Inflarx N.v. · NASDAQ:IFRX
Inflarx — Investor Presentation (April 2026)
67 slides from Inflarx's investor presentation, Apr 9, 2026
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Slide 2: Important Notice and Disclaimer
CONTROLLING INFLAMMATION Important Notice and Disclaimer This presentation has been prepared by InflaRx N.V. (“InflaRx” or “we”). This presentation is made for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities in any jurisdiction in
Slide 3: Important Notice and Disclaimer
CONTROLLING INFLAMMATION Important Notice and Disclaimer InflaRx data presented The data presented herein are topline results based on the number of patients indicated and are subject to final data review and quality checks. Data from patients still completing treatment are not included in the curre
Slide 4: Harnessing C5a/C5aR with izicopan for controlling inflammation in I&I
Harnessing C5a/C5aR with izicopan for controlling inflammation in I&I § Lead asset izicopan is an oral inhibitor of C5a/C5aR, a validated target and critical part of the inflammatory cascade in disease areas in need of new mechanisms of action § Phase 2a indicate izicopan has potential for biologic-
Slide 5: C5a/C5aR are validated targets promoting inflammation
C5a/C5aR are validated targets promoting inflammation Targeting strong pro-inflammatory mechanisms vilobelimab izicopan intravenous mAb oral small molecule C5 C5a C5aR Cleavage of C5a through complement pathway or enzymatic strong amplifier expressed on many immune cells of inflammation and upregula
Slide 6: C5a/C5aR signaling inhibition: Izicopan prevents binding of C5a to C5aR
C5a/C5aR signaling inhibition: Izicopan prevents binding of C5a to C5aR Complement Pathways Classical Lectin Alternative Antibody binding Mannose binding Foreign surfaces through C5 convertases C3 activation 1 (complement mediated) MG7 domain C5-convertases C5 2 through enzymatic cleavage at scissil
Slide 7: C5a-led pipeline targets multiple sizable markets
Izicopan-led pipeline targets multiple sizable markets INDICATION PRECLIN PHASE 1 PHASE 2 PHASE 3 MARKET STATUS & MILESTONES hidradenitis suppurativa Topline Phase 2a reported with Ph2b planning ongoing chronic spontaneous Topline Phase 2a reported izicopan urticaria Oral C5aR inhibitor I&I other im
Slide 8: C5a & C5aR inhibition has potential medical utility in broader I&I
C5a & C5aR inhibition has potential medical utility in broader I&I Infectious Autoimmune Immuno-derm Initial focus on HS and immuno- dermatology Additional development expansion C5a Neoplastic Renal opportunity in various chronic inflammatory disease areas, including ANCA-associated vasculitis C5aR1
Slide 9: Izicopan: An oral C5aR antagonist with best-in-class potential
Izicopan: An oral C5aR antagonist with best-in-class potential Superior PK/PD profile in Phase 1 and Phase 2 studies compared to reported data from marketed comparator avacopan (graphs at right*/**) § ~10-fold higher AUClast and ~3-fold higher Cmax (Phase 1 SAD) § Significantly increased blocking ac
Slide 10: Izicopan’s improved chemistry, metabolic & safety features
Izicopan’s improved chemistry, metabolic & safety features Feature Avacopan Izicopan Key differentiation for izicopan Izicopan has improved PK/PD profiling in humans and improved Used as a lead compound series for the Further structure-activity optimization Medicinal chemistry safety features (e.g.
