Agomab Therapeutics NV

AGMB

Business Summary

AgomAb Therapeutics NV is a clinical-stage biopharmaceutical company incorporated in Belgium on April 13, 2017, and converted to a Belgian limited liability company on March 14, 2019, focused on developing novel disease-modifying therapies for fibro-inflammatory diseases with high unmet medical need ¹. The company's principal executive offices are located in Antwerpen, Belgium, with a Spanish subsidiary, Agomab Spain, S.L.U., in A Coruña, Spain, and a U.S. subsidiary, Agomab US, Inc., in Cambridge, Massachusetts ². The company's American Depositary Shares (ADSs) have been listed on the Nasdaq Global Select Market under the ticker "AGMB" since February 6, 2026 ³.

The core business model of AgomAb Therapeutics NV revolves around the discovery and development of disease-modifying therapies for fibro-inflammatory disorders, leveraging established and clinically validated targets. The company aims to overcome limitations of previous therapeutic approaches by focusing on underlying biological processes that drive disease pathology, with an emphasis on organ-restricted approaches to maximize efficacy while minimizing safety liabilities ⁴. Revenue generation is currently through grants and equity financing, as the company has not yet generated revenue from product sales ⁵. Primary customer segments, once products are commercialized, would be patients suffering from chronic fibro-inflammatory disorders, such as Fibrostenosing Crohn's Disease (FSCD) and Idiopathic Pulmonary Fibrosis (IPF) ⁶.

The company's lead product candidate, Ontunisertib (AGMB-129), is an oral, gastrointestinal-restricted small molecule inhibitor of ALK5 (TGFβR1) in development for the treatment of FSCD ⁷. FSCD is a severe complication of Crohn's Disease (CD), affecting approximately 620,000 patients, or 46%, of the 1.4 million CD patients in the seven major markets (United States, France, Germany, Italy, Spain, United Kingdom, and Japan) ⁸. There are currently no approved pharmacologic therapies for FSCD ⁹. Ontunisertib is designed to act locally in the GI tract and be rapidly inactivated in the liver to avoid systemic toxicities associated with TGFβ signaling inhibition ¹⁰. The STENOVA Phase 2a trial achieved its primary endpoint of safety and tolerability, with positive signals on several exploratory clinical endpoints ¹¹. Ontunisertib received Fast Track Designation for FSCD from the FDA in 2023 ¹².

The second clinical-stage product candidate, AGMB-447, is an inhaled small molecule inhibitor of ALK5 (TGFβR1) for the treatment of Idiopathic Pulmonary Fibrosis (IPF) ¹³. IPF is a rare, progressive fibrotic lung disease affecting approximately 240,000 people in the United States, Japan, the United Kingdom, and the four largest European markets, with 30,000 to 40,000 new cases diagnosed annually in the United States ¹⁴. Existing therapies for IPF generated approximately $4.1 billion in aggregate annual revenue in 2024 across IPF and other fibrosing interstitial lung diseases ¹⁵. AGMB-447 is designed for high local exposure in lung tissue and rapid inactivation in the bloodstream to avoid systemic toxicities ¹⁶. It received Orphan Drug Designation for IPF from the FDA in May 2024 ¹⁷. Interim analysis of the SAD and MAD B1-6 stages in healthy participants showed positive topline results ¹⁸.

The discovery and preclinical portfolio includes AGMB-101, a hepatocyte growth factor (HGF)-mimetic monoclonal antibody that stimulates the MET receptor, demonstrating antifibrotic and regenerative activity in preclinical models ¹⁹. IND-enabling studies for AGMB-101 have concluded, and regulatory clearance has been received for a Phase 1 single ascending dose trial in healthy participants and liver cirrhosis patients ²⁰.

