Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — 67th ASH Annual Meeting and Exposition 2025
17 slides from Novo Nordisk A/s Class B's conference presentation, December 2025
Slide 1: Mim8 Prophylaxis in Adults and Adolescents with Hemophilia A: 52-Week Outcomes
537 Mim8 Prophylaxis in Adults and Adolescents with Hemophilia A: 52-Week Efficacy and Safety Outcomes from the Phase 3 FRONTIER2 Study Steven R. Lentz,1 Aby Abraham,2 Cihan Ay,3 Anthony KC Chan,4 Victor Jiménez-Yuste,5 Johannes Oldenburg,6 Maria Elisa Mancuso,7,8 Johnny Mahlangu,9 Tadashi Matsushit
Slide 2: Disclaimer
Disclaimer Mim8 is not approved for the treatment of hemophilia. Safety and efficacy are not established. There is no guarantee that Mim8 will become commercially available for the use(s) under investigation.
Slide 3: Mim8 (denecimig), a new-generation FVIIIa mimetic
Mim8 (denecimig), a new-generation FVIIIa mimetic • Mim8 is a bispecific IgG4 antibody FVIIIa mimetic with distinct binding epitopes • Optimized for increased FIXa cofactor activity1 • 15-fold higher potency than emicizumab, as assessed by thrombin generation*2 Anti-FX arm Subcutaneous administratio
Slide 4: FRONTIER2: Study design
FRONTIER2: Study design Arm 1: on-demand Mim8 PPX QW/QM treatment On-demand Follow-up or Enrollment OLE study Randomization 1:1:1 Arm 2a: Mim8 PPX QW Mim8 PPX QW Stratification: • FVIII inhibitor status • ABR <18 or ≥18 Arm 2b: Mim8 PPX QM Mim8 PPX QM V1 V3 V10 V13 Treatment prior Main period Extens
Slide 5: FRONTIER2: Eligibility criteria
FRONTIER2: Eligibility criteria Key inclusion criteria Key exclusion criteria • Male or female aged ≥12 years • Exposure to non-factor hemostatic products for bleeding prophylaxis within 6 months before randomization • Body weight ≥30 kg • Ongoing or planned immune tolerance induction therapy • Hemo
Slide 6: FRONTIER2: Endpoints and objectives
FRONTIER2: Endpoints and objectives Pre-study on-demand treatment group: Number of treated bleeding episodes during in the 26-week main period Co-primary endpoints Pre-study CFC prophylaxis group: Number of treated bleeding episodes from initiation of run-in to Week 0 and from The main period of ran
Slide 7: Demographics and baseline characteristics were generally balanced across groups
Demographics and baseline characteristics were generally balanced across groups Pre-study on-demand treatment group Pre-study CFC PPX group Demographics and baseline characteristics (N=281*) Arm 1 Arm 2a Arm 2b Arm 3 Arm 4 On demand Mim8 QW Mim8 QM Mim8 QW Mim8 QM Number of patients, n 18 22 21 111
Slide 8: A reduction in mean estimated ABR was observed upon transitioning to Mim8
A reduction in mean estimated ABR was observed upon transitioning to Mim8 QW and QM in the extension period Pre-study on-demand group (Arm 1) Main (Weeks 0–26) Extension (Weeks 26–52) On-demand (n=18) Mim8 QW (n=8) Mim8 QM (n=10) Mean treatment analysis period (years) 0.50 0.51 0.51 Median ABR 12.24
Slide 9: Mim8 QW and QM demonstrated sustained bleed protection in the extension period
Mim8 QW and QM demonstrated sustained bleed protection in the extension period Pre-study on-demand treatment group (Arms 2a and 2b) Main (Weeks 0–26) Extension (Weeks 26–52) Mim8 QW (n=22) Mim8 QM (n=21) Mim8 QW (n=21) Mim8 QM (n=21) Mean treatment analysis period (years) 0.47 0.50 0.52 0.51 Median
Slide 10: Mim8 QW and QM demonstrated sustained bleed protection in the extension period
Mim8 QW and QM demonstrated sustained bleed protection in the extension period Pre-study CFC prophylaxis group (Arms 3 and 4) Main (Weeks 0–26) Extension (Weeks 26–52) Mim8 QW (n=111) Mim8 QM (n=109) Mim8 QW (n=104) Mim8 QM (n=108) Mean treatment analysis period (years) 0.48 0.50 0.51 0.50 Median AB
Slide 11: Most patients had zero treated bleeds
Most patients had zero treated bleeds Pre-study on-demand group Pre-study CFC PPX group Main Arm 1 Arm 2a Arm 2b Arm 3 Arm 4 On demand Mim8 QW Mim8 QM Mim8 QW Mim8 QM (Weeks 0–26) (n=18) (n=22) (n=21) (n=111) (n=109) All participants treated Proportion of participants with on-demand experienced no t
Slide 12: Few severe bleeds were observed with Mim8
Few severe bleeds were observed with Mim8 Extension (Weeks 26–52) Main + Extension (Weeks 0–52) Arm 1 Arm 1 Arm 2a Arm 2b Arm 3 Arm 4 Mim8 QW Mim8 QM Mim8 QW Mim8 QM Mim8 QW Mim8 QM Number of patients, N 8 10 22 21 111 109 Total exposure time (years) 4.1 5.1 21.3 21.2 106.1 108.3 Number of bleeds, N
Slide 13: Mim8 plasma concentrations were consistent and comparable within dosing frequencies
Mim8 plasma concentrations were consistent and comparable within dosing frequencies 10 9 Mim8 concentration (µg/µL) 8 7 6 5 4 3 2 Arm 1 participants 1 begin Mim8 treatment 0 -1 -4 0 4 8 12 16 20 24 28 32 36 40 44 48 52 Main Extension Planned time since first dosing (weeks) Dashed line represents low
Slide 14: A low number of severe adverse events were observed over 52 weeks
A low number of severe adverse events were observed over 52 weeks Mim8 QW Total exposure: Mim8 QM Total exposure: (n=141) 135.7 years (n=140) 136.3 years AEs by severity AEs by severity 9 Severe AEs 4 Severe AEs 67 in 7 patients 65 399 321 in 4 patients Mild events Moderate events Mild events Modera
Slide 15: Low rate of injection-site reactions and no clinical evidence of neutralizing antibodies
Low rate of injection-site reactions (ISRs) and no clinical evidence of neutralizing anti-Mim8 antibodies over 52 weeks • The majority of ISRs were transient; Low proportion of patients with ISRs: all were mild in severity and all Mim8 QW Mim8 QM recovered/resolved (n=141) (n=140) • The most common
Slide 16: Conclusions
Conclusions Mim8 QW and QM prophylaxis provided sustained bleed protection in adults and adolescents with HA, with or without inhibitors, supporting its use as a long-term prophylactic option Mim8 was well tolerated with no safety concerns • Over 52 weeks, there was a low frequency of ISRs, few seve
Slide 17: Acknowledgements
Acknowledgements Special thanks to the participants of the FRONTIER2 study and their supporters, as well as the investigators and site staff of all 117 sites from 29 countries. Study investigators: Aby Abraham, Javier Morales Adrian, Sanjay Ahuja, Hazzaa Alzahrani, Kagehiro Amano, Tatyana Andreeva,
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