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Agomab Reviews Complete Yr 2025 Monetary Effects and Confirms 2026 Outlook
Company Announcement

Agomab Reviews Complete Yr 2025 Monetary Effects and Confirms 2026 Outlook

spsingh
Last updated: April 24, 2026 12:03 am
spsingh
Published: April 24, 2026
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— Money and Money Investments at December 31, 2025 of €116.5 Million and Gross Proceeds of $208 Million from Preliminary Public Providing (IPO) Anticipated to Prolong Money Runway into First Part of 2029 —

— Sure Interactions with U.S. Meals and Drug Management (FDA) on Design of Segment 2b Find out about with Ontunisertib in Fibrostenosing Crohn’s Illness (FSCD) —

— On Observe to Start up Segment 2b Find out about in FSCD with Ontunisertib and Segment 2 Find out about in Idiopathic Pulmonary Fibrosis (IPF) with AGMB-447 in 2d Part of 2026 —

— Topline Information from Open-Label Lengthy-term Extension Find out about (OLE) A part of STENOVA Find out about with Ontunisertib in FSCD and from Segment 1b IPF Find out about Cohort with AGMB-447 Anticipated in 2d Part of 2026 —

Antwerp, Belgium, April 23, 2026 – Agomab Therapeutics NV (Nasdaq: AGMB) (“Agomab”), a clinical-stage biopharmaceutical corporate inquisitive about fibro-inflammation, lately reported monetary effects for the total yr length ended December 31, 2025, and showed 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,” stated Tim Knotnerus, Leader Govt 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, Leader Monetary 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.”

Contemporary Program Highlights and 2026 Expected Milestones 

Ontunisertib (AGMB-129), a gut-restricted small molecule inhibitor of ALK5 for the remedy of FSCD  We proceed to have certain interactions with the FDA to align at the learn about design of the Segment 2b learn about with ontunisertib in FSCD and are heading in the right direction to start up the learn about in the second one part of 2026.We’re progressing the OLE a part of the STENOVA learn about (Phase B) with ontunisertib in FSCD sufferers, with topline effects anticipated in the second one part of 2026. The 48-week information would possibly supply essential insights into prolonged remedy with ontunisertib in FSCD sufferers.As of February 2026, the Information Protection and Tracking Board has no longer raised any protection factor and has really helpful for the OLE learn about to proceed as according to the protocol with 200mg BID ontunisertib for as much as 60 weeks. The result of the 12-week placebo-controlled double-blind a part of the STENOVA Segment 2a learn about with ontunisertib in FSCD (Phase A) had been offered as a late-breaker on the twenty first Congress of ECCO (ECCO’26) in Stockholm, Sweden in February 2026. The late-breaking presentation was once additionally featured via Nature Opinions Gastroenterology & Hepatology as one of the vital highlights of ECCO’26. AGMB-447, an inhaled small molecule inhibitor of ALK5 in construction for the remedy of IPF We proceed to sign up contributors within the IPF cohort of the Segment 1b learn about with AGMB-447. On this cohort, as much as 12 contributors with IPF will obtain a couple of doses of AGMB-447 or placebo over 14 days. We’ve got dosed the primary contributors, and be expecting to record topline leads to the second one part of 2026.We won certain clinical recommendation from the United Kingdom Drugs and Healthcare merchandise Regulatory Company (MHRA), supporting our deliberate Segment 2 trial in IPF sufferers. We’re heading in the right direction to start up a Segment 2 proof-of-concept learn about with AGMB-447 in IPF in the second one part of 2026. We had been granted a patent protecting the composition of topic of AGMB-447 via america Patent and Trademark Place of business (USPTO), solidifying the foundational IP for AGMB-447 within the U.S.

Complete Yr 2025 Monetary Effects (consolidated)

Money Place: Money, coins equivalents and non permanent coins investments totaled €116.5 million as of December 31, 2025. Due to this fact, in February 2026, we finished our IPO, by which we raised gross proceeds of roughly $208 million, together with the proceeds from the underwriters’ partial workout in their overallotment possibility, earlier than deducting underwriting reductions and commissions and different providing bills. We predict that our current coins and coins investments, together with the web proceeds from our IPO, will allow us to fund our working bills and capital expenditure necessities into the primary part of 2029.R&D Bills: Analysis and construction (R&D) bills had been €48.9 million for the yr ended December 31, 2025, as when put next with €39.3 million for the yr ended December 31, 2024. The rise in R&D bills of €9.6 million for the yr was once basically because of higher scientific trial bills, which can be outsourced actions, in particular for the 2 lead techniques ontunisertib and AGMB-447.G&A Bills: Normal and administrative (G&A) bills had been €12.8 million for the yr ended December 31, 2025, as when put next with €10.1 million for the yr ended December 31, 2024. The rise of €2.7 million for the yr principally pertains to higher worker advantages, reflecting organizational scaling to beef up corporate enlargement, together with stock-based reimbursement.Web Loss: Web loss was once €62.5 million for the total yr ended December 31, 2025, in comparison to €46.3 million for the total yr ended December 31, 2024.

