Welcome to our dedicated page for Agomab Therapeutics NV SEC filings (Ticker: AGMB), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Agomab Therapeutics NV filings document the company's foreign private issuer reports, ADS public offering disclosures, governance materials, and clinical-stage biopharmaceutical updates. Form 6-K reports have included the closing of the company's initial public offering of American Depositary Shares, amended and restated articles of association, press releases, annual meeting materials, proxy forms, and voting documentation.
AGMB's regulatory record also discloses capital-structure matters tied to ADSs and common shares, incorporation of materials into a Form S-8 registration statement, financial results, business updates, shareholder voting matters, and clinical or regulatory disclosures related to its fibro-inflammatory disease programs.
Agomab Therapeutics NV is calling a special and extraordinary general shareholders’ meeting on September 11, 2026 at 2:30pm CEST in Antwerp. The board proposes appointing Marino Garcia and Dr. Naimish Patel as non-executive directors for four-year terms ending after the 2030 annual meeting, subject to shareholder approval.
The notice sets out Belgian-law procedures for participation, including a Record Date of September 4, 2026, advance notification or proxy/voting form submission by September 9, 2026, and clarifies that holders of subscription rights and ADS holders may attend or act through specific channels with defined rights.
Agomab Therapeutics, a clinical-stage biopharmaceutical company focused on fibro-inflammatory diseases, reported half year 2026 results for the period ended June 30, 2026. The company recorded a net loss of €30,971 thousand on total operating expenses of €35,138 thousand, including research and development expenses of €22,967 thousand and general and administrative expenses of €12,171 thousand.
Agomab strengthened its balance sheet through a Nasdaq initial public offering, raising $208 million in gross proceeds. Cash and cash investments totaled €252 million at June 30, 2026, including €221,588 thousand of cash and cash equivalents, which management expects to support the cash runway into the first half of 2029.
Clinically, Agomab reported regulatory alignment with the U.S. FDA on key elements of the NOV-ERA Phase 2b study of ontunisertib in Fibrostenosing Crohn’s Disease, and plans to initiate this trial and a Phase 2 study of AGMB-447 in idiopathic pulmonary fibrosis in the second half of 2026. Topline data from the OLE part of the STENOVA study with ontunisertib and from the Phase 1b IPF cohort with AGMB-447 are expected in the coming months.
Agomab Therapeutics outlined the design of its NOV-ERA Phase 2b trial of ontunisertib for fibrostenosing Crohn’s disease (FSCD), a form of Crohn’s that affects an estimated 46% of patients and currently has no approved drug treatments. The company has aligned with the FDA on a novel primary endpoint: endoscopic passability of the ileal index stricture at Week 24, assessed by the SES-CD narrowing score.
The randomized, double-blind, placebo-controlled study will enroll up to 320 adults worldwide. Participants will receive ontunisertib 400 mg, 200 mg, 100 mg, or placebo twice daily over a 52-week treatment period, after a 6-week screening and before a 2-week follow-up. Agomab plans to dose the first participants in the second half of 2026, following remaining regulatory and ethics approvals. Ontunisertib is an oral, GI-restricted ALK5/TGF-β RI inhibitor with FDA Fast Track designation.
Agomab Therapeutics NV, a clinical-stage biopharmaceutical company focused on fibro-inflammation, reported that all items on the agenda at its Annual General Meeting held on May 26, 2026 were approved. Detailed voting results and meeting documents are available on the company’s investor relations website.
The Form 6-K primarily furnishes the related press release as an exhibit and clarifies that this information is provided for disclosure purposes under U.S. securities rules.
AgomAb Therapeutics NV reported that Redmile Group, LLC and affiliated persons beneficially hold 2,735,926 Common Shares, representing 5.6% of the class. The 5.6% percentage is calculated using 49,247,975 Common Shares outstanding as of March 31, 2026, per the issuer's Form 20-F. The disclosed stake consists of 2,579,676 Common Shares and 156,250 ADS (each ADS representing one Common Share) held by Redmile Biopharma Investments III, L.P.; Redmile acts as investment manager and Jeremy C. Green is identified as a principal. The filing states shared voting and dispositive power over the 2,735,926 shares and contains customary disclaimers of beneficial ownership by Redmile and Mr. Green.
Agomab Therapeutics NV files a Schedule 13G reporting ownership by Cormorant Asset Management and Bihua Chen. The Reporting Persons state 2,465,348 American Depositary Shares beneficially owned, representing 5.01% of common stock outstanding as of March 31, 2026. The filing shows shared voting and dispositive power over these shares.
AgomAb Therapeutics NV reports that Sanofi beneficially owns 2,783,096 Common Shares, representing 5.71% of the class. The filing states Sanofi directly holds 2,708,096 Common Shares and 75,000 ADSs (each ADS represents one Common Share). The shares are held of record by Sanofi Foreign Participations B.V., an indirect wholly owned subsidiary.
Agomab Therapeutics reported full-year 2025 results and confirmed its 2026 outlook, highlighting a strengthened balance sheet and advancing clinical pipeline. The company ended 2025 with cash and cash investments of €116.5 million and subsequently raised $208 million in gross proceeds from its February 2026 IPO, which it expects will fund operations into the first half of 2029.
In 2025 Agomab recorded a consolidated operating loss of €59.3 million and a net loss of €62.5 million, driven mainly by €48.9 million in research and development spending as it progressed ontunisertib for fibrostenosing Crohn’s disease and AGMB-447 for idiopathic pulmonary fibrosis. The company plans to start a Phase 2b study in FSCD and a Phase 2 IPF study in the second half of 2026, with key data readouts from ongoing studies also expected in that period.
The 6-K also furnishes materials for the May 26, 2026 annual general meeting, including financial statements, board and auditor reports, proposed director reappointments and auditor fee adjustments, and confirms that the 2025 statutory accounts are prepared on a going concern basis.
AgomAb Therapeutics, a clinical-stage biopharmaceutical company, reports continued operating losses as it advances fibrotic-disease drug candidates. The company recorded total comprehensive losses of €62.5 million in 2025 and €46.4 million in 2024, mainly from research, development and administrative costs.
As of December 31, 2025, AgomAb held €116.5 million in cash, cash equivalents and cash investments and expects this to fund operations into the first half of 2029. The 20-F highlights 34,167,168 common shares outstanding, IFRS-based financials, extensive risk factors, and reliance on future capital raises and regulatory success for ontunisertib, AGMB-447 and earlier-stage programs.
Agomab Therapeutics reports that Pontifax-related reporting persons beneficially own 3,305,846 common shares representing 6.8% of the class as of 03/31/2026. The filing is a joint Schedule 13G showing shared voting and dispositive power over those shares and includes a Joint Filing Agreement dated April 16, 2026.
The ownership block consists of four Pontifax entities with shared control through Pontifax VI G.P. L.P. and Pontifax Management; Messrs. Tomer Kariv and Ran Nussbaum disclaim beneficial ownership of the underlying entity holdings per the filing.