Slide 1: Rosnilimab: Phase 2b Top-line Data in RA
Feb. 12, 2025 Rosnilimab: Phase 2b Top-line Data in RA
Slide 2: Forward-looking statements
This presentation and any accompanying oral presentation contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from the Company’s clinical trials
Slide 3: Agenda
TOPIC SPEAKER Introduction and Summary Dan Faga Chief Executive Officer Phase 2b Top-line Data Readout Paul Lizzul, M.D., Ph.D. Chief Medical Officer Moving Forward Dan Faga Q&A Dan Faga Paul Lizzul Martin Dahl, Ph.D. SVP, Research Agenda 3
Slide 4: Phase 2b efficacy summary and comparison with competitors
• Statistically significant on primary endpoint (DAS28-CRP) at Week 12 as well as on key secondary endpoints at both Week 12 and Week 14 • Absolute Week 12 and Week 14 data surpass our benchmarked Phase 2 target product profile • CDAI LDA responders3 appear to show sustained CDAI LDA and ACR50 and p
Slide 5: Phase 2b trial design
5 Screening Period (up to 35 days) Blinded Placebo-Controlled Treatment Period (12 weeks) Follow-Up Period (10 weeks) Blinded All-Active Treatment Period (16 weeks) Week -5 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 34 38 Visit V1 V2 V3 V4 V5 V6 V7 V8 V9 V10 V11 V12 V13 V14 V15 V16 FUV1 FUV2 FUV3 Do
Slide 6: Participant disposition through Week 14
6 Participant disposition through Week 12 *ITT – Intent-to-Treat (all randomized participants) ITT* (n=424) Placebo, n=106 Naïve – n=62 (59%) Experienced – n=44 (42%) Discontinued treatment, n=9 (8%) Primary reason: Adverse events, n=1 Disease progression, n=0 Withdrawal of consent, n=7 Other, n=1 C
Slide 7: Baseline characteristics
7 Baseline Characteristic Placebo (n=106) 100mg Q4W (n=106) 400mg Q4W (n=107) 600mg Q2W (n=105) Overall (N=424) Age, years, mean (SD) 58 (11) 57 (10) 57 (12) 56 (11) 57 (11) Female, n (%) 83 (78%) 79 (75%) 79 (74%) 80 (76%) 321 (76%) Weight (kg), mean (SD) 78 (17) 78 (19) 81 (19) 77 (16) 78 (18) Geo
Slide 8: Black box warnings have not impeded blockbuster sales
Black box warnings for increasing SAE incidence of commercial products have not impeded blockbuster sales Black box warning ~30% infection rate vs. 28% placebo5 ~0.7% MACE rate vs. 0.4% placebo5 ~54% infection rate vs. 48% placebo5 ~0.2% MACE rate vs. 0.5% placebo5 Black box warning ~20% infection r
Slide 9: Adverse events through Week 12
9 Adverse Events through Week 12, n (%) Placebo (n=106) 100mg Q4W (n=106) 400mg Q4W (n=107) 600mg Q2W (n=105) Participants with any AE, n (%) 36 (34%) 51 (48%) 48 (45%) 38 (36%) Any SAE1 1 (1%) 1 (1%) 1 (1%) 3 (3%) Any Drug-Related SAE 1 (1%) 0 (0%) 0 (0%) 0 (0%) Severe AE2 2 (2%) 1 (1%) 0 (0%) 4 (4
Slide 10: Translational biomarker data show on-target activity
10 -100% -80% -60% -40% -20% 0% 20% 40% 60% C el l C o u n t (% C h a n g e fr o m B a se li n e) PD-1high T Cells PD-1+ T Cells Total Treg Total T Cell Representative Rosnilimab T Cell Impact Overall Population – 400mg Q4W1 Wk0 Wk6 Wk12 10-wk off-drug follow-up Translational biomarker data in the p
Slide 11: Rosnilimab significantly decreased CRP
11 -1.0 -9.7 -10.1 -7.6 -2.3 -9.6 -10.0 -9.7 -12.0 -10.0 -8.0 -6.0 -4.0 -2.0 0.0 Placebo Rosnilimab 100mg Q4W Rosnilimab 400mg Q4W Rosnilimab 600mg Q2W M e a n C h a n g e f ro m B a se li n e • Clear and consistent on target reduction at all rosnilimab doses • No immunological change on placebo at
