Agomab Therapeutics NV

Agomab Therapeutics NV announced the proposed appointments of Marino Garcia and Naimish Patel, M.D. to its Board of Directors. These appointments, aimed at strengthening the Board with extensive biotech and clinical development expertise, will be put to a shareholder vote at a Special General Meeting on September 11, 2026. Concurrently, the company will hold an Extraordinary General Shareholders' Meeting to seek approval for the consolidation and split of outstanding pre-IPO warrants, adjusting them to reflect the share split implemented during its February 2026 IPO.

Agomab Therapeutics reported its half-year 2026 financial results, showcasing a strong cash position of €252 million, including $208 million gross proceeds from its recent IPO, which is expected to fund operations into the first half of 2029. The company announced regulatory alignment with the FDA on the design of its NOV-ERA Phase 2b study for Ontunisertib in Fibrostenosing Crohn’s Disease. Agomab is on track to initiate this Phase 2b study and a Phase 2 study for AGMB-447 in Idiopathic Pulmonary Fibrosis in the second half of 2026, with key topline data from ongoing studies anticipated soon.

Agomab Therapeutics NV announced the design of its upcoming Phase 2b NOV-ERA study for ontunisertib, an investigational oral ALK5 inhibitor for Fibrostenosing Crohn’s Disease (FSCD). The company has aligned with the FDA on the study design, including the primary efficacy endpoint, and has received approvals from Health Canada and central IRB in the U.S. The randomized, double-blind, placebo-controlled trial will enroll up to 320 adult patients globally, with the first participants expected to be dosed in the second half of 2026. Ontunisertib, which has U.S. FDA Fast Track Designation, addresses a significant unmet medical need as there are no approved pharmacological therapies for FSCD.

Agomab Therapeutics announced regulatory alignment with the U.S. FDA on the design of its Phase 2b NOV-ERA study for ontunisertib, an investigational treatment for Fibrostenosing Crohn’s Disease (FSCD). The study's primary endpoint is endoscopic passability at Week 24. The company expects to initiate the study and dose the first participants in the second half of 2026, with global enrollment of up to 320 adult patients.

Agomab Therapeutics NV announced the results of its Annual General Meeting, which took place on May 26, 2026. The company furnished a press release detailing these results as Exhibit 99.1 to its Form 6-K filing.

Agomab Therapeutics NV announced the results of its Annual General Meeting (AGM) held on May 26, 2026. All items on the agenda were approved, including the statutory financial statements for the financial year ended December 31, 2025. Shareholders also approved the discharge of current and former Board members and the statutory auditor, and reappointed Mr. Ohad Hammer for a one-year term and Mr. Tim Knotnerus for a four-year term to the Board of Directors.

Agomab Therapeutics announced its management team will participate in several upcoming industry and investor conferences. The company will present preclinical data for AGMB-447, an inhaled TGFβR1/ALK5 inhibitor for Idiopathic Pulmonary Fibrosis, at the ATS International Conference 2026, highlighting its robust anti-fibrotic activity and target engagement. Additionally, Agomab will hold fireside chats and investor meetings at other key events through July 2026, enhancing its visibility within the biopharmaceutical and investment communities.

Agomab Therapeutics NV announced its full year 2025 financial results and reaffirmed its 2026 outlook via a press release on April 23, 2026. Concurrently, the company published materials for its Annual General Meeting (AGM), scheduled for May 26, 2026, at 4:00 pm CEST. These AGM materials, including the convening notice and annual report, are incorporated by reference into the company's Form S-8 registration statement.

Agomab Therapeutics NV announced its full year 2025 financial results and confirmed its 2026 outlook via a press release on April 23, 2026. Concurrently, the company published materials related to its Annual General Meeting (AGM), which is scheduled for May 26, 2026. These materials, including the Convening Notice and Annual Report, were made available on its website and furnished as exhibits.

Agomab Therapeutics NV, a clinical-stage biopharmaceutical company, reported a total comprehensive loss of €62.5 million for the year ended December 31, 2025, following a €46.4 million loss in 2024. The company's cash, cash equivalents, and cash investments stood at €116.5 million as of December 31, 2025, expected to fund operations into the first half of 2029. Agomab anticipates significant future losses and will require additional funding to advance its product candidates, including ontunisertib, AGMB-447, and AGMB-101, through lengthy and uncertain clinical development. The company also highlighted past material weaknesses in internal control over financial reporting.