AVTX

Achieved positive topline results in Phase 2 LOTUS trial of abdakibart in moderate to severe hidradenitis suppurativa (HS) and plan to advance into a registrational phase 3 program Completed public offering of equity securities for gross proceeds of $431.3 million Cash, cash equivalents, and short-term investments of $82 million as of March 31, 2026, not including the subsequent financing WAYNE, Pa., May 13, 2026 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX) (“Avalo”), a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases, today announced business updates and first quarter 2026 financial results. “The positive Phase 2 LOTUS trial results of abdakibart in HS, which demonstrated a deep and consistent clinical response across both HiSCR75 and HiSCR50 endpoints, mark the beginning of a transformative period for Avalo,” said Garry Neil, MD, Chief Executive Officer of Avalo. “With our recently secured financing, Avalo is well-positioned to advance abdakibart into a registrational phase 3 program. Our focus remains on delivering this innovative mechanism of action via a patient-friendly potential monthly dosing regimen to provide a much-needed new treatment option for those living with HS.” Recent Corporate Highlights: On May 5, 2026, Avalo reported positive topline Phase 2 LOTUS results for abdakibart in adults with moderate to severe HS. The trial successfully met its primary endpoint at both doses studied (p=0.018 150mg, p=0.015 300mg and p=0.004, combined), demonstrating a 42.2% and 42.9% absolute improvement in HiSCR75 response rates at Week 16, respectively (42.5% combined; placebo rate 25.6%). These results represented the highest absolute improvement in HiSCR75 and HiSCR50 reported in similarly sized (or larger) HS trials at each individual dose and on a combined dose basis. Abdakibart also demonstrated statistically significant benefit across the key secondary endpoints, including HiSCR50, change in IHS4, and change in draining tunnel count. On May 7, 2026, Avalo completed an underwritten public offering of its common stock and pre-funded warrants to purchase shares of common stock for gross proceeds of $431.3 million. On April 26, 2026, Avalo entered into a Milestone Buyout Option and Amendment Agreement related to its March 2024 acquisition of AlmataBio, Inc. Un...

Successfully met primary endpoint of HiSCR75 for both doses studied, demonstrating response rates of 42.2% for 150 mg dose (p=0.018) and 42.9% for 300 mg dose (p=0.015) at Week 16, which are the highest rates observed in a trial of this size or larger Statistically significant benefit was demonstrated on key secondary endpoints of HiSCR50, change in IHS4 and change in draining tunnel count Abdakibart was well tolerated with a favorable safety profile Avalo plans to advance abdakibart into a registrational phase 3 program WAYNE, Pa., May 05, 2026 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company fully dedicated to developing IL-1β based treatments for immune-mediated inflammatory diseases, today announced positive topline results from its Phase 2 LOTUS trial evaluating the efficacy and safety of abdakibart in adults with moderate to severe hidradenitis suppurativa (HS). The LOTUS trial successfully met its primary endpoint at both doses studied. Based on these data, Avalo plans to advance abdakibart into a registrational phase 3 program. "We are proud to report that abdakibart has delivered a strong, consistent, and deep response across both the HiSCR75 and HiSCR50 endpoints in our Phase 2 trial. This achievement powerfully validates the clinical promise of IL-1β inhibition for hidradenitis suppurativa," said Garry Neil, MD, Chief Executive Officer of Avalo Therapeutics. “This de-risking data set gives us tremendous confidence to advance abdakibart into a pivotal phase 3 registrational program. With a differentiated and patient friendly potential monthly dosing regimen, we aim to offer a truly innovative mechanism of action to the HS community. Our heartfelt thank you goes to the patients, caregivers, investigators, and site teams whose dedication made this successful Phase 2 trial possible." The LOTUS trial (NCT06603077), which enrolled 253 adults, was a randomized, double-blind, placebo-controlled parallel-group Phase 2 trial to evaluate the efficacy, safety and tolerability of abdakibart across two dose regimens and placebo in a 1:1:1 ratio over a 16-week treatment period. Subjects received either a 600mg loading dose of abdakibart followed by 300mg every four weeks or a 300mg loading dose followed by 150mg every two weeks. The trial’s primary efficacy endpoint was the proportion of patients achieving HiSCR...

