AgomAb Therapeutics NV · NASDAQ:AGMB

AgomAb Therapeutics NV — Investor Presentation (October 2026)

29 slides from AgomAb Therapeutics NV's investor presentation, Oct 1, 2026

  1. Slide 1: Unlocking disease modification in fibro-inflammation

    Unlocking disease modification in fibro-inflammation STENOVA Open-Label Extension (OLE) Study Results October 1, 2026

  2. 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

  3. Slide 3: Today's speakers

    Today’s speakers Florian Rieder, MD Tim Knotnerus Philippe Wiesel, MD Pierre Kemula Vice-Chair Department of Gastroenterology, Chief Executive Officer Chief Medical Officer Chief Financial Officer Hepatology and Nutrition 3

  4. Slide 4: Agenda

    Agenda 1. Introduction 2. Fibrostenosing Crohn’s disease & the unmet need in fibro-inflammation 3. STENOVA Part B results: Open-label extension (OLE) study with ontunisertib in FSCD 4. Next steps with ontunisertib 5. Q&A 4

  5. Slide 5: Focused pipeline of product candidates for fibro-inflammatory diseases

    Focused pipeline of product candidates for fibro-inflammatory diseases Anticipated Milestones Indication Preclinical Phase 1 Phase 2a Phase 2b Phase 3 Ontunisertib (AGMB-129) GI-restricted Fibrostenosing Crohn‘s disease (FSCD) Start NOV-ERA oral small molecule Ph2b study in 2H 2026 ALK5 inhibitor AG

  6. Slide 6: Agenda

    Agenda 1. Introduction 2. Fibrostenosing Crohn's disease & the unmet need in fibro-inflammation 3. STENOVA Part B results: Open-label extension (OLE) study with ontunisertib in FSCD 4. Next steps with ontunisertib 5. Q&A 6

  7. Slide 7: Fibro-inflammation drives disease progression in IBD

    Fibro-inflammation drives disease progression in IBD Current treatment paradigm focuses on treating inflammatory flares Potential for Inflammation ontunisertib Fibrosis Advanced anti-inflammatory therapies Disease CD Onset FSCD Stricture Recurrent onset diagnosis symptoms surgery stricture Fibrosis

  8. Slide 8: 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 Fibrostenosing Crohn’s disease (FSCD) 2 Dietary changes ~620,00

  9. Slide 9: FSCD's unmet need defines what a new therapy must deliver

    FSCD’s unmet need defines what a new therapy must deliver CURRENT STATUS UNMET MEDICAL NEED WHAT SHOULD A DRUG LOOK LIKE Fibrosis remains untreated 1,2 Restore normal everyday life 3,4 Designed for long-term use 5,6 Inflammation control not enough Live free of symptoms — Safe especially pain Standar

  10. Slide 10: Agenda

    Agenda 1. Introduction 2. Fibrostenosing Crohn's disease & the unmet need in fibro-inflammation 3. STENOVA Part B results: Open-label extension (OLE) study with ontunisertib in FSCD 4. Next steps with ontunisertib 5. Q&A 10

  11. 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 Ontunisertib 200 mg BID (n=34) Randomization 1:1:1 (n=103) Screening Ontunisertib 100 mg QD (n=34) Ontunisertib 200 mg BID (n=49) Fol

  12. Slide 12: Majority of eligible patients rolled over into OLE

    Majority of eligible patients rolled over into OLE OLE initiated early 2025, with STENOVA Part A already underway Ontunisertib Ontunisertib Ontunisertib Treatment disposition 200 mg BID after 200 mg BID after All Subjects 200 mg BID n (%) 100 mg QD Placebo (N=49) (N=16) (N=19) (N=14) Completed 14 (8

  13. Slide 13: OLE patient population similar to overall STENOVA population

    OLE patient population similar to overall STENOVA population Baseline characteristics  Predominantly male (>70%)  Long disease history (>15 years)  Approx. 40% prior surgery  75% on advanced biologics  Mild luminal disease activity  Approx. 40% isolated ileal disease 13

  14. Slide 14: Favorable long-term safety and tolerability profile

    Favorable long-term safety and tolerability profile Low number of non-related SAEs in 48wk period Ontunisertib Ontunisertib Ontunisertib 200mg BID All Subjects 200 mg BID Parameter 200 mg BID after 100 mg (N=49) after Placebo (N=16) QD (N=14) (N=19) TEAE 9 (56.3) 16 (84.2) 10 (71.4) 35 (71.4) • 5 SA

  15. Slide 15: OLE shows favorable long-term safety and tolerability profile of ontunisertib in FSCD up to 60 weeks

    OLE shows favorable long-term safety and tolerability profile of ontunisertib in FSCD up to 60 weeks  Unremarkable AE profile in patients receiving ontunisertib 200 mg BID for up to 60 weeks  No signals of cardiac injury, pro-inflammatory effects, or vasculitis  No liver toxicity and no increase

