Gubra A/s · OMXCOP:GUBRA

Gubra A/s — Q1 2025 Earnings Presentation

40 slides from Gubra A/s's earnings presentation, May 9, 2025

  1. Slide 1: First Quarter 2025 Investor Presentation

    SHARE TICKER: GUBRA l NASDAQ COPENHAGEN FIRST QUARTER 2025 INVESTOR PRESENTATION 9 MAY 2025 Present from Gubra: Henrik Blou, CEO Louise S. Dalbøge, CSO Kristian Borbos, CFO INVESTOR CONFERENCE CALL 9 May 2025, 10:00am CET Follow live via: https://events.q4inc.com/attendee/420991451 DIAL-IN NUMBERS D

  2. Slide 2: Forward looking statements

    Forward looking statements Matters discussed in this presentation may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and that can be identified by words such as “believe“, “expect“, “anticipate“, “intends“, “estimate“, “will“, “may“, “c

  3. Slide 3: CRO services, discovery & partnerships

    CRO SERVICES DISCOVERY & ~270 30% PARTNERSHIPS Specialized pre-clinical Discovery, design, and contract research and development of peptide- EMPLOYEES YEARLY development services based drug candidates MARCH 2025 REVENUE GROWTH* for the pharma and with the aim of entering biotech industry. partnershi

  4. Slide 4: Key operational highlights 2025

    Key operational highlights 2025 GUBamy GUBamy UCN2 CRO ABBVIE MAD PART A HEALTHY SLIGHT DECLINE DEAL PHASE 1 RESULTS WEIGHT LOSS VS Q1 2024 Landmark AbbVie deal Strong MAD results Additional compelling data Slight revenue decline + Outlicensing GUBamy + Well tolerated + Results show restoration of +

  5. Slide 5: R&D Pipeline

    R&D Pipeline Partnered and internal programs (Drug Discovery and onwards) 5

  6. Slide 6: An exclusive global license agreement with AbbVie

    An exclusive global license agreement with AbbVie + Gubra grants AbbVie an exclusive global license to develop and commercialize GUBamy, a long-acting amylin analogue + Deal terms: + Gubra will receive USD 350 million upfront + Gubra is also eligible to receive up to USD 1.875 billion in development

  7. Slide 7: GUBamy

    AMYLIN GUBAMY Once-weekly amylin analogue for the treatment of obesity 7

  8. Slide 8: GUBamy holds potential to become the next generation weight management therapy

    GUBamy holds potential to become the next generation weight management therapy GUBamy § Balanced Long half-life Body weight loss Physical and Very long receptor profile (T½) alone and in chemical stable patent exclusivity (AMYR and CTR) combination at neutral pH 8

  9. Slide 9: Phase 1 Multiple Ascending Dose (MAD)

    Phase 1 Multiple Ascending Dose (MAD) NCT06144684 (Phase 1, Part 2) Part A (completed) Part B (ongoing) (6 weeks dosing) (12 weeks dosing incl. titration) + Randomized + Double-blinded within cohorts Dose 5 + Placebo-controlled Dose 4 + Once weekly subcutaneous dosing Dose 3 + 52 subjects (males and

  10. Slide 10: MAD part A Study conclusions

    MAD part A Study conclusions + GUBamy was well tolerated with adverse events being predominantly GI related, mild and consistent with SAD study. + Study confirmed the favorable half-life of 11 days. + Mean BMI was 24.33 (2mg cohort) and 27.63 (placebo). + Doses of 1 mg and 2 mg led to a dose-depende

  11. Slide 11: GUB-UCN2

    UCN2 GUB-UCN2 High quality weight loss with once weekly UCN2 analogue 11 11

  12. Slide 12: Time to focus on healthy weight loss

    Time to focus on healthy weight loss Treatment paradigm for future obesity treatment TODAY: FUTURE: Loss of lean mass Healthy weight loss 100 100 90 Fat mass Fat mass 90 Lean mass Lean mass • Maximize loss of fat mass 80 80 70 Lost weight (%) Lost weight (%) 70 60 60 50 50 • While preserving/increas

  13. Slide 13: Selective long-acting UCN2 analogues

    Selective long-acting UCN2 analogues Ready for development Selective receptor profile Excellent physical and Pharmacokinetics: chemical stability: + Allometric scaling from data + No amyloid fibril formation in mouse, rat and minipig support once-weekly dosing in humans + High chemical stability + H

  14. Slide 14: UCN2 Delivers Lean Mass Protection and Additive Fat Mass Loss in Combination Therapy

    UCN2 Delivers Lean Mass Protection and Additive Fat Mass Loss in Combination Therapy + Earlier studies in DIO rats showed that UCN2 combined with a weight-lowering agent enhances fat mass loss while fully preventing lean mass loss in DIO rats. + New robust 2025 data in aged diet induced obese rats v

