-- Positive Interactions with U.S. Food and Drug Administration (FDA) on Design of Phase 2b Study with Ontunisertib in Fibrostenosing Crohn's Disease (FSCD) ---- On Track to Initiate Phase 2b Study in FSCD with Ontunisertib and Phase 2 Study in Idiopathic Pulmonary Fibrosis (IPF) with AGMB-447 in Second Half of 2026 ---- Topline Data from Open-Label Long-term Extension Study (OLE) Part of STENOVA Study with Ontunisertib in FSCD and from Phase 1b IPF Study Cohort with AGMB-447 Expected in Second Half of 2026 --
Antwerp, Belgium, April 23, 2026, Agomab Therapeutics NV (NASDAQ:AGMB) ("Agomab"), a clinical-stage biopharmaceutical company focused on fibro-inflammation, today reported financial results for the full year period ended December 31, 2025, and confirmed its outlook for 2026.
"2025 was a pivotal year for Agomab, with significant progress across our clinical programs and the positive topline results of the STENOVA Phase 2a study with ontunisertib in FSCD. Our momentum has continued into 2026 with positive Phase 1 results for AGMB-447 in healthy participants and the successful completion of our IPO," said Tim Knotnerus, Chief Executive Officer of Agomab. "In the second half of this year, we expect the full read-out of the OLE study with ontunisertib in FSCD as well as the topline IPF cohort data of the Phase 1b study with AGMB-447. Based on the positive regulatory interactions on trial design, we are on track to start both the Phase 2b study with ontunisertib in FSCD and Phase 2 study with AGMB-447 in IPF later this year."
Pierre Kemula, Chief Financial Officer of Agomab, added, "Thanks to the $208 million in gross proceeds raised from our IPO in February 2026, we are well-capitalized and we expect our cash reserves to last into the first half of 2029. With major milestones approaching later this year, we remain laser-focused on delivering on our corporate and clinical strategy."Recent Program Highlights and 2026 Anticipated Milestones
Ontunisertib (AGMB-129), a gut-restricted small molecule inhibitor of ALK5 for the treatment of FSCD
We continue to have positive interactions with the FDA to align on the study design of the Phase 2b study with ontunisertib in FSCD and are on track to initiate the study in the second half of 2026.
We are progressing the OLE part of the STENOVA study (Part B) with ontunisertib in FSCD patients, with topline results expected in the second half of 2026. The 48-week data may provide important insights into extended treatment with ontunisertib in FSCD patients.
As of February 2026, the Data Safety and Monitoring Board has not raised any safety issue and has recommended for the OLE study to continue as per the protocol with 200mg BID ontunisertib for up to 60 weeks.
The results of the 12-week placebo-controlled double-blind part of the STENOVA Phase 2a study with ontunisertib in FSCD (Part A) were presented as a late-breaker at the 21st Congress of ECCO (ECCO'26) in Stockholm, Sweden in February 2026. The late-breaking presentation was also featured by Nature Reviews Gastroenterology & Hepatology as one of the highlights of ECCO'26.
AGMB-447, an inhaled small molecule inhibitor of ALK5 in development for the treatment of IPF
We continue to enroll participants in the IPF cohort of the Phase 1b study with AGMB-447. In this cohort, up to 12 participants with IPF will receive multiple doses of AGMB-447 or placebo over 14 days. We have dosed the first participants, and expect to report topline results in the second half of 2026.
We received positive scientific advice from the UK Medicines and Healthcare products Regulatory Agency (MHRA), supporting our planned Phase 2 trial in IPF patients. We are on track to initiate a Phase 2 proof-of-concept study with AGMB-447 in IPF in the second half of 2026.
We were granted a patent covering the composition of matter of AGMB-447 by the United States Patent and Trademark Office (USPTO), solidifying the foundational IP for AGMB-447 in the U.S.
Full Year 2025 Financial Results (consolidated)
Cash Position: Cash, cash equivalents and short-term cash investments totaled €116.5 million as of December 31, 2025. Subsequently, in February 2026, we completed our IPO, in which we raised gross proceeds of approximately $208 million, including the proceeds from the underwriters' partial exercise of their overallotment option, before deducting underwriting discounts and commissions and other offering expenses. We expect that our existing cash and cash investments, including the net proceeds from our IPO, will enable us to fund our operating expenses and capital expenditure requirements into the first half of 2029.
R&D Expenses: Research and development (R&D) expenses were €48.9 million for the year ended December 31, 2025, as compared with €39.3 million for the year ended December 31, 2024. The increase in R&D expenses of €9.6 million for the year was primarily due to increased clinical trial expenses, which are outsourced activities, specifically for the two lead programs ontunisertib and AGMB-447.
G&A Expenses: General and administrative (G&A) expenses were €12.8 million for the year ended December 31, 2025, as compared with €10.1 million for the year ended December 31, 2024. The increase of €2.7 million for the year mainly relates to increased employee benefits, reflecting organizational scaling to support company growth, including stock-based compensation.
Net Loss: Net loss was €62.5 million for the full year ended December 31, 2025, compared to €46.3 million for the full year ended December 31, 2024.
Corporate
The company has filed its Annual Report on Form 20-F with the U.S. Securities and Exchange Commission (SEC). The Annual Report is available on the Agomab website at https://agomab.com/ and on the SEC's website at www.sec.gov.
The company will hold its Annual General Meeting (AGM) at 4:00pm CEST on May 26, 2026. The convening notice for the AGM as well as all documents relevant for the meeting are available via the Agomab website at https://ir.agomab.com/governance/shareholder-meetings.
Financial performance
Consolidated statement of profit and loss
For the year ended December 31
(in thousands of €), except per share data
2025
2024
2023
Research and development expenses
(48,877)
(39,310)
(26,311)
General and administrative expenses
(12,791)
(10,133)
(6,097)
Total operating expenses
(61,668)
(49,443)
(32,408)
Other operating income
2,393
1,422
1,218
Operating loss
(59,275)
(48,021)
(31,190)
Changes in fair value of financial liabilities
(4,857)
848
18,964
Financial expenses
(133)
(357)
(86)
Financial income
1,718
1,267
303
Loss before taxes
(62,547)
(46,263)
(12,009)
Income tax (expense)/income
—
(4)
619
Loss for the year
(62,547)
(46,267)
(11,390)
—
Weighted average number of common shares outstanding
541,126
541,126
541,126
Basic and diluted loss per share (in €)
(143.22)
(107.09)
(35.63)
For the year ended December 31
(in thousands of €)
2025
2024
2023
Loss for the year
(62,547)
(46,267)
(11,390)
Items that may be reclassified to profit or loss
Foreign currency translation differences
21
(10)
—
Items that will not be reclassified to profit or loss
Remeasurement of post-employment benefit obligations
(8)
(73)