For the fiscal year ended December 31, 2025, AgomAb Therapeutics NV reported total comprehensive losses of €62.5 million ²¹. This compares to total comprehensive losses of €46.4 million for the year ended December 31, 2024 ²². As of December 31, 2025, the company's cash, cash equivalents, and cash investments were €116.5 million ²³. The company has not generated any revenue to date ²⁴. Capital expenditure on property, plant and equipment was minimal at €4 thousand in 2025, following an investment of €675 thousand in 2024 ²⁵. The net carrying amount of property, plant and equipment was €503 thousand as of December 31, 2025, compared to €619 thousand in 2024 ²⁶. The company had 34,167,168 common shares outstanding as of December 31, 2025 ²⁷.

Year-over-year, the total comprehensive loss increased from €46.4 million in 2024 to €62.5 million in 2025 ²⁸. Cash, cash equivalents, and cash investments decreased from an unspecified amount in 2024 to €116.5 million in 2025 ²⁹. Capital expenditure on property, plant and equipment significantly decreased from €675 thousand in 2024 to €4 thousand in 2025 ³⁰. The net carrying amount of property, plant and equipment decreased from €619 thousand in 2024 to €503 thousand in 2025 ³¹.

During 2025, the company signed an amendment to the Share Purchase Agreement related to the acquisition of Agomab Spain, S.L.U., restructuring the first earn-out milestone ³². A first milestone payment of €3 million was paid in the second quarter of 2025 upon the signature of this amendment ³³. In November 2025, the company announced topline results from Part A of the STENOVA Phase 2a trial for ontunisertib, which achieved its primary endpoint of safety and tolerability ³⁴. The company also received regulatory clearance to proceed with a Phase 1 single ascending dose trial for AGMB-101 in healthy participants and liver cirrhosis patients ³⁵.

Business Outlook

AgomAb Therapeutics NV expects its existing cash, cash equivalents, and cash investments of €116.5 million ³⁶, including net proceeds from its IPO, to be sufficient to fund current operations into the first half of 2029 ³⁷. The company anticipates incurring significant expenses and increasing operating losses for the foreseeable future as it continues research and development activities, preclinical testing, clinical trials, regulatory compliance, market access, commercialization, and business development efforts ³⁸.

A major growth area for the company is the advancement of Ontunisertib (AGMB-129) for the treatment of Fibrostenosing Crohn's Disease (FSCD). Based on positive interactions with the FDA and results from the STENOVA Phase 2a study, the company is preparing to initiate a Phase 2b trial of ontunisertib in patients with symptomatic FSCD in the second half of 2026 ³⁹. The 48-week open-label treatment extension of the STENOVA trial is ongoing, with results expected in the second half of 2026 ⁴⁰. The company believes ontunisertib has the potential to transform the treatment paradigm for FSCD, addressing a significant unmet medical need in a patient population of approximately 620,000 in the seven major markets ⁴¹. The planned Phase 2b trial will include the 400mg BID dose level for long-term treatment evaluation ⁴².

Another key growth area is the advancement of AGMB-447 for the treatment of Idiopathic Pulmonary Fibrosis (IPF). The company expects to report data from IPF patients in the Phase 1b study in the second half of 2026 ⁴³. Following positive scientific advice from the UK MHRA, AgomAb is on track to initiate a Phase 2 proof-of-concept study with AGMB-447 in IPF patients in the second half of 2026 ⁴⁴. IPF affects approximately 240,000 people in the United States, Japan, the United Kingdom, and the four largest European markets, with 30,000 to 40,000 new cases diagnosed annually in the United States alone ⁴⁵. The company believes AGMB-447 has the potential to demonstrate a low potential for drug-drug interactions, making it suitable for single-agent use and in combination with current standard of care therapies ⁴⁶.

In terms of operational outlook, the company expects its expenses to increase substantially as it continues its research and development activities, expands the scope of clinical studies, initiates additional trials, discovers new product candidates, and potentially establishes a sales, marketing, and distribution infrastructure ⁴⁷. The company also anticipates increased costs related to chemistry, manufacturing, and controls (CMC) as product candidates advance ⁴⁸. The company had 62 employees and 18 consultants as of December 31, 2025, and expects significant growth in employee numbers and operational scope, particularly in drug research, development, regulatory affairs, operations, corporate, and sales and marketing ⁴⁹.