  15. Slide 15: GUB-UCN2 Restores GLP-1 induced Lean Mass Loss and Potentiates Fat Reduction

    GUB-UCN2 Restores GLP-1 induced Lean Mass Loss and Potentiates Fat Reduction Body weight (%) Lean mass (% change) Decreased fat mass (% change) 120 25 20 15 20 10 Lean mass change (%) Fat mass change (%) 5 Body weight (%) 110 15 0 -5 10 -10 100 -15 5 -20 -25 GUB-UCN2 added to 0 -30 Semaglutide (pink

  16. Slide 16: UCN2: Planning for clinical testing

    UCN2: Planning for clinical testing • GMP-production of UCN2 API has been initiated • Non-clinical toxicity programme ongoing • Clinical Phase 1 expected to start early 2026 16

  17. Slide 17: Q1 2025 financial results

    DISCOVERY & PARTNERSHIPS Q1 2025 financial results Total adjusted costs DKKm Revenue DKKm 61 7 7 + Revenue of DKK 7 million, up 7% y/y 33 + Upfront payment of USD 350 million (DKK 2.4 billion) received in Q2 and therefore not recognised in Q1 accounts Q1 2024 Q1 2025 Q1 2024 Q1 2025 + Total costs in

  18. Slide 18: Q1 2025 financial results (CRO business)

    CRO BUSINESS CRO revenue (organic) DKKm Q1 2025 financial results 59 51 Revenue + Growth y/y down 14% and down 8% compared Q1 2024 Q1 2025 to quarterly average in 2024 CRO adjusted EBIT* CRO adjusted EBIT-margin* Earnings DKKm + EBIT decline as a consequence of lower revenue 39% 23 21% 11 Q1 2024 Q1

  19. Slide 19: Financial outlook and guidance (unchanged)

    Financial outlook and guidance (unchanged) Outlook Mid-term Guidance items 2025 Guidance CRO segment Organic revenue growth 10-20% 10% annually EBIT-margin 25-31% n/a Discovery & Partnerships segment Total costs1 DKK 230-250 million n/a 1) Total costs are cost of sales and operating costs 19

  20. Slide 20: Appendix

    ubr. Appendix

  21. Slide 21: Our Discovery & Partnerships business (D&P)

    Our Discovery & Partnerships business (D&P) + Discovery, design and development of peptide-based drug candidates + Through our streaMLine platform we can: + Accelerate clinical candidate identification + Enhance potential for stronger patent protection + Portfolio approach to partnering to balance r

  22. Slide 22: Our CRO business

    CRO BUSINESS OVERVIEW OF GUBRA’S DISEASE AREAS AND SERVICE OFFERING Our CRO business 3D Imaging Diabetes Liver Lungs (NASH/MASH) + Specialised in the pre-clinical phase with a stronghold in metabolic and fibrotic diseases 2D Histology + Highly ranked translatable rodent models Obesity Kidney Brain (

  23. Slide 23: GUBamy

    GUBamy GUBamy Once-weekly amylin analogue for the treatment of obesity 23

  24. Slide 24: GUBamy could be positioned as both an addition and an alternative to incretin-based therapies

    GUBamy could be positioned as both an addition and an alternative to incretin-based therapies + Extensive need GUBamy as GUBamy as for alternative stand-alone combination therapies therapy therapy 24

  25. Slide 25: Amylin: An important player in appetite regulation

    Amylin: An important player in appetite regulation Amylin From pancreas to the brain Decreases food intake Reduces blood glucose + Amylin is a 37 amino acid peptide Delays gastric emptying hormone. It is produced in the Decreases glucagon secretion pancreatic β-cells and co-secreted with insulin in

  26. Slide 26: GUBamy holds potential to become the next generation weight management therapy

    GUBamy holds potential to become the next generation weight management therapy GUBamy § Balanced Long half-life Body weight loss Physical and Very long receptor profile (T½) alone and in chemical stable patent exclusivity (AMYR and CTR) combination at neutral pH 26

  27. Slide 27: Phase 1a Study results

    Phase 1a Study results jw G i J

  28. Slide 28: Phase 1 Single Ascending Dose (SAD) in healthy men

    Phase 1 Single Ascending Dose (SAD) in healthy men NCT06144684 (Phase 1, Part 1) 6.0 mg + Randomized + Double-blind within cohorts 4.75 mg + Placebo-controlled 3.5 mg + Single subcutaneous administration + Single site (CRO in UK) 2.0 mg + 8 subj. per cohort 1.0 mg (2 placebo & 6 GUBamy) + 48 subject

  29. Slide 29: Study population: Healthy males normal to overweight

    Study population: Healthy males normal to overweight Baseline characteristics Placebo GUBamy GUBamy GUBamy GUBamy GUBamy GUBamy (all) 0.5 mg 1.0 mg 2.0 mg 3.5 mg 4.75 mg 6.0 mg n 12 6 6 6 6 6 6 Mean age, years (range) 35.7 34.8 38.0 43.5 48.8 40.2 32.0 (23-53) (22-51) (24-50) (28-53) (33-55) (34-46)

