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]

Company Overview - Avalo Therapeutics, Inc. is a clinical-stage biotechnology company focused on treating immune dysregulation [4] - The company's lead asset is AVTX-009, an anti-IL-1β monoclonal antibody targeting inflammatory diseases [4][5] Leadership Changes - Michael Heffernan has been appointed as the new Chairman of the Board, succeeding Dr. Garry Neil, who remains as a Board member and CEO [1][2] - Dr. Neil emphasized the importance of Heffernan's experience in building biopharmaceutical companies and driving shareholder value during a critical growth phase for Avalo [2] Strategic Direction - Heffernan expressed confidence in Avalo's potential for success, citing a strong management team, promising mechanisms of action, and sufficient capital to achieve transformative data from the ongoing Phase 2 LOTUS trial for hidradenitis suppurativa [2] - The company is considering indication expansion as part of its strategic growth [2] Product Information - AVTX-009 is designed to bind to interleukin-1β (IL-1β) with high affinity, neutralizing its activity, which is crucial in the inflammatory process [5] - The inhibition of IL-1β is believed to be effective in treating hidradenitis suppurativa and various inflammatory diseases across dermatology, gastroenterology, and rheumatology [5]

Core Viewpoint - Stifel has initiated coverage on Avalo Therapeutics, highlighting the potential of its lead asset AVTX-009 in treating inflammatory diseases, particularly hidradenitis suppurativa (HS) [1][4]. Group 1: Clinical Trials and Efficacy - Avalo is conducting a Phase 2 LOTUS trial with approximately 180 adults to assess the efficacy and safety of AVTX-009 with bi-weekly and monthly dosing regimens compared to placebo, with topline data expected in 2026 [1]. - The proof-of-concept data from AbbVie's lebrikizumab suggests that IL-1β blockade is a key driver of efficacy, which de-risks the development of AVTX-009 for HS [2]. - AbbVie's Phase 2 results indicated that patients receiving lutikizumab had higher response rates compared to placebo, with 59.5% and 48.7% response rates for different dosing schedules [3]. Group 2: Market Potential and Financial Outlook - Stifel believes that AVTX-009 can achieve comparable efficacy to lutikizumab, potentially capturing a meaningful share of the HS market, which is projected to exceed $2 billion in the US [4]. - The company has a favorable risk-reward profile heading into the Phase 2 data release in 2026, supported by strong external newsflow in the next 12 months [5]. - As of December 31, 2024, Avalo had cash and cash equivalents of $134.5 million, which is expected to fund operations into at least 2027 [5]. Group 3: Stock Performance and Analyst Rating - Stifel has initiated coverage with a Buy rating and a price target of $36 for Avalo Therapeutics [4]. - The stock price of AVTX increased by 15.5% to $8.81 as of the last check [5].

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].

Core Insights - Avalo Therapeutics, Inc. reported significant advancements in 2024, including the acquisition of AVTX-009, a monoclonal antibody targeting interleukin-1β, and the initiation of the Phase 2 LOTUS trial for hidradenitis suppurativa [2][5][9] Business Updates - The company acquired AVTX-009 in March 2024 and filed an IND application with the FDA, launching the Phase 2 LOTUS trial, with the first patient enrolled in October 2024 [2][5] - The primary focus for 2025 is executing the LOTUS trial, with topline data expected in 2026, while also exploring broader applications for AVTX-009 [2][5][6] - Jennifer Riley was appointed as Chief Strategy Officer to guide strategy and pipeline planning for HS and other inflammatory market opportunities [5][6] Financial Performance - As of December 31, 2024, Avalo had approximately $135 million in cash, expected to fund operations into at least 2027 [5][6] - Research and development expenses increased to $24.4 million in 2024, up from $13.8 million in 2023, primarily due to costs associated with the Phase 2 LOTUS trial [6][8] - The net loss for 2024 was $35.1 million, an increase from $31.5 million in 2023, driven by higher operating expenses [6][8] Key Financial Metrics - Cash and cash equivalents were $134.5 million as of December 31, 2024, compared to $7.4 million in 2023 [7] - Total revenues for 2024 were $441,000, down from $1.9 million in 2023 [8] - Basic net loss per share was $7.94 for 2024, compared to $113.58 for 2023 [8]

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]

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]

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]