Slide 1: Rosnilimab: Updated Phase 2b Data in RA
Rosnilimab: Updated Phase 2b Data in RA June 3, 2025
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: Participants on today's call
3 Dan Faga CEO and president Anaptys Paul Lizzul, M.D., Ph.D. CMO Anaptys Paul Emery, M.D. Professor, Rheumatology, University of Leeds; Leeds Biomedical Research Centre, UK Jonathan Graf, M.D. Professor of Medicine, Rheumatology, University of California, San Francisco; RENOIR investigator Particip
Slide 4: Recap of previously reported RENOIR data
4 Safe and well tolerated: similar AE rate versus placebo Within 3 months, most had symptomatic improvement (>70% ACR20) with statistical significance at all doses vs. placebo Impressive achievement of CDAI LDA at 3 months with signal of stable outcomes through 6 months Robust translational and phar
Slide 5: Rosnilimab demonstrates best-in-disease profile in RA
5 Responses durable after 6 months • Potential for maintenance dosing with extended dosing intervals (e.g. Q8W) Best-in-disease profile through 6 months • JAK-like efficacy in both 3-month placebo-controlled portion and through 6 months • Favorable safety and tolerability, particularly when compared
Slide 6: Rosnilimab shows JAK-like efficacy in naïve patients
6 64% 60% 48% 53% 54% 35% 38% 42% 23% 42% 46% 23% 0% 10% 20% 30% 40% 50% 60% 70% 80% % o f P a ti e n ts Rosnilimab - Pooled Doses Rinvoq - SELECT-COMPARE Humira - SELECT-COMPARE Kevzara - MONARCH Week 28 Week 24/26 Week 28 Week 24/26 Week 28 Week 24/26 CDAI LDA ACR50 ACR70 1. Non-responder imputate
Slide 7: Rosnilimab in experienced patients versus JAKs and Orencia
7 34% 27% 23% 56% 44% 36% 49% 42% 29% 58% 59% 37% 52% 50% 27% 20% 10% 0% 10% 20% 30% 40% 50% 60% 70% 80% % o f P a ti e n ts Rosnilimab - 100mg Q4W Rosnilimab - 400mg Q4W Rosnilimab - 600mg Q2W Rinvoq - SELECT-CHOICE Orencia - SELECT-CHOICE Orencia - Phase 3 Week 28 Week 24 Week 28 Week 24 Week 28 W
Slide 8: Rosnilimab Phase 2b trial design
8 Screening Period (up to 35 days) Blinded Placebo-Controlled Treatment Period All-Active Follow-Up Period Blinded All-Active Treatment Period 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 Dosing ()
Slide 9: CDAI disease activity and continuation criteria
9 C D A I S c o r e 0 2.8 10 22 38 Remission (CDAI < 2.8) Low Disease Activity (LDA) (CDAI ≤ 10) Moderate Disease Activity (CDAI 10 - 22) High Disease Activity (CDAI >22) Trial baseline: median CDAI-= 36 mean CDAI = 38 Disease Activity ACR20 Initial signal of efficacy; typically plateaus at 3 months
Slide 10: Patient disposition
Rosnilimab-treated: n=318 b/tsDMARD-Naïve n=188 rosnilimab treated b/tsDMARD-Experienced n=130 rosnilimab treated 10 ITT population1 N=424 (n=318 rosnilimab; n=106 placebo) b/tsDMARD-Naïve: n=250 (188 on rosnilimab; 62 placebo) b/tsDMARD-Experienced: n=1742 (130 on rosnilimab; 44 placebo) Discontinu
Slide 11: ACR20 response rates comparable to Rinvoq
11 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% % o f P a ti e n ts RinvoqTM (P3 SELECT-CHOICE5) Rinvoq vs. Orencia H2H All-Active ACR20: b/tsDMARD-Experienced1 NRI analysis on ITT population (n=174 total; n=44 placebo, n=130 rosnilimab)2 ACR20 at Week 12 Arm Absolute PBO Adjusted b/tsDMARD-Experienc
Slide 12: Mean change in CRP
12 -20 -18 -16 -14 -12 -10 -8 -6 -4 -2 0 2 4 M e a n C h a n g e f r o m B a s e li n e ( m g / L ) Wk0 Wk2 Wk4 Wk6 Wk8 Wk10 Wk12 Wk14 RinvoqTM (P3 SELECT-CHOICE5) RinvoqTM vs. Orencia H2H All-Active RinvoqTM (Phase 2b TNF-Experienced Study4) Dark Orange – RinvoqTM 6mg BID Light Orange – Placebo Mea
Slide 13: KOL Point of View
Paul Emery, M.D. Professor, Rheumatology, University of Leeds; Leeds Biomedical Research Centre, UK Jonathan Graf, M.D. Professor of Medicine, Rheumatology, University of California, San Francisco; RENOIR investigator KOL Point of View 13
