Anaptysbio, Inc. · NASDAQ:ANAB
Anaptysbio — Investor Presentation (June 2025)
55 slides from Anaptysbio's investor presentation, Jun 3, 2025
Slide 1: June 2025 Corporate Overview
June 2025 Corporate Overview
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: Immune Cell Modulators and capital position
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 Healthy V
Slide 4: Leading pipeline of immune cell modulating antibodies with multiple 2025 catalysts
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 4 Up
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 efficacy in b/tsDMARD-experienced patients
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% 36%
Slide 8: Rosnilimab (PD-1 Depleter and Agonist)
(PD-1 Depleter and Agonist) Rosnilimab
Slide 9: RA and UC market similarities and opportunity
Similarities: • Focus on achieving low disease activity or remissions long-term • 1/3 to 1/2 relapse within 1 year following initial response at 3-6 months on induction therapy4 • 2L+ markets with blockbuster opportunity • Minimal differentiation between biologics • Assess combinations to enhance sp
Slide 10: PD-1 expressed on activated Teff and Tfh/Tph cells
Adapted from Akiyama et al, Ann Rheum Dis, 2023. 10 PD-1 is expressed preferentially on activated Teff and Tfh/Tph cells that mediate autoimmune pathology Lymphoid tissues Periphery Inflamed tissue 10 B cell PD-1high Tfh Plasma celllg lg lg PD-1high Tfh FDC Generation CXCL13 IL-21 PD-1high Tfh Type
Slide 11: Rosnilimab targets activated PD-1+ T cells
11 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 12: Rosnilimab restores immune homeostasis
12 Pre- treatment Post Rosnilimab RA Synovial Tissue PD-1neg PD-1neg PD-1int PD-1high Rosnilimab is designed to bring the immune system back to homeostasis and modify disease Pre- treatment Post Rosnilimab Healthy Periphery PD-1neg PD-1neg PD-1neg Treg PD-1int Treg PD-1high PD-1neg PD-1int PD-1int P
Slide 13: PD-1+ T cells prevalent in inflamed tissue in RA and UC
Adapted from Nguyen et al, Human Pathology (2022) 126, 19e27; Guo et al, PLoS One 2018; 13(2). Roosenboom et al, Scand J of Gastro. 2021; 56(6):671-679. 1. Chen et al, Clinical and Translational Immunology, 2024. 13 PD-1+ T cells are prevalent in inflamed tissue and periphery in RA and UC RA UC AA 0
Slide 14: PD-1+ Tregs exhibit dysregulated phenotype in disease
14 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
Slide 15: Rosnilimab Phase 2b trial in RA design
15 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 16: Phase 2b patient disposition
Rosnilimab-treated: n=318 b/tsDMARD-Naïve n=188 rosnilimab treated b/tsDMARD-Experienced n=130 rosnilimab treated 16 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 17: ACR20 response in b/tsDMARD-experienced
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-Experienced
Slide 18: Mean change in CRP
-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 Mean C
Slide 19: Synovial biopsies show ~90% reduction of PD-1+ T cells
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 target i
Slide 20: 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 21: Downstream pathways including TNF and IL-6 reduced
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 22: CDAI disease activity and continuation criteria
22 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 month
Slide 23: 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 24: CDAI remission in b/tsDMARD-experienced
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 grap
Slide 25: Pain VAS and CRP change
-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 26: Durable responses 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 27: PD-1 Agonist Landscape
27 PD-1 Agonist Landscape Fc receptor binding affinity Depletion Agonism Membrane- proximal epitope S tr u c tu r a l c h a r a c te r is ti c s F u n c ti o n a l o u tp u ts Rosnilimab is a best-in-class PD-1 depleter and agonist Lilly’s patent notes peresolimab’s “modest” activity and disclosed m
Slide 28: Rosnilimab vs peresolimab comparison
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 29: 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 30: Safety summary adverse events
30 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 31: Next steps for rosnilimab
31 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 32: PD-1+ T cell activation drives UC pathogenesis
Adapted from Gastroenterology & Hepatology Volume 18, Issue 8 August 2022. 1. Chen et al, Clinical and Translational Immunology, 2024. 37 >40% of T cells in lamina propria in UC are PD-1 2x increase of PD-1+ T cells observed in blood vs. healthy controls1 B cells IL-23 antagonists αEβ7 Lymph node S1
Slide 33: Depletion and agonism reduce cytokines in UC
Reduction of Tfh/Tph cytokine 0 25 50 75 100 0 0.1 1 10 100 Antibody (nM) C X C L 1 3 & I L -2 1 (% I s o ty p e C o n tr o l) IL-21 CXCL13 Clinical range Reduction of inflammatory cytokine Agonism of PD-1+ T cellsDepletion of PD-1high T Cells Parmley et. al. UEGW 2024. October 2024; Anti-CD3+ anti-
Slide 34: Efficacy in murine colitis model
Therapeutic dosing of rosnilimab demonstrated efficacy in a murine model of colitis PD-1high Tph cells are reduced with remission in UC1,2 Tph impact seen in RA Phase 2b trial relevant to UC biology and correlates to reduction of remission % P D -1 h ig h T p h c e ll s % P D -1 h ig h T p h c e ll
