AgomAb Therapeutics NV · NASDAQ:AGMB
AgomAb Therapeutics NV — Investor Presentation (August 2026)
50 slides from AgomAb Therapeutics NV's investor presentation, August 2026
Slide 1: Unlocking disease modification in fibrosis
Unlocking disease modification in fibrosis Corporate Presentation August 2026
Slide 2: Disclaimer
Disclaimer Forward-Looking Statements This presentation includes forward looking statements, including without limitation, statements relating to the expected timing, design and readouts of our ongoing and planned preclinical studies and clinical trials, interim and topline data from our preclinical
Slide 3: Focused pipeline of product candidates for fibrotic diseases
Focused pipeline of product candidates for fibrotic diseases Anticipated Indication Preclinical Phase 1 Phase 2a Phase 2b Phase 3 Milestones Ontunisertib (AGMB-129) GI-restricted Fibrostenosing Crohn‘s Disease Ph2a full OLE oral small molecule data in 2H 2026 ALK5 inhibitor AGMB-447 Ph1b IPF data Lu
Slide 4: Experienced team building a leading I&I biopharma company
Experienced team building a leading I&I biopharma company Leadership team Tim Knotnerus Philippe Wiesel Pierre Kemula Andrea Sáez Paul van der Horst Ellen Lefever Chief Executive Officer Chief Medical Officer Chief Financial Officer Chief Development Officer Chief Business Officer General Counsel Bo
Slide 5: Ontunisertib: STENOVA Phase 2a results
Ontunisertib Oral ALK5 inhibitor for Fibrostenosing Crohn’s Disease STENOVA Phase 2a results A Landmark Study in FSCD
Slide 6: Main unmet needs in Crohn's disease: fibrotic strictures & efficacy ceiling
Main unmet needs in Crohn's disease: fibrotic strictures & efficacy ceiling CROHN’S DISEASE DEVELOPMENT CURRENT MEDICAL NEED AND GOAL 2 Luminal CD 1 FSCD 1 Fibrostenosing CD (FSCD) Medical need: no approved treatment available for fibrotic strictures Goal: provide first therapeutic to halt or revers
Slide 7: Fibrotic stricturing is the leading unresolved issue in Crohn's Disease
Fibrotic stricturing is the leading unresolved issue in Crohn’s Disease FIBROTIC STRICTURE IN CD PATIENT 1 PATIENT IMPACT PREVALENCE & COST BURDEN Increased Pain, cramps & ~46% wall thickness vomiting after meals Of all CD patients have FSCD 2 Dietary changes ~620,000 patients with FSCD 3 Prestenoti
Slide 8: TGFβ pathway is the main driver of fibrosis
TGFβ pathway is the main driver of fibrosis Development of systemic ALK5 inhibitors hampered by toxicity OVERVIEW OF TGFβ AND SMAD SIGNALING IN TISSUE FIBROSIS TGFβ plays key role in fibrosis ▪ TGFβ levels are increased in fibrotic tissue TGFβ1 ▪ TGFβ induction in mouse models causes fibrosis, while
Slide 9: Our approach: GI-restricted ALK5 inhibitor ontunisertib (AGMB-129)
Our approach: GI-restricted ALK5 inhibitor ontunisertib (AGMB-129) Designed to expose the GI tract to high levels of active drug while minimizing systemic exposure Given orally ontunisertib Portal vein Liver absorption Inactive metabolites in the bloodstream Gut wall Absorbed in GI tract, Rapidly me
Slide 10: STENOVA: Trailblazing proof-of-concept study in FSCD
STENOVA: Trailblazing proof-of-concept study in FSCD INDICATION DRUG CANDIDATE Fibrostenosing Crohn’s Disease Ontunisertib (AGMB-129) 1 Can we run a clinical study in FSCD patients? 3 Can we safely target ALK5 in a GI-restricted fashion? 2 Can we identify future registrational endpoints? 4 Can we sh
Slide 11: STENOVA: 2-part Phase 2a trial of ontunisertib in patients with FSCD
STENOVA: 2-part Phase 2a trial of ontunisertib in patients with FSCD TRIAL DESIGN Part A 12-week double-blind treatment Part B Additional 48-week open-label treatment Randomization 1:1:1 Ontunisertib 200mg BID (n=34) (n=103) Screening Ontunisertib 100mg QD (n=34) Ontunisertib 200mg BID Follow-up Pla
Slide 12: Subject disposition, demographics & baseline disease characteristics
Subject disposition, demographics & baseline disease characteristics
Slide 13: Landmark study in FSCD showing good recruitment
Landmark study in FSCD showing good recruitment Subject disposition indicates high completion rate AGMB-129 AGMB-129 Treatment disposition Placebo All Subjects 200mg BID 100mg QD n (%) (N=35) (N=103) (N=34) (N=34) Completed 29 (85.3) 32 (94.1) 31 (88.6) 92 (89.3) Discontinued 5 (14.7) 2 (5.9) 4 (11.
