-- Cash and Cash Investments at December 31, 2025 of EUR116.5 Million and Gross Proceeds of $208 Million from Initial Public Offering (IPO) Expected to Extend Cash Runway into First Half of 2029 --
-- Positive Interactions with U.S. Food and Drug Administration (FDA) on Design of Phase 2b Study with Ontunisertib in Fibrostenosing Crohn's Disease (FSCD) --
-- On Track to Initiate Phase 2b Study in FSCD with Ontunisertib and Phase 2 Study in Idiopathic Pulmonary Fibrosis (IPF) with AGMB-447 in Second Half of 2026 --
-- Topline Data from Open-Label Long-term Extension Study (OLE) Part of STENOVA Study with Ontunisertib in FSCD and from Phase 1b IPF Study Cohort with AGMB-447 Expected in Second Half of 2026 --
Antwerp, Belgium, April 23, 2026 -- Agomab Therapeutics NV (Nasdaq: AGMB) ("Agomab"), a clinical-stage biopharmaceutical company focused on fibro-inflammation, today reported financial results for the full year period ended December 31, 2025, and confirmed 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," said Tim Knotnerus, Chief Executive 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, Chief Financial 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."
Recent Program Highlights and 2026 Anticipated Milestones
-- Ontunisertib (AGMB-129), a gut-restricted small molecule inhibitor of
ALK5 for the treatment of FSCD
-- We continue to have positive interactions with the FDA to align on
the study design of the Phase 2b study with ontunisertib in FSCD
and are on track to initiate the study in the second half of 2026.
-- We are progressing the OLE part of the STENOVA study (Part B) with
ontunisertib in FSCD patients, with topline results expected in
the second half of 2026. The 48-week data may provide important
insights into extended treatment with ontunisertib in FSCD
patients.
-- As of February 2026, the Data Safety and Monitoring Board has not
raised any safety issue and has recommended for the OLE study to
continue as per the protocol with 200mg BID ontunisertib for up to
60 weeks.
-- The results of the 12-week placebo-controlled double-blind part of
the STENOVA Phase 2a study with ontunisertib in FSCD (Part A) were
presented as a late-breaker at the 21st Congress of ECCO (ECCO'26)
in Stockholm, Sweden in February 2026. The late-breaking
presentation was also featured by Nature Reviews Gastroenterology
& Hepatology as one of the highlights of ECCO'26.
-- AGMB-447, an inhaled small molecule inhibitor of ALK5 in development for
the treatment of IPF
-- We continue to enroll participants in the IPF cohort of the Phase
1b study with AGMB-447. In this cohort, up to 12 participants with
IPF will receive multiple doses of AGMB-447 or placebo over 14
days. We have dosed the first participants, and expect to report
topline results in the second half of 2026.
-- We received positive scientific advice from the UK Medicines and
Healthcare products Regulatory Agency (MHRA), supporting our
planned Phase 2 trial in IPF patients. We are on track to initiate
a Phase 2 proof-of-concept study with AGMB-447 in IPF in the
second half of 2026.
-- We were granted a patent covering the composition of matter of
AGMB-447 by the United States Patent and Trademark Office (USPTO),
solidifying the foundational IP for AGMB-447 in the U.S.
Full Year 2025 Financial Results (consolidated)
-- Cash Position: Cash, cash equivalents and short-term cash investments
totaled EUR116.5 million as of December 31, 2025. Subsequently, in
February 2026, we completed our IPO, in which we raised gross proceeds of
approximately $208 million, including the proceeds from the underwriters'
partial exercise of their overallotment option, before deducting
underwriting discounts and commissions and other offering expenses. We
expect that our existing cash and cash investments, including the net
proceeds from our IPO, will enable us to fund our operating expenses and
capital expenditure requirements into the first half of 2029.
-- R&D Expenses: Research and development (R&D) expenses were EUR48.9
million for the year ended December 31, 2025, as compared with EUR39.3
million for the year ended December 31, 2024. The increase in R&D
expenses of EUR9.6 million for the year was primarily due to increased
clinical trial expenses, which are outsourced activities, specifically
for the two lead programs ontunisertib and AGMB-447.