Slide 11: Izicopan: Oral C5aR antagonist with best-in-class potential 2X
Izicopan: Oral C5aR antagonist with best-in-class potential Double the inhibitory effect in vivo in a pre-clinical model compared to avacopan Inhibition of in vivo neutrophil activation by izicopan compared to avacopan-like molecule* 2X APPROXIMATELY izicopan doubled the in vivo inhibitory effect at
Slide 12: Izicopan therapeutic exposure reached within the first week in Phase 2a
Izicopan therapeutic exposure reached within the first week in Phase 2a Trough Concentrations Initial considerations (Mean + SD) 1000 § Lower dose of 60 mg bid projected to result in complete signal control based on Phase 1 data 800 * § Explore efficacy at the high end by adding 90 mg bid (HS) and 1
Slide 13: Izicopan for Hidradenitis Suppurativa
Izicopan for Hidradenitis Suppurativa § All Ph2a data presented herein for end of treatment (EOT) at week 4 show results for n=29 evaluable patients § All Ph2a data presented herein for end of study (EOS) at week 8 (after 4-week follow-up period) show results for n=25 evaluable patients § Ph2a data
Slide 14: A strong rationale for developing izicopan in HS
A strong rationale for developing izicopan in HS § HS is a chronic, recurring, debilitating neutrophil-driven inflammatory disease • Prevalence in the US and EU is estimated to be 0.7% - 1.2% • We estimate there are clearly more than 200,000 moderate to severe HS patients in the US alone § New mecha
Slide 15: C5aR and Neutrophils play a critical role in HS pathogenesis
C5aR and Neutrophils play a critical role in HS pathogenesis especially in draining tunnels (dTs) and abcesses Standard H&E tissue staining C5aR staining T: Tunnel Hurley stage III patient with tunnel formation and G: Granuloma surrounding granulomatous inflammation with F: Fibrosis foreign body gia
Slide 16: Izicopan Phase 2a in HS: Trial design
Izicopan Phase 2a in HS: Trial design 4 weeks treatment n=10 per arm 4 weeks follow-up Baseline EOT EOS Primary & secondary objectives Arm 1 izicopan 60 mg BID Safety & PK R Arm 2 izicopan 90 mg BID Exploratory objectives 1:1:1 Clinical endpoints AN, dT, ANdT, HiSCR, NRS-Skin Pain, DLQI Arm 3 izicop
Slide 17: Izicopan Phase 2a in HS: Meaningful and consistent AN count reductions
Izicopan Phase 2a in HS: Meaningful and consistent AN count reductions Baseline A,N, AN counts (mean) AN absolute CFB over time Baseline W1 W2 W3 W4 20.0 18.3 0 18.0 -0.4 16.0 14.7 14.9 -1 -1.5 14.0 12.5 -1.2 11.4 11.5 -2.0 12.0 10.3 -1.7 10.0 -2 8.1 -1.9 8.0 6.8 -2.8 6.0 4.7 -3 -3.6 4.4 3.4 -3.4 4.
Slide 18: Izicopan Phase 2a in HS: AN reductions in line with successful studies
Izicopan Phase 2a in HS: AN reductions in line with successful studies Comparison to average of reported successfully completed Phase 2 (moved into Phase 3) and all available completed Phase 3 drug data* AN CFB (mean) 0.0 -1.0 -2.0 Ph2 placebo (povorcitinib) -3.0 -4.0 Ph3 placebo izicopan pooled -5.
Slide 19: Izicopan Phase 2a in HS: Significant draining tunnel (dT) count reductions
Izicopan Phase 2a in HS: Significant draining tunnel (dT) count reductions dT CFB mean ( ≥1 dT at baseline) 0 0.0 -0.2 dT 100 at W4 -0.3 -0.5 60% -0.5 -0.2 50% -0.8 50% -0.9 40% -1 -0.9 -1.0 -1.0 29% -1.0 -1.3 30% 25% 60 n=7 -1.5 -1.3 20% -1.4 14% 90 n=8 -1.4 10% 120 n=6 -2 0% dT n=21 All only n=21
Slide 20: Izicopan Phase 2a in HS: dT reductions vs reported successful Ph3 trials