Slide 35: Milestones in UC treatment
3 Months 6 Months Fast relief needed in most severe patients (<10%) to continue therapy (e.g. JAKs or IV TNF) Symptomatic improvement (e.g. ∆pMMS) needed to continue on therapy; potentially without being re-scoped Clinical Remission or Endoscopic Remission targeted to reduce symptomatic relapse rate
Slide 36: Rosnilimab Phase 2 in moderate-to-severe UC
Rosnilimab Phase 2 in moderate-to-severe UC Enrollment ongoing; On track for interim 6-month data in Q4 2025 Blinded Placebo-controlled Treatment Extension Period (TEP) (26 weeks) Screening Period (up to 35 days) Follow-Up Period (10 weeks) Week -5 0 12 24 Rosnilimab SC Dose 1 Q2W Rosnilimab SC Dose
Slide 37: ANB033 (CD122 antagonist)
Autoimmune and Inflammatory Diseases ANB033 (CD122 antagonist)
Slide 38: ANB033: CD122 antagonist reduces pathogenic T cells and NK cells
38 CD122 is a shared beta subunit of the receptors for IL-15 and IL-2 CD122 antagonist mAb will potently inhibit IL-15 and IL-2 biology Both IL-15 and IL-2 mediate: • Proliferation and survival of T cell subsets, particularly CD8+ TEMRA, and NK cells • Inflammatory cytokine secretion (IFNγ) during T
Slide 39: ANB033 durable survival in GVHD model
Note: ANB033 treated mice dosed twice per week through Day 28. 39Hare E, et al. FOCIS 2023. June 2023. GVHD model is biologically relevant to CD122 antagonist MoA with translation to inflammatory diseases driven by pathogenic TRM and Treg imbalance including rheumatology, dermatology, gastroenterolo
Slide 40: ANB101 (BDCA2 modulator)
Autoimmune and Inflammatory Diseases ANB101 (BDCA2 modulator)
Slide 41: ANB101 modulator of pDC function
ANB101 will potently inhibit interferon secretion and immune activation 41 Activated pDCs bridge innate and adaptive immunity • Secrete Type I IFN (1000x increase over other cell types) • Present antigens to adaptive immune system pDCs enriched in tissue in rheumatology and other inflammatory diseas
Slide 42: GSK Immuno-Oncology Financial Collaboration
JemperliTM (dostarlimab, PD-1 Antagonist) Cobolimab (TIM-3 Antagonist) GSK Immuno- Oncology Financial Collaboration
Slide 43: Jemperli sales and growth drivers
Actuals $31 $57 $73 $101 $137 $170 $190 $220 $0 $50 $100 $150 $200 $250 Q2 2023 Q3 2023 Q4 2023 Q1 2024 Q2 2024 Q3 2024 Q4 2024 Q1 2025 S a le s ( in U S D m il li o n s ) 1. GSK earnings presentation, US dollar conversion 2. GSK analyst consensus as of 1/27/2025 converted to USD (1.25 conversion ra
Slide 44: Potential royalties and milestones; capped non-recourse monetization
“Jemperli – only” capped non-recourse monetization • Jemperli receivables payable to Sagard until cumulative $600MM paydown by Mar. 31, 20311,2 • ~$104MM paid to Sagard as of March 2025 • Projected cumulative $600MM paydown by 2029 based on Wall Street Consensus3 Potential royalties and milestones t
Slide 45: Additional dostarlimab and cobolimab opportunities
Lung cancer • 2L NSCLC: P3 COSTAR trial (docetaxel vs dostarlimab + docetaxel vs docetaxel + dostarlimab + cobolimab) • Top-line data expected in mid-2025 • Significant U.S. market opportunity with 237,000 new NSCLC diagnoses/year1 • Head-to-Head vs. Keytruda: P2 PERLA trial (46% cORR for dostarlima
Slide 46: Imsidolimab Vanda Financial Collaboration
Imsidolimab (IL-36R antagonist) Vanda Pharmaceuticals Financial Collaboration
Slide 47: Imsidolimab out-licensed to Vanda
47 Exclusive global license to Vanda announced February 2025 $15 million upfront payment $10 million upfront and $5 million for existing drug supply 10% royalties on global net sales FDA BLA submission for generalized pustular psoriasis (GPP) expected in 2025 Imsidolimab completed two positive globa
Slide 48: Appendix
Appendix
Slide 49: Reducing PD-1+ T cells impacts RA drivers
Adapted from Aletaha and Smolen, JAMA, 2018; 1. Chen et al, Clinical and Translational Immunology, 2024. 49 Reducing PD-1+ T cells broadly impacts multiple downstream, clinically validated drivers of RA pathogenesis >80% of T cells in RA synovium are PD-1+ • Similar findings are observed in treatmen
Slide 50: Rosnilimab optimizes PD-1+ T cell inhibitory signaling
Parmley S, et al. ECCO 2024. February 2024. 1. Adapted from Suzuki et al., Sci. Immunol. 8, eadd4947 (2023). 50 Dendritic cell T cell T cell Activation MHCCD80/86 SHP2 TCRCD28 P PD-1 PD-L1 Rosnilimab Fc Receptor #3, 4 Functional assay of antagonism or agonism1 Lilly epitope PD-L1 epitope Lilly PD-1
Slide 51: Depletion and agonism reduce proliferation and cytokines
51 1. Healthy donor purified DCs + autologous total T cells stimulated with anti-CD3, cultured for 3 days for assessment of T cell proliferation 2. Anti-CD3+ anti-CD28 stimulation of RA patient PBMCs for assessment of depletion and agonism MOA, representative data from N=8 donors. Two-way ANOVA, Tuk
Slide 52: Baseline characteristics
33 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 53: Mean change in DAS28-CRP over time
34 -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 54: CDAI LDA in b/tsDMARD-experienced
35 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 55: ACR50 and ACR70 in b/tsDMARD-experienced
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 36 0% 10% 20% 30% 40% 50% 60% % o f P a ti e n ts Wk 12 Wk 28 Wk 12 W