-- G&A Expenses: General and administrative (G&A) expenses were EUR12.8
million for the year ended December 31, 2025, as compared with EUR10.1
million for the year ended December 31, 2024. The increase of EUR2.7
million for the year mainly relates to increased employee benefits,
reflecting organizational scaling to support company growth, including
stock-based compensation.
-- Net Loss: Net loss was EUR62.5 million for the full year ended December
31, 2025, compared to EUR46.3 million for the full year ended December
31, 2024.
Corporate
-- The company has filed its Annual Report on Form 20-F with the U.S.
Securities and Exchange Commission (SEC). The Annual Report is available
on the Agomab website at https://agomab.com/ and on the SEC's
website at www.sec.gov.
-- The company will hold its Annual General Meeting $(AGM)$ at 4:00pm CEST on
May 26, 2026. The convening notice for the AGM as well as all documents
relevant for the meeting are available via the Agomab website at
https://ir.agomab.com/governance/shareholder-meetings.
Financial performance
Consolidated statement of profit and loss
For the year ended December 31
----------------------------------
(in thousands of
EUR), except per
share data 2025 2024 2023
------------ --------- ---------
Research and
development
expenses (48,877) (39,310) (26,311)
General and
administrative
expenses (12,791) (10,133) (6,097)
------------ --------- ---------
Total operating
expenses (61,668) (49,443) (32,408)
------------ --------- ---------
Other operating
income 2,393 1,422 1,218
------------ --------- ---------
Operating loss (59,275) (48,021) (31,190)
------------ --------- ---------
Changes in fair
value of financial
liabilities (4,857) 848 18,964
Financial expenses (133) (357) (86)
Financial income 1,718 1,267 303
------------ --------- ---------
Loss before taxes (62,547) (46,263) (12,009)
------------ --------- ---------
Income tax
(expense)/income -- (4) 619
------------ --------- ---------
Loss for the year (62,547) (46,267) (11,390)
------------ --------- ---------
--
---------
Weighted average
number of common
shares outstanding 541,126 541,126 541,126
Basic and diluted
loss per share (in
EUR) (143.22) (107.09) (35.63)
------------ --------- ---------
For the year ended December 31
----------------------------------
(in thousands of EUR) 2025 2024 2023
---------- ---------- ----------
Loss for the year (62,547) (46,267) (11,390)
---------- ---------- ----------
Items that may be reclassified
to profit or loss
Foreign currency translation
differences 21 (10) --
Items that will not be
reclassified to profit or loss
Remeasurement of post-employment
benefit obligations (8) (73) --
---------- ---------- ----------
Other comprehensive income or loss
for the year, net of tax 13 (83) --
---------- ---------- ----------
Total comprehensive income or loss
for the year (62,534) (46,350) (11,390)
---------- ---------- ----------
Consolidated statement of financial position
For the year ended per
December 31
----------------------------------
(In thousands of EUR) 2025 2024
---------------------- ----------
Assets
Non-current assets
Intangible assets 20,110 20,110
Goodwill 8,612 8,612
Property, plant and equipment 503 619
Right-of-use assets 1,083 1,373
Other financial assets 11 12
Other non-current assets 2,150 1,787
---------------------- ----------
Total non-current assets 32,469 32,513
---------------------- ----------
Current assets
Other current assets 4,723 2,386
Current financial
investments 30,096 --
Cash and cash equivalents 86,418 171,459
---------------------- ----------
Total current assets 121,237 173,845
---------------------- ----------
Total assets 153,706 206,358
---------------------- ----------
Equity
Share capital 223,072 223,072
Share premium reserve 76,634 76,634
Retained earnings (181,714) (119,181)
Share-based payment reserves 13,877 8,522
Other reserves (967) (966)
---------------------- ----------
Equity attributable to the
owners of the parent 130,902 188,081
---------------------- ----------
Total equity 130,902 188,081
---------------------- ----------
Liabilities
Non-current liabilities
Non-current lease liabilities 1,005 1,272
Non-current contingent
consideration 3,210 7,879
---------------------- ----------
Total non-current liabilities 4,215 9,151
---------------------- ----------
Current liabilities
Current lease liabilities 249 273
Anti-dilutive warrants -- --
Current contingent
consideration 6,526 --
Trade and other payables 10,266 8,052
Deferred income and accrued
charges 1,548 801
