AgomAb Therapeutics files for U.S. IPO of ADSs, seeks Nasdaq listing as AGMB

What was filed

AgomAb Therapeutics NV, a Belgian clinical-stage company based in Antwerp, filed a registration statement on Form F-1 on January 16, 2026 for an initial public offering of American Depositary Shares, or ADSs. Each ADS represents one common share with no nominal value. The document is a preliminary prospectus marked "Subject To Completion." The expected price range and the number of ADSs are blank, and the company may not sell the securities until the SEC declares the registration statement effective. There is no public market for the ADSs or the common shares.

AgomAb has applied to list the ADSs on the Nasdaq Global Market under the symbol AGMB. The offering depends on final Nasdaq approval of the listing, and the filing says there is no guarantee the ADSs will be approved. The company says it is both an emerging growth company and a foreign private issuer, which allows reduced reporting requirements.

Banks and counsel

J.P. Morgan, Morgan Stanley, Leerink Partners and Van Lanschot Kempen are the underwriters named on the cover. The company has granted them an option, for 30 days from the date of the prospectus, to buy additional ADSs at the offering price, less discounts and commissions. The number of additional ADSs is blank. The cover page's copies-to block lists four law firms: Goodwin Procter LLP, Baker McKenzie BV/SRL, Clifford Chance LLP and Davis Polk & Wardwell LLP. The filing text does not say which acts for the company and which for the underwriters. It names no placement agent or lender, and the underwriting discounts and commissions are blank.

The business

AgomAb says it is developing disease-modifying therapies for immunology and inflammatory diseases, with an initial focus on chronic fibrotic disease driven by the transforming growth factor beta, or TGFβ, pathway. The company says earlier inhibitors of the ALK5 receptor were limited by safety concerns, because systemic blocking of TGFβ causes toxicity in the heart and large vessels. Its two clinical-stage drugs are built to act locally and to be inactivated once absorbed.

The lead candidate, ontunisertib (AGMB-129), is an oral, gut-restricted ALK5 inhibitor for fibrostenosing Crohn's disease. The company says there are no approved drugs for that condition and puts the Crohn's population at about 1.4 million treated patients in seven major markets, about 620,000 of whom it says have the fibrostenosing form. In November 2025 it reported topline results from the Phase 2a STENOVA trial in 103 symptomatic patients. Part A met its primary endpoint of assessing safety and tolerability at 100mg once daily and 200mg twice daily. The company says the severity and incidence of adverse events were balanced across all arms, including placebo, and that it also observed "positive signals on several exploratory clinical endpoints." The summary gives no efficacy figures. A 48-week open-label extension is under way, with results expected in the second half of 2026, and a Phase 2b trial is planned for the second half of 2026.

The second candidate, AGMB-447, is an inhaled ALK5 inhibitor for idiopathic pulmonary fibrosis. A Phase 1 trial has enrolled 108 healthy participants, and the company reports interim topline results it calls positive. It has begun an IPF patient cohort and expects data from patients in the second half of 2026. AgomAb acquired both drugs through its purchase of Origo Biopharma, S.L., and says its lead program received Fast Track designation from the FDA in 2023.

Losses and cash

AgomAb has not generated any revenue. It reports total comprehensive losses of €46.4 million for 2024 and €11.4 million for 2023, and an accumulated loss of €164.3 million as of September 30, 2025. Cash and cash equivalents were €129.6 million on that date, according to the filing. The prospectus says it expects to keep incurring significant losses for at least the next several years. It plans to use the proceeds, with existing cash, to advance both clinical programs, fund preclinical work, make one milestone payment under the Origo acquisition agreement and cover general expenses. The filing also warns that selling more equity or convertible securities would dilute existing shareholders.

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