Agomab reports first-half 2026 results, confirms FDA alignment on Crohn's trial design

Agomab Therapeutics NV reported financial results for the six months ended June 30, 2026, and confirmed its outlook for the rest of the year in a release dated August 6, 2026.

The company said it reached agreement with the FDA on the design of its NOV-ERA Phase 2b study of ontunisertib in Fibrostenosing Crohn's Disease. The alignment covers the study's primary efficacy endpoint of endoscopic passability at Week 24, measured by the SES-CD narrowing score, along with several secondary endpoints relevant to FSCD patients.¹ The protocol has cleared central Institutional Review Board approval in the U.S. and has also been approved by Health Canada and the UK's Medicines and Healthcare products Regulatory Agency.¹ Agomab expects to dose the first participants in the second half of 2026.¹

Separately, the company has enrolled 10 participants in the IPF cohort of its Phase 1b study of AGMB-447, where participants receive multiple doses of drug or placebo over 14 days, with topline results expected in the coming months.¹ Agomab also said it is on track to start a Phase 2 trial of AGMB-447 in IPF in the second half of the year.¹

On financials, cash, cash equivalents and short-term investments totaled €252.0 million as of June 30, 2026.¹ In February 2026 the company completed its IPO titled to raise about $208 million in gross proceeds, a figure that included partial exercise of the underwriters' overallotment option, before fees.¹ Agomab said this cash, together with IPO proceeds, should fund operations into the first half of 2029.¹

Research and development spending rose to €23.0 million for the first half of 2026, up from €22.0 million in the same period of 2025.¹ General and administrative expenses increased to €12.2 million from €6.7 million, an increase the company attributed mainly to one-time IPO-related costs.¹ Net loss for the period was €31.0 million, compared with €26.9 million a year earlier.¹