---------------------- ----------
Total current liabilities 18,589 9,126
---------------------- ----------
Total liabilities 22,804 18,277
---------------------- ----------
Total equity and liabilities 153,706 206,358
---------------------- ----------
Consolidated statement of cash flows
For the years ended per December 31
---------------------------------------
(In thousands of EUR) 2025 2024 2023
------------ ------------ -----------
Net loss for the year (62,547) (46,267) (11,390)
------------ ------------ -----------
Adjustments for non-cash
items:
Current income tax expense
(income) -- 4 3
Deferred income tax expense
(income) -- -- (622)
Fair value (gain) loss on
financial assets (96) -- --
Fair value (gain) loss on
financial liabilities 4,857 (848) (18,964)
Depreciation & amortization 219 311 99
Share-based payment expenses 5,355 1,071 2,159
Net foreign exchange losses
(gains) 57 231 --
Interest expense 69 77 86
Interest income (1,614) (1,218) (303)
Operating cash flows before
movements in working capital (53,700) (46,640) (28,932)
movements in working capital:
Decrease/(increase) in other
current assets (2,337) (315) 1,343
Decrease/(increase) in other
non-current assets (363) (342) (331)
Increase/(decrease) in trade
and other payables 2,359 (230) 3,686
Increase/(decrease) in
deferred income 747 (395) (580)
Income taxes paid -- (4) (3)
Interest paid (69) (10) (20)
Interest received 1,622 1,106 245
Net cash flow from /(used in)
operating activities (51,741) (46,828) (24,592)
------------ ------------ -----------
Purchases of property, plant
and equipment (4) (675) --
Purchase of financial
investments (30,000) -- 40,000
Payment of contingent
consideration from previous
acquisition (3,000) -- --
------------ ------------ -----------
Net cash flow from /(used in)
investing activities (33,004) (675) 40,000
------------ ------------ -----------
Repayment of lease liabilities (338) (163) (100)
Proceeds from capital increase -- 97,055 79,871
Share issue costs -- (129) (453)
Other financial expense, net -- -- 6
------------ ------------ -----------
Net cash flow from /(used in)
financing activities (338) 96,762 79,324
------------ ------------ -----------
Net increase/(decrease) in cash
and cash equivalents (85,083) 49,260 94,732
------------ ------------ -----------
Cash and cash equivalents at
beginning of year 171,459 122,402 27,670
Effect of foreign exchange rate
changes 45 (204) --
Cash and cash equivalents at
end of year 86,418 171,459 122,402
------------ ------------ -----------
Ontunisertib and AGMB-447 are investigational drugs and not approved by any regulatory authority. Their efficacy and safety have not been established.
About Agomab
Agomab is a clinical-stage biopharmaceutical company focused on developing novel disease-modifying therapies for fibro-inflammatory diseases with high unmet medical need. Agomab's product candidates are designed to target established potent pathways and utilize organ-restricted approaches, with the aim of increasing efficacy while minimizing safety liabilities. Fostering a culture of excellence, Agomab's mission is to pioneer therapeutics that aim to resolve fibro-inflammation and restore organ function to enable people with these disorders to live fuller and healthier lives.
Cautionary Note Regarding Forward-Looking Statements
This press release includes certain disclosures that contain "forward-looking statements," including, without limitation, statements regarding our expected cash runway, including that we anticipate our cash and cash investments and IPO proceeds will extend our runway into the first half of 2029, our focus on the discovery and development of our pipeline of novel product candidates for fibro-inflammatory disorders, the design of planned Phase 2 clinical trials with ontunisertib for FSCD and AGMB-447 for IPF, our expectation to initiate our Phase 2b Study of ontunisertib in FSCD and our Phase 2 study of AGMB-447 in IPF in the second half of 2026, as well as statements regarding future data readouts, including our expectation to release topline data from the OLE part of the STENOVA study and of the Phase 1b IPF Study Cohort with AGMB-447 in the second half of 2026. Forward-looking statements are based on Agomab's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to the results of our clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements for product candidates; the impact of governmental laws and regulations on our business; disruptions
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