Open-Label Extension (OLE) Data of STENOVA Phase 2a study with ontunisertib in Fibrostenosing Crohn’s disease (FSCD) selected for oral presentation at UEG Week 2026
Results support initiation of global NOV-ERA Phase 2b study in FSCD
Agomab-sponsored symposium to discuss the importance of targeting fibro-inflammation in inflammatory bowel disease (IBD)

Antwerp, Belgium, October 8, 2026 – Agomab Therapeutics NV (‘Agomab’) a clinical-stage biopharmaceutical company focused on fibro-inflammation, today announced that OLE data of the Phase 2a STENOVA study will be presented in an oral session at United European Gastroenterology (UEG) Week 2026, taking place October 17-20 in Barcelona, Spain. The OLE study (Part B of STENOVA) evaluated long-term treatment with ontunisertib 200 mg BID for up to 60 weeks in symptomatic FSCD patients. The study assessed the long-term safety and PK profile of ontunisertib and explored the event rate and disease progression in FSCD patients.

• Favorable safety and tolerability profile maintained through up to 60 weeks of treatment with ontunisertib in Fibrostenosing Crohn’s disease (FSCD) patients
• Low annualized FSCD-related event rate of 3%, with one endoscopic balloon dilation (EBD) and no surgeries reported over the full treatment period
• Radiological assessment shows trend for fibrotic stricture stabilization over treatment course
• Sustained disease control observed across symptoms and disease activity scores in Open-Label Extension Study (OLE)
• Results support initiation of global NOV-ERA Phase 2b study in FSCD in the coming months
• Company to host webcast today at 8:30 a.m. Eastern Time

Antwerp, Belgium, October 1, 2026 – Agomab Therapeutics NV (‘Agomab’) a clinical-stage biopharmaceutical company focused on fibro-inflammation, today announced positive results of the 48-week OLE portion of the Phase 2a STENOVA trial evaluating ontunisertib in patients with FSCD, a severe manifestation of Crohn’s disease characterized by progressive bowel fibrosis and intestinal strictures.
The OLE study (Part B) evaluated long-term treatment with ontunisertib 200 mg BID on top of standard of care. Of the participants eligible to roll over into the OLE study from the 12-week placebo-controlled Part A of STENOVA, 94% elected to enter the study (n=49).
The results demonstrated a generally favorable long-term safety and tolerability profile of ontunisertib 200 mg BID for up to 60 weeks of treatment, as well as maintenance of the gut-restricted pharmacokinetic (PK) profile observed in Part A of the trial. Sustained disease control, with low symptoms and disease activity scores and radiological stricture stabilization, was also observed. Importantly, a low FSCD-related annualized event rate of 3% was reported in patients treated with ontunisertib 200 mg BID up to 60 weeks.

• Topline Phase 1 data shows generally favorable safety and tolerability profile of AGMB-447
• Pharmacokinetic profile confirms efficient lung restriction with low systemic exposure and high exposure of AGMB-447 in the lung, in line with prior results observed in healthy participants
• Robust target engagement of ALK5 observed with AGMB-447 in IPF patients
• Clinical Trial Application (CTA) for INSPIRIA Phase 2 study in IPF patients submitted; Company intends to initiate study before year-end

Antwerp, Belgium, September 14, 2026 – Agomab Therapeutics NV (‘Agomab’), a clinical-stage biopharmaceutical company focused on fibro-inflammation, today announced positive results of the Phase 1 study of AGMB-447 in IPF patients. AGMB-447 is an investigational inhaled lung-restricted small molecule inhibitor of ALK5 (or TGFβR1) intended for the treatment of Idiopathic Pulmonary Fibrosis (IPF).