Topline data expected from Phase 2 LOTUS trial of abdakibart (AVTX-009) for the treatment of hidradenitis suppurativa in the second quarter of 2026 Cash, cash equivalents and short-term investments of approximately $98 million as of December 31, 2025 expected to provide runway into 2028 WAYNE, Pa., March 23, 2026 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX) (“Avalo”), a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases, today announced business updates and year-end financial results for 2025. “2025 was a year of disciplined execution focused on the LOTUS trial, and we are thrilled to be approaching a transformational milestone with our topline data release expected in the second quarter of 2026,” said Dr. Garry Neil, Chief Executive Officer. “We look forward to sharing the results which have the potential to demonstrate abdakibart’s (AVTX-009) high affinity inhibition of IL-1β and positive impact on addressing the large unmet need of patients living with hidradenitis suppurativa.” Upcoming Anticipated Milestone: Abdakibart (AVTX-009) Phase 2 LOTUS trial: The global study which includes approximately 250 adults with hidradenitis suppurativa (HS) is designed to evaluate the efficacy and safety of subcutaneous bi-weekly and monthly dosing regimens compared to placebo. Topline data expected in the second quarter of 2026. 2025 Financial Update: Cash, cash equivalents and short-term investments were $98.3 million as of December 31, 2025. Net cash used in operating activities was $51.5 million for the year ended December 31, 2025. Avalo’s current cash, cash equivalents and short-term investments are expected to fund operations into 2028. Research and development expenses were $50.1 million for the year ended December 31, 2025, an increase of $25.6 million from the year ended December 31, 2024, driven by costs related to and supporting the Phase 2 LOTUS trial. General and administrative expenses were $22.9 million for the year ended December 31, 2025, an increase of $5.7 million from the year ended December 31, 2024, primarily driven by stock-based compensation expense and headcount additions. Net loss was $78.3 million for the year ended December 31, 2025, as compared to net loss of $35.1 million for the year ended December 31, 2024. The difference was driven by $38.7 m...

Completed enrollment in Phase 2 LOTUS trial of AVTX-009 for the treatment of hidradenitis suppurativa; topline data expected mid-2026 Appointed Kevin Lind to Board of Directors Expanded leadership team with key appointments in business development and human resources Cash and short-term investments of approximately $112 million as of September 30, 2025 expected to provide runway into 2028 WAYNE, Pa., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases, today announced business updates and financial results for the third quarter of 2025. “Now that enrollment is complete, we’re fully focused on completing the LOTUS trial, preparing for the data readout in mid-2026, and progressing our Phase 3 planning,” said Dr. Garry Neil, Chief Executive Officer. “This marks an important transition for Avalo as we turn our focus from enrollment to completion of the trial, guided by strong conviction in AVTX-009’s high-affinity inhibition of IL-1β and its potential to deliver meaningful benefit for people living with hidradenitis suppurativa.” Recent Corporate Highlights and Upcoming Anticipated Milestones: Announced completion of enrollment of the Phase 2 LOTUS trial. The global trial includes approximately 250 adults with moderate to severe hidradenitis suppurativa to evaluate the efficacy and safety of subcutaneous bi-weekly and monthly dosing regimens compared to placebo. Topline data expected in mid-2026. Appointed Kevin Lind to the Board of Directors. Mr. Lind brings extensive leadership experience spanning financial and corporate strategy as well as business development execution at development-stage biotech companies. Expanded leadership team with the appointment of Taylor Boyd as Chief Business Officer and Ashley Ivanowicz as Senior Vice President, Human Resources. Third Quarter 2025 Financial Update: Cash, cash equivalents and short-term investments were $111.6 million as of September 30, 2025. Net cash used in operating activities was $37.2 million for the nine months ended September 30, 2025. The Company’s current cash, cash equivalents and short-term investments are expected to fund operations into 2028. Research and development expenses were $13.6 million for the third quarter of 2025, an increase of $4.1 mi...