Planned capital allocation includes continued investment in research and development activities for product candidates, including through clinical development and later-stage clinical trials ⁵⁰. The company will also incur costs for preparing, filing, and prosecuting patent applications, maintaining, protecting, and enforcing intellectual property rights ⁵¹. The company has received several technological innovation grants in Belgium, totaling €2.8 million as of December 31, 2025, to support various research programs ⁵².

Management has flagged several structural headwinds and execution risks. The company will need to raise additional funding beyond its current cash runway, and failure to obtain this capital on acceptable terms may force delays or termination of product development efforts ⁵³. The regulatory approval processes are lengthy, complex, and unpredictable, with no guarantee of success ⁵⁴. Difficulties in enrolling patients in clinical trials could delay development activities ⁵⁵. There is no established endpoint for FSCD therapies, and the development and validation of efficacy endpoints may delay development or increase costs ⁵⁶. The company's products may have serious adverse side effects, which could interrupt or halt clinical trials or lead to restrictive labeling ⁵⁷. Commercial success depends on market acceptance, which is uncertain ⁵⁸. The company relies on third parties for clinical trials and manufacturing, and their failure to perform could cause delays or increased costs ⁵⁹.

Geographic, regulatory, and macro factors identified as constraints include the potential for the FDA not to accept data from clinical trials conducted outside the U.S., which could delay development plans ⁶⁰. Unfavorable pricing regulations or third-party coverage and reimbursement policies could harm the business ⁶¹. Enacted and future healthcare reform legislation, such as the U.S. federal government's efforts to reduce drug prices, could impact demand and profitability ⁶². Significant political, trade, and regulatory developments, including tariffs and changes in U.S. federal policy, could have an adverse effect on financial condition or results of operations ⁶³. The BIOSECURE Act, signed into law on December 18, 2025, could negatively impact the company's ability to contract with or receive funding from the U.S. government if any Chinese partners are identified as "biotechnology companies of concern" ⁶⁴.

Risk Factors

AgomAb Therapeutics NV faces significant risks, including the inherent uncertainty of clinical-stage biopharmaceutical development, having incurred total comprehensive losses of €62.5 million in 2025 and expecting continued losses for the foreseeable future ⁶⁵. The company will require substantial additional capital beyond its current €116.5 million cash, cash equivalents, and cash investments, which are projected to fund operations only into the first half of 2029 ⁶⁶. Failure to secure this funding on acceptable terms could force delays or termination of product development ⁶⁷. The lengthy, complex, and unpredictable regulatory approval processes of the FDA and comparable foreign authorities, coupled with the absence of established endpoints for FSCD therapies, could lead to significant delays or outright denial of marketing approval, increasing development costs ⁶⁸. Product candidates may exhibit serious adverse side effects during clinical trials or post-approval, potentially leading to trial interruptions, restrictive labeling, or market withdrawal ⁶⁹. Commercial success is contingent on market acceptance, which is uncertain and influenced by factors like efficacy, safety, and pricing ⁷⁰. The company's reliance on third-party manufacturers and contract research organizations (CROs) for preclinical studies, clinical trials, and commercial supply introduces risks of delays, increased costs, and non-compliance with regulatory requirements like GCP and cGMP ⁷¹. Intellectual property protection is critical, but patents may be challenged, invalidated, or circumvented, and the cost of global patent enforcement is prohibitive ⁷². The company is subject to evolving data privacy laws, such as GDPR and CCPA, with potential for significant fines of up to €20 million or 4% of total worldwide annual turnover under GDPR, and up to £17.5 million or 4% of annual global revenue under UK GDPR, for non-compliance ⁷³. Geopolitical developments, including the BIOSECURE Act, could restrict the company's ability to contract with or receive U.S. government funding if its Chinese partners are designated as "biotechnology companies of concern" ⁷⁴.