Slide 14: Baseline characteristics indicate long-standing disease, majority on advanced therapy
Baseline characteristics indicate long-standing disease, with majority of patients on advanced therapy Well-balanced baseline demographics & disease characteristics AGMB-129 AGMB-129 Placebo All Subjects Parameter 200mg BID 100mg QD (N=35) (N=103) (N=34) (N=34) Age (years), mean (SD) 44.2 (12.6) 41.
Slide 15: Well-balanced use of biologics across treatment arms
Well-balanced use of biologics across treatment arms >70% of patients on stable anti-inflammatory biologics during the study AGMB-129 AGMB-129 Concomitant biologic Placebo All Subjects 200mg BID 100mg QD n (%) (N=35) (N=103) (N=34) (N=34) Adalimumab 6 (17.6) 7 (20.6) 7 (20.0) 20 (19.4) Infliximab 4
Slide 16: Can we safely target ALK5 in a gut-restricted fashion? Safety & tolerability
Can we safely target ALK5 in a gut-restricted fashion? Safety & tolerability
Slide 17: Ontunisertib shows favorable safety & tolerability profile in FSCD patients over 12 weeks
Ontunisertib shows favorable safety & tolerability profile in FSCD patients over 12 weeks ▪ Balanced numbers of TEAEs across treatments arms, including placebo ▪ No treatment related safety signal in any safety lab, vital signs, and physical examination, and echocardiography ▪ No treatment related s
Slide 18: No relevant safety signals based on adverse events
No relevant safety signals based on adverse events Incidence and severity of AEs balanced across study arms, including placebo AGMB-129 AGMB-129 Subjects with any Placebo 200mg BID 100mg QD n (%) (N=35) (N=34) (N=34) TEAE 21 (61.8) 22 (64.7) 25 (71.4) Serious TEAE 4 (11.8) 0 4 (11.4) Worst-case: Mod
Slide 19: STENOVA Part A - Four SAEs in placebo and 200mg BID arms
STENOVA Part A - Four SAEs in placebo and 200mg BID arms, none in 100mg QD arm No concerns raised by DSMB on SAE profile 200mg BID: 4 patients with SAEs Placebo: 4 patients with SAEs • Atrial fibrillation and lacunar infarct in a 75y-old male • 2 cases of Ileus: with Type 2 DM, hypertension, obesity
Slide 20: Open-label extension data support longer-term safety and tolerability profile
Open-label extension data support longer-term safety and tolerability profile Data snapshot* in 24 patients treated with ontunisertib 200mg BID for up to 36 weeks ▪ Unremarkable AE profile in patients receiving ontunisertib 200mg BID for up to 9 months ▪ Similar to lower AE incidence with extended t
Slide 21: Can we safely target ALK5 in a gut-restricted fashion? Systemic & local PK
Can we safely target ALK5 in a gut-restricted fashion? Systemic & local PK
Slide 22: Confirmed low systemic exposure of ontunisertib
Confirmed low systemic exposure of ontunisertib High systemic exposure of main inactive metabolite Ontunisertib IC50 ▪ Ontunisertib systemic exposure is >50x below its own IC50 ▪ Inactive metabolite MET-158 systemic exposure is significantly >50x higher than ontunisertib, supporting GI absorption an
Slide 23: High local ileal exposure in FSCD patients
High local ileal exposure in FSCD patients Based on observations with confirmed timing within 5 hours post-dose LLOQ, lower limit of quantification 23
Slide 24: Can we show improvements in strictures in FSCD patients?