Slide 12: Mean change in DAS28-CRP over time
12 -3.0 -2.5 -2.0 -1.5 -1.0 -0.5 0.0 Week 0 Week 2 Week 4 Week 6 Week 8 Week 10 Week 12 Week 14 M e a n C h a n g e f ro m B a se li n e • All rosnilimab doses statistically significant at Week 12 • All rosnilimab doses continue to improve into Week 14 with no evidence of flattening • Following Week
Slide 13: CDAI LDA responders
13 31% 46% 50% 38% 0% 10% 20% 30% 40% 50% 60% Placebo Rosnilimab 100mg Q4W Rosnilimab 400mg Q4W Rosnilimab 600mg Q2W % o f P a ti e n ts • Physicians minimally seek to achieve LDA by 6-months • Approximately half of rosnilimab-treated patients achieved LDA by Week 12 CDAI, a compositive assessment,
Slide 14: ACR50 and ACR70 responses
14 33% 44% 36% 47% 0% 10% 20% 30% 40% 50% 60% 70% 80% Placebo Rosnilimab 100mg Q4W Rosnilimab 400mg Q4W Rosnilimab 600mg Q2W % o f P a ti e n ts 27% 65% 61% 73% 0% 10% 20% 30% 40% 50% 60% 70% 80% Placebo Rosnilimab 100mg Q4W Rosnilimab 400mg Q4W Rosnilimab 600mg Q2W % o f P a ti e n ts 23% 52% 56% 5
Slide 15: ACR50 and ACR70 responses over time
0% 20% 40% 60% 80% 100% A C R 5 0 Wk0 Wk2 Wk4 Wk6 Wk8 Wk10 Wk12 Wk14 Wk16 W18 Wk20 Wk22 Wk24 Wk26 Wk28 100mg Q4W n=73 n=34 400mg Q4W n=75 n=34 600mg Q4W n=74 n=33 0% 20% 40% 60% 80% 100% A C R 7 0 Wk0 Wk2 Wk4 Wk6 Wk8 Wk10 Wk12 Wk14 Wk16 W18 Wk20 Wk22 Wk24 Wk26 Wk28 Completers as of Dec. 10th 100mg Q
Slide 16: DAS28-CRP over time in CDAI LDA responders
-3.5 -3 -2.5 -2 -1.5 -1 -0.5 0 M e a n C h a n g e f ro m B a se li n e f o r D A S 2 8 -C R P Wk0 Wk2 Wk4 Wk6 Wk8 Wk10 Wk12 Wk14 Wk16 W18 Wk20 Wk22 Wk24 Wk26 Wk28 100mg Q4W n=73 n=34 400mg Q4W n=75 n=34 600mg Q4W n=74 n=33 Mean Change in DAS28-CRP Over Time Overall Population, CDAI LDA Responders a
Slide 17: Next steps for rosnilimab in RA
Screening Period (up to 35 days) Blinded Placebo-Controlled Treatment Period (12 weeks) Follow-Up Period (10 weeks) Blinded All-Active Treatment Period (16 weeks) Week -5 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 34 38 Rosnilimab SC 100mg Q4W Rosnilimab SC 400mg Q4W Rosnilimab SC 600mg Q2W Placebo
Slide 18: Rosnilimab has potential to treat wide range of systemic inflammatory diseases
1. Expected by 2028 (Evaluate 29 Nov 2022); 2. Market research conducted by Ambit in 2022; 3. Expected by 2028 (Evaluate 21 Aug 2023); 4. Phase 3 registrational data from product labels. RA and UC are large commercial markets with high unmet need Potential first new differentiated class in RA in ove
Slide 19: Jemperli quarterly performance and consensus
Actuals $31 $57 $73 $101 $137 $170 $190 $0 $50 $100 $150 $200 Q2 2023 Q3 2023 Q4 2023 Q1 2024 Q2 2024 Q3 2024 Q4 2024 S al es ( in U S D m ill io ns ) Jemperli Quarterly Performance1 1. GSK earnings presentation, US dollar conversion 2. GSK analyst consensus as of 1/27/2025 converted to USD (1.25 co
Slide 20: Leading pipeline of immune cell modulating antibodies
Antibody Program Therapeutic Indication Development Stage and Anticipated Milestones IND Enabling Phase 1 Phase 2 Phase 3 Rosnilimab (PD-1 depleter and agonist) Rheumatoid Arthritis Ulcerative Colitis ANB033 (CD122 antagonist) Inflammatory Diseases ANB101 (BDCA2 modulator) Inflammatory Diseases 20 W