Management Priorities

Management's message to shareholders emphasizes a commitment to pioneering therapeutics that resolve fibro-inflammation and restore organ function, driven by a culture of excellence and a strong executive team with deep scientific and clinical development expertise ⁷⁵. They highlight the strategic approach of targeting well-validated pathways with organ-restricted methods to increase efficacy and minimize safety liabilities ⁷⁶. The company is focused on advancing its pipeline, particularly Ontunisertib (AGMB-129) for FSCD and AGMB-447 for IPF, with expectations to initiate a Phase 2b trial for ontunisertib and a Phase 2 proof-of-concept study for AGMB-447 in the second half of 2026 ⁷⁷. Management explicitly states that existing cash, cash equivalents, and cash investments of €116.5 million ⁷⁸, including IPO proceeds, are expected to fund current operations into the first half of 2029 ⁷⁹. They acknowledge the need for additional funding in the future and the inherent risks and uncertainties associated with drug development, regulatory approvals, and commercialization, including the potential for significant losses and the challenges of managing anticipated growth ⁸⁰.

View Source Annual Report on SEC.gov ↗

References

[1] Item 4.A, History and Development of the Company
[2] Item 4.A, History and Development of the Company
[3] Item 4.A, History and Development of the Company
[4] Item 4.B, Business Overview — Our approach and strategy
[5] Item 3.D, Risk Factors — We are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
[6] Item 4.B, Business Overview — Our approach and strategy
[7] Item 4.B, Business Overview — Our pipeline
[8] Item 4.B, Business Overview — Ontunisertib (AGMB-129): Potential treatment for Fibrostenosing Crohn’s Disease
[9] Item 4.B, Business Overview — Ontunisertib (AGMB-129): Potential treatment for Fibrostenosing Crohn’s Disease
[10] Item 4.B, Business Overview — Ontunisertib (AGMB-129): Potential treatment for Fibrostenosing Crohn’s Disease
[11] Item 4.B, Business Overview — Ontunisertib (AGMB-129): Potential treatment for Fibrostenosing Crohn’s Disease
[12] Item 4.B, Business Overview — Ontunisertib (AGMB-129): Potential treatment for Fibrostenosing Crohn’s Disease
[13] Item 4.B, Business Overview — AGMB-447: Potential treatment for IPF
[14] Item 4.B, Business Overview — AGMB-447: Potential treatment for IPF
[15] Item 4.B, Business Overview — AGMB-447: Potential treatment for IPF
[16] Item 4.B, Business Overview — AGMB-447: Potential treatment for IPF
[17] Item 4.B, Business Overview — AGMB-447: Potential treatment for IPF
[18] Item 4.B, Business Overview — AGMB-447: Potential treatment for IPF
[19] Item 4.B, Business Overview — Discovery and preclinical portfolio
[20] Item 4.B, Business Overview — Discovery and preclinical portfolio
[21] Item 3.D, Risk Factors — We are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
[22] Item 3.D, Risk Factors — We are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
[23] Item 3.D, Risk Factors — We will need to raise capital to finance our operations. Failure to obtain this necessary capital when needed, or on acceptable terms, may force us to delay, limit or terminate our product development efforts or other operations.
[24] Item 3.D, Risk Factors — We have never generated revenue from product sales and may never become profitable.
[25] Item 4.A, History and Development of the Company
[26] Item 4.A, History and Development of the Company
[27] Item 3.D, Risk Factors — A significant portion of our total outstanding common shares are restricted or will be restricted from immediate resale but may be sold into the market in the near future, which could cause the market price of the ADSs to drop significantly, even if our business is performing well.
[28] Item 3.D, Risk Factors — We are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
[29] Item 3.D, Risk Factors — We will need to raise capital to finance our operations. Failure to obtain this necessary capital when needed, or on acceptable terms, may force us to delay, limit or terminate our product development efforts or other operations.
[30] Item 4.A, History and Development of the Company
[31] Item 4.A, History and Development of the Company
[32] Item 4.A, History and Development of the Company
[33] Item 4.B, Business Overview — Our approach and strategy
[34] Item 4.B, Business Overview — STENOVA Phase 2a results-Part A
[35] Item 4.B, Business Overview — Discovery and preclinical portfolio