Can we show improvements in strictures in FSCD patients? Clinical response based on established luminal endoscopic endpoint (SES-CD)
Slide 25: Improvement in SES-CD score in the 200mg BID group ontunisertib
Improvement in SES-CD score in the 200mg BID group ontunisertib More pronounced effect in relevant subgroups *Based on post-hoc analysis; not powered for statistical significance BSL, baseline; SE, standard error 25
Slide 26: High endoscopic response & remission rates in 200mg BID, on top of SoC
High endoscopic response & remission rates in 200mg BID, on top of SoC SES-CD-based definitions recommended by FDA Placebo 100mg QD 200mg BID Endoscopic response: ≥50% decrease; endoscopic remission: SES-CD ≤4 and no item >1 26
Slide 27: Improvement in stricture passability at Week 12 in ontunisertib 200mg BID group
Improvement in stricture passability at Week 12 in ontunisertib 200mg BID group Non-passable stricture at baseline Non-passable stricture at Week 12 -6.5% 31 -7.7% Non-passable strictures (n) 29 26 -31.8% 24 22 15 Placebo 100mg QD 200mg BID 27
Slide 28: Can we show improvements in strictures in FSCD patients? Novel endpoints
Can we show improvements in strictures in FSCD patients? Clinical response based on novel FSCD-specific endpoints (S-PRO and MRE)
Slide 29: S-PRO severity score requires further refinement
S-PRO severity score requires further refinement ▪ Data suggest participants reach efficacy floor after 4-8 weeks, across treatment arms ▪ Further refinement of S-PRO score ongoing, in collaboration with STAR Consortium ▪ Exploring additional Clinical Outcome Assessments (COAs) 29
Slide 30: Magnetic resonance enterography (MRE) shows trend after 12 weeks
Magnetic resonance enterography (MRE) shows trend after 12 weeks Strongest trend observed for stricture length Bowel wall thickness Pre-stenotic associated Stricture dilation diameter length Mean values at baseline (in mm): Stricture length, 104mm; Associated dilation diameter, 28.3mm; Bowel wall th
Slide 31: Further improvement in stricture length beyond Week 12 in OLE
Further improvement in stricture length beyond Week 12 in OLE Internal analysis of 22 patients for additional 24-week 200mg BID treatment, for a total of 36 weeks Subjects are grouped by their originally allocated arm; all receive ontunisertib 200mg BID after Week 12. Analyses are non-validated draf
Slide 32: Favorable safety and tolerability with doses up to 400mg BID in Phase 1 study
Favorable safety and tolerability profile of ontunisertib with doses up to 400mg BID in recent Phase 1 study TRIAL DESIGN OBJECTIVES AND RESULTS Phase 1 MAD, 7-day treatment, cohort size of 10 HVs (8:2) ▪ Study initiated following Phase 2 STENOVA interim results ▪ Objective: investigate higher doses
Slide 33: Conclusion
Conclusion
Slide 34: STENOVA: a landmark study in FSCD
STENOVA: a landmark study in FSCD INDICATION DRUG CANDIDATE Fibrostenosing Crohn’s Disease Ontunisertib 1 Can we run a clinical study in FSCD patients? 3 Can we safely target ALK5 in a GI-restricted fashion? ▪ Well-executed first-in-indication clinical study in FSCD ▪ Favorable safety and tolerabili
Slide 35: Ontunisertib could provide solution for strictures and efficacy ceiling
Ontunisertib could provide solution for strictures and efficacy ceiling CROHN’S DISEASE DEVELOPMENT CURRENT MEDICAL NEED AND GOAL 2 Luminal CD 1 FSCD 1 Fibrostenosing Crohn's disease (FSCD) Medical need: no approved treatment available for fibrotic strictures Goal: INFLAMMATION ❑ Provide first thera
Slide 36: NOV-ERA, a global Phase 2b study to confirm efficacy of ontunisertib in FSCD
NOV-ERA, a global Phase 2b study to confirm efficacy of ontunisertib in FSCD Phase 2b to validate and inform selection of registrational endpoints 52-week double-blind treatment on top of SoC 1:1:1:1 (n=300-400) Ontunisertib 400mg BID (n=80) Randomization Ontunisertib 200mg BID (n=80) Screening Foll
Slide 37: AGMB-447: Inhaled ALK5 inhibitor for Idiopathic Pulmonary Fibrosis
AGMB-447 Inhaled ALK5 inhibitor for Idiopathic Pulmonary Fibrosis (IPF) 37
Slide 38: Fibrotic remodeling of the lungs is the key driver of disease in IPF
