QTTB — what changed in the latest 10-Q

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

• We are a clinical stage biotechnology company focused on developing innovative therapies for alopecia areata (“AA”) and other autoimmune and inflammatory diseases.

• Across all clinical trials, bempikibart has been dosed in over 150 participants to-date and has demonstrated a favorable safety and tolerability profile, with no Grade 3 or higher related adverse events.

• We announced completion of enrollment in the SIGNAL-AA Part B clinical trial in October 2025. We enrolled 33 patients in the SIGNAL-AA Part B trial and dosing remains ongoing. We expect to report 36-week topline data from the SIGNAL-AA Part B trial in mid-2026.

• Following completion of the SIGNAL-AA Part B trial through 52 weeks, eligible patients can enter an open-label extension (“OLE”) period to enable longer-term follow-up and continued dosing. The first patient has been dosed in the OLE portion of Part B.

• In April 2025, we announced the initiation of an OLE trial for eligible patients that completed Part A to enable longer-term follow-up of patients. The OLE trial is complete, and we intend to report findings from the trial with the Part B 36-week topline results in mid-2026.

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• We are a clinical stage biotechnology company focused on developing novel biologics to effectively and safely restore healthy immune balance in patients with autoimmune and inflammatory diseases driven by pathological immune dysfunction.

• Bempikibart is being evaluated for the treatment of AA in the ongoing Part B of the SIGNAL-AA Phase 2a clinical trial. Enrollment has been completed in the Part B portion of the clinical trial, with 33 patients enrolled and dosing remains ongoing.

• In April 2025, we announced that the FDA has granted Fast Track designation (“FTD”) to bempikibart for the treatment of AA. FTD is a process designed to facilitate the development and expedite the review of new drugs to treat serious diseases and fill an unmet medical need with the purpose of gettin…

• ADX-097, a Phase 2 asset and the lead product candidate from our complement inhibitor platform, is a humanized anti-C3d monoclonal antibody (“mAb”) fusion protein. ADX-097 is designed to restore complement regulation – an integral part of the innate immune system – through a tissue targeted mechanis…

• In preclinical studies, ADX-097 distributed to affected tissues/organs and demonstrated durable tissue PK and PD properties. We have completed a Phase 1 clinical trial of ADX-097 in healthy volunteers and observed circulating PK/PD consistent with preclinical studies, which established in vivo integ…

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

• We previously completed a Phase 1 clinical trial of ADX-097 in healthy volunteers and initiated a Phase 2 clinical trial of this candidate. However, in November 2025, we sold to Akebia substantially all of our assets related to the research, development, manufacture and commercialization of ADX-097.…

• Before obtaining marketing approval from regulatory authorities for the sale of any product candidate, we must complete preclinical studies and then conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidate in humans. Our clinical trials may not be conducted a…

• Additionally, we are currently conducting an “open-label” clinical trial. An open-label trial is one where both the patient and investigator know whether the patient is receiving the investigational product candidate. Such trials may test only the investigational product candidate and sometimes may …

• Although we plan to seek regulatory guidance in designing and conducting our development plans, we cannot be sure that the FDA or comparable foreign regulatory authorities will agree with these plans. If the FDA or comparable regulatory authorities requires us to revise or amend a clinical trial, ge…

• For example, the OBBBA enacted significant Medicaid reforms, including approximately $1 trillion in federal spending reductions through 2034. Among other provisions, the legislation imposes work requirements for certain adult Medicaid enrollees, mandates more frequent eligibility redeterminations, a…

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• We previously completed a Phase 1 clinical trial of ADX-097 in healthy volunteers and initiated a Phase 2 clinical trial of this candidate. However, in February 2025, we announced that we were discontinuing the Phase 2 clinical trial of ADX-097 to focus our resources on the bempikibart clinical deve…

• Before obtaining marketing approval from regulatory authorities for the sale of any product candidate, we must complete preclinical studies and then conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidate in humans. Our clinical trials may not be conducted a…

• Although we plan to seek regulatory guidance in designing and conducting our development plans, we cannot be sure that the FDA or comparable foreign regulatory authorities will agree with these plans. If the FDA or comparable regulatory authorities requires us to revise or amend a clinical study, ge…

• policies or guidance that adversely affect us or create a more challenging or costly environment to pursue the development of new therapeutic candidates.

• For example, the Inflation Reduction Act of 2022 (IRA) previously exempted an orphan drug from Medicare drug price negotiations if the drug had received only one orphan designation and was approved solely for that rare disease or condition. However, the One Big Beautiful Bill Act of 2025 (the “OBBBA…