[36] Item 3.D, Risk Factors — We will need to raise capital to finance our operations. Failure to obtain this necessary capital when needed, or on acceptable terms, may force us to delay, limit or terminate our product development efforts or other operations.
[37] Item 3.D, Risk Factors — We will need to raise capital to finance our operations. Failure to obtain this necessary capital when needed, or on acceptable terms, may force us to delay, limit or terminate our product development efforts or other operations.
[38] Item 3.D, Risk Factors — We are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
[39] Item 4.B, Business Overview — Ontunisertib (AGMB-129): Potential treatment for Fibrostenosing Crohn’s Disease
[40] Item 4.B, Business Overview — Ontunisertib (AGMB-129): Potential treatment for Fibrostenosing Crohn’s Disease
[41] Item 4.B, Business Overview — Ontunisertib (AGMB-129): Potential treatment for Fibrostenosing Crohn’s Disease
[42] Item 4.B, Business Overview — Additional MAD study confirmed safety and tolerability profile of ontunisertib for doses up to 400mg BID
[43] Item 4.B, Business Overview — AGMB-447: Potential treatment for IPF
[44] Item 4.B, Business Overview — AGMB-447: Potential treatment for IPF
[45] Item 4.B, Business Overview — AGMB-447: Potential treatment for IPF
[46] Item 4.B, Business Overview — AGMB-447: Potential treatment for IPF
[47] Item 3.D, Risk Factors — We are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
[48] Item 3.D, Risk Factors — We will need to raise capital to finance our operations. Failure to obtain this necessary capital when needed, or on acceptable terms, may force us to delay, limit or terminate our product development efforts or other operations.
[49] Item 3.D, Risk Factors — We will need to develop and expand our company, and we may encounter difficulties in managing this development and expansion, which could disrupt our operations.
[50] Item 3.D, Risk Factors — We will need to raise capital to finance our operations. Failure to obtain this necessary capital when needed, or on acceptable terms, may force us to delay, limit or terminate our product development efforts or other operations.
[51] Item 3.D, Risk Factors — We will need to raise capital to finance our operations. Failure to obtain this necessary capital when needed, or on acceptable terms, may force us to delay, limit or terminate our product development efforts or other operations.
[52] Item 3.D, Risk Factors — We may be forced to repay the technological innovation grants if we fail to comply with our contractual obligations under the applicable grant agreements.
[53] Item 3.D, Risk Factors — We will need to raise capital to finance our operations. Failure to obtain this necessary capital when needed, or on acceptable terms, may force us to delay, limit or terminate our product development efforts or other operations.
[54] Item 3.D, Risk Factors — The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
[55] Item 3.D, Risk Factors — If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
[56] Item 3.D, Risk Factors — There is no established endpoint for FSCD therapies, and the development and validation of efficacy endpoints to support approval may delay the development of our product candidates or increase development costs.
[57] Item 3.D, Risk Factors — Our products and product candidates may have serious adverse, undesirable or unacceptable side effects, or even cause death, and we or others may identify undesirable or unacceptable side effects caused by any of our product candidates during clinical trials or after they have received marketing approval.
[58] Item 3.D, Risk Factors — The commercial success of our products and product candidates, including in new indications or methods of administration, will depend on the degree of market acceptance.
[59] Item 3.D, Risk Factors — We rely, and intend to rely, on third parties to conduct our clinical trials and perform some of our research and preclinical studies. If these third parties do not satisfactorily carry out their contractual duties or fail to meet expected deadlines, our development programs may be delayed or subject to increased costs, each of which may have an adverse effect on our business and prospects.
[60] Item 3.D, Risk Factors — We have conducted and may continue to conduct clinical trials for our product candidates outside of the U.S., and the FDA may not accept data from such trials, in which case our development plans may be delayed, which could materially harm our business.
