Earnings summaries and quarterly performance for Avalo Therapeutics.
Executive leadership at Avalo Therapeutics.
Board of directors at Avalo Therapeutics.
Research analysts covering Avalo Therapeutics.
Recent press releases and 8-K filings for AVTX.
Avalo Therapeutics Awaits Key Phase II Data for HS Program in Q2 2026
AVTX
New Projects/Investments
Guidance Update
- Avalo Therapeutics (AVTX) anticipates a key clinical readout for its AVTX-009 program in moderate to severe hidradenitis suppurativa (HS) in Q2 2026.
- The AVTX-009 program utilizes a novel anti-IL-1\u03b2 mechanism and targets a HiSCR75 primary endpoint, a more stringent measure, with trial design efforts to manage placebo response.
- The company highlights AVTX-009's potential for monthly dosing convenience and a favorable safety profile compared to existing treatments, which could be disruptive in the sizable HS market.
- Avalo Therapeutics has approximately $95 million in cash, providing runway beyond the upcoming data release, but will need to raise capital for Phase III trials.
3 days ago
Avalo Therapeutics Awaits Key Phase II Data for HS Treatment in Q2
AVTX
New Projects/Investments
Guidance Update
- Avalo Therapeutics (AVTX) is expecting a top-line phase II data reveal for its anti-IL-1β monoclonal antibody, AVTX-009, in moderate to severe hidradenitis suppurativa (HS) in 2Q.
- The company emphasizes the significant market opportunity in HS, noting it is a multi-billion dollar and rapidly growing U.S. market affecting over 1% of the population.
- AVTX-009 is distinguished by its high affinity for IL-1β, which is intended to improve drug penetration into lesions, and the trial's primary endpoint is HiSCR75, a more clinically relevant measure than HiSCR50. The drug also aims for a convenient single dose every 4 weeks and a potentially benign safety profile.
- Avalo Therapeutics reported $95 million in cash, which is sufficient to fund operations comfortably beyond the upcoming data release, with plans to raise capital for Phase III trials, potentially commencing in 2027.
3 days ago
Avalo Therapeutics Discusses AVTX-009 Phase II Readout and Future Plans
AVTX
New Projects/Investments
Guidance Update
- Avalo Therapeutics (AVTX) is developing AVTX-009, an anti-IL-1β monoclonal antibody, for moderate to severe hidradenitis suppurativa (HS).
- A key clinical readout (top-line phase II reveal) for AVTX-009 in HS is expected in 2Q.
- The Lotus trial's primary endpoint is HiSCR75, representing a 75% or greater reduction in abscess or inflammatory nodule count, which is considered more clinically relevant than HiSCR50.
- The company plans to discuss Phase III design with the FDA after the Phase II data release, potentially aiming for a single pivotal trial, with Phase III possibly starting in 2027.
- Avalo Therapeutics reported approximately $95 million in cash, which is sufficient to fund operations beyond the data release, but will require additional capital for Phase III.
3 days ago
Avalo Therapeutics Provides Update on AVTX-009 Phase IIb LOTUS Trial and Q2 2026 Data Readout
AVTX
Guidance Update
New Projects/Investments
- Avalo Therapeutics (AVTX) is preparing to release Phase IIb data from its LOTUS trial for AVTX-009 in moderate to severe Hidradenitis Suppurativa (HS) during the second quarter of 2026.
- The LOTUS trial is a placebo-controlled study with over 250 patients, evaluating two doses of AVTX-009, an anti-IL-1 beta monoclonal antibody, which the company believes has a 10-fold higher affinity and a longer half-life compared to competitors.
- Enrollment for the 16-week study concluded in late October, with the last patients completing the 16-week efficacy visit by mid-February 2026 and the six-week safety follow-up by the end of March 2026, ensuring the full data set is available for the Q2 2026 release.
- The company reported a cash position of $100 million at the end of 2025, with a burn rate of $50 million in 2025, providing sufficient cash to reach the data readout, but additional capital will be required for Phase III development.
- Management indicates that a 20% placebo-subtracted response rate would be a "clear win" for commercial success, with 25% considered a "home run".
Feb 11, 2026, 3:00 PM
Avalo Therapeutics, Inc. Provides Q4 2025 Financial Update and Clinical Development Timelines
AVTX
Guidance Update
New Projects/Investments
- Avalo Therapeutics, Inc. reported estimated cash, cash equivalents, and short-term investments of approximately $98 million as of December 31, 2025, which is expected to provide a cash runway into 2028.
- The company's lead compound, AVTX-009, an anti-IL-1β monoclonal antibody for hidradenitis suppurativa (HS), has completed enrollment in its Phase 2 LOTUS trial.
- Topline data from the Phase 2 LOTUS trial for AVTX-009 is expected in Q2 2026, with the HS market projected to grow to over $10 billion by 2035.