Izicopan Phase 2a in HS: dT reductions vs reported successful Ph3 trials Comparison to average of available reported completed Phase 3 drug data* dT CFB (mean) 0.0 Ph3 Placebo -0.5 -1.0 Ph3 completed izicopan pooled, all pts izicopan pooled (dT) -1.5 izicopan 120mg, all pts -2.0 izicopan 120mg (dT)
Slide 21: Izicopan Phase 2a in HS: Early improvements in HiSCR
Izicopan Phase 2a in HS: Early improvements in HiSCR HiSCR50 over time HiSCR30, 40, 50 and 75 over time 63 % 60% n=8 60mg n=10 90mg n=11 64% 50% 120mg n=8 44% all n=29 44% 40% 38% n=9 52% 30% 30% 30% 56% 27% 28% 41% 28% 24% 27% 27% 25% 25% n=8 20% 28% 20% 41% 31% 14% 11% 13% 44% 28% 10% 10% 14% 9% 2
Slide 22: Izicopan Phase 2a in HS: HiSCR vs successful Ph3 trials
Izicopan Phase 2a in HS: HiSCR vs successful Ph3 trials HiSCR50 EOS (n=8) 60% 50% EOS visit (n=25) Ph3 completed 40% izicopan 120mg 30% izicopan pooled Ph3 placebo 20% 10% 0% 0 2 4 6 8 10 12 14 16 Weeks * Data are derived from different completed Phase 3 clinical trials and averages were created usi
Slide 23: Izicopan Phase 2a in HS: High pain score reduction (NRS30)
Izicopan Phase 2a in HS: High pain score reduction (NRS30) Comparison to average of available reported completed Phase 3 data* Skin Pain NRS30 change over time NRS30 response 100% 100% 60 n=10 90 n=11 80% 75% 75% 80% 120 n=8 izicopan 120mg 66% All n=29 59% 64% izicopan pooled 60% 60% 50% 55% 60% 40%
Slide 24: Izicopan Phase 2a in HS: Comparison to reported avacopan data
Izicopan Phase 2a in HS: Comparison to reported avacopan data* Izicopan Week 4 Avacopan Week 12 dT CFB (mean) - avacopan comparison 0.0 AN CFB (mean) AN CFB (mean) -0.2 Placebo INF 120 INF all Placebo Ava 10 Ava 30 -0.4 0.0 -0.6 -2.0 avacopan 30mg -4.0 -3.1 -3.4 -0.8 -6.0 -5.1 -5.1 -1.0 -8.0 izicopa
Slide 25: Highlights of izicopan Phase 2a data in HS
Highlights of izicopan Phase 2a data in HS § Izicopan showed biologic-like efficacy in the first 4 weeks with AN count reduction and HiSCR in line with successful Phase 3 comparators § Preliminary week 8 data indicated that HiSCR response further deepens in the 4 weeks after end of treatment § Izico
Slide 26: Izicopan for Chronic Spontaneous Urticaria
Izicopan for Chronic Spontaneous Urticaria § All Ph2a data presented herein for end of treatment (EOT) at week 4 show results for n=30 evaluable patients § All Ph2a data presented herein for end of study (EOS) at week 8 (after 4-week follow-up period) show results for n=23 evaluable patients § Ph2 d
Slide 27: A strong rationale for developing izicopan in CSU
A strong rationale for developing izicopan in CSU § CSU is a chronic inflammatory skin disorder, with mast cell degranulation leading to various inflammatory cascades that leave patients predisposed to intensely debilitating itchy hives and wheals for > 6 weeks and often associated with angioedema §
Slide 28: Role of complement C5a/C5aR1 and neutrophils in CSU
Role of complement C5a/C5aR1 and neutrophils in CSU 1. C5a is a potent mast-cell and basophil activator via C5aR1 which directly triggers degranulation and it can further amplify this response independent of IgE. 2. C5a can be generated via autoantibody-driven complement activation (IgG) on the FcRI
Slide 29: Pathogenic loop linking C5a, neutrophils & mast cells in CSU
Pathogenic loop linking C5a, neutrophils & mast cells in CSU Complement C5a & Neutrophils in CSU Complement C5a & Neutrophils in CSU C5aR1 Histamine Coagulation pathway activated by Tissue Factor Kulthanan et al Asian Pac J Allergy Immunol 2023;41:179-185 DOI 10.12932/AP-180623-1638. 29
