Earnings summaries and quarterly performance for Avalo Therapeutics.
Executive leadership at Avalo Therapeutics.
Board of directors at Avalo Therapeutics.
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Recent press releases and 8-K filings for AVTX.
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
Avalo Therapeutics provides update on AVTX-009 Phase 2B trial for HS
AVTX
New Projects/Investments
- Avalo Therapeutics (AVTX) is developing AVTX-009, a potent anti-IL-1β inhibitor, for Hidradenitis Suppurativa (HS).
- The company acquired the asset in 2024 and has since fully enrolled its Phase 2B trial for AVTX-009, completing enrollment at the end of October, ahead of schedule.
- Data from the Phase 2B trial is anticipated by the end of the second quarter next year.
- The trial was initially powered for 180 patients but over-enrolled to over 250 patients, increasing statistical power.
- AVTX-009 is expected to offer a more patient-friendly dosing regimen of every four weeks and has a favorable safety profile compared to other treatments.
Nov 13, 2025, 2:00 PM
Avalo Therapeutics Provides Update on AVTX-009 Phase 2b Trial
AVTX
New Projects/Investments
Guidance Update
- Avalo Therapeutics is developing AVTX-009, a fully human anti-IL-1β monoclonal antibody, currently in a Phase 2b trial for Hidradenitis Suppurativa (HS).
- Enrollment for the Phase 2b Lotus study was completed on October 28th with over 250 patients.
- Topline data from the Phase 2b trial is anticipated by mid-2026.
- The company has $110 million in cash, providing a runway through 2028, and plans to raise capital for Phase 3 development.
- AVTX-009 is characterized by its 15 times higher potency compared to Lutikizumab, along with a longer half-life and higher bioavailability.
Nov 12, 2025, 7:40 PM
Avenzo Therapeutics Receives Fast Track Designation for AVZO-1418
AVTX
New Projects/Investments
- Avenzo Therapeutics announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to AVZO-1418 (DB-1418).
- AVZO-1418 is a potential best-in-class EGFR/HER3 bispecific antibody-drug conjugate.
- The designation is for the treatment of patients with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations, whose disease has progressed after EGFR tyrosine kinase inhibitor (TKI) therapy.
- This Fast Track designation is expected to expedite the development and review of AVZO-1418, which is currently in a Phase 1/2 clinical study.
Nov 10, 2025, 2:00 PM
Avalo Therapeutics Reports Q3 2025 Financial Results and Business Updates
AVTX
Earnings
Guidance Update
Board Change
- Avalo Therapeutics, Inc. reported a net loss of $30.6 million for the third quarter of 2025, compared to a net income of $23.0 million for the third quarter of 2024. Basic and diluted net loss per share for Q3 2025 was $2.19.
- As of September 30, 2025, the company had $111.6 million in cash, cash equivalents, and short-term investments, which is expected to fund operations into 2028.
- Research and development expenses increased by $4.1 million to $13.6 million in Q3 2025, while general and administrative expenses rose by $1.3 million to $5.6 million compared to the third quarter of 2024.
- Enrollment for the Phase 2 LOTUS trial of AVTX-009 for hidradenitis suppurativa has been completed, with topline data anticipated in mid-2026.
- Kevin Lind was appointed to the Board of Directors, and the leadership team was expanded with new appointments in business development and human resources.
Nov 6, 2025, 12:02 PM
Avalo Therapeutics Reports Third Quarter 2025 Financial Results and Business Updates
AVTX
Earnings
Board Change
Management Change
- Avalo Therapeutics reported cash and short-term investments of $111.6 million as of September 30, 2025, which are expected to fund operations into 2028. The company posted a net loss of $30.6 million for the third quarter of 2025.
- The company completed enrollment in its Phase 2 LOTUS trial of AVTX-009 for hidradenitis suppurativa, with topline data anticipated in mid-2026.
- Kevin Lind was appointed to the Board of Directors, and the leadership team was expanded with Taylor Boyd as Chief Business Officer and Ashley Ivanowicz as Senior Vice President, Human Resources.
Nov 6, 2025, 12:00 PM
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