- As of December 31, 2025, the company had 18.5 million common shares outstanding and an adjusted common share count of 37.3 million (assuming conversion of preferred stock), leading to an adjusted market capitalization of $677.5 million.
Jan 12, 2026, 12:53 PM
Avalo Therapeutics Announces Q2 2026 Top-Line Data for LOTUS Trial
AVTX
New Projects/Investments
Guidance Update
Product Launch
- Avalo Therapeutics (AVTX) expects to release top-line data from its Phase 2 LOTUS trial for AVTX-009 in Hidradenitis Suppurativa (HS) in Q2 2026.
- The LOTUS trial over-enrolled with 250 patients (exceeding the target of 222) and is generously powered to demonstrate a 20% delta difference in HiSCR75 with 80% power.
- The company implemented rigorous measures to mitigate the placebo effect, including selecting an experienced CRO (Parexel), comprehensive training for investigators and patients, and strict site monitoring.
- AVTX-009 is expected to differentiate from competitors like Lutikismab due to its 15-fold higher potency and longer half-life, potentially enabling less frequent dosing and superior efficacy.
- Following successful Phase 2 results, Avalo plans to advance AVTX-009 into Phase 3 studies, with the every four-week dose as the preferred anchor, and will seek capital for these trials.
Dec 2, 2025, 3:30 PM
Avalo Therapeutics Provides Update on AVTX-009 LOTUS Trial and Future Plans
AVTX
New Projects/Investments
Guidance Update
- Avalo Therapeutics (AVTX) anticipates releasing top-line data from its Phase II LOTUS trial for AVTX-009 in Hidradenitis Suppurativa (HS) in Q2 2026.
- The LOTUS trial over-enrolled from a target of 222 to over 250 patients, making it one of the largest Phase II HS trials and providing generous powering for subgroup analyses.
- Over one-third of enrolled patients are biologically experienced, and AVTX-009 is positioned to differentiate from competitors like lutikizumab due to its 15x higher potency and longer half-life, potentially enabling less frequent dosing and superior efficacy.
- Following positive Phase II results, Avalo plans to advance AVTX-009 into Phase III studies, with a preferred every four-week dosing regimen, and anticipates seeking capital for these trials, while also exploring other IL-1 beta related indications.
Dec 2, 2025, 3:30 PM
Evolva Therapeutics Provides Update on AVTX009 LOTUS Trial and Phase III Plans
AVTX
Product Launch
New Projects/Investments
- Evolva Therapeutics (AVTX) expects to release top-line data from its Phase II LOTUS trial for AVTX009 in Hidradenitis Suppurativa (HS) in Q2 2026.
- The LOTUS study completed enrollment on October 29 with over 250 patients, exceeding its target, and is generously powered to show an 80% power for a 20% delta difference in HiSCR 75. Over one-third of patients in the trial are biologically experienced, including TNF and IL-17 failures.
- AVTX aims to differentiate AVTX009 from competitors like lutekizumab through a longer dosing interval and potential for higher efficacy due to its 15-fold higher affinity for IL-1 beta.
- The company plans to advance one of the two Phase II doses, preferably the every four-week dose with a 600 mg loading dose, into two large Phase III trials, acknowledging the substantial capital requirements for these studies.
Dec 2, 2025, 3:30 PM
Avalo Therapeutics Posts Updated Investor Presentation
AVTX
New Projects/Investments
Guidance Update
- Avalo Therapeutics, Inc. (AVTX) posted an updated investor presentation on December 2, 2025.
- The company's lead asset, AVTX-009, an anti-IL-1β monoclonal antibody, is being developed for hidradenitis suppurativa (HS).
- Enrollment for the Phase 2 LOTUS trial in HS was completed in October 2025, with topline data expected in Q2 2026.
- The HS market is projected to grow to over $10 billion by 2035.
- Avalo Therapeutics has an expected cash runway into 2028, supported by approximately $112 million in cash, cash equivalents, and short-term investments as of September 30, 2025.
Dec 2, 2025, 11:38 AM
Avalo Therapeutics Provides Update on AVTX-009 Development and Financials
AVTX
New Projects/Investments
Guidance Update
Product Launch
- Avalo Therapeutics' lead compound, AVTX-009 (an anti-IL-1\u03b2 mAb), is being developed for hidradenitis suppurativa (HS) and is anticipated to have a best-in-class profile.
- Enrollment for the Phase 2 LOTUS trial in HS is complete, with topline data expected in Q2 2026.
- The hidradenitis suppurativa market is projected to grow to over $10 billion by 2035.
- As of September 30, 2025, Avalo Therapeutics reported approximately $112 million in cash, cash equivalents, and short-term investments, providing an expected cash runway into 2028.
- The company's adjusted market capitalization was $472.7 million as of September 30, 2025, based on an adjusted share count of 37.2 million and a stock price of $12.71.
Nov 30, 2025, 11:00 PM
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