Slide 30: C5a in CSU and its role in IgE-independent histamine release
C5a in CSU and its role in IgE-independent histamine release CSU patients have elevated C5a induces histamine release from C5a mediated histamine release is C5a levels basophils in a dose-dependent manner independent of the IgE pathway 46.9 ng/ml p = 0.004 20.1 ng/ml N=95 N=42 § CSU patients show ev
Slide 31: Izicopan Phase 2a in CSU: Phase 2a trial design
Izicopan Phase 2a in CSU: Phase 2a trial design CSU 4 weeks treatment n=15 per arm 4 weeks follow-up Baseline EOT EOS Primary & secondary objectives R Arm 1 izicopan 60 mg BID Safety & PK 1:1 Arm 2 izicopan izicopan60 120mg mg BID BID n=10 Exploratory objectives Clinical endpoints include UAS7,UCT7,
Slide 32: Izicopan Phase 2a in CSU: Effect on UAS7 at W4 continued to end of study
Izicopan Phase 2a in CSU: Effect on UAS7 at W4 continued to end of study (W8) after end of treatment UAS7 mean absolute CFB Baseline W1 W2 W3 W4 EOS (w8) 0 n=23 -2 -3.5 -4 -4.0 -5.4 -4.6 -6 -6.0 -7.1 -8.1 -7.9 n=13 -8 -6.9 -9.0 -10.4 -10 -11.1 -10.3 n=23 -12 -14 -13.7 -16 -16.3 n=10 -18 60 mg BID n=
Slide 33: Izicopan Phase 2a in CSU: Phase 2 UAS7 data at W4 from competition
Izicopan Phase 2a in CSU: Phase 2 UAS7 data at W4 from competition (products progressed to Phase 3*) Phase 2 UAS7 CFB for placebo at W4 Phase 2 UAS7 CFB for treatments at W4 0 0 -5 -5 -5.4 -6.0 -6.9 -7.0 -10 -10 -9.1 -9.8 Average change in UAS7: -6.3 -15 -12.9 -15 -13.7 -14.6 -16.0 -20 -20 -19.0 -19
Slide 34: Izicopan Phase 2a in CSU: Comparative Phase 3 UAS7 data at W4
Izicopan Phase 2a in CSU: Comparative Phase 3 UAS7 data at W4 Phase 3: UAS7 CFB for placebo Phase 3 studies UAS7 CFB for treatments 0 0 -5 -5 -6.0 -6.5 -7.0 -7.0 -10 -10 -8.5 -10.0 -10.0 -9.5 -10.5 -15 -15 -17.0 -20 -18.0 -20 -19.0 Average change in UAS7: -7.4 Average change in UAS7: -13.1 -25 -25 -
Slide 35: Izicopan Phase 2a in CSU: Substantial reduction in UAS7 in sub-populations
Izicopan Phase 2a in CSU: Substantial reduction in UAS7 in sub-populations Patients with severe disease and those with angioedema UAS7 mean CFB by dose - severe CSU UAS7 mean CFB for subjects with angioedema at baseline 0 0 -2 -2 -4 -4.7 -4 -5.9 -4.3 -5.1 -6 -6 -6.6 -6.9 -8 -8 -7.3 -8.8 -10.2 -9.4 -
Slide 36: Izicopan Phase 2a in CSU: UAS7 reduced in patients with low IgE at baseline
Izicopan Phase 2a in CSU: UAS7 reduced in patients with low IgE at baseline UAS7 mean absolute CFB according to IgE level at baseline Baseline W1 W2 W3 W4 0 -2 -3.0 * Placebo average -3.8 *Placebo rates tend to be lower in the low-IgE group -4 from remibrutinib and barzovolimab Ph2 W12 data -4.3 -6
Slide 37: Izicopan Phase 2a in CSU: Disease control with improvement in UCT7
Izicopan Phase 2a in CSU: Disease control with improvement in UCT7 UCT7 mean absolute CFB UCT7 ≥12 over time 6 35% 31% 5.1 4.9 31% 30% 5 4.9 29% 4.7 4.9 25% 25% 25% 4 24% 3.5 4.0 20% 20% 3 3.1 2.5 14% 14% 15% 2.3 2 2.5 13% 10% 7% 10% 2.0 1 5% 0 0% Baseline W1 W2 W3 W4 Baseline W1 W2 W3 W4 60 mg BID
Slide 38: Highlights of izicopan Phase 2a in CSU
Highlights of izicopan Phase 2a in CSU § Izicopan drives reduction in disease activity (UAS7 reduction) within a range indicative of clinical activity (as observed from Phase 2 & 3 comparators) o 60mg dose achieved the highest reduction of UAS7 –13.7 o In those with "most severe" CSU (defined as UAS
Slide 39: InflaRx N.V.