Topline data from Phase 2 LOTUS trial of AVTX-009 for the treatment of hidradenitis suppurativa expected mid-2026 Rita Jain, M.D. appointed to Board of Directors Cash and short-term investments of approximately $113 million as of June 30, 2025 expected to provide runway into 2028 WAYNE, Pa., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases, today announced business updates and financial results for the second quarter of 2025. “The team has made tremendous progress on the execution of the Phase 2 LOTUS trial in hidradenitis suppurativa (HS). We have enrolled over three-quarters of the planned patients and are on track to complete enrollment by year end with top-line results expected mid-2026,” said Dr. Garry Neil, Chief Executive Officer. “We are focused on executing the LOTUS trial and advancing toward Phase 3 readiness.” Recent Corporate Highlights and Upcoming Anticipated Milestones: Phase 2 LOTUS trial: The global study design includes approximately 222 adults with HS to evaluate the efficacy and safety of subcutaneous bi-weekly and monthly dosing regimens compared to placebo. Topline data expected in mid-2026. Appointed Rita Jain, M.D. to the Board of Directors. Dr. Jain brings extensive experience spanning clinical development, regulatory strategy, and executive leadership at development-stage biopharma companies. Second Quarter 2025 Financial Update: Cash, cash equivalents and short-term investments were $113.3 million as of June 30, 2025. Net cash used in operating activities was $20.8 million for the six months ended June 30, 2025. The Company’s current cash, cash equivalents and short-term investments are expected to fund operations into 2028. Research and development expenses were $14.1 million for the second quarter of 2025, an increase of $9.5 million from the second quarter of 2024, driven by costs related to and supporting the Phase 2 LOTUS trial. General and administrative expenses were $5.2 million for the second quarter of 2025, an increase of $0.7 million from the second quarter of 2024, primarily driven by stock-based compensation expense. Net loss was $20.8 million for the second quarter of 2025, as compared to net income of $98.5 million for the second quarter of 2024. The differe...

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 year-end financial results for 2024. “2024 was a transformational year for Avalo, and I am proud of the accomplishments the team has made in a short amount of time,” said Dr. Garry Neil, Chief Executive Officer and Chairman of the Board. “In March 2024, we acquired AVTX-009, a promising monoclonal antibody targeting interleukin-1β. We filed our IND application with the FDA, designed and launched the Phase 2 LOTUS trial in hidradenitis suppurativa (“HS”) and rapidly progressed its initiation, including IND activation in July and enrollment of the first patient in October. Our primary focus in 2025 is executing the LOTUS trial to release data in 2026, while exploring broader applications for AVTX-009 and announcing a second indication.” Recent Corporate Highlights and Upcoming Anticipated Milestones: Initiation of Phase 2 LOTUS trial: The global study design includes approximately 180 adults with HS to evaluate the efficacy and safety of subcutaneous bi-weekly and monthly dosing regimens compared to placebo. Topline data is expected in 2026. Second Indication Exploration: Avalo continues to evaluate AVTX-009 for additional immune-mediated diseases with plans to announce a second indication. Appointment of Jennifer Riley as Chief Strategy Officer: Effective January 1, 2025, Ms. Riley is guiding strategy and pipeline planning for HS and other inflammatory market opportunities. 2024 Financial Update: Cash and cash equivalents were $134.5 million as of December 31, 2024, supported by $185 million in gross proceeds received from a private placement in 2024. Net cash used in operating activities was $49.1 million for the year ended December 31, 2024, which includes $12.5 million of milestone payments to former shareholders of AlmataBio, Inc. pursuant to the terms of the acquisition. The Company’s current cash on hand is expected to fund operations into at least 2027...