Company

The corporate has filed its Annual Document on Shape 20-F with the U.S. Securities and Change Fee (SEC). The Annual Document is to be had at the Agomab web site at https://agomab.com/ and at the SEC’s web site at www.sec.gov.The corporate will cling its Annual Normal Assembly (AGM) at 4:00pm CEST on Might 26, 2026. The convening understand for the AGM in addition to all paperwork related for the assembly are to be had by the use of the Agomab web site at https://ir.agomab.com/governance/shareholder-meetings. 

Monetary efficiency

Consolidated commentary of benefit and loss

             For the yr ended December 31(in 1000’s of €), with the exception of according to percentage information        2025    2024    2023Research and construction bills   (48,877)  (39,310)  (26,311)Normal and administrative bills   (12,791)  (10,133)  (6,097)General working bills   (61,668)  (49,443)  (32,408)        Different working source of revenue   2,393  1,422  1,218Operating loss   (59,275)  (48,021)  (31,190)        Adjustments in truthful price of monetary liabilities    (4,857)  848  18,964Financial bills    (133)  (357)  (86)Monetary source of revenue   1,718  1,267  303Loss earlier than taxes   (62,547)  (46,263)  (12,009)        Source of revenue tax (expense)/source of revenue   —  (4)  619Loss for the yr    (62,547)  (46,267)  (11,390)        —Weighted reasonable collection of commonplace stocks exceptional    541,126  541,126  541,126Basic and diluted loss according to percentage (in €)   (143.22)  (107.09)  (35.63)

 

 

 

  For the yr ended December 31(in 1000’s of €)        2025    2024    2023Loss for the yr   (62,547)  (46,267)  (11,390)Pieces that can be reclassified to learn or loss       Foreign currency echange translation variations   21  (10)  —Pieces that is probably not reclassified to learn or loss       Remeasurement of post-employment receive advantages duties   (8)  (73)  —Different complete source of revenue or loss for the yr, internet of tax   13  (83)  —General complete source of revenue or loss for the yr   (62,534)  (46,350)  (11,390)   

Consolidated commentary of monetary place

   For the yr ended according to     December 31 (In 1000’s of €)        2025    2024 Property       Non-current property       Intangible property   20,110  20,110 Goodwill    8,612  8,612 Assets, plant and gear   503  619 Proper-of-use property    1,083  1,373 Different monetary property    11  12 Different non-current property    2,150  1,787 General non-current property   32,469  32,513        Present property       Different recent property    4,723  2,386 Present monetary investments   30,096  — Money and coins equivalents   86,418  171,459 General recent property   121,237  173,845 General property   153,706  206,358        Fairness       Proportion capital    223,072  223,072 Proportion top rate reserve    76,634  76,634 Retained profits   (181,714)  (119,181) Proportion-based cost reserves   13,877  8,522 Different reserves    (967)  (966) Fairness as a result of the house owners of the mum or dad   130,902  188,081 General fairness   130,902  188,081        Liabilities       Non-current liabilities       Non-current rent liabilities    1,005  1,272 Non-current contingent attention   3,210  7,879 General non-current liabilities   4,215  9,151        Present liabilities       Present rent liabilities    249  273 Anti-dilutive warrants    —  — Present contingent attention   6,526  — Industry and different payables   10,266  8,052 Deferred source of revenue and amassed fees   1,548  801 General recent liabilities   18,589  9,126 General liabilities    22,804  18,277        General fairness and liabilities   153,706  206,358                            