CONTROLLING INFLAMMATION InflaRx N.V. Winzerlaer Str. 2 07745 Jena, Germany Email: IR@inflarx.com Tel: +49-3641-508180 Fax: +49-3641-508181 www.inflarx.com 39
Slide 40: Appendix
CONTROLLING INFLAMMATION Appendix 40
Slide 41: Izicopan Ph2a HS & CSU: Safety in patients taking at least 1 dose
Izicopan Ph2a HS & CSU: Safety in patients taking at least 1 dose HS (n = 33) CSU (n = 33) § No signals of safety concern detected § No signals of safety concern detected § No reported serious adverse events § No reported serious adverse events § 3 adverse events (AEs) in 2 patients reported as poss
Slide 42: Izicopan: Oral C5aR antagonist with best-in-class potential
Izicopan: Oral C5aR antagonist with best-in-class potential C5a-mediated CD11b upregulation on neutrophils ex vivo up to 14-day dosing IZICOPAN: 30 MG QD IZICOPAN: 30 MG BID IZICOPAN: 90 MG BID ( ) * + , # * 6 ! ! 7 - ; 4 < = R L < 4 > - ? " - @ 3 -A B C B > - ! % -C R < 4 < ( ) * + , # * 6 ! ! 7 -;
Slide 43: Izicopan therapeutic exposure reached within the first week in Phase 2a
Izicopan therapeutic exposure reached within the first week in Phase 2a Initial considerations H I - . L 0 N 2 - 3 4 5 3 S I T S U- 3 * 9W 5 T 3 ;N3 L <W = > § Lower dose of 60 mg bid projected to result in complete signal AB C a ! C E 2 c G control based on Phase 1 data H I - . L 0 N 4 - 3 4 5 3 S
Slide 44: HS Appendix
HS Appendix
Slide 45: Strong rationale for developing an anti-C5a/C5aR in HS
Strong rationale for developing an anti-C5a/C5aR in HS HS Patients Have Elevated C5a, a Major Neutrophil Activator That Can Be Blocked by an Anti-C5a/C5aR HS patients have significant complement C5a/C5aR activation is a key neutrophil activation with elevated C5a levels activator in HS patient plasm
Slide 46: Izicopan Phase 2a in HS: Baseline characteristics
Izicopan Phase 2a in HS: Baseline characteristics ANdT- IHS4- mean HS % pts prior AN-count dT-count Pain Score DLQI Hurley III mean age n count score diagnosis with ≥ 1 biologic mean BMI % female mean mean mean mean (%) (years) mean mean (years) dT use 60 mg bid 10 12.5 4.2 16.7 33.7 7.1 12.4 50% 14
Slide 47: Hidradenitis suppurativa and HiSCR
Hidradenitis suppurativa and HiSCR § There are 3 inflammatory lesions: inflammatory nodules (N), abscesses (A) and draining tunnels (dT) § ANdT = total inflammatory burden (TIB) § A and N are present in all disease stages, can fluctuate strongly week to week which can drive placebo responses § dT ar
Slide 48: Baseline AN count impact on HiSCR placebo response rates
Baseline AN count impact on HiSCR placebo response rates Learnings from the PIONEER studies researching Humira in HS Proportion of subjects achieving HiSCR at week 12 (NRI) by subgroup (ITT_A population, integrated analyses) extracted from EMA Assessment Report: Humira - No. EMEA/H/C/000481/II/0137
Slide 49: Izicopan drives draining tunnel (dT) count reductions
Izicopan drives draining tunnel (dT) count reductions dT CFB mean (all patients) dT CFB mean (all) – wk 4 0.0 60 n=10 90 n=11 120 n=8 All n=29 0 0.0 -0.1 -0.1 -0.2 -0.4 -0.5 -0.5 -0.6 -0.5 -0.7 -0.7 -0.7 -0.8 -0.9 dT 100 at W4 -1 60 n=10 -1.0 -1.0 -1.0 90 n=11 -1.0 60% 120 n=8 50% 50% -1.5 All n=29
Slide 50: Izicopan drives reduction in total inflammatory burden (TIB)
