AVTX — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-06

• We are a clinical stage biotechnology company dedicated to developing therapeutics targeting the IL-1β pathway for immune-mediated inflammatory diseases. Avalo is advancing its lead anti-IL-1β monoclonal antibody (“mAb”) drug candidate, abdakibart, into a phase 3 registrational program in hidradenit…

• In the second quarter of 2026, we 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=0.018 150 mg, p=0.015 300mg and p=0.004, combined), demonstrating a 42.2% and 42.9% absolute…

• In June 2026, we announced the appointment of Ron Philip to our Board of Directors. Mr. Philip contributes deep strategic and commercial expertise, with a proven track record of bringing novel therapeutics to market.

• Based on our current operating plans, we expect that our existing cash, cash equivalents and investments are sufficient to fund operations into 2029. We closely monitor our cash and cash equivalents and seek to balance the level of cash and cash equivalents with our projected needs to allow us to wi…

• •Advancing our pipeline through development to regulatory approval—notably and in the near term by preparing to initiate our pivotal trials and considering further indication expansion for abdakibart;

Text removed vs the prior filing · source: 10-Q · 2026-05-13

• We are a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases. Our lead asset, abdakibart (AVTX-009), is an anti-IL-1β monoclonal antibody (“mAb”). Positive topline data was recently reported for abdakibart in a Phase 2 c…

• 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 re…

• On May 5, 2026, the Company announced positive topline results from its Phase 2 LOTUS trial evaluating the efficacy and safety of abdakibart in adults with moderate to severe HS. The trial successfully met its primary endpoint at both doses studied. Based on these data, we plan to advance abdakibart…

• On April 26, 2026, the Company entered into a Milestone Buyout Option and Amendment Agreement to the Agreement and Plan of Merger and Reorganization (the “Buyout Agreement”) pursuant to which the Company agreed to pay $2.25 million to the former AlmataBio, Inc. (“AlmataBio”) stockholders for an opti…

• On May 7, 2026, the Company completed a follow-on offering of its common stock and pre-funded warrants to purchase shares of common stock. The Company issued and sold 22,899,500 shares of common stock, including full exercise of the underwriters’ option to purchase an additional 3,169,500 shares, at…

Text added vs the prior filing · source: 10-Q · 2026-08-06

• During the three months ended June 30, 2026, the following directors and executive officers had adopted, modified or terminated contracts, instructions or written plans for purchase or sale of our securities as follows:

• Name and TitleType of Trading ArrangementAction Taken (Date of Action)Duration or End Date

• Garry Neil, M.D., Chief Executive OfficerTrading plan intended to satisfy the affirmative defense conditions of Securities Exchange Act Rule 10b5-1(c)Adoption (May 28, 2026)May 31, 2027227,080Exercises of vested stock options and sales of shares of the Company’s common stock pursuant to terms of the…

• Christopher Sullivan, Chief Financial OfficerTrading plan intended to satisfy the affirmative defense conditions of Securities Exchange Act Rule 10b5-1(c)Modification (May 18, 2026)May 31, 2027

• Exercises of vested stock options and sales of shares of the Company’s common stock pursuant to terms of the trading plan

Text removed vs the prior filing · source: 10-Q · 2026-05-13

• During the three months ended March 31, 2026, none of our directors or officers (as defined in rule 16a-1 (f) under the Exchange Act) adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement” (as such terms are defined in Item 408 of Regulation S-…