  30. Slide 30: GUBamy Phase 1a SAD key study endpoints

    GUBamy Phase 1a SAD key study endpoints Primary Endpoint Safety and tolerability incl. number of treatment-emergent adverse events (TEAEs) Secondary Endpoints (Pharmacokinetic) Pharmacokinetic (PK) evaluation incl. half-life (T½) Exploratory Endpoints (Pharmacodynamic) Change in body weight (%) 30

  31. Slide 31: GUBamy was well tolerated

    GUBamy was well tolerated Treatment Emergent Adverse Events (TEAEs) Treatment group Placebo GUBamy GUBamy GUBamy GUBamy GUBamy GUBamy Dose (volume mL) 0 mg 0.5 mg 1 mg 2.0 mg 3.5 mg 4.75 mg 6.0 mg (0.1-1.2 mL) (0.1 mL) (0.2 mL) (0.4 mL) (0.7 mL) (0.95 mL) (1.2 mL) n (%) E n (%) E n (%) E n (%) E n (

  32. Slide 32: Dose dependent GI adverse events

    Dose dependent GI adverse events Treatment Emergent Adverse Events (TEAEs) Treatment group Placebo GUBamy GUBamy GUBamy GUBamy GUBamy GUBamy Dose (volume) 0 mg 0.5 mg 1.0 mg 2.0 mg 3.5 mg 4.75 mg 6.0 mg (0.1-1.2 mL) (0.1 mL) (0.2 mL) (0.4 mL) (0.7 mL) (0.95 mL) (1.2 mL) n = 12 n=6 n=6 n=6 n=6 n=6 n=

  33. Slide 33: GUBamy Phase 1a SAD key study endpoints

    GUBamy Phase 1a SAD key study endpoints Primary Endpoint Safety and tolerability incl. number of treatment-emergent adverse events (TEAEs) Secondary Endpoints (Pharmacokinetic) Pharmacokinetic (PK) evaluation incl. half-life (T½) Exploratory Endpoints (Pharmacodynamic) Change in body weight (%) 33

  34. Slide 34: Long half-life (11 days) supports weekly dosing

    Long half-life (11 days) supports weekly dosing GUBamy shows a favourable pharmacokinetic profile 1000 Plasma concentration (ng/mL) 100 T½ 0.5 mg 1.0 mg 2.0 mg 3.5 mg 10 4.75 mg ≈ 270 hours 6.0 mg (11 days) 1 0 72 144 216 288 360 432 504 576 648 720 792 864 936 1008 Time point (h) A long half-life o

  35. Slide 35: GUBamy Phase 1a SAD key study endpoints

    GUBamy Phase 1a SAD key study endpoints Primary Endpoint Safety and tolerability incl. number of treatment-emergent adverse events (TEAEs) Secondary Endpoints (Pharmacokinetic) Pharmacokinetic (PK) evaluation incl. half-life (T½) Exploratory Endpoints (Pharmacodynamic) Change in body weight (%) 35

  36. Slide 36: Dose dependent body weight reduction

    Dose dependent body weight reduction Relative weight change from baseline in percentage 4 3 Change from baseline in body weight (%) 2 1 PLACEBO Placebo 0.5 mg 0 1.0 mg 2.0 mg -1 3.5 mg 4.75 mg -2 6.0 mg -3 -4 Pre-dose Day 4 Day 8 Day 15 Day 22 Day 29 Follow-up (Day 43) Time since dosing (day) 36

  37. Slide 37: Sustained body weight reduction for weeks

    Sustained body weight reduction for 6 weeks Relative weight change from baseline in percentage (SD) 4 3 Change from baseline in body weight (%) 2 1 Placebo PLACEBO 0 3.5 mg -1 4.75 mg 6.0 mg -2 -3 -4 Pre-dose Day 4 Day 8 Day 15 Day 22 Day 29 Follow-up (Day 43) Time since dosing (day) 37

  38. Slide 38: SAD study conclusions

    SAD study conclusions GUBamy dosed once in a dose range from 0.5 mg to 6.0 mg + GUBamy was well tolerated with adverse events being predominantly GI related, mild and transient. + GUBamy had a favourable pharmacokinetic profile with a half-life of 11 days supporting once weekly dosing. + A single do

  39. Slide 39: GUB-UCN2

    UCN2 GUB-UCN2 High quality weight loss with once weekly UCN2 analogue 39 39

  40. Slide 40: GUB-UCN2 eliminates lean mass loss induced by other anti-obesity agents in DIO rats

    GUB-UCN2 eliminates lean mass loss induced by other anti-obesity agents in DIO rats Sustained body weight Increased lean mass Decreased fat mass Relative body weight Lean mass change from baseline Fat mass change from baseline 110 Lean mass change from baseline (g) Fat mass change from baseline (g)

Gubra — Q1 2025 Earnings Presentation on 6ix