Izicopan drives reduction in total inflammatory burden (TIB) TIB = ANdT count Comparison to average of reported successfully completed povorcitinib Phase 2 data* TIB = ANdT CFB (mean) TIB (ANdT) CFB (mean) -0.4 0 0.0 -1.9 -1.3 -2.1 -2 -2.6 -2.0 -2.0 -3.4 Ph2 placebo -4 -4.0 -4.5 (povorcitinib) -4.0
Slide 51: Izicopan drives reductions in IHS4 score
Izicopan drives reductions in IHS4 score Comparison to average of available reported completed Phase 3 data* IHS4 CFB (mean) IHS4 CFB (mean) -0.5 0 0.0 -2 -1.9 -2.0 -4.4 -4 -3.3 -5.2 -4.0 -2.5 -7.1 -6 -6.2 -6.0 -8 -6.8 -7.7 Ph3 placebo -7.3 -8.4 -8.0 -7.9 -10 -10.8 -10.0 -12 izicopan pooled -11.8 -1
Slide 52: Izicopan drives Dermatology Life Quality Index (DLQI) improvements
Izicopan drives Dermatology Life Quality Index (DLQI) improvements Comparison to average of available reported completed Phase 3 DLQI mean absolute CFB at W4 data* 60 n=10 90 n=11 120 n=8 All n=29 0.0 DLQI CFB (mean) -2.0 0.0 -2.9 -4.0 -2.0 -6.0 -5.0 Ph3 placebo -5.6 -8.0 -4.0 -10.0 izicopan pooled
Slide 53: Evidence for efficacy of C5aR inhibition in HS: Avacopan data
Evidence for efficacy of C5aR inhibition in HS: Avacopan data Efficacy Evidence in Total Data Set* AN count reduction (w12)* 0 Primary outcome** Absolute change -2 -4 -3.1 -3.4 -6 -5.1 -8 Spalte4 IHS-4 count change (w12)* 0 Absolute change -2 -4 -6 -8 -6.4 -7.9 -10 -9.4 -12 Placebo Spalte4 Avacopan
Slide 54: Avacopan data in Phase 2 showed efficacy emerging only at week 12
Avacopan data in Phase 2 showed efficacy emerging only at week 12 Results From Avacopan in HS Patients (Hurley III)* • Avacopan’s efficacy (separation from placebo group) in HS only starts to emerge at W12 – please note: steady state reported from ANCA patients was only reached at approx. 3 months d
Slide 55: Avacopan data in ANCA patients show steady state reached by 13 weeks
Avacopan data in ANCA patients show steady state reached by 13 weeks • Steady state plasma levels of avacopan 30mg BID are reached by 13 weeks and the accumulation is approximately 4-fold • Mean steady state plasma exposure estimates of avacopan are: 3466 h*ng/mL for the (AUC0-12hr) in Avacopan repo
Slide 56: CSU Appendix
CSU Appendix
Slide 57: CSU endotypes: Type I auto-allergens and type IIb autoimmunity
CSU endotypes: Type I auto-allergens and type IIb autoimmunity C5aR signaling is suggested to be involved in Activated Coagulation Factors II and X generate C5a from C5 both Type I and Type IIb endotypes 1 Type I autoimmune (IgE mediated) Also known as autoallergic CSU, is characterized by the prese
Slide 58: C5aR1-mediated induction of anaphylaxis via mast cell activation
C5aR1-mediated induction of anaphylaxis via mast cell activation Activation of the C5a/C5aR1 axis drives the development of anaphylaxis at several levels 1 The regulation of the B cell response in male mice that leads to the production of 3 antigen-specific lgE. 2 2 The enhancement of FceR1- depende
Slide 59: CSU: Baseline characteristics
CSU: Baseline characteristics mean CSU mean age mean % female duration mean UCT7 IgE (IU/L) anti IgE experienced (years) UAS7 (years) 60 mg BID n=14 41.3 86% 3.6 33.5 5.0 283.4 7% 120 mg BID n=16 47.8 81% 3.3 29.5 4.3 178.0 19% All n=30 44.8 83% 3.5 31.4 4.6 230.7 13% Anti IgE Naive n=25 43.7 80% 2.