Consolidated commentary of money flows

  For the years ended according to December 31(In 1000’s of €)    2025    2024    2023Net loss for the yr  (62,547)  (46,267)  (11,390)Changes for non-cash pieces:               Present source of revenue tax expense (source of revenue)  —  4  3Deferred source of revenue tax expense (source of revenue)   —  —  (622)Truthful price (achieve) loss on monetary property  (96)  —  —Truthful price (achieve) loss on monetary liabilities  4,857  (848)  (18,964)Depreciation & amortization   219  311  99Share-based cost bills  5,355  1,071  2,159Net foreign currency echange losses (beneficial properties)   57  231  —Passion expense  69  77  86Interest source of revenue   (1,614)  (1,218)  (303)Running coins flows earlier than actions in operating capital   (53,700)  (46,640)  (28,932)       actions in operating capital:               Lower/(building up) in different recent property   (2,337)  (315)  1,343Decrease/(building up) in different non-current property   (363)  (342)  (331)Build up/(lower) in industry and different payables  2,359  (230)  3,686Increase/(lower) in deferred source of revenue  747  (395)  (580)       Source of revenue taxes paid  —  (4)  (3)Passion paid   (69)  (10)  (20)Passion won   1,622  1,106  245Net coins go with the flow from /(utilized in) working actions   (51,741)  (46,828)  (24,592)       Purchases of belongings, plant and gear   (4)  (675)  —Acquire of monetary investments  (30,000)  —  40,000Payment of contingent attention from earlier acquisition  (3,000)  —  —Web coins go with the flow from /(utilized in) making an investment actions   (33,004)  (675)  40,000       Compensation of rent liabilities   (338)  (163)  (100)Proceeds from capital building up  —  97,055  79,871Share factor prices  —  (129)  (453)Different monetary expense, internet   —  —  6Net coins go with the flow from /(utilized in) financing actions  (338)  96,762  79,324       Web building up/(lower) in coins and coins equivalents  (85,083)  49,260  94,732       Money and coins equivalents at starting of yr   171,459  122,402  27,670Effect of foreign currency echange fee adjustments  45  (204)  —Money and coins equivalents at finish of yr   86,418  171,459  122,402   

Ontunisertib and AGMB-447 are investigational medication and no longer licensed via any regulatory authority. Their efficacy and protection have no longer been established.  

About AgomabAgomab is a clinical-stage biopharmaceutical corporate inquisitive about growing novel disease-modifying treatments for fibro-inflammatory illnesses with top unmet scientific want. Agomab’s product applicants are designed to focus on established potent pathways and make the most of organ-restricted approaches, with the purpose of accelerating efficacy whilst minimizing protection liabilities. Fostering a tradition of excellence, Agomab’s venture is to pioneer therapeutics that goal to unravel fibro-inflammation and repair organ serve as to allow other people with those problems to reside fuller and fitter lives.

Cautionary Be aware Referring to Ahead-Having a look Statements This press liberate contains positive disclosures that comprise “forward-looking statements,” together with, with out limitation, statements relating to our anticipated coins runway, together with that we await our coins and coins investments and IPO proceeds will prolong our runway into the primary part of 2029, our center of attention at the discovery and construction of our pipeline of novel product applicants for fibro-inflammatory problems, the design of deliberate Segment 2 scientific trials with ontunisertib for FSCD and AGMB-447 for IPF, our expectation to start up our Segment 2b Find out about of ontunisertib in FSCD and our Segment 2 learn about of AGMB-447 in IPF in the second one part of 2026, in addition to statements relating to long term information readouts, together with our expectation to liberate topline information from the OLE a part of the STENOVA learn about and of the Segment 1b IPF Find out about Cohort with AGMB-447 in the second one part of 2026. Ahead-looking statements are in response to Agomab’s recent expectancies and are topic to inherent uncertainties, dangers and assumptions which might be tricky to are expecting. Elements that might purpose exact effects to fluctuate come with, however don’t seem to be restricted to, dangers and uncertainties associated with the result of our scientific trials; expectancies in regards to the inherent uncertainties related to the improvement of novel drug treatments; preclinical and scientific trial and product construction actions and regulatory approval necessities for product applicants; the affect of governmental regulations and laws on our industry; disruptions brought about via our reliance on 3rd birthday celebration providers and repair suppliers; the chance that our expectancies and control’s steering relating to our coins place and different monetary estimates could also be improper; and dangers associated with geopolitical conflicts and macro-economic occasions. Those and different dangers and uncertainties are described extra totally in our filings and studies with the SEC, together with in our most up-to-date annual record on Shape 20‐F filed with the SEC and our next filings and studies filed with the SEC. Ahead-looking statements contained on this announcement are made as of this date, and Agomab undertakes no accountability to replace such data with the exception of as required below appropriate regulation. Readers must no longer depend on the guidelines on this announcement as recent or correct after its newsletter date.

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