  16. Slide 16: Low systemic exposure of ontunisertib maintained over additional 48 weeks

    Low systemic exposure of ontunisertib maintained over additional 48 weeks Gut-restricted pharmacokinetics profile of ontunisertib sustained over time LOW SYSTEMIC EXPOSURE (PLASMA) in STENOVA and OLE Ontunisertib systemic IC50  Ontunisertib and main inactive MET-158 200 mg BID metabolite MET-158 po

  17. Slide 17: Extended treatment with ontunisertib on top of SoC achieved low event rate (3%)

    Extended treatment with ontunisertib on top of SoC achieved low event rate (3%) in symptomatic FSCD patients EVENT RATE (SURGERY or EBD) Ontunisertib Event-free survival BMC 2026 1 (vedolizumab, retrospective cohort) UEGJ 2022 2 Standard of care (SoC, retrospective cohort) ECCO-JCC 2026 3 (ustekinum

  18. Slide 18: Extended treatment with ontunisertib on top of SoC achieves low event rate (3%)

    Extended treatment with ontunisertib on top of SoC achieves low event rate (3%) in symptomatic FSCD patients Study 12-month event rate STENOVA STENOVA results 3% • Only 1 event (EBD) recorded (3%) (ontunisertib, Part A + Part B, prospective) • No patients progressed to surgery for up to 60 weeks on

  19. Slide 19: Events have a high impact on patients and healthcare systems

    Events have a high impact on patients and healthcare systems Bowel damage leads to events (surgery), poor quality of life and increased healthcare costs FSCD-related events have high burden on patient quality of life 1 And translate into high healthcare costs 1 5-8x 2-4x >$80K more likely to undergo

  20. Slide 20: MRE data suggest stricture stabilization & possible improvement in OLE

    MRE data suggest stricture stabilization & possible improvement in OLE STRICTURE LENGTH BOWEL WALL THICKNESS ASSOCIATED DILATATION DIAMETER Part A OLE (200 mg BID) Part A OLE (200 mg BID) Part A OLE (200 mg BID) Change from baseline in mm Placebo  200 mg BID 100 mg QD  200 mg BID 200 mg BID only A

  21. Slide 21: MRE results over Parts A & B: short vs longer strictures

    MRE results over Parts A & Part B: variability for short strictures (<5cm) vs consistent pattern for longer strictures (≥5cm) Stricture length < 5cm Stricture length ≥ 5cm Part A OLE (200 mg BID) Part A OLE (200 mg BID) Placebo  200 mg BID 100 mg QD  200 mg BID 200 mg BID only 21

  22. Slide 22: Lower variability observed in patients with longer strictures at baseline

    Lower variability observed in patients with longer strictures at baseline Subgroup: stricture length ≥5cm at baseline STRICTURE LENGTH BOWEL WALL THICKNESS ASSOCIATED DILATATION DIAMETER Part A OLE (200 mg BID) Part A OLE (200 mg BID) Part A OLE (200 mg BID) Change from baseline in mm Placebo  200

  23. Slide 23: Endoscopic passability – Limited dataset precludes interpretation

    Endoscopic passability – Limited dataset precludes interpretation Number of endoscopies available in patients with non-passable strictures at baseline Start of STENOVA n=79  OLE study limitations STENOVA Week 12 • Endoscopy elective at Week 48 in OLE n=70 • Absence of control arm in open-label part

  24. Slide 24: Sustained symptomatic control over 48-week treatment period

    Sustained symptomatic control over 48-week treatment period S-PRO SEVERITY SCORE CDAI TOTAL SCORE SHORT IBD-Q (QUALITY OF LIFE) Part A OLE (200 mg BID) Part A OLE (200 mg BID) Part A OLE (200 mg BID) Minimal obstructive symptoms Clinical remission Improved quality of life (97% in remission at W48) P

  25. Slide 25: STENOVA open-label extension study – key takeaways

    STENOVA open-label extension study – key takeaways  Generally favorable long-term safety and tolerability profile  Confirmed gut-restricted PK profile  Very low annualized FSCD-related event rate (surgery/EBD) of 3%  Sustained disease control: • Low symptoms and disease activity scores (S-PRO, C

  26. Slide 26: Agenda

    Agenda 1. Introduction 2. Fibrostenosing Crohn's Disease & the unmet need in fibro-inflammation 3. STENOVA Part B results: Open-label extension (OLE) study with ontunisertib in FSCD 4. Next steps with ontunisertib 5. Q&A 26

  27. Slide 27: 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 Ontunisertib 400 mg BID (n=80) Randomization 1:1:1:1 (n=320) Ontunisertib 200 mg BID (n=80) Screening Follow

  28. Slide 28: Agenda

    Agenda 1. Introduction 2. Fibrostenosing Crohn's Disease & the unmet need in fibro-inflammation 3. STENOVA Part B results : Open-label extension (OLE) study with ontunisertib in FSCD 4. Next steps with ontunisertib 5. Q&A CONFIDENTIAL 28

  29. Slide 29: Thank you!

    Thank you! Contact: sofie.vangijsel@agomab.com 29

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