Slide 60: CSU: Izicopan achieved UAS7 reduction at W4
CSU: Izicopan achieved UAS7 reduction at W4 UAS7 mean absolute CFB UAS7 mean relative CFB Baseline W1 W2 W3 W4 Baseline W1 W2 W3 W4 0 0% -2 -5% -3.5 -10% -10% -4 -4.0 -5.4 -13% -4.6 -15% -6 -6.0 -19% -15% -7.9 -20% -19% -8.1 -8 -6.9 -20% -26% -26% -9.0 -25% -10 -28% -10.4 -30% -10.3 -30% -33% -12 -3
Slide 61: CSU: Izicopan reduced UAS7 in anti-IgE naïve and experienced patients
CSU: Izicopan reduced UAS7 in anti-IgE naïve and experienced patients UAS7 mean absolute CFB according to prior anti-IgE exposure Mean UAS7 relative CFB according to prior anti-IgE experience Baseline W1 W2 W3 W4 Baseline W1 W2 W3 W4 0 0 -2 -3.4 -11% -0.1 -4 -5.8 -19% -6 -0.2 -23% -7.5 -8 -23% -7.6
Slide 62: CSU: Izicopan improves angioedema consistently up to W4
CSU: Izicopan improves angioedema consistently up to W4 AAS7 mean absolute CFB AAS7 mean relative CFB Baseline W1 W2 W3 W4 Baseline W1 W2 W3 W4 0 0% -10% -10 -20% -30% -20 -40% -30 -50% -36.3 -39.3 -60% -69% -40 -44.7 -70% -76% -51.7 -50 -80% -87% -90% -96% -60 -100% AAS7 n=3 AAS7 n=3 No episodes: 0
Slide 63: CSU: Izicopan UAS7 and UCT7 at Week 4
CSU: Izicopan UAS7 and UCT7 at Week 4 UAS7 mean absolute responders UAS7 = 0 UAS7 ≤ 6 UCT7 ≥ 12 CFB W4 at W4 at W4 at W4 All n=30 -10.4 7% 11% 29% 60 mg BID n=14 -13.7 0% 8% 31% 120 mg BID n=16 -7.9 13% 13% 25% UAS7 [responders of disease activity]. UCT7 [responders of disease control]. 63
Slide 64: Gohibic Appendix
Gohibic Appendix
Slide 65: Emergency Use Authorization (EUA) granted for Gohibic
Emergency Use Authorization (EUA) granted for Gohibic Gohibic (vilobelimab) has not been approved, but has been Discussions with US FDA ongoing related to future authorized for emergency use by FDA under an EUA*, for the BLA submission treatment of COVID-19 in hospitalized adults when initiated with
Slide 66: COVID-19: Disease progression and therapeutic interventions
COVID-19: Disease progression and therapeutic interventions Versterben oder Vaccines Antiviral Treatments Anti-inflammatory Anti-inflammatorische Treatments Behandlung Death or Recovery Heilung Healthy Early Stage Intermediate to Severe Stage Critical Stage Recovery (pre-infection) Incubation / asym
Slide 67: PANAMO Phase 3 primary endpoint: 28-day all-cause mortality
PANAMO Phase 3 primary endpoint: 28-day all-cause mortality PANAMO Phase 3 trial 1:1 randomized, double-blind, placebo-controlled, multi- national trial in (n=369) invasive mechanically ventilated Placebo + SOC COVID-19 patients Day 28: 23.9 % relative reduction Kaplan-Meier point estimate: SOC incl