Slide 14: Deep, sustained reduction of PD-1+ T cells
Wk0 Wk6 Wk12 Wk28 Wk38 (12-wk off-drug) -100% -75% -50% -25% 0% 25% 50% 75% 100% C e ll C o u n t ( % C h a n g e f r o m B a s e li n e ) Rosnilimab 400mg Q4W T Cell Impact Rosnilimab Tph Impact – Pooled Doses Rosnilimab 600mg Q2W T Cell Impact Rosnilimab 100mg Q4W T Cell Impact -100% -75% -50% -25
Slide 15: Synovial biopsies show ~90% reduction of PD-1+ T cells
15 Rosnilimab 400mg Q4W Rosnilimab 600mg Q2W T cell markers CD3 PD-1 CXCR5 400mg/600mg doses ~90% reduction 100mg dose Inconclusive reduction Placebo Increased Impact on PD-1+ T cells (Tph and Teff) Baseline Week 6 APC markers PD-L1 Synovial biopsies show ~90% reduction of PD-1+ T cells in the targe
Slide 16: Reduction of T and B cell activation in synovium
Fold decrease: 4.03, p=1.09e-24 T Cell Activation Fold decrease: 4.06, p=1.77e-18 B Cell Activation G e n e e x p r e s s io n ( Z -s c o r e ) G e n e e x p r e s s io n ( Z -s c o r e ) 5.5 2.9 2.0 0 2 4 6 8 6.1 3.9 1.0 0 2 4 6 8 M a g n it u d e o f r e d u c ti o n Magnitude of reduction: 4.03,
Slide 17: Reduction of TNF and IL-6 pathways in synovium
IL-6 Production G e n e e x p r e s s io n ( Z -s c o r e ) G e n e e x p r e s s io n ( Z -s c o r e ) Significantly downregulated (p<0.05) genes of interest in RA: Baseline TNF Production Magnitude of reduction: 3.38, p=4.39e-15 Magnitude of reduction: 5.63, p=2.61e-21 T cell activation: IL2RA, TN
Slide 18: KOL Point of View
Paul Emery, M.D. Professor, Rheumatology, University of Leeds; Leeds Biomedical Research Centre, UK Jonathan Graf, M.D. Professor of Medicine, Rheumatology, University of California, San Francisco; RENOIR investigator KOL Point of View 18
Slide 19: Median change from baseline in CDAI
0 10 20 30 40 50 60 M e d ia n C D A I Wk 0 Wk 2 Wk 4 Wk 6 Wk 8 Wk 10 Wk 12 Wk 14 Wk 16 Wk 18 Wk 20 Wk 22 Wk 24 Wk 26 Wk 28 Wk 30 Wk 34 Wk 38 High Disease Activity (CDAI >22) Low Disease Activity (LDA) (CDAI ≤ 10) Last dose for Week 14 CDAI >10 participants given at Week 12 for Q4W doses and Week 14
Slide 20: 6-month analysis in experienced patients vs target product profile
20 58% 59% 37% 52% 50% 27% 20% 10% 0% 10% 20% 30% 40% 50% 60% 70% 80% % o f P a ti e n ts Rosnilimab - 100mg Q4W Rosnilimab - 400mg Q4W Rosnilimab - 600mg Q2W Rinvoq - SELECT-CHOICE Orencia - SELECT-CHOICE Orencia - Phase 3 Week 28 Week 24 Week 28 Week 24 Week 28 Week 24 N/R 43% 56% 49% 27% 44% 42%
Slide 21: JAK-like CDAI remission rates
21 0% 5% 10% 15% 20% % o f P a ti e n ts CDAI Remission: b/tsDMARD-Experienced NRI+W18 analysis* on ITT population (n=130 rosnilimab patients)1 Wk 12 Wk 28 Wk 12 Wk 28 Wk 12 Wk 28 100mg Q4W 400mg Q4W 600mg Q2W 7% 9% 12% CDAI Remission at Week 28 Arm NRI NRI+W18 b/tsDMARD-Experienced Population (as g
Slide 22: Pain VAS and CRP in CDAI responders
-37.3 -42.6 -42.8 -47.0 -49.9 -52.4 -60 -50 -40 -30 -20 -10 0 M e a n C h a n g e P a in V A S Pain VAS: Overall MMRM analysis on CDAI Responder Population (n=220)1 Wk 12 Wk 28 Rosnilimab - 100mg Q4W Rosnilimab - 400mg Q4W Rosnilimab - 600mg Q2W 1. Mixed Model for Repeated Measures (MMRM) analysis o
Slide 23: Durable responses for at least 2 months off-drug
81% 90% 83% 0% 20% 40% 60% 80% 100% % o f P a ti e n ts CDAI LDA: b/tsDMARD-Naïve Week 34 completer analysis (n=101)1 CDAI LDA: b/tsDMARD-Experienced Week 34 completer analysis (n=38)1 Wk34 Wk34 Wk34 88% 87% 73% 0% 20% 40% 60% 80% 100% % o f P a ti e n ts Wk34 Wk34 Wk34 n=29/36 n=27/30 n=29/35 n=7/8
Slide 24: Rosnilimab versus peresolimab
0% 10% 20% 30% 40% 50% 60% 70% 80% % o f P a ti e n ts 100mg Q4W 400mg Q4W 600mg Q2W Wk 12 Wk 14 Wk 28 0% 10% 20% 30% 40% 50% 60% 70% 80% % o f P a ti e n ts 300mg Q4W 700mg Q4W Wk 12 Wk 14 Wk 24 Wk 0 Wk 0 (12-wk off-drug) Wk 383 (12-14 wk off-drug) Wk 36 Rosnilimab P2b: CDAI LDA NRI analysis on ITT
Slide 25: KOL Point of View
