randomized, double-blind, placebo-controlled study involving approximately 180 adults with moderate to severe hidradenitis suppurativa [5] - The primary endpoint is the proportion of subjects achieving a specific clinical response at Week 16, with various secondary objectives related to disease severity and patient-reported outcomes [5]

Company Overview - Avalo Therapeutics, Inc. is a clinical stage biotechnology company focused on the treatment of immune dysregulation [2] - The company's lead asset is AVTX-009, an anti-IL-1β monoclonal antibody targeting inflammatory diseases [2] - Avalo has two additional drug candidates: quisovalimab (anti-LIGHT monoclonal antibody) and AVTX-008 (BTLA agonist fusion protein) [2] Product Details - AVTX-009 is a humanized monoclonal antibody (IgG4) that binds to interleukin-1β (IL-1β) with high affinity and neutralizes its activity [3] - IL-1β is a central driver in the inflammatory process, and its overproduction is implicated in many autoimmune and inflammatory diseases [3] - Evidence suggests that inhibition of IL-1β could be effective in treating conditions such as hidradenitis suppurativa and various inflammatory diseases in dermatology, gastroenterology, and rheumatology [3] Upcoming Events - Garry A. Neil, M.D., CEO and Chairman of the Board, will present at the Stifel 2024 Healthcare Conference on November 18, 2024, at 3:35 PM ET [1] - He will also present at the Piper Sandler 36th Annual Healthcare Conference on December 5, 2024, at 11:00 AM ET [1] - Live webcasts and replays of these presentations will be available on the Avalo Therapeutics website [1]