[61] Item 3.D, Risk Factors — Even if we are able to commercialize any product candidate, such product candidate may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which could harm our business.
[62] Item 3.D, Risk Factors — Enacted and future healthcare reform legislation could impact demand for our product candidates, if approved, which could impact our business and future results of operations.
[63] Item 3.D, Risk Factors — Significant political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations.
[64] Item 3.D, Risk Factors — Unstable global economic or political conditions, inflation, increases in interest rates, natural disasters, public health crises, political crises, geopolitical events such as the crisis in Ukraine, the Iran-US-Israel conflict and the Israel-Hamas war, tensions in U.S.-China relations, or other macroeconomic conditions, could adversely affect our business, financial condition or results of operations.
[65] Item 3.D, Risk Factors — We are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
[66] Item 3.D, Risk Factors — We will need to raise capital to finance our operations. Failure to obtain this necessary capital when needed, or on acceptable terms, may force us to delay, limit or terminate our product development efforts or other operations.
[67] Item 3.D, Risk Factors — We will need to raise capital to finance our operations. Failure to obtain this necessary capital when needed, or on acceptable terms, may force us to delay, limit or terminate our product development efforts or other operations.
[68] Item 3.D, Risk Factors — The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
[69] Item 3.D, Risk Factors — Our products and product candidates may have serious adverse, undesirable or unacceptable side effects, or even cause death, and we or others may identify undesirable or unacceptable side effects caused by any of our product candidates during clinical trials or after they have received marketing approval.
[70] Item 3.D, Risk Factors — The commercial success of our products and product candidates, including in new indications or methods of administration, will depend on the degree of market acceptance.
[71] Item 3.D, Risk Factors — We rely, and intend to rely, on third parties to conduct our clinical trials and perform some of our research and preclinical studies. If these third parties do not satisfactorily carry out their contractual duties or fail to meet expected deadlines, our development programs may be delayed or subject to increased costs, each of which may have an adverse effect on our business and prospects.
[72] Item 3.D, Risk Factors — Our commercial success depends on our ability to obtain, maintain, enforce, and otherwise protect our current and any future intellectual property and proprietary technology, and if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products and product candidates similar or identical to ours and our ability to successfully develop and commercialize our product candidates may be adversely affected.
[73] Item 3.D, Risk Factors — We are subject to privacy laws, regulation and potential enforcement and contractual obligations related to data privacy and security. Our failure to comply with these laws, regulations and contractual obligations could lead to potential government enforcement actions and significant penalties against us, and harm our results, operations and/or financial conditions.
[74] Item 3.D, Risk Factors — Unstable global economic or political conditions, inflation, increases in interest rates, natural disasters, public health crises, political crises, geopolitical events such as the crisis in Ukraine, the Iran-US-Israel conflict and the Israel-Hamas war, tensions in U.S.-China relations, or other macroeconomic conditions, could adversely affect our business, financial condition or results of operations.
[75] Item 4.B, Business Overview
[76] Item 4.B, Business Overview — Our approach and strategy
[77] Item 4.B, Business Overview — Our current development strategy includes:
[78] Item 3.D, Risk Factors — We will need to raise capital to finance our operations. Failure to obtain this necessary capital when needed, or on acceptable terms, may force us to delay, limit or terminate our product development efforts or other operations.
[79] Item 3.D, Risk Factors — We will need to raise capital to finance our operations. Failure to obtain this necessary capital when needed, or on acceptable terms, may force us to delay, limit or terminate our product development efforts or other operations.
[80] Item 3.D, Risk Factors — We are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.

Analysis on 5/22/2026