25 Paul Emery, M.D. Professor, Rheumatology, University of Leeds; Leeds Biomedical Research Centre, UK Jonathan Graf, M.D. Professor of Medicine, Rheumatology, University of California, San Francisco; RENOIR investigator KOL Point of View
Slide 26: RA patients have significant co-morbidities
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 27: Adverse event summary
27 Study Period Week 0 through Week 12 (N=424) Week 0 through Week 28 (N=424) Participants with Adverse Events, n (%) Participants with Adverse Events, n (per 100 PY)* Placebo (n=106) 100mg Q4W (n=106) 400mg Q4W (n=107) 600mg Q2W (n=105) Placebo (n=106) 100mg Q4W (n=106) 400mg Q4W (n=107) 600mg Q2W
Slide 28: KOL Point of View
28 Paul Emery, M.D. Professor, Rheumatology, University of Leeds; Leeds Biomedical Research Centre, UK Jonathan Graf, M.D. Professor of Medicine, Rheumatology, University of California, San Francisco; RENOIR investigator KOL Point of View
Slide 29: Next steps for rosnilimab
29 Next steps for rosnilimab • Plan to present RA Phase 2b data at a future medical congress • Assessing two, alternative, strategic paths forward ― Secure a global partnership, to help advance in all indications, including P3 for both RA and UC ― Independently advance UC into P3 (assuming P2 data m
Slide 30: Best-in-class immune cell modulating antibodies
30 Immune Cell Modulators ANB033 (CD122 antagonist) P1 in Healthy Volunteers Rosnilimab (PD-1 depleter and agonist) P2b in Rheumatoid Arthritis P2 in Ulcerative Colitis Autoimmune and inflammatory diseases including dermatology, gastroenterology and rheumatology ANB101 (BDCA2 modulator) P1 in Health
Slide 31: Rosnilimab demonstrates best-in-disease profile in RA
31 Responses durable after 6 months • Potential for maintenance dosing with extended dosing intervals (e.g. Q8W) Best-in-disease profile through 6 months • JAK-like efficacy in both 3-month placebo-controlled portion and through 6 months • Favorable safety and tolerability, particularly when compare
Slide 32: Appendix
Appendix AnaptysBioW
Slide 33: Rosnilimab selectively targets activated PD-1+ T cells
33 Dendritic cell T cell T cell Activation MHCCD80/86 SHP2 TCRCD28 P PD-1 PD-L1 Rosnilimab Fc Receptor Rapidly engage homeostatic mechanisms to induce clinical response1 2 Rosnilimab aims to: Immune Cells Impacted Mechanism Immunologic Outcome PD-1high Tfh/Tph depletes downstream effect on B cells P
Slide 34: Baseline characteristics
34 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) Ge
Slide 35: Mean change in DAS28-CRP over time
35 -3.0 -2.5 -2.0 -1.5 -1.0 -0.5 0.0 M e a n C h a n g e f r o m B a s e li n e ** Week 12 statistical significance • 600mg Q2W: p=0.0062 • 400mg Q4W: p=0.0016 • 100mg Q4W: p=0.0092 ** ** * * Mean Change in DAS28-CRP Over Time MMRM analysis on ITT population (N=424 total; n=106 placebo, n=318 rosnil
Slide 36: JAK-like CDAI LDA rates by 6 months
36 0% 20% 40% 60% 80% % o f P a ti e n ts 43% 51% 29%34% CDAI LDA: b/tsDMARD-Experienced NRI+W18 analysis* on ITT population (n=130 rosnilimab patients)1 Wk 12 Wk 28 Wk 12 Wk 28 Wk 12 Wk 28 100mg Q4W 400mg Q4W 600mg Q2W Demonstrated JAK-like CDAI LDA rates by 6 months CDAI LDA at Week 28 Arm NRI NRI
Slide 37: ACR50 and ACR70 in experienced patients
0% 10% 20% 30% 40% 50% % o f P a ti e n ts ACR50: b/tsDMARD-Experienced NRI+W18 analysis* on ITT population (n=130 rosnilimab patients)1 ACR70: b/tsDMARD-Experienced NRI+W18 analysis* on ITT population (n=130 rosnilimab patients)1 37 0% 10% 20% 30% 40% 50% 60% % o f P a ti e n ts Wk 12 Wk 28 Wk 12 W
Slide 38: PD-1+ Tregs in RA
38 In disease, PD-1+ Tregs exhibit a dysregulated phenotype, which induce proinflammatory cytokines Very low % Tregs (<20%) are PD-1+ in RA synovium, even fewer are PD- 1high1 In Phase 2b RA trial, few PD-1+ Tregs were present in periphery and were reduced proportionally to PD-1+ T cells overall Min