Full Press Release Details
Reports Full Year 2025 Financial Results and Confirms 2026 Outlook
Cash and Cash Investments at December 31, 2025 of 116.5 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
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 --
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.
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."
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."
Program Highlights and 2026 Anticipated Milestones
Year 2025 Financial Results (consolidated)
statement of profit and loss
| For the year ended December 31 | ||||||||||||
| (in thousands of ), 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 ) | (143.22 | ) | (107.09 | ) | (35.63 | ) |
| For the year ended December 31 | ||||||||||||
| (in thousands of ) | 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 ) | 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 ) | 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.
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
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 caused by our reliance on third party
suppliers and service providers; the risk that our expectations and management's guidance regarding our cash position and other
financial estimates may be incorrect; and risks related to geopolitical conflicts and macro-economic events. These and other risks and
uncertainties are described more fully in our filings and reports with the SEC, including in our most recent annual report on Form 20-F
filed with the SEC and our subsequent filings and reports filed with the SEC. Forward-looking statements contained in this announcement
are made as of this date, and Agomab undertakes no duty to update such information except as required under applicable law. Readers should
not rely upon the information in this announcement as current or accurate after its publication date.
VP of Investor Relations
Phone: +1 781 296 1143
Trophic Communications
E-Mail: agomab@trophic.eu
Phone: +49 172 861 8540