Fibrotic remodeling of the lungs is the key driver of disease in IPF FIBROSIS LIMITS RESPIRATION IN IPF PATIENTS 1 PATIENT IMPACT 2 PREVALENCE & COST BURDEN Shortness of ~240K breath, coughing Total IPF patients in 2025 (US, EU4+UK, JPN) 3 Fatigue and ~$110K general Annual IPF drug costs per patient
Slide 39: Despite approved therapies, the unmet medical need in IPF remains high
Despite approved therapies, the unmet medical need in IPF remains high LIMITED EFFICACY & TOLERABILITY 1,2 ... WHICH LEAD TO POOR USE ... 3 …YET ACCOUNT FOR A LARGE MARKET 4,5 Global Pulmonary Fibrosis sales ($B) 26% Forecast of IPF patients initiate $10 treatment $6.9-8.3B $8 CAGR 5.3-7.4% $6 43% B
Slide 40: Our proposed solution: AGMB-447, an inhaled lung-restricted ALK5 inhibitor
Our proposed solution: AGMB-447, an inhaled lung-restricted ALK5 inhibitor Designed to avoid systemic toxicity through rapid hydrolysis, limiting exposure to lung Administration by inhalation (nebulization) Well absorbed in lung, achieving local effects Upon absorption, AGMB-447 is rapidly hydrolyze
Slide 41: Phase 1 clinical trial assessing safety and target engagement of AGMB-447
Phase 1 clinical trial assessing safety and target engagement of AGMB-447 in healthy participants and IPF patients ongoing TRIAL DESIGN 1 TRIAL OBJECTIVES & STATUS ▪ Safety ▪ Systemic & local PK: SAD MAD Repeat dose in IPF In HV in HV, 7 days2 patients, 2 weeks ▪ evaluating AGMB-447 & metabolite lev
Slide 42: AGMB-447 has shown favorable safety & tolerability profile in healthy participants
AGMB-447 has shown generally favorable safety & tolerability profile in healthy participants ▪ A total of 108 healthy participants included in the SAD and MAD 1-6 part of the study ▪ No systemic safety signal observed at different dose levels tested in healthy participants • Most common tolerability
Slide 43: Observed low systemic exposure of AGMB-447 in healthy participants
Observed low systemic exposure of AGMB-447 in healthy participants (MAD 1-6; Day 7) AGMB-447 (total) AGMB-447 (free) Free: free fraction in plasma, considered at 1%; ND: New dilution procedure with 0.9% NaCl (sodium chloride) Cp,ss, plasma concentration at steady state 43
Slide 44: Rapid and higher exposure of inactive MET-093 supports absorption and hydrolysis
Rapid and higher exposure of inactive MET-093 supports absorption, tissue penetration and efficient hydrolysis (MAD 1-6; Day 7) MET-093 (total) ND: New dilution procedure with 0.9% NaCl (sodium chloride) 44
Slide 45: Target engagement: dose-dependent inhibition of ALK5 in BAL cells
Target engagement: dose-dependent inhibition of ALK5 observed in BAL cells in healthy participants 4.5mg BID and 9mg QD achieved robust target engagement, as measured by pSMAD3 inhibition in BAL cells pSMAD3 inhibition in BAL cells 6h timepoint Fold changes were normalized to the overall geometric m
Slide 46: AGMB-447 – a Phase 2 ready asset addressing high unmet need in IPF
AGMB-447 – a Phase 2 ready asset with the potential to address the high unmet medical need in IPF ▪ Validated fibrotic target ALK5/TGFβR1 addressing underlying disease pathology of fibrotic interstitial lung diseases ▪ Lung-restricted, inhaled and rapidly metabolized MoA offers Inhalation potential
Slide 47: Outlook & Financials
Outlook & Financials AGOMAB
Slide 48: Significant value inflection points expected across pipeline programs
Significant value inflection points expected across pipeline programs ontunisertib ✓ Topline Ph2a STENOVA Part A; Update on OLE STENOVA; Ph1 MAD (Oct-25) ✓ Regulatory interactions with FDA on Ph2b NOV-ERA trial design in FSCD • Ph2b initiation (2H 2026) • Full OLE STENOVA data in FSCD (2H 2026) ✓ To
Slide 49: Strong Financial Position Enables Value Creation
Strong Financial Position Enables Value Creation €252 million of cash Gross proceeds of $208 million from as of June 30, 20261 IPO in Feb 2026 (NASDAQ: AGMB) Expected cash runway into 1H 2029 Fully unencumbered pipeline Robust cash position to deliver on key pipeline milestones 1 Cash, cash equivale
Slide 50: Thank you!
Thank you! For more information, please contact Investor Relations at sofie